Supporting information from theNational Accreditation Bodiesfor the European Commission
Initiative on Breast Cancer
Aslı Ulutürk, Silvia Deandrea, Donata Lerda, Jesús López Alcalde, Luciana Neamtiu, Zuleika Saz-Parkinson
2015
J R C S C I E N C E A N D P O L I C Y R E P O R T
Report EUR 27382 EN
and conformity assessmentReport of a survey on accreditation
in the field of breast cancer in Europe
European CommissionJoint Research Centre
Institute for Health and Consumer Protection (IHCP)
Contact informationDonata Lerda
Address: Joint Research Centre, IHCP, Public Health Policy Support
Via Enrico Fermi 2749, TP 127, 21027 Ispra (VA), Italy
E-mail: [email protected]
Tel.: +39 0332 78 6201
Fax: +39 0332 78 9059
https://ec.europa.eu/jrc/en/institutes/ihcp
https://ec.europa.eu/jrc/en
Legal NoticeThis publication is a Science and Policy Report by the Joint Research Centre, the European Commission’s in-house science service. It aims
to provide evidence-based scientific support to the European policy-making process. The scientific output expressed does not imply a policy
position of the European Commission. Neither the European Commission nor any person acting on behalf of the Commission is responsible
for the use which might be made of this publication.
JRC92204
EUR 27382 EN
ISBN 978-92-79-50318-4 (pdf)
ISBN 978-92-79-50334-4 (print)
ISSN 1831-9424 (online)
ISSN 1018-5593 (print)
doi:10.2788/15049
Luxembourg: Publications Office of the European Union, 2015
© European Union, 2015
Reproduction is authorised provided the source is acknowledged.
AbstractBackground: The objective of this survey was to collect information from the National Accreditation Bodies in collaboration with European
Cooperation for Accreditation on the accreditation status of the countries. Methods: The survey included two questionnaires and a data
protection form distributed by e-mail. The participants were the members of EA. Results: Twenty-five out of 35 contacted countries re-
sponded, corresponding to a response rate of 71%. The most applied standard resulted to be ISO 15189 and the most covered stage of care
diagnosis. Conclusions: Accreditation status is diverse across Europe; some countries don’t harbor accredited/certified organisations on
breast cancer care, and others use different standards in different stages of care. A harmonisation in quality benchmarking would enhance
equality in patients’ care.
Supporting information
from the National Accreditation Bodies
for the European Commission
Initiative on Breast Cancer
Aslı Ulutürk, Silvia Deandrea,
Donata Lerda, Jesús López Alcalde,
Luciana Neamtiu,
Zuleika Saz-Parkinson
2015
and conformity assessmentReport of a survey on accreditation
in the field of breast cancer in Europe
Report EUR 27382 EN
Table of contents | 3
List of abbreviations 4Glossary 5Foreword 6Executive summary 7 1. Introduction to the European Commission Initiative on Breast Cancer 9 2. Introduction to the accreditation and conformity assessment terminology 11 3. Scope of the survey 13 4. Survey organisation 14 Method 14 Timeframe 16 Participants 16 5. Survey results 19 General overview 19 5.1. Section 1: Contact details and area of competence 19 5.2. Section 2: Gate questions 20 5.3. Section 3: The standards in use 21 5.3.1. ISO 15189:2012 24 5.3.2. ISO/IEC 17020:2012 25 5.3.3. ISO/IEC 17021:2011 25 5.3.4. ISO/IEC 17025:2005 25 5.3.5. Clinical Pathology Accreditation standard (CPA) 25 5.3.6. Imaging Services Accreditation Scheme (ISAS) 26 5.3.7. Quality Management System Standards 26 5.4. Section 4: The stages of breast cancer care and transversal items covered by the standards 27 5.4.1. The screening stage 28 5.4.2. The diagnosis stage 29 5.4.3. The treatment stage 29 5.4.4. The survivorship and management of recurrence stage 30 5.4.5. Transversal items 31 6. Conclusions 33 7. Acknowledgements 35 8. Bibliography 35 9. Useful links 35Annex I: Data protection form and questionnaire 37Annex II: E-mail communications 61Annex III: Tables 67
Table of contents
4 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
BCS Breast Cancer ServiceCPA Clinical Pathology AccreditationEA European co-operation for Accreditation EC European CommissionECIBC European Commission Initiative on Breast CancerJRC Joint Research CentreJRC-IHCP Joint Research Centre - Institute for Health and Consumer ProtectionISO International Organization for StandardizationNAB National Accreditation BodyQA Quality AssuranceEUR Euratom, a number of JRC cataloguing, a series unique for JRC (JRC was formerly called)
List of abbreviations
Glossary | 5
Breast Cancer Care: Any kind of healthcare intervention aimed at preventing, diagnosing or treating breast cancer, including the follow-up of any other condition caused by the disease or the treatment itself. It may include primary prevention when the intervention is specifically targeted to breast cancer (e.g. dietary recommendations for high-risk women).
Breast Cancer Services: Comprises all services covering, in continuum, the full extent of management of breast cancer, from screening to follow-up and in some cases end-of-life care. These services may involve both primary care and a range of high speciality services including but not limited to screening, diagnostic imaging, pathology, surgery, radiation and medical oncology.
Stages of Breast Cancer Care: These stages imply the steps of cancer care which a patient goes through in the pathway of cancer care. In ECIBC, breast cancer care is divided into five stages: (1) screening, (2) diagnosis, (3) treatment, (4) rehabilitation and (5) follow-up. These stages should be distinguished from clinical breast cancer stages defining the extent of disease which are usually expressed in numbers 0 through 4. In this report, rehabilitation and follow-up stages are combined into one stage (survivorship and management of recurrence) to make the data more easily conveyed and interpreted.
Transversal items: This term refers to the horizontal aspects of breast cancer care that may be used in more than one stage or all through the care and for different diseases other than cancer (in other documents transversal items might be mentioned as ‘horizontal aspects’).
Glossary
6 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
The European Commission’s Joint Research Centre (JRC) has been assigned the task of steering and coordinating the European Commission Initiative on Breast Cancer. This includes the development of a Euro-pean quality assurance scheme underpinned by accreditation and the establishment of a platform of evidence-based guidelines, in-cluding a new version of the European guide-lines for breast cancer screening and diagnosis.
Developing a single European quality assur-ance scheme in order to assure competence and quality of European breast cancer ser-vices is very complex. In order to map out the situation in Europe and understand the differences in healthcare systems settings and quality assurance schemes within each country, a series of surveys were launched. The outcomes of the first survey were de-scribed in the Report of a European survey on the organisation of breast cancer care services.1 A second survey was conducted on the accredi-tation and conformity assessment standards in use in the Member States and other Euro-pean countries and it was the first survey to be conducted among the National Accredi-tation Bodies in the healthcare area. The re-sults are reported in this document.
These two survey reports, along with the JRC report on review and analysis of external quality assessment of breast cancer services in Europe (soon to be published) allow us to map similarities and differences across coun-
1. http://bookshop.europa.eu/en/report-of-a-european-survey-on-the-organisation-of-breast-cancer-care-services-pbLBNA26593/.
tries and sometimes also highlighting dis-crepancies within countries (e.g. for data held by different entities like the Health Authori-ties and the National Accreditation Bodies). JRC also detected diverse interpretations of the term ‘accreditation’ depending on the respondent’s profile (healthcare service or accreditation service) and future reports will address these glossary divergences so as to create a common base of understanding for all stakeholders’ profiles.
I highly value and support our coordination role in this initiative and its mandate to sup-port countries and stakeholders in improving healthcare quality for all European citizens.
This EUR report, being based on the infor-mation provided by many National Accred-itation Bodies on several healthcare topics, is a reference for subsequent stages of the JRC project and provides publicly available information for other projects in the field. I warmly encourage all stakeholders to care-fully read the report and to provide their feed-back on its potential use and impact. You are also invited to provide any additional information (not covered by this survey) as the JRC may organise further surveys.
Last but not least, I wish to express my grati-tude to all National Accreditation Bodies’ delegates, who contributed to the survey and we look forward to collaborating with them in the future.
Krzysztof Maruszewski Director, JRC-IHCP
Foreword
Executive summary | 7
The JRC, the European Commission’s in-house science service, was assigned in De-cember 2012 with the tasks of (i) developing a new version of the European guidelines for breast cancer screening and diagnosis (in the following mentioned as ‘the new European Guidelines’) and of (ii) developing a volun-tary European Quality Assurance scheme for breast cancer services based on the Euro-pean legislative framework on accreditation (defined in Regulation (EC) No 765/2008) (in the following mentioned as European QA scheme). Those tasks, among others, are part of the European Commission Initiative on Breast Cancer (ECIBC).
With the scope of building up the knowl-edge base for the ECIBC and in view of designing a QA scheme flexible enough to adapt and embrace the differences in stand-ards use in different countries, a survey was conducted to gather information about the use of standards issued by the International Organization for Standardization (ISO) and ISO CASCO, the ISO committee that de-velops standards and addresses issues related to conformity assessment.
The survey targeted the National Accredita-tion Bodies (NAB), which are full members of the European co-operation for Accredi-tation (EA). The countries covered include Euro pean Union (EU) Member States plus Iceland, Montenegro, Norway, the former Yu-goslav Republic of Macedonia, Turkey, Serbia and Switzerland. Contact persons for each NAB were identified with the support of EA.
Twenty-five of the 35 contacted countries re-sponded to the survey, corresponding to a response rate of 71%. The primary findings are as follows:
• Nineteen of the 25 responding countries (76%) have at least one healthcare organisa-tion in the breast cancer care pathway which includes accredited conformity assessment activities or which is holding an accredited conformity assessment certificate.
• In 15 of these 19 countries (79%) the men-tioned healthcare organisation(s) take part in the diagnosis or treatment of breast cancer at any stage of care (from screen-ing to follow-up).
• Four ISO standards are in place for either accrediting the laboratories within the mentioned organisations or for accredita-tion of Conformity assessment bodies to assess these organisations: ISO 15189:2012, ISO/IEC 17020:2012, ISO/IEC 17021:2011, and ISO/IEC 17025:2005. Only UK re-ports the use of national standards be-sides ISO standards, which are mapped on ISO standards.
• ISO 15189:2012 and ISO/IEC 17021:2011 were the standards used in most countries (14 and 11, respectively). ISO 15189 can be applied directly in breast cancer services to accredit their laboratory (diagnostic ac-tivities) units. The ISO 17021 standard is in-stead used to accredit a certification body, which will as such certify the management system of the breast cancer service.
• Among different stages of breast cancer care (hereinafter, those stages will be re-
Executive summary
8 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
ferred to as stages of care), the diagnosis stage was most widely addressed with the standard in place. Laboratory tests, quality management and personal competence re-quirements were the items most addressed.
• Six countries do not have a healthcare or-ganisation in the breast cancer pathway which is running accredited laboratory activities or holding an accredited certifi-cate of conformity.
1. Introduction to the European Commission Initiative on Breast Cancer | 9
In 1987, the European Commission initiated the ‘Europe against cancer programme’. This programme was instrumental in funding the actions to develop the European guidelines for quality assurance in breast cancer screening and diagnosis.
In 2003, the European Council issued a re-commendation 2 to the Member States to of-fer evidence-based cancer screening through a systematic population-based approach with quality assurance at all appropriate levels and in accordance with the Euro pean guidelines for quality assurance in breast cancer screening and diagnosis (now in their fourth edition since 2006). This was followed by the Council’s conclusions in 2008 which invited the Euro-pean Commission to explore the potential for developing a European pilot quality as-surance scheme for breast cancer screening and follow-up, based on European guidelines for breast cancer screening and diagnosis and on other evidence-based guidelines for the nec-essary follow-up (other stages of care).
The ECIBC, underway at the Joint Research Centre’s Institute for Health and Consumer Protection (JRC-IHCP), is aimed at setting up one single system for defining, estab-lishing and auditing/monitoring a mini-mum set of quality requirements for breast
2. Council Recommendation of 2 December 2003 on cancer screening (2003/878/EC): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF.
cancer healthcare across Europe. The project has two main pillars:
1. to develop the new European Guidelines based on new knowledge and evidence;
2. to develop a voluntary European QA scheme, which will fulfil the European legal frame for Accreditation and therefore will be in fact a European QA scheme for Breast Can-cer Services based on the EU legislative framework on accreditation, as defined in the Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accredi-tation and market surveillance 3 and by a set of evidence-based guidelines.
This initiative is in response to the Council Conclusions on reducing the burden of cancer 4 and it aims to minimize the risks connected to poor quality of care. Its concept foresees that all stages of care, i.e. screening, diag-nosis, treatment, rehabilitation, and fol-low-up (including surveillance and, where necessary, management of recurrences); in addition, other aspects such as psychologi-cal support and palliative care, which are essential for a patient-centred concept of
3. Regulation (EC) No 765/2008, OJ L 218, 13.8.2008, p. 30: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF.4. Council of the European Union: Council Conclusions on reduc-ing the burden of cancer, 2876th Employment, Social Policy, Health and Consumer Affairs Council meeting, Luxembourg, 10 June 2008: http://www.eu2008.si/en/News_and_Documents/Council_ Conclusions/June/0609_EPSCO-cancer.pdf.
1. Introduction to the European Commission Initiative on Breast Cancer
10 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
quality, are also covered. It foresees that a person’s centred and multidisciplinary ap-proach will be applied.
The processes involved in the development of this European QA scheme will rely on infor-
mation gathered through bilateral meetings, workshops and a series of past, on-going and future surveys and studies. The reports partially or totally derived from surveys are listed below.
The European QA scheme will be based on the new European Guidelines (and, if neces-sary, on the selection of existing guidelines and recommendations for other stages and
aspects of care not covered in the new Euro-pean Guidelines). A more detailed description of the ECIBC is available on the JRC Sci-ence Hub.5
5. https://ec.europa.eu/jrc/en/research-topic/healthcare-quality.
Name of the report Scope of the report Timing
Report of a European survey on the organi-sation of breast cancer care services
To collect information from the countries involved in the ECIBC on the organisation of breast cancer services and to map out the organisation of breast cancer care and screening across Europe
Report published
Report of a survey on accreditation and conformity assessment in the field of breast cancer care in Europe (this one)
To understand the wide picture of accreditation and conformity assessment of breast cancer care path-way across Europe
Report published
Review and analysis of external quality assessment of breast cancer services in Europe
To describe current QA schemes in place in Europe that are affecting the breast cancer pathway
Report published
Project workshops report Includes the narration of the two workshops, the conclusions derived and their impact on the planning of activities for meeting the requirements of the two tasks.
Report published
Events’ report A summary of the meetings JRC embarked with a wide range of stakeholders, experts and concerned authorities at the national level.
Report published
2. Introduction to the accreditation and conformity assessment terminology | 11
In this document, the relevant terminol-ogy follows the strict European legislative framework in place for accreditation, which is detailed in Regulation (EC) No 765/2008 6 and Decision (EC) 768/2008 7 and might differ from the use of that terminology in healthcare or other areas.
Healthcare organisations may undergo ex-ternal assessments for various purposes such as improving safety and quality or demon-strating the achievement of certain require-ments (Shaw 2013). These assessment modal-ities are normally outside the European legal framework for Accreditation (henceforth mentioned as the European legal framework) and may lead to an organisation obtaining a ‘certificate’ attesting their compliance with performance requirements which might contain the words ‘accreditation’, ‘certifica-tion’, ‘designation’ or others but with a dif-ferent legal meaning than what is proposed in the European legal framework. To avoid confusion arising from possible different meanings, the definition of the terminology according to Regulation (EC) No 765/2008 was used in this report as given below.
6. OJ L 218, 13.8.2008, p. 30: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF.7. OJ L 218, 13.8.2008, p. 82: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:en:PDF.
• National accreditation body: the sole body in a Member State that performs accreditation with authority derived from the State (Regula-tion (EC) No 765/2008).It is agreed that each Member State will appoint one National accreditation body (NAB) or address the NAB of another Member State. The NABs operate on a non-profit basis and the Member State is expected to provide the appropriate finan-cial and personnel resources. They are in charge of assessing, accrediting and moni-toring conformity assessment bodies and are able to restrict, suspend or withdraw the given accreditation certificates in case of a breach.The NAB can accredit conformity assess-ment bodies. If a breast cancer service in-cludes a laboratory or performs tests which can be considered as a laboratory activity, these activities can be accredited by the NAB. However a NAB is not allowed to provide certification or inspection services and they generally are not allowed to pro-vide those services they accredit.Each NAB must be a member of the Euro-pean cooperation for accreditation (list of members: http://www.european-accredi-tation.org/ea-members).
• Accreditation: an attestation by a national accreditation body that a conformity assess-ment body meets the requirements set by har-monised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a spe-
2. Introduction to the accreditation and conformity assessment terminology
12 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
cific conformity assessment activities (Regula-tion (EC) No 765/2008).This term has gained different meanings among different professional groups (Shaw 2000). In this document, accreditation is strictly interpreted as defined above.The accreditation procedure, if the evalu-ated organisation is found to be compe-tent, ends with an accreditation certificate being issued. This certificate is subject to be restricted, suspended or withdrawn.
• Conformity assessment body: a body that performs conformity assessment activities in-cluding calibration, testing, certification and inspection (Regulation (EC) No 765/2008) upon accreditation from the NAB.As an example, a conformity assessment body (CAB) can verify compliance of radiotherapy services to specific require-ments derived from healthcare guidelines.
• Conformity assessment: the process dem-onstrating whether specified requirements re-lating to a product, process, service, system, person or body have been fulfilled (Regulation (EC) No 765/2008).Conformity assessment can be applied to a product, a process (such as surgery, psy-chosocial care or survivorship support of-fered to cancer patients), a system, a body and includes activities such as testing, in-spection and certification of management systems, products or services and persons.
• Notified body: is a conformity assessment body which is granted an accreditation certificate and notified to the Commis-sion by the relevant Member State its ability to carry out third-party conform-ity assessment services (Decision (EC) No 768/2008).
• Certification: it is the process of provi-sion of a certificate by an independent body that the product, process, service or system in question meets specific require-ments.
• Inspection: inspection describes the regu-lar checking of a product, a service or a system to make sure it meets specified cri-teria. For example some diagnostic equip-ment needs to be inspected regularly to ensure their efficacy and safety.
• European co-operation for Accreditation (EA) (http://www.european-accreditation. org/home): according to Regulation (EC) No 765/2008, every NAB appointed by a Member State is required to be a mem-ber of EA, which is formally appointed as the body responsible for the European accreditation infrastructure in the same regulation. EA is given the task of coop-eration with all stakeholders and the Euro-pean Commission and provides peer eval-uation services to its members.
3. Scope of the survey | 13
In 2012, a contact person responsible for co-ordinating responses at country level was identified for each of the full members of EA. The survey consisted of a data protec-tion form and two questionnaires. The first questionnaire included gate questions about the presence of a healthcare organisation which is running an accredited laboratory or holding an accredited conformity assessment certificate for activities part of or relevant for breast cancer care. The second questionnaire (annexed to the first questionnaire) covered information on the standards used in the pathway, including details on the stages of care and transversal items (e.g. quality man-agement) covered by each standard.
The survey was organised primarily to un-derstand the wide picture of accreditation and conformity assessment in the field of breast cancer care across Europe. The infor-mation requested is crucial to set-up a Euro-pean QA scheme which will fulfil the European legal framework and therefore will be in fact an accreditation and conformity assessment scheme taking into account the significant experiences already built in the use of ISO standards for breast cancer care.
This report should be considered comple-mentary with the JRC report Review and analysis of external quality assessment of breast cancer services in Europe in providing a better insight of the European situation in qual-ity assurance. The two reports, together with the Report of a European survey on the organisa-tion of breast cancer care services, will describe the origins of different data received from different sources and provide countries a better insight of the connections between the different involved authorities.
It should be highlighted that the initiative aims to encourage application of evidence-based guidelines and harmonised operating procedures. The research JRC conducted so far, was functional for optimising the Euro-pean QA scheme design and, consequently, enhancing impact of evidence-based health-care on outcomes of women affected by breast cancer.
3. Scope of the survey
14 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Method
The Adobe LiveCycle Designer® tool was used to design, distribute and manage the infor-mation provided (using the distribute form and collect answers tools). This tool allows the creation of interactive forms with an automatic submission (e.g. via e-mail) and a functional mail-box ([email protected]), accessible to all group members, that was used to communicate with the designated respondents. In this way, full-time assistance and support could be provided to all participants.
Participants in the survey received three PDF forms: a data protection form and two questionnaires–the core form and the an-nex form. All documents used are visible in Annex I.
The core form included two sections, the contact and affiliation details and the gate questions. If the first gate question was re-plied positively, reflecting the presence of organisations accredited or holding accred-ited certificates of conformity for activities part of or relevant for breast cancer care in the country, the participants were asked to fill in the second questionnaire, the annex form.
For each of the ISO/ISO CASCO standards in place, an annex form had to be filled in. It was divided into five sections:
1. Name of the ISO/ISO CASCO standard.2. Where the standard ISO/IEC 17021 was
mentioned, additional information about the quality management system standard used was asked.
3. The stages of care addressed by the stand-ard.
4. Transversal items of breast cancer care ad-dressed by the standard (e.g. safety, and other items covering the whole process of breast cancer care).
5. Additional comments.
All the questions were mandatory, except for those in section 5 and the additional in-formation part (free text) at the end of each section.
Upon receipt of all the questionnaires, the data were collated into a database, a manual data cleaning procedure was performed and inconsistencies and/or missing data were re-ported for each participating country.
The data protection form included a privacy statement and asked for consent to use the data provided in this survey for the devel-opment of the European QA scheme and for research purposes. As this report will be publicly available, a Request of Consent for Publication was sent to all participating countries which provided information (see e-mail in Annex II).
4. Survey organisation
4. Survey organisation | 15
Table 1: ISO codes of countries.
Countries Twere coded according to the In-ternational Organisation of Standardisation (ISO) 3166 standard (reported in Table 1 and
available at: (https://www.iso.org/obp/ui/# search).
Country Name ISO Code Country Name ISO Code
Austria AT Lithuania LT
Belgium BE Luxembourg LU
Bulgaria BG Latvia LV
Switzerland CH Montenegro ME
Cyprus CY The former Yugoslav Republic of Macedonia MK
Czech Republic CZ Malta MT
Germany DE Netherlands (the) NL
Denmark DK Norway NO
Estonia EE Poland PL
Spain ES Portugal PT
Finland FI Romania RO
France FR Serbia RS
Greece GR Slovenia SI
Croatia HR Slovakia SK
Hungary HU Sweden SE
Ireland IE Turkey TR
Iceland IS United Kingdom UK
Italy IT
16 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Timeframe
All nominated contact persons were con-tacted by e-mail via the functional mailbox.
1. The survey was launched on 9 August 2013 and the deadline for completion was 15 September 2013.
2. By the deadline, 16 countries had sent back a completed questionnaire. For all the others, an individual reminder e-mail was sent on 20 September 2013.
3. After an intense period of follow-up, the last questionnaire was received on 19 Jan-uary 2014.
4. A request for clarifications was sent out starting from 4 March 2014.
5. Upon a second follow-up phase, the last clarifications were received on 2 June 2014.
6. On 5 June 2014 respondents were asked to approve the proposal of JRC for the summary tables of the individual data, as they would have been published (and ap-pear in this document at Annex IV). Sev-enteen of the countries approved the data within the deadline. The last approval was received on 12 August 2014 after several communications.
7. Between 6 and 8 August 2014, participat-ing countries, who already had approved their individual data, were asked to pro-vide their consent for publication of the data with the information, that in the absence of a reply before August 15th, the ‘Silence gives consent’ statement (con-sent is assumed when there’s no evidence of disagreement) would be applied and it would be recorded as a consent. The countries which had not sent the approval in time were sent a reminder mail to both approve their individual data and to pro-vide their consent for publication of this data.
8. All the NABs finally approved their indi-vidual data.
Participants
In Table 2, the nominated contact persons from the 35 countries contacted are listed. Twenty-five of them responded and the non-responding countries are shaded in grey. In two countries (BE and CY), the contact per-son was replaced between the questionnaire in 2013 and the follow-up in 2014.
4. Survey organisation | 17
Table 2: List of participants.
Country Nominated contacts Other collaborators Accreditation body
AT Johanna STAMPLER - Akkreditierung Austria
BEVeerle NOTEN (2013)Nicole VANLAETHEM (2014)
- BELAC: Belgian Accreditation Organization
BG Elza JANEVA - BAS: Bulgarian accreditation service
CH Rolf STRAUB - SAS: Swiss Accreditation Service
CYKyriakos TSIMILLIS (2013)Antonis IOANNOU (2014)
- CYS-CYSAB: Ministry of Health, Nicosia
CZ Martina BEDNAROVA - CAI: Czech Accreditation Institute
DE Uwe ZIMMERMANN - DAkkS: Germany’s National Accreditation Body
DKHenrik Lykkegaard JØRGENSEN
-DANAK: Danish Accreditation and Metrology Fund
EE Kaire TÕUGU - EAK: Estonian Accreditation Centre
ES Isabel de la VILLA - ENAC: Spanish National Accreditation Body
FI Tuija SINERVO - FINAS: Finnish Accreditation Service
FR Hélène MEHAY - COFRAC: French Accreditation Committee
GR Aliki STATHOPOULOU - ESYD: Hellenic Accreditation System
HR Dragica KRIZANEC - HAA: Croatian Accreditation Agency
HU Rozsa RING - NAT: Hungarian Accreditation Board
IE Marie O’MAHONY - INAB: Irish National Accreditation Board
IS Sigurlinni SIGURLINNASON - ISAC: Icelandic Board for Technical Accreditation
IT Filippo TRIFILETTI - ACCREDIA: Italian National Accreditation Body
LT Danutė JANULIONIENĖ - LA: Lithuanian National Accreditation Bureau
LU Ferrand DOMINIQUE Monique JACOBYOLAS: Luxembourg Accreditation and Surveillance Office
LV Zinaida GORINA - LATAK: Latvian National Accreditation Bureau
MK Dragan VELEVSKI -IARM: Institute for Accreditation of the Republic of Macedonia
MT Claudio BOFFA -NAB-Malta: National Accreditation Board of Malta
ME Ranko NIKOLIC - ATCG: Accreditation Body of Montenegro
18 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 2: (cont.)
Country Nominated contacts Other collaborators Accreditation body
NL Jan C. van der POEL - RVA: Dutch Accreditation Council
NO Cecilie LAAKE - NA: Norwegian Accreditation
PL Eugeniusz ROGUSKI Malgorzata OLCZAK-WASIK PCA: Polish Centre for Accreditation
PT Leopoldo CORTEZ - IPAC: Portugal Accreditation Institute
RO Cristian NICHITA - RENAR: Romanian Association for Accreditation
RS Ljubinka GLIGIC - ATS: Accreditation Body of Serbia
SE Annika LYDÉN -SWEDAC: Swedish Board for Accreditation and Conformity Assessment
SI Bostjan GODEC - SA: Slovenian Accreditation
SK Tibor CZOCHER - SNAS: Slovak National Accreditation Service
TR Gokhan BIRBIL - TURKAK- Turkish accreditation Agency
UK Lorraine TURNER Jane BEAUMONT UKAS: United Kingdom Accreditation Service
5. Survey results | 19
Countries which did not respond to the sur-vey were not included in the following ta-bles, but they are visible on every map.
In all the descriptions, response rates are rounded to the closest whole number and expressed in relation to the 25 countries re-sponding (for instance, 84% of the countries means that this was the response of 21 coun-tries out of 25).
A standard may be applied to more than one stage of care or a stage of care may be addressed by more than one standard. For example when a stage of care is addressed by two different standards in a country, they are considered as two diverse applications. Therefore the total number of applications may exceeds the number of countries. To provide a clearer view, data will be displayed in terms of numbers of applications where needed.
General overview
Twenty-five countries out of the 35 contacted responded to the questionnaire, which cor-responds to a response rate of 71%. HU, IS, LV, MT, NO, PT, RO, SK, CH and TR did not respond to the survey, therefore, no in-formation is available for these countries. In Figure 1 the contacted countries are depicted in different colours according to their reac-tion to the questionnaire.
The ideal response rate could be higher; however, taking into account that this was the first approach to the NABs for a survey on the healthcare system, the achieved 71% was considered as sufficient to draw a reli-able picture of the current European situa-tion in terms of accreditation and conform-ity assessment in breast cancer care.
Figure 1: Country participation map.
5.1. Section 1: Contact details and area of competence
All the respondents were employed by the corresponding NABs. In all cases, due to the procedure applied for identifying respond-ents, they were the responsible staff mem-
5. Survey results
Responded
Not responded
IS
NO
SE
FI
EE
LV
LTBY
RU
UA
MD
RO
TR
CY
BGRS
MEMK
GRAL
BA
HU
SK
PL
CZ
DE
AT
SI HR
NLBE
LU
CHFR
IT
MT
AD
ESPT
UKIE
DK
20 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Existing
Not existing
IS
NO
SE
FI
EE
LV
LTBY
RU
UA
MD
RO
TR
CY
BGRS
MEMK
GRAL
BA
HU
SK
PL
CZ
DE
AT
SI HR
NLBE
LU
CHFR
IT
MT
AD
ESPT
UKIE
DK
Not responded
bers within their organisations for the spe-cific area of activity (healthcare). They were considered responsible for the information provided for the whole of their country.
The fact that most of the persons responsible for the questionnaire compilation were em-ployees of and nominated by the respective NABs provides a high degree of reliability to the information received. In the following, when a response typology is attributed to a country it means that the information was provided by the respective NAB.
Figure 2a: Existence of a healthcare organisation with accredited laboratories or holding accredited certificates of conformity in the breast cancer care
pathway.
5.2. Section 2: Gate questions
In this section, participants were firstly asked to report if in their country there is at least one healthcare organisation (such as a hospital, outpatient clinic, local health authority, laboratory, etc.), which is either accredited or holding an accredited cer-tificate of conformity for all or part of the breast cancer care pathway. And, secondly, if such an organisation exists, they were asked whether that organisation is treating breast cancer patients before, during or after diagnosis (e.g. screening, biopsy, treatment).
Nineteen of the 25 responding countries (76%) reported having an accredited labora-tory in a healthcare organisation or having an organisation holding an accredited cer-tificate of conformity. Out of these 19, one country stated that these healthcare organi-sations are not carrying out activities related to breast cancer care, two countries noted that this information is not known, one did not respond to this question and 15 coun-tries stated that the organisation(s) take part in breast cancer care either before or after the diagnosis.
The responses to the gate questions are mapped in Figure 2a and the aggregated data are shown in Figure 2b.
5. Survey results | 21
Figure 2b: When such an organisation exists, involve - ment of this organisation in breast cancer treatment.
5.3. Section 3: The standards in use
The 19 countries which reported either hav-ing at least one healthcare organisation’s lab- oratory accredited and/or that at least one healthcare organisation held an accredited certificate of conformity in the first ques-tionnaire, were asked to complete a second questionnaire (one per each of the standards applied).
In the second questionnaire, the countries were asked to note all the standards in place in their country and give details for each standard, including the stages of care and transversal items addressed. Breast cancer care was divided into the following stages of care:
1. The whole breast cancer pathway.2. Screening.3. Diagnosis.4. Treatment.5. Survivorship and follow-up.
The individual answers of the countries are reported in Tables 1 to 7 in Annex III.
Out of the 19 countries, 11 (52%) declared one standard running in the country, three coun-tries (CZ, DE, FR) reported two standards, four countries (ES, FI, GR, SE) reported three and one country (UK) reported five accreditation standards in place.
With the sole exception of UK, standards reported by the countries included only ISO or ISO CASCO. UK reported, besides three ISO standards, two national standards which are both based on ISO standards: Clinical Pathology Accreditation Standard and Imaging Services Accreditation Scheme.
ISO 15189:2012, ISO/IEC 17020:2012, ISO/IEC 17021:2011, and ISO/IEC 17025:2005 were used as accreditation standards. Where ISO/IEC 17021 is in place, ISO 9001:2008, ISO/IEC 27001:2013, ISO 13485:2003, ISO 14001:2004 and ISO/IEC TR 18001:2004 were reported as the management system standards.
Details of the mentioned ISO standards’ scope are shown in Table 3.
15
31
Involved in treatment of cancer
Not involved in treatment of cancer
Not known or not reported
22 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 3: ISO standards used by the NABs in the covered countries.
* ICS: International Classification for Standards. In grey are the certification standards.
Figure 3: Number of NABs using each standard.
Standard name Field (according to ICS* Specifications
ISO 15189:2012Laboratory medicine in general.Quality management and quality assurance
Medical laboratories–Requirements for quality and competence
ISO/IEC 17020:2012Product and company certification. Conformity assessment
Conformity assessment–Requirements for the operation of various types of bodies performing inspection
ISO/IEC 17021:2011Product and company certification. Conformity assessment
Conformity assessment–Requirements for bodies providing audit and certification of management systems
ISO/IEC 17025:2005Product and company certification. Conformity assessment
General requirements for the competence of testing and calibration laboratories
ISO 9001:2008 Quality management and quality assurance Quality management systems–Requirements
ISO/IEC 27001:2013 Character sets and information codingInformation technology–Security techniques–Information security management systems–Requirements
ISO 13485:2003Quality management and quality assurance.Medical equipment in general
Medical devices–Quality management sys-tems–Requirements for regulatory purposes
ISO 14001:2004 Environmental managementEnvironmental management systems– Requirements with guidance for use
ISO/IEC TR 18001:2004 Character sets and information codingInformation technology–Radio frequency identification for item management–Applica-tion requirements profiles
ISO 15189:2012 ISO/IEC 17020 ISO/IEC 17021:2011 ISO/IEC 17025:2005
Num
ber
of c
ount
ries
usi
ng t
he s
tand
ard
Standard in use
5. Survey results | 23
Figure 4: Total number of applications of each standard by all NABs and for all stages of care.
Figure 5: Total number of applications of each standard by all NABS and per stage of care.
ISO 15189:2012 ISO/IEC 17020 ISO/IEC 17021:2011 ISO/IEC 17025:2005
Tota
l num
ber
of a
pplic
atio
ns
Standard in use
Survivorship
Treatment
Diagnosis
Screening
The whole pathway
ISO 15189:2012
ISO/IEC 17020
ISO/IEC 17021:2011
ISO/IEC 17025:2005
24 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
The most commonly used standard among countries was ISO 15189:2012, used by 14 countries out of 19 (74%) indicating the ten-dency of the NABs to directly audit the lab-oratories in healthcare organisations (ISO/IEC 17025:2005 can be used in alternative).
The second most common standard used by NABs was ISO/IEC 17021:2011 with 11 countries (58%); this is the standard used by NABs to accredit certification bodies.
A brief explanation of the standard and an overview on how the countries applied each standard is reported below. Ratios are given with respect to the 19 countries using at least one standard. While discussing the stand-ard, only the stage of care which it addresses most frequently is detailed. For all the other stages of care, details of individual answers are available in Tables 4-7, Annex IV.
5.3.1. ISO 15189:2012
ISO 15189:2012 is used by the accreditation bodies to assess and to accredit medical laboratories and provides recognition of the medical laboratory’s competence in both its management system and technical practice. It covers the requirements for medical labo-ratories to ensure the quality and compe-tence of their services, and their consistency in delivering technically valid test results. It is the translation of ISO/IEC 17025:2005 for the medical field.
This standard was the most addressed one, reported by 14 countries (74%). As the stand-ard is to be used in the laboratory field, 13 of
these 14 (92%) countries addressed the diag-nosis phase. Seven countries addressed the transversal items and each of the screening, treatment and survivorship and follow-up stages were addressed by three countries.
The wide usage of this standard shows that in breast cancer care, the services most fre-quently seeking accreditation are linked to measurement and testing activities (e.g. lab-oratories and, more in general, diagnostics) and this may be explained by the fact that diagnostic activities were historically one of the first areas covered by accreditation in the medical field. Another important reason for targeting the diagnostic stage is the im-pact of diagnosis results for all the following stages of care and; hence the importance of a high degree of quality assessment imple-mentation.
Figure 6: Total number of applications of ISO 15189:2012 per stage.
Of the 13 countries using this standard in the diagnosis phase, the aspiration of fluid and subsequent testing item was covered in eight; biopsy and tissue histology item in nine. Five countries declared that the stand-ard was also used to address some molecular bio logy tests (such as HER2/neu tests).
Screening
Diagnosis
Treatment
Survivorship13
3
43
ISO 15189:2012
5. Survey results | 25
5.3.2. ISO/IEC 17020:2012
ISO/IEC 17020:2012 is used to assess inspec-tion bodies for the impartiality, competence and consistency of their inspection activities. Inspection bodies provide information to their clients about the conformity of inspect-ed items with regulations, standards, specifi-cations, inspection criteria or contracts.
This standard was reported only by DE and FR. DE addressed the biopsy and tissue his-tology item of the diagnosis stage. FR report-ed addressing accreditation of inspection bodies for medical devices and external qual-ity control by the standard.
5.3.3. ISO/IEC 17021:2011
This standard is intended for use by accredi-tation bodies to assess certification bod-ies which provide audit and certification of management systems (e.g. using ISO 9001). Accredited bodies will grant certification of applicants after a successful audit and provid-ed that the criteria of the respective standard, as e.g. the ISO 9001 standard, are fulfilled.
Figure 7: Total number of applications of ISO/IEC 17021:2011 per stage.
Eleven countries out of 19 (58%) reported hav-ing this standard in place. Four of these coun-tries (ES, IT, PL and SE) reported to address the whole breast cancer pathway. With this standard, the screening stage was addressed by five countries, the diagnosis and treatment stages by four countries, and the survivorship and follow-up stage by one country.
Nine countries out of the 11 (82%) addressed some transversal items using this standard. The items mostly covered were quality man-agement (nine countries), mammography (eight countries), ultrasonography, informa-tion systems and personal competence re-quirements (seven countries each).
5.3.4. ISO/IEC 17025:2005
This standard is applied to laboratories per-forming testing/calibration activities to rec-ognize their competency in these activities. These also can include laboratories where testing and/or calibration are a part of in-spection and product certification.
Four countries had this standard in place: ES, FE, GR and SE. It addresses the diagno-sis stage in three countries, treatment stage and transversal items in two, screening and survivorship and follow-up stages in only one country.
5.3.5. Clinical Pathology Accreditation standard (CPA)
This standard is a national one only reported by UK. It has been in use for accreditation of medical laboratories for over 20 years.
The whole pathway
Screening
Diagnosis
Treatment
Survivorship
ISO/IEC 17021:20115
8
4
9
8
26 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
The laboratories are now undergoing transi-tion to UKAS accreditation with ISO 15189.
Diagnosis and survivorship and manage-ment of recurrence stages are covered by this standard as well as some transversal items.
5.3.6. Imaging Services Accreditation Scheme (ISAS)
Similar to CPA, this standard is a national one and only reported by UK. It has been mapped on ISO 17020 and ISO 15189, de-signed to be applied to all current imaging modalities and to interventional radiology services.
The standard covers items related to imag-ing studies in the diagnosis stage, the sur-vivorship and management of recurrence stage and among the transversal items. Pop-ulation based breast screening services are not covered by the standard.
5.3.7. Quality Management System Standards
These standards are used by the accredited certification bodies to audit and certify the management systems of organisations. They provide a model to achieve more efficient use of resources and improved risk manage-ment.
In this survey, the following (quality) man-agement system standards used by the certifi-cation bodies were reported: ISO 9001:2008, ISO/IEC 27001:2013, ISO 13485:2003, ISO 14001:2004 and ISO/IEC TR 18001:2004.
• ISO 9001:2008: specifies requirements for a quality management system where an organization needs to demonstrate its ability to deliver products that meet the expected requirements. It is applicable to organizations of all types and size.
• ISO/IEC 27001:2013: specifies the require-ments for an organisation’s information security management system. It also in-cludes requirements for the treatment of information security risks tailored to the needs of the organization.
• ISO 13485:2003: sets out the requirements for a quality management system for an organization providing medical devices and related services. It aims to facilitate harmonized medical device regulatory re-quirements for quality management sys-tems of producers of medical devices.
• ISO 14001:2004: provides requirements for an environmental management sys-tem where an organization demonstrates that their policy takes into account legal requirements and company specific re-quirements to improve environmental aspects.
• ISO/IEC TR 18001:2004: consists of the results of three surveys on the applica-tions for radio frequency identification and provides classification of these appli-cations and recommendations for areas of standardization based on these surveys.
5. Survey results | 27
Figure 9: Total number of applications of standards in each stage.
5.4. Section 4: The stages of breast cancer care and transversal items covered by the standards
While in section three the total frequency of standards application was reported, in this section, the standards used in health-care systems are evaluated and reported in a stage-wise approach. The data included be-low are derived from the 19 countries which addressed breast cancer care with at least one standard.
Figure 8: Number of NABs addressing each stage.
For the ease of classifying, the stages of care are divided into screening, diagnosis, treat-ment and survivorship and management of recurrence. Each stage includes some sub-stages which are discussed in the relevant sections below. The transversal items are also included in the questionnaire in addi-tion to the stages of care.
The wholepathway
Screening Diagnosis Treatment
Num
ber
of c
ount
ries
Breast cancer care stage
Survivorshipand follow-up
ISO/IEC 17025:2005
ISO 15189:2012
ISO/IEC 17020
ISO/IEC 17021:2011
SurvivorshipScreening Diagnosis TreatmentThe whole pathway
28 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Figure 10: Number of NABs addressing the screening stage by each standard.
In general, the standards were mostly ad-dressing the diagnosis stage. This is in cor-relation with the result that ISO 15189:2012 which is used to accredit medical laborato-ries such as pathology laboratories, is the most widely used standard.
The survivorship and follow-up stage was the least addressed by countries and least covered by a standard.
5.4.1. The screening stage
Screening includes asymptomatic healthy women in a certain age range undergoing screening mammography at specified in-tervals for early diagnosis of breast cancer. Screening can be organised or opportunistic. In organised screening programmes, women are invited to attend a population breast cancer screening programme. If they are pre-scribed a screening mammography by their general practitioner or gynaecologist, it is de-fined as opportunistic screening.
Countries were asked whether the screen-ing stage was addressed by a standard. The ones addressing this stage were further asked if the screening is an organised one and if not, to provide a detailed description of the screening.
In 11 of the 19 countries (58%), this stage was addressed by at least one standard and in the remaining eight countries it was not ad-dressed at all. The most widely used stand-ard for this stage was ISO/IEC 17021:2011, reflecting that the management systems are crucial in screening programmes.
Seven of the 11 countries (63%) addressing the screening stage declared that screening is an organised one, three informed that the situa-tion was not known. The remaining country did not respond to this question.
ISO 15189:2012 ISO/IEC 17020 ISO/IEC 17021:2011 ISO/IEC 17025:2005
Num
ber
of c
ount
ries
Standard in use
No standards
5. Survey results | 29
Figure 11: Number of NABs addressing the diagnosis stage by each standard.
5.4.2. The diagnosis stage
Women with signs or symptoms in their breast or women with a positive screening mammography undergo a diagnostic as-sessment in order to get a final diagnosis. This assessment can involve aspiration or a biopsy and the samples will then be assessed by subsequent tests. Diagnosis stage and its standardisation are of great importance as the future decisions and patterns of care de-pend on it.
Countries were asked whether the diagno-sis stage is addressed by a standard. If the stage was covered, they were further asked to specify if two items–aspiration and sub-sequent testing and biopsy and tissue histol-ogy–were covered.
This was the stage of care most covered by any standard, being addressed in 14 out of the 19 countries (74%). ISO 15189:2012 was the standard most used to cover this stage, used in 13 of these 14 (93%) countries.
Among the 28 cases where this stage was ad-dressed by a standard, the aspiration of fluid and subsequent testing item was addressed in 19 and biopsy and tissue histology item was addressed in 23.
5.4.3. The treatment stage
Women diagnosed with breast cancer then undergo a treatment which may include, depending on multiple factors such as the stage of the disease, a surgical removal of the mass, a part of or the entire breast, radio-therapy, chemotherapy, hormonal therapy. Plastic reconstructive breast surgery is fre-quently proposed to these women.
ISO 15189:2012 ISO/IEC 17020 ISO/IEC 17021:2011 ISO/IEC 17025:2005
Num
ber
of c
ount
ries
Standard in use
No standards
30 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Figure 12: Number of NABs addressing the treatment stage by each standard.
When the country addressed this stage, it was asked to detail the inclusion of the items: sur-gery, breast reconstruction, radiotherapy and chemotherapy, and hormonal therapy.
Eleven countries out of 19 (58%) addressed this stage and most of them (eight countries) applied ISO/IEC 17021:2011. Like in the screening stage, quality management systems were the first undergoing quality assessment.
In the 13 applications of this stage, surgery was covered in nine, reconstruction in five, radiotherapy in nine and chemotherapy and hormonal therapy in eleven.
5.4.4. The survivorship and management of recurrence stage
Women with a malignant lesion who un-dergo relevant treatment procedures are en-rolled to follow-up in order to detect and manage possible recurrences and metastasis
at an early phase. During this stage, the sur-vivors may also benefit from psychosocial and other support therapies. Palliative care can be provided at every step of the treat-ment (e.g. pain control) and in case of a negative outcome, end-of-life care could be delivered.
Where the standards cover this stage, the country is asked to detail if it covers these four items: follow-up and management of recurrence, psychosocial care, survivorship support, palliative care and end-of-life care.
This stage of care was covered in eight coun-tries making it the stage least addressed by a standard.
In the 10 cases where this stage is addressed, ISO/IEC 17021:2011 was utilized in five, ISO 15189:2012 was utilized in four and ISO/IEC 17025:2005 in one.
ISO 15189:2012 ISO/IEC 17020 ISO/IEC 17021:2011 ISO/IEC 17025:2005
Num
ber
of c
ount
ries
Standard in use
No standards
5. Survey results | 31
Figure 13: Number of NABs addressing the survivorship and management of recurrence stage by each standard.
Among these 10 cases, follow-up and man-agement of recurrence was covered in eight, psychosocial care and palliative care and end-of-life care in four, and survivorship support in three countries.
This data shows that this stage, especially psychosocial care, palliative care and end-of-life care and survivorship support fields are highly neglected.
5.4.5. Transversal items
These aspects or items include elements of breast cancer care that are used in several stag-es of care throughout the pathway and cover:
• Mammography.• Ultrasound.• Magnetic Resonance Imaging.• Pathology.• Laboratory tests.• Medication management.• Communication.• Information systems.• Quality management.• Proficiency testing.• Personnel competence requirements.• Hygiene.• Safety.• Research.
Countries were asked to report whether these items were covered.
ISO 15189:2012 ISO/IEC 17020 ISO/IEC 17021:2011 ISO/IEC 17025:2005
Num
ber
of c
ount
ries
Standard in use
No standards
32 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Figure 14: Number of applications of standards to each transversal item.
Standards were applied to laboratory tests and quality management items in 20 cases and to personnel competence requirements
in 19 cases, making these three items the most addressed ones. Research, with seven cases, was the least covered item.
Mammog
raph
y
Ultras
ound MRI
Patho
logy
Num
ber
of a
pplic
atio
ns
Transversal item addressed by the standard
Rese
arch
Labo
ratory
tests
Medica
tion
Commun
icatio
n
Inform
ation
syste
ms
Quality
man
agem
ent
Profic
iency
testi
ng
Perso
nnel
compe
tence
Hygien
e
Safet
y
6. Conclusions | 33
Even if this survey does not cover the data from all the contacted NABs, a response rate of 71% can draw a reliable picture of the current European situation in terms of the accreditation and conformity assessment of breast cancer care. All the respondents are active within their respective NABs, ensur-ing a high level and up-to-date knowledge and therefore, reliable information.
The data collected in this survey were very important and relevant to design a European QA scheme for Breast Cancer Services (BCS). The JRC report Review and analysis of exter-nal quality assessment of breast cancer services in Europe will help to provide a more detailed map of the European situation.
The following conclusions can be derived from the results of the survey:
• Nineteen of the 25 responding countries (76%) have at least one healthcare organi-sation in the breast cancer care pathway which is accredited or holding an accred-ited certificate of conformity. This leaves 24% having no such healthcare organisa-tion and reflects the need for enhance-ment and unification of quality assurance in breast cancer care services throughout Europe.
• Four ISO and ISO CASCO standards were applied for accrediting the men-tioned organisations: ISO 15189:2012, ISO/IEC 17020:2012, ISO/IEC 17021:2011, and
ISO/IEC 17025:2005. Only UK reported the use of national standards besides ISO standards.
• ISO 15189:2012 and ISO/IEC 17021:2011 were the most used standards (14 and 11 times, respectively). ISO 15189:2012 speci-fies requirements for medical laborato-ries, and the wide usage of this standard is coherent with the result that the diag-nosis stage is the one most addressed by a standard. ISO/IEC 17021:2011 addresses the certification bodies auditing the man-agement systems and is mostly used in screening programs according to norma-tive criteria; ISO 9001:2008 is the stand-ard applied by certification bodies.
• Among different stages of care, diagnosis was the most widely addressed with any standard. This is coherent with the impor-tance of this stage for the following care decisions.
• Laboratory tests, quality management and personal competence requirements were the transversal items most addressed.
• None of the responding countries re-ported using the standard ISO/IEC 17065 for product or process certification, even though this standard could be envisioned to potentially address quality management within all the stages and aspects (or items) of breast cancer diagnosis and care. How-ever, this would require the establishment of criteria that certification bodies, accred-ited according to ISO/IEC 17065, would have to apply when certifying BCS.
6. Conclusions
34 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
These data reflect the heterogeneity in the accreditation status of breast cancer care ser-vices throughout Europe. The implementa-tion of the European QA scheme would foster a unification of the accreditation and con-formity assessment, and thus the implemen-tation of the scheme by the BCS across Eu-rope will have positive consequences on the quality of provided services.
Although this report provides detailed in-formation about accreditation and con-formity assessment of breast cancer care in Europe, the number of accredited/certified institutions is not discussed, therefore the information on the geographical prevalence and distribution of these standards cannot be derived through this survey.
7. Acknowledgements | 8. Bibliography | 9. Useful links | 35
We would like to thank Thomas Facklam (EA chair) for his input and support in an-nouncing the survey and in providing the list of contacts; Jane Beaumont (The United Kingdom Accreditation Service), for her ac-curate revision of the draft survey. We are also grateful to Hanspeter Ischi (former member of the Swiss NAB-SAS) for his very
valuable review and Manuel Florensa-Molist (JRC) for providing the design of the final product.
Most of all, we would like to express our gratitude to all those responding to the sur-vey and for the extremely valuable informa-tion they provided.
7. Acknowledgments
8. Bibliography
1. Shaw CD, Braithwaite J, Moldovan M, Nicklin W, Grgic I, Fortune T, et al. Profiling health-care accreditation organi-zations: an international survey. Int J Qual Health Care. 2013 Jul;25(3):222-31.
2. Shaw C, Groene O, Mora N, Sunol R. Accreditation and ISO certification: do they explain differences in quality man-agement in European hospitals? Int J Qual Health Care. 2010 Dec;22(6):445-51.
9. Useful links
1. http://www.iso.org/iso/home.html2. http://www.european-accreditation.org3. http://www.cen.eu/Pages/default.aspx
4. http://www.iec.ch5. https://standardsdevelopment.bsigroup.
com
Annex I: Data protection form and questionnaire | 37
Annex I: Data protection form and questionnaire
38 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
1. Data protection form
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2. Questionnaire Form 1–Core Form
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3. Questionnaire Form 2–Annex Form
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Annex II: E-mail communications | 61
Annex II: E-mail communications
62 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
From: JRC CANCER POLICY SUPPORTSent: 09 August 2013 12:02Subject: Ares(2013)2784082: Survey on accreditation and certification of breast cancer care in EuropeAttachments: NABs_CORE FORM_distributed.pdf; NABs_ANNEX FORM_distributed.pdf; NABs_ DATA PROTECTION_distributed.pdf
Ares(2013)2784082
Dear Madam, dear Sir,
you may already be aware of the discussions that have been taking place with the EA Chair, Dr Thomas Facklam, about the role of National Accreditation Bodies (NABs) in a very important project prompted by the European Council’s invitation to the Commission to explore the possibility of developing a voluntary accreditation scheme for breast cancer screening and care.
As a follow up of an earlier survey to Member States on how breast cancer services are being delivered across Europe, now we are directly approaching NABs in order to go into more details in the identification of ISO accreditation and/or certification/inspection standards which have an im-pact on breast cancer care and might be in place in different countries. This survey is being carried out to ensure that all EA NABs have the opportunity to provide information to the project coordina-tors, European Commission Joint Research Centre (JRC) in Ispra (Italy). The information required concerns the accreditation work that has already been undertaken in each Member State and that may contribute to supporting any or all aspects of the breast cancer care pathway.
The survey is enclosed (first two attachments) in this mail and the third attachment is the data privacy statement.
As regards the survey, please note the following important points:
1) The survey consists in two different forms: CORE and ANNEX. CORE form should be filled in as first because it includes the gate questions that determine the necessity to compile the ANNEX one. The number of ANNEX forms to be filled in is variable and depends to the answers given in the CORE form. Further instructions are available in the form itself.
2) The survey can be saved at any stage of the process. It does not therefore need to be completed in one go.
3) The survey can be partially completed and then sent to someone else for further completion. The form will automatically save all the answers.
Annex II: E-mail communications | 63
4) Once the form is completed, it can be submitted by clicking on the button Submit by Email (Please always use the option “Desktop Email application”): this will send the survey response directly to us. Note however that this operation will not succeed if any of the mandatory questions have been left unanswered.
As regards the privacy statement and the agreement of consent of use of data, please check the appropriate box and then click on the button Submit by Email (Please always use the option “Desk-top Email application”): this will send the data protection form directly to us. Note that you can change/revoke your choice at any time. All you need to do is to send us an e-mail informing us of your change and we will reply with confirmation.
Please note that the deadline for submission of survey responses is 15/09/2013.
If you should need any further information, please do not hesitate to contact us at this e-mail box or via the phone numbers listed in the questionnaire and/or visit our webpage:http://ihcp.jrc.ec.europa.eu/our_activities/public-health/cancer_policy_support.
We would like to thank you and your collaborators in advance for dedicating your time to complet-ing this questionnaire. Since the information you provide will be important to design the accredita-tion scheme that must be implementable in all EU Member States and in the other participating countries, we kindly ask you to provide as much information as possible.
Best regards,
Silvia DEANDREAon behalf of Healthcare Quality group_______________________________________
SILVIA DEANDREAMD, PhD
European CommissionDG Joint Research Centre (JRC)Institute for Health and Consumer ProtectionPublic Health Policy Support UnitVia E. Fermi 2749I-21027 Ispra (VA)/ItalyPhone: +39 0332 [email protected]
64 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
From: JRC CANCER POLICY SUPPORTSent: 05 June 2014 09:15Subject: Approval of data in “Survey on accreditation and certification of Breast Cancer Care”
Dear Sir/Madam,
Thanks to the efforts and cooperation of you and the other survey participants, we are finalising a report on Survey on accreditation and certification of Breast Cancer Care.
In the file enclosed you can find the data that you have provided showed in a tabular representation; due to confidentiality issues, you see only the row corresponding to your country. As these tables correspond to what will be actually published in the final report, we suggest that you carefully check the content. An official request for consent to publication will immediately follow your data approval.
In order to make this data available to European citizens and stakeholders as soon as possible, we would ask to provide an answer by June 17th. As for the previous step of the survey, we are fully available for any support or clarification needed.
We would like to thank you again for the time you dedicated for contributing to such an important collection of information and to the final document derived.
With grateful greetings by the JRC team on Healthcare Quality,
Asli Uluturk
DG Joint Research CentreInstitute for Health and Consumer ProtectionPublic Health Policy SupportBuilding 58AVia Enrico Fermi 274921027 Ispra (VA)ITALY+39 [email protected]
Annex II: E-mail communications | 65
From: JRC CANCER POLICY SUPPORTSent: 06 August 2014 14:29Subject: Publication of the “Survey on accreditation and certification of Breast Cancer Care”
Dear Sir/Madam,
Thanks to the efforts and cooperation of you and other survey participants, we are now finalising the “Survey on accreditation and certification of Breast Cancer Care” and we envisage having it published within few weeks.
We are coming back to you in order to ask your consent for the publication of the data that you provided last year and that you confirmed with your last e-mail on DD/MM/YYY: this can be done by simply replying YES to this e-mail. If we do not hear from you by 13/08/2014, we will apply the rule “Silence gives consent” (consensus is assumed when there’s no evidence of disagreement).
With kindest regards,
Asli ULUTURK
We are recruiting: http://recruitment.jrc.ec.europa.eu/?type=GH.
DG Joint Research CentreInstitute for Health and Consumer ProtectionPublic Health Policy SupportBuilding 58AVia Enrico Fermi 274921027 Ispra (VA)ITALY+39 [email protected]
Annex III: Tables | 67
Annex III: Tables
68 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 1. ISO standards used in countries and stages of breast cancer care addressed by the standard.
Gate questions:
• Are there any organisations accredited or holding accredited certification/inspection for activities part of or relevant for breast cancer care?
• Are these organisations treating breast cancer either before (e.g. screening, early diagnosis, biopsy, analysis) or after the diagnosis?
Questions on the standards for Breast Cancer Care:
• Name of the standard(s) used.• Breast cancer stages addressed by the standard in the healthcare institutions present in the
country.• Transversal items addressed by the standard in the healthcare institutions present in the
country.
Annex III: Tables | 69
Table 1. (cont.)
Coun
try
Is th
ere
an a
ccre
dite
d/
cert
ified
org
anis
atio
n Is
thi
s or
gani
sati
on
diag
nos i
ng o
r tr
eati
ng
brea
st c
ance
r
Whi
ch s
tand
ards
are
in p
lace
Whi
ch b
reas
t ca
ncer
sta
ges
are
add
ress
ed b
y th
e st
anda
rdW
hich
tra
nsve
rsal
item
s
are
addr
esse
d by
the
stan
dard
ATYe
sYe
sIS
O/IE
C 17
021:
2011
(und
er IS
O
9001
:200
8)Sc
reen
ing
Dia
gnos
isTr
eatm
ent
BEYe
sYe
sIS
O 1
5189
:200
7D
iagn
osis
–bi
opsy
and
tiss
ue
hist
olog
y, m
olec
ular
test
ing
to
dete
ct a
ny m
utat
ions
cau
sing
br
east
can
cer o
r infl
uenc
ing
trea
tmen
t (fo
r exa
mpl
e: H
ER2/
neu
FISH
: if
posi
tive,
a tr
eat-
men
t with
her
cept
in w
ill b
e st
arte
d).
Path
olog
y, la
bora
tory
test
s,
med
icat
ion
man
agem
ent,
qual
-ity
man
agem
ent,
pers
onne
l co
mpe
tenc
e re
quire
men
ts
BGYe
sN
oIS
O/IE
C 17
021:
2011
(und
er IS
O
9001
:200
8)Sc
reen
ing
Dia
gnos
is
Trea
tmen
t Su
rviv
orsh
ip a
nd m
anag
e-m
ent
of r
ecur
renc
e
CYN
oN
R*–
––
CZYe
sYe
sIS
O 1
5189
:201
2D
iagn
osis
–bio
psy
and
tissu
e hi
stol
ogy
Path
olog
y, la
bora
tory
test
s
ISO
/IEC
1702
1:20
11 (u
nder
ISO
90
01:2
008,
ISO
134
85:2
003,
IS
O/IE
C 27
001:
2013
)
Scre
enin
g–
orga
nise
d sc
reen
-in
g fo
r asy
mpt
omat
ic w
omen
, sc
reen
ing
of c
olor
ecta
l car
ci-
nom
a, c
arci
nom
a ce
rvic
is u
teri,
ca
rcin
oma
of th
e pr
osta
te g
land
Dia
gnos
is–
aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bio
psy
and
tissu
e hi
stol
ogy
Trea
tmen
t–su
rger
y, b
reas
t re
cons
truc
tion,
radi
othe
rapy
, ch
emot
hera
py, P
ET c
ente
rsSu
rviv
orsh
ip a
nd m
anag
emen
t of
recu
rren
ce–f
ollo
w-u
p an
d m
anag
emen
t of r
ecur
renc
e, p
al-
liativ
e ca
re a
nd e
nd-o
f-lif
e ca
re
Mam
mog
raph
y, u
ltras
ound
s,
MRI
, Inf
orm
atio
n sy
stem
, qua
l-ity
man
agem
ent
70 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 1. (cont.)
Coun
try
Is th
ere
an a
ccre
dite
d/
cert
ified
org
anis
atio
n Is
thi
s or
gani
sati
on
diag
nos i
ng o
r tr
eati
ng
brea
st c
ance
r
Whi
ch s
tand
ards
are
in p
lace
Whi
ch b
reas
t ca
ncer
sta
ges
are
add
ress
ed b
y th
e st
anda
rdW
hich
tra
nsve
rsal
item
s
are
addr
esse
d by
the
stan
dard
DE
Yes
Yes
ISO
151
89:2
012
Dia
gnos
is–
aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing
Labo
rato
ry te
sts
ISO
/IEC
1702
0:20
12D
iagn
osis
–bi
opsy
and
tiss
ue
hist
olog
yPa
thol
ogy
DK
No
NR*
––
–
EEYe
sYe
sIS
O 1
5189
:201
2D
iagn
osis
–as
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g, b
iops
y an
d tis
sue
hist
olog
y, B
RCA1
an
d 2
test
s
–
ESYe
sYe
sIS
O/IE
C 17
021:
2011
(und
er IS
O
9001
:200
8)Th
e w
hole
bre
ast
canc
er
path
way
Mam
mog
raph
y, u
ltras
ound
, M
RI, p
atho
logy
, lab
orat
ory
test
s, q
ualit
y m
anag
emen
t, pe
rson
nel c
ompe
tenc
e re
quire
-m
ents
, hyg
iene
, saf
ety
ISO
151
89:2
012
Scre
enin
g–
orga
nise
d sc
reen
-in
g fo
r asy
mpt
omat
ic w
omen
Dia
gnos
is–
aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bio
psy
and
tissu
e hi
stol
ogy,
mol
ecul
ar
path
olog
y: e
.g.;
HER
2
Path
olog
y, la
bora
tory
test
ing,
in
form
atio
n sy
stem
s, q
ual-
ity m
anag
emen
t, pr
ofici
ency
te
stin
g, p
erso
nnel
com
pete
nce
requ
irem
ents
, hyg
iene
, saf
ety
ISO
/IEC
1702
5:20
05Tr
eatm
ent–
radi
othe
rapy
, the
re
is o
ne l
abor
ator
y ac
cred
ited
for c
alib
ratio
n of
the
stan
d-ar
d us
ed fo
r the
rapy
leve
ls,
Gam
ma
radi
atio
n of
Cob
alt 6
0,
0,81
Gy/
min
, CM
C=0,
8 %
Annex III: Tables | 71
Table 1. (cont.)
Coun
try
Is th
ere
an a
ccre
dite
d/
cert
ified
org
anis
atio
n Is
thi
s or
gani
sati
on
diag
nos i
ng o
r tr
eati
ng
brea
st c
ance
r
Whi
ch s
tand
ards
are
in p
lace
Whi
ch b
reas
t ca
ncer
sta
ges
are
add
ress
ed b
y th
e st
anda
rdW
hich
tra
nsve
rsal
item
s
are
addr
esse
d by
the
stan
dard
FIYe
sYe
sIS
O 1
5189
:201
2D
iagn
osis
–as
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g, b
iops
y an
d tis
sue
hist
olog
y
Path
olog
y, la
bora
tory
test
ing,
co
mm
unic
atio
n, in
form
atio
n sy
stem
s, q
ualit
y m
anag
emen
t, pr
ofici
ency
test
ing,
, pe
rson
-ne
l com
pete
nce
requ
irem
ents
, hy
gien
e, s
afet
y
ISO
/IEC
1702
5:20
05D
iagn
osis
–as
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g, b
iops
y an
d tis
sue
hist
olog
y
Path
olog
y, la
bora
tory
test
ing,
co
mm
unic
atio
n, in
form
atio
n sy
stem
s, q
ualit
y m
anag
emen
t, pr
ofici
ency
test
ing,
per
sonn
el
com
pete
nce
requ
irem
ents
, hy
gien
e, s
afet
y
ISO
/IEC
1702
1:20
11Sc
reen
ing
–or
gani
sed
scre
en-
ing
for a
sym
ptom
atic
wom
enTr
eatm
ent–
surg
ery,
bre
ast
reco
nstr
uctio
n, ra
diot
hera
py,
chem
othe
rapy
and
hor
mon
al
ther
apy
Mam
mog
raph
y, m
edic
atio
n m
anag
emen
t, co
mm
unic
atio
n,
info
rmat
ion
syst
ems,
qua
lity
man
agem
ent,
pers
onne
l com
-pe
tenc
e re
quire
men
ts, h
ygie
ne,
safe
ty
FR**
Yes
Not
kno
wn
ISO
151
89:2
012
Dia
gnos
is–a
spira
tion
of fl
uid
and
subs
eque
nt te
stin
g, b
iops
y an
d tis
sue
hist
olog
y
Path
olog
y, la
bora
tory
test
s
ISO
/IEC
1702
0:20
12Sc
reen
ing
–ac
cred
itatio
n of
in
spec
tion
bodi
es fo
r med
ical
de
vice
s (m
amm
ogra
phy)
Mam
mog
raph
y
72 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 1. (cont.)
Coun
try
Is th
ere
an a
ccre
dite
d/
cert
ified
org
anis
atio
n Is
thi
s or
gani
sati
on
diag
nos i
ng o
r tr
eati
ng
brea
st c
ance
r
Whi
ch s
tand
ards
are
in p
lace
Whi
ch b
reas
t ca
ncer
sta
ges
are
add
ress
ed b
y th
e st
anda
rdW
hich
tra
nsve
rsal
item
s
are
addr
esse
d by
the
stan
dard
GR
Yes
Yes
ISO
151
89:2
012
Diag
nosi
s–as
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g, b
iops
y an
d tis
sue
hist
olog
y , b
lood
mar
ker
test
s fo
r CA
15.3
, CA1
25, C
EA
(car
cino
embr
yoni
c an
tigen
)Tr
eatm
ent–
chem
othe
rapy
an
d ho
rmon
al th
erap
y, b
lood
ce
ll co
unts
: whi
te b
lood
cel
ls,
red
bloo
d ce
lls, h
emog
lobi
n,
hem
atoc
rit, p
late
lets
, blo
od
chem
istr
ies
: le
vels
of
liver
en
zym
es ,
leve
ls o
f po
tass
ium
, ch
lorid
e, a
nd u
rea
nitr
ogen
lev-
els,
cal
cium
leve
ls, b
lood
sug
ar
leve
ls, d
eter
min
atio
n of
dru
g le
vels
in b
lood
, blo
od m
arke
r te
sts
for C
A 15
.3, C
A125
, CEA
(c
arci
noem
bryo
nic
antig
en),
FISH
Tes
t (Fl
uore
scen
ce In
Situ
H
ybrid
izat
ion)
, mol
ecul
ar te
sts
for m
utat
ion
anal
ysis
(eg.
real
tim
e PC
R, A
RMS
PCR,
NG
S)Su
rviv
orsh
ip a
nd m
anag
e-m
ent
of r
ecur
renc
e–
follo
w-u
p an
d m
anag
emen
t of
recu
rren
ce
Labo
rato
ry te
sts,
com
mun
i-ca
tion,
info
rmat
ion
syst
ems,
qu
ality
man
agem
ent,
profi
cien
-cy
test
ing,
per
sonn
el c
ompe
-te
nce
requ
irem
ents
, hyg
iene
, sa
fety
ISO
170
21:2
011
(ISO
90
01:2
008)
Scre
enin
g–
orga
nise
d sc
reen
-in
g fo
r asy
mpt
omat
ic w
omen
Dia
gnos
is–
aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bio
psy
and
tissu
e hi
stol
ogy
Mam
mog
raph
y, u
ltras
ound
, M
RI, l
abor
ator
y te
sts,
qua
lity
man
agem
ent,
pers
onne
l com
-pe
tenc
e re
quire
men
ts, h
ygie
ne,
safe
ty
ISO
170
25:2
005
Dia
gnos
is–
Labo
rato
ry’s
equ
ip-
men
t cal
ibra
tion.
Trea
tmen
t–M
olec
ular
and
cel
l bi
olog
y te
sts
for r
esea
rch
use
only
(eg.
cel
l via
bilit
y te
st, g
ene
expr
essi
on a
naly
sis)
.
Labo
rato
ry te
sts,
qua
lity
man
-ag
emen
t, pr
ofici
ency
test
ing,
pe
rson
nel c
ompe
tenc
e re
quire
-m
ents
, res
earc
h, e
quip
men
t ca
libra
tion
and
met
rolo
gica
l tr
acea
bilit
y
Annex III: Tables | 73
Table 1. (cont.)
Coun
try
Is th
ere
an a
ccre
dite
d/
cert
ified
org
anis
atio
n Is
thi
s or
gani
sati
on
diag
nos i
ng o
r tr
eati
ng
brea
st c
ance
r
Whi
ch s
tand
ards
are
in p
lace
Whi
ch b
reas
t ca
ncer
sta
ges
are
add
ress
ed b
y th
e st
anda
rdW
hich
tra
nsve
rsal
item
s
are
addr
esse
d by
the
stan
dard
HR
Yes
Yes
ISO
151
89:2
012
Trea
tmen
t–ch
emot
hera
py a
nd
horm
onal
ther
apy
IEYe
sYe
sIS
O 1
5189
:201
2D
iagn
osis
–as
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g, b
iops
y an
d tis
sue
hist
olog
y
ITYe
sN
R*IS
O/IE
C 17
021:
2011
(und
er IS
O
9001
:200
8)Th
e w
hole
bre
ast
canc
er
path
way
Mam
mog
raph
y, u
ltras
ound
, M
RI, p
atho
logy
, lab
orat
ory
test
s, m
edic
atio
n m
anag
emen
t, co
mm
unic
atio
n, in
form
atio
n sy
stem
s, q
ualit
y m
anag
emen
t, pr
ofici
ency
test
ing,
per
sonn
el
com
pete
nce
requ
irem
ents
, hy
gien
e, s
afet
y, re
sear
ch
LTYe
sN
ot k
now
nIS
O/IE
C 17
021:
2011
(und
er IS
O
9001
:200
8)Sc
reen
ing
–or
gani
sed
scre
en-
ing
for a
sym
ptom
atic
wom
enD
iagn
osis
- as
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g, b
iops
y an
d tis
sue
hist
olog
yTr
eatm
ent–
surg
ery,
radi
o-th
erap
y, c
hem
othe
rapy
and
ho
rmon
al th
erap
y
Mam
mog
raph
y, u
ltras
ound
, M
RI, l
abor
ator
y te
sts,
med
ica-
tion
man
agem
ent,
com
mun
i-ca
tion,
info
rmat
ion
syst
ems,
qu
ality
man
agem
ent,
pers
onne
l co
mpe
tenc
e re
quire
men
ts
LUN
oN
R*–
––
ME
No
NR*
––
–
MK
No
NR*
––
–
NL
Yes
Yes
ISO
151
89:2
012
Dia
gnos
is–
biop
sy a
nd ti
ssue
hi
stol
ogy
Profi
cien
cy te
stin
g
74 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 1. (cont.)
Coun
try
Is th
ere
an a
ccre
dite
d/
cert
ified
org
anis
atio
n Is
thi
s or
gani
sati
on
diag
nos i
ng o
r tr
eati
ng
brea
st c
ance
r
Whi
ch s
tand
ards
are
in p
lace
Whi
ch b
reas
t ca
ncer
sta
ges
are
add
ress
ed b
y th
e st
anda
rdW
hich
tra
nsve
rsal
item
s
are
addr
esse
d by
the
stan
dard
PLYe
sYe
sIS
O/IE
C 17
021:
2011
(und
er IS
O
9001
:200
8)Th
e w
hole
bre
ast
canc
er
path
way
–su
rger
y, ra
diot
hera
py,
chem
othe
rapy
and
hor
mon
al
ther
apy,
psy
chos
ocia
l car
e
Mam
mog
raph
y, u
ltras
ound
, M
RI, p
atho
logy
, lab
orat
ory
test
s, m
edic
atio
n m
anag
emen
t, co
mm
unic
atio
n, in
form
atio
n sy
stem
s, q
ualit
y m
anag
e-m
ent,
pers
onne
l com
pete
nce
requ
irem
ents
, hyg
iene
, saf
ety,
re
sear
ch
ISO
/IEC
1702
1:20
11 (u
nder
ISO
14
001:
2004
)Th
e w
hole
bre
ast
canc
er
path
way
–su
rger
y, ra
diot
hera
py,
chem
othe
rapy
and
hor
mon
al
ther
apy,
psy
chos
ocia
l car
e
Mam
mog
raph
y, u
ltras
ound
, M
RI, p
atho
logy
, lab
orat
ory
test
s, m
edic
atio
n m
anag
emen
t, co
mm
unic
atio
n, in
form
atio
n sy
stem
s, q
ualit
y m
anag
e-m
ent,
pers
onne
l com
pete
nce
requ
irem
ents
, hyg
iene
, saf
ety,
re
sear
ch
ISO
/IEC
1702
1:20
11 (u
nder
ISO
/IE
C TR
180
01:2
004)
The
who
le b
reas
t ca
ncer
pa
th w
ay–
surg
ery,
radi
othe
rapy
, ch
emot
hera
py a
nd h
orm
onal
th
erap
y, p
sych
osoc
ial c
are
Mam
mog
raph
y, u
ltras
ound
, M
RI, p
atho
logy
, lab
orat
ory
test
s, m
edic
atio
n m
anag
emen
t, co
mm
unic
atio
n, in
form
atio
n sy
stem
s, q
ualit
y m
anag
e-m
ent,
pers
onne
l com
pete
nce
requ
irem
ents
, hyg
iene
, saf
ety,
re
sear
ch
Annex III: Tables | 75
Table 1. (cont.)
Coun
try
Is th
ere
an a
ccre
dite
d/
cert
ified
org
anis
atio
n Is
thi
s or
gani
sati
on
diag
nos i
ng o
r tr
eati
ng
brea
st c
ance
r
Whi
ch s
tand
ards
are
in p
lace
Whi
ch b
reas
t ca
ncer
sta
ges
are
add
ress
ed b
y th
e st
anda
rdW
hich
tra
nsve
rsal
item
s
are
addr
esse
d by
the
stan
dard
RSYe
sYe
sIS
O 1
5189
:201
2Sc
reen
ing
–gen
etic
stu
dies
–one
la
b is
accr
edita
tion
per I
SO 1
5189
: 20
12 (e
xam
inat
ion
of m
utat
ions
in
BRC
A-1
and
Brca
-2 g
ene)
Dia
gnos
is–
biop
sy a
nd ti
ssue
hi
stol
ogy,
Cyt
opat
holo
gica
l ex
amin
atio
n of
bio
psy-
mon
-oc
lona
l ant
ibod
y (1
lab)
ISO
15
189:
2012
Trea
tmen
t–su
rger
y, ra
dio-
ther
apy,
che
mot
hera
py a
nd
horm
onal
ther
apy
Surv
ivor
ship
and
man
age-
men
t of
rec
urre
nce
Path
olog
y, la
bora
tory
test
s,
profi
cien
cy te
stin
g , p
erso
n-ne
l com
pete
nce
requ
irem
ents
, hy
gien
e, s
afet
y, re
sear
ch
SEYe
sYe
sIS
O/IE
C 17
021:
2011
(ISO
/IEC
2700
1:20
13)
The
who
le b
reas
t ca
ncer
pa
thw
ayM
amm
ogra
phy,
ultr
asou
nd,
path
olog
y, la
bora
tory
test
s,
med
icat
ion
man
agem
ent,
info
rmat
ion
syst
ems,
qua
lity
man
agem
ent,
pers
onne
l com
-pe
tenc
e re
quire
men
ts, h
ygie
ne
ISO
/IEC
1702
1:20
11 (I
SO
9001
:200
8)Th
e w
hole
bre
ast
canc
er
path
way
Mam
mog
raph
y, u
ltras
ound
, pa
thol
ogy,
labo
rato
ry te
sts,
m
edic
atio
n m
anag
emen
t, in
form
atio
n sy
stem
s, q
ualit
y m
anag
emen
t, pe
rson
nel c
om-
pete
nce
requ
irem
ents
, hyg
iene
ISO
/IEC
1702
5:20
05 a
nd/o
r ISO
15
189:
2012
Scre
enin
g–
orga
nise
d sc
reen
-in
g fo
r asy
mpt
omat
ic w
omen
Dia
gnos
is–
aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bio
psy
and
tissu
e hi
stol
ogy,
Mol
ecul
ar
biol
ogy
met
hods
, Im
mun
o hi
s-to
lgy
met
hods
, Flo
w c
ytom
etry
Surv
ivor
ship
and
man
agem
ent
of r
ecur
renc
e–
follo
w-u
p an
d m
anag
emen
t of
recu
rren
ces
Mam
mog
raph
y, p
atho
logy
, la
bora
tory
test
s, q
ualit
y m
an-
agem
ent,
profi
cien
cy te
stin
g, ,
pers
onne
l com
pete
nce
requ
ire-
men
ts
76 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 1. (cont.)
Coun
try
Is th
ere
an a
ccre
dite
d/
cert
ified
org
anis
atio
n Is
thi
s or
gani
sati
on
diag
nos i
ng o
r tr
eati
ng
brea
st c
ance
r
Whi
ch s
tand
ards
are
in p
lace
Whi
ch b
reas
t ca
ncer
sta
ges
are
add
ress
ed b
y th
e st
anda
rdW
hich
tra
nsve
rsal
item
s
are
addr
esse
d by
the
stan
dard
SIN
oN
R*–
––
UK
Yes
Yes
ISO
151
89:2
012
Dia
gnos
is–
aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bio
psy
and
tissu
e hi
stol
ogy
Surv
ivor
ship
–fo
llow
-up
and
man
agem
ent o
f re
curr
ence
s
Path
olog
y, la
bora
tory
test
s,
com
mun
icat
ion,
info
rmat
ion
syst
ems,
qua
lity
man
agem
ent,
profi
cien
cy te
stin
g, ,
pers
on-
nel c
ompe
tenc
e re
quire
men
ts,
hygi
ene,
saf
ety
ISO
/IEC
1702
1:20
11 (u
nder
ISO
90
01:2
008)
Qua
lity
man
agem
ent
ISO
/IEC
1702
1:20
11 (I
SO/IE
C 27
001:
2013
)In
form
atio
n sy
stem
s
Clin
ical
Pat
holo
gy A
ccre
dita
tion
stan
dard
(lab
orat
orie
s ar
e un
-de
rgoi
ng tr
ansi
tion
to U
KAS
ac-
cred
itatio
n to
ISO
151
89:2
012)
Dia
gnos
is–
aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bio
psy
and
tissu
e hi
stol
ogy
Surv
ivor
ship
and
man
age-
men
t of
rec
urre
nce
–fo
llow
-up
and
man
agem
ent o
f rec
urre
nces
, th
e sa
mpl
ing
and
exam
inat
ion
of
aspi
rate
s an
d bi
opsi
es d
urin
g fo
llow
-up
surv
eilla
nce
activ
ities
.
Path
olog
y, la
bora
tory
test
s,
com
mun
icat
ion,
info
rmat
ion
syst
ems,
qua
lity
man
agem
ent,
profi
cien
cy te
stin
g, p
erso
nnel
co
mpe
tenc
e re
quire
men
ts,
hygi
ene,
saf
ety
Annex III: Tables | 77
Table 1. (cont.)
Coun
try
Is th
ere
an a
ccre
dite
d/
cert
ified
org
anis
atio
n Is
thi
s or
gani
sati
on
diag
nos i
ng o
r tr
eati
ng
brea
st c
ance
r
Whi
ch s
tand
ards
are
in p
lace
Whi
ch b
reas
t ca
ncer
sta
ges
are
add
ress
ed b
y th
e st
anda
rdW
hich
tra
nsve
rsal
item
s
are
addr
esse
d by
the
stan
dard
UK
(con
t.)Im
agin
g Se
rvic
es A
ccre
dita
tion
Sc
hem
e (IS
AS) w
hich
has
be
en ‘m
appe
d’ a
gain
st IS
O/
IEC
1702
0:20
12 a
nd IS
O
1518
9:20
12
Dia
gnos
is–
Sym
ptom
atic
sc
reen
ing,
dia
gnos
tic m
amm
o-gr
aphy
, dia
gnos
tic u
ltras
ound
an
d ot
her i
mag
ing
and
inte
rven
-tio
nal r
adio
logy
ser
vice
s.Su
rviv
orsh
ip a
nd m
anag
e-m
ent
of r
ecur
renc
e–
Follo
w-u
p an
d m
anag
emen
t of r
ecur
renc
-es
, per
iodi
c im
agin
g an
d in
ter-
vent
iona
l rad
iolo
gy s
cree
ning
to
det
ect p
oten
tial r
ecur
renc
e.
Mam
mog
raph
y, u
ltras
ound
, M
RI, c
omm
unic
atio
n, in
form
a-tio
n sy
stem
s, q
ualit
y m
anag
e-m
ent,
pers
onne
l com
pete
nce
requ
irem
ents
, hyg
iene
, saf
ety,
re
sear
ch(T
he S
tand
ard
is d
esig
ned
to b
e ap
plie
d to
all
curr
ent i
mag
ing
mod
aliti
es a
nd to
inte
rven
tiona
l ra
diol
ogy
serv
ices
: gen
eral
x-
ray;
ultr
asou
nd; c
ompu
ted
tom
ogra
phy
(CT)
; int
erve
n-tio
nal r
adio
logy
(IR)
; mag
netic
re
sona
nce
imag
ing
(MRI
); du
al
ener
gy x
-ray
abs
orpt
ion
(DEX
A);
radi
onuc
lide
imag
ing
(RN
I);
sym
ptom
atic
bre
ast m
amm
og-
raph
y. N
on-i
mag
ing
aspe
cts
of N
ucle
ar M
edic
ine
(incl
udin
g ra
diop
harm
acy)
and
asy
mpt
o-m
atic
bre
ast s
cree
ning
ser
vice
s ar
e no
t cur
rent
ly in
clud
ed in
th
e sc
ope
of th
is S
tand
ard.
)
* N
R: N
ot R
epor
ted.
Rel
evan
t dat
a w
as n
ot p
rovi
ded
or th
at th
e qu
estio
n w
as n
ot re
leva
nt ta
king
into
con
side
ratio
n th
e an
swer
s to
pre
viou
s qu
estio
ns.
** I
SO/I
EC
1702
1:20
11 a
nd I
SO/I
EC
1706
5:20
12 m
aybe
in u
se b
ut th
e re
spon
dent
cho
se n
ot to
repo
rt th
e in
form
atio
n du
e to
unc
erta
in/m
issi
ng d
ata.
78 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 2. Overview of the breast cancer stages addressed by the standard.
Questions:
• ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care.
• Countries using the standard.• The breast cancer stages covered by the standard.
Annex III: Tables | 79
Table 2. (cont.)
ISO
sta
ndar
dCo
untr
ies
usin
g th
e st
anda
rdTh
e w
hole
bre
ast
canc
er p
athw
aySc
reen
ing
Dia
gnos
isTr
eatm
ent
Surv
ivor
ship
an
d fo
llow
-up
Tran
sver
sal
Item
s
ISO
15
189:
2012
BE, C
Z, D
E, E
E, E
S,
FI, F
R, G
R, H
R, IE
, N
L, R
S, S
E, U
K
ES, S
E, R
SBE
, CZ,
DE,
EE,
ES,
FI
, FR,
GR,
IE, N
L,
RS, S
E, U
K
GR,
HR,
RS,
G
R, S
E, U
KBE
, CZ,
DE,
ES,
FR,
G
R, N
L, R
S, U
K
ISO
/IEC
1702
0:20
12D
E, F
RFR
DE
DE,
FR
ISO
/IEC
1702
1:20
11AT
¹, BG
¹, CZ
³, ES
¹, FI
, GR¹
, IT¹
, LT¹
, PL
⁴, SE
², U
K²
ES, I
T, P
L, S
EAT
, CZ,
FI,
GR,
,LT
AT, C
Z, F
I, LT
AT, C
Z, F
I, LT
CZCZ
, ES,
FI,
IT, L
T,
PL, S
E, U
K
ISO
/IEC
1702
5:20
05ES
, FI,
GR,
SE
SEFI
, GR,
SE
ES, G
RSE
SE
Clin
ical
Pat
holo
gy
Accr
edit
atio
n st
anda
rd
UK
UK
UK
UK
Imag
ing
Serv
ices
Ac
cred
itat
ion
Sche
me
UK
UK
UK
UK
1. Th
ese
coun
trie
s us
ed th
e IS
O/I
EC
1702
1:20
11 u
nder
the
man
agem
ent s
yste
m s
tand
ard
ISO
900
1:20
08.
2.
Thes
e co
untr
ies
used
the
ISO
/IE
C 17
021:
2011
und
er th
e m
anag
emen
t sys
tem
sta
ndar
ds I
SO 9
001:
2008
and
ISO
/IE
C 2
7001
:201
3.3.
C
Z u
sed
the
ISO
/IE
C 17
021:
2011
und
er th
e m
anag
emen
t sys
tem
sta
ndar
ds I
SO 9
001:
2008
, ISO
1348
5:20
03 a
nd I
SO/I
EC
270
01:2
013.
4.
PL u
sed
the
ISO
/IE
C 17
021:
2011
und
er th
e m
anag
emen
t sys
tem
sta
ndar
ds I
SO 9
001:
2008
, ISO
1400
1:20
04 a
nd I
SO/I
EC
TR
1800
1:20
04.
80 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 3. Detailed description of breast cancer stages addressed by standards in each country.
Questions:
• ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care.
• Countries using the standard.• The breast cancer stages covered by the standard.
Annex III: Tables | 81
Table 3. (cont.)
ISO
sta
ndar
dCo
untr
ies
usin
g
the
stan
dard
The
who
le b
reas
t ca
ncer
pat
hway
Scre
enin
gD
iagn
osis
Trea
tmen
tSu
rviv
orsh
ip
and
follo
w-u
p
ISO
15
189:
2012
BEN
oN
oBi
opsy
and
tiss
ue
his t
olog
y, m
olec
ular
te
stin
g to
det
ect a
ny
mut
atio
ns c
ausi
ng
brea
st c
ance
r or
influ
enci
ng tr
eatm
ent
(for
exa
mpl
e: H
ER2/
Neu
FIS
H: i
f po
sitiv
e,
a tr
eatm
ent w
ith h
er-
cept
in w
ill b
e st
arte
d).
No
No
CZN
oN
oBi
opsy
and
tiss
ue
hist
olog
yN
oN
o
DE
No
No
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing
No
No
EEN
oN
oAs
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g,
biop
sy a
nd ti
ssue
hi
stol
ogy,
BRC
A1 a
nd
BRCA
2 te
sts
No
No
ESN
oO
rgan
ised
scr
eeni
ng
for a
sym
ptom
atic
w
omen
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue
hist
olog
y, m
olec
ular
pa
thol
ogy:
e.g
.; H
ER-2
No
No
FIN
oN
oAs
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g,
biop
sy a
nd ti
ssue
hi
stol
ogy
No
No
FRN
oN
oAs
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g,
biop
sy a
nd ti
ssue
hi
stol
ogy
No
No
82 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 3. (cont.)
ISO
sta
ndar
dCo
untr
ies
usin
g
the
stan
dard
The
who
le b
reas
t ca
ncer
pat
hway
Scre
enin
gD
iagn
osis
Trea
tmen
tSu
rviv
orsh
ip
and
follo
w-u
p
ISO
15
189:
2012
(con
t.)
GR
No
No
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue h
is-
tolo
gy, b
lood
mar
ker
test
s fo
r CA
15.3
, CA
125,
CEA
(car
ci-
noem
bryo
nic
antig
en)
See
Tabl
e 6
Follo
w-u
p an
d
man
agem
ent o
f re
curr
ence
HR
No
No
No
Chem
othe
rapy
and
ho
rmon
al th
erap
yN
o
IEN
oN
oAs
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g,
biop
sy a
nd ti
ssue
hi
stol
ogy
No
No
NL
No
No
Biop
sy a
nd ti
ssue
hi
stol
ogy
No
No
RSN
oG
enet
ic s
tudi
es–
one
labo
rato
ry is
acc
red-
ited
(exa
min
atio
n of
m
utat
ions
in B
RCA-
1 an
d BR
CA-2
gen
e)
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue
hist
olog
y, c
ytop
atho
-lo
gica
l exa
min
atio
n of
bio
psy-
mon
oclo
nal
antib
ody
(1 la
b)
Surg
ery
, rad
ioth
erap
y,
chem
othe
rapy
and
ho
rmon
al th
erap
y, Im
-m
unoc
hem
ical
met
h-od
s (C
A 15
-3; C
EA)
(7 la
bs),
Cyto
path
o-lo
gica
l exa
min
atio
n of
bio
psy-
mon
oclo
nal
antib
ody
(1 la
b)
See
Tabl
e 7
SEN
oO
rgan
ised
scr
eeni
ng
for a
sym
ptom
atic
w
omen
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue
hist
olog
y, m
olec
ular
bi
olog
y m
etho
ds, i
m-
mun
ohis
tolo
gy m
eth-
ods,
flow
cyt
omet
ry
No
Follo
w-u
p an
d
man
agem
ent o
f re
curr
ence
UK
No
No
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue
hist
olog
y
No
Follo
w-u
p an
d m
an-
agem
ent o
f re
cur-
renc
e
Annex III: Tables | 83
Table 3. (cont.)
ISO
sta
ndar
dCo
untr
ies
usin
g
the
stan
dard
The
who
le b
reas
t ca
ncer
pat
hway
Scre
enin
gD
iagn
osis
Trea
tmen
tSu
rviv
orsh
ip
and
follo
w-u
p
ISO
/IEC
1702
0:20
12D
EN
oN
oBi
opsy
and
tiss
ue
hist
olog
y N
oN
o
FRN
oAc
cred
itatio
n of
in
spec
tion
bodi
es
for m
edic
al d
evic
es
(mam
mog
raph
y) e
x-te
rnal
qua
lity
cont
rol
No
No
No
ISO
/IEC
1702
1:20
11AT
(und
er
ISO
900
1:20
08)
No
See
Tabl
e 4
See
Tabl
e 5
See
Tabl
e 6
No
BG (u
nder
IS
O 9
001:
2008
)N
oBA
S ha
ve n
ot in
for-
mat
ion
rela
ted
BA
S ha
ve n
ot in
for-
mat
ion
rela
ted
BAS
have
not
info
r-m
atio
n re
late
d BA
S do
es n
ot h
ave
info
rmat
ion
rela
ted
to
the
topi
c
CZ (u
nder
IS
O 9
001:
2008
, IS
O 1
3485
:200
3,
ISO
270
01:2
013)
No
Org
anis
ed s
cree
ning
fo
r asy
mpt
omat
ic
wom
en, c
olor
ecta
l ca
ncer
cer
vica
l can
-ce
r, pr
osta
te c
ance
r
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue
hist
olog
y
Surg
ery,
bre
ast r
econ
-st
ruct
ion,
radi
othe
ra-
py, c
hem
othe
rapy
, PET
ce
nter
s
Follo
w-u
p an
d m
an-
agem
ent o
f re
cur-
renc
e, p
allia
tive
care
an
d en
d-of
-life
car
e
ES (u
nder
IS
O 9
001:
2008
)Th
e w
hole
bre
ast
canc
er p
athw
ay–
––
–
FI (u
nder
IS
O 9
001:
2008
)N
oO
rgan
ised
scr
eeni
ng
for a
sym
ptom
atic
w
omen
No
Surg
ery,
bre
ast r
econ
-st
ruct
ion,
radi
othe
ra-
py, c
hem
othe
rapy
and
ho
rmon
al th
erap
y
No
GR
(und
er
ISO
900
1:20
08)
No
Org
anis
ed s
cree
ning
fo
r asy
mpt
omat
ic
wom
en
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue
hist
olog
y
No
No
IT (u
nder
IS
O 9
001:
2008
)Th
e w
hole
bre
ast
canc
er p
athw
ay–
––
–
LT (u
nder
IS
O 9
001:
2008
)N
oO
rgan
ised
scr
eeni
ng
for a
sym
ptom
atic
w
omen
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue
hist
olog
y
Surg
ery,
radi
othe
rapy
, ch
emot
hera
py a
nd
horm
onal
ther
apy
No
84 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 3. (cont.)
ISO
sta
ndar
dCo
untr
ies
usin
g
the
stan
dard
The
who
le b
reas
t ca
ncer
pat
hway
Scre
enin
gD
iagn
osis
Trea
tmen
tSu
rviv
orsh
ip
and
follo
w-u
p
ISO
/IEC
1702
1:20
11(c
0nt.)
PL (u
nder
IS
O 9
001:
2008
, IS
O14
001:
2004
, IS
O/IE
C TR
180
01:2
004)
The
who
le b
reas
t ca
ncer
pat
hway
––
Surg
ery,
radi
othe
rapy
, ch
emot
hera
py a
nd
horm
onal
ther
apy
Psyc
hoso
cial
car
e
SE (u
nder
IS
O 2
7001
:201
3,
ISO
900
1:20
08)
The
who
le b
reas
t ca
ncer
pat
hway
––
––
UK
(und
er
ISO
900
1:20
08,
ISO
270
01:2
013)
No
No
No
No
No
ISO
/IEC
1702
5:20
05ES
No
No
No
Radi
othe
rapy
, the
re
is o
ne l
abor
ator
y ac
cred
ited
for c
alib
ra-
tion
of th
e st
anda
rd
used
for t
hera
py le
v-el
s, G
amm
a ra
diat
ion
of C
obal
t 60,
0,8
1 G
y/m
in, C
MC=
0,8
%
No
FIN
oN
oAs
pira
tion
of fl
uid
and
subs
eque
nt te
stin
g,
biop
sy a
nd ti
ssue
hi
stol
ogy
No
No
GR
No
No
Labo
rato
ry’s
equ
ip-
men
t cal
ibra
tion.
Mol
ecul
ar a
nd c
ell
biol
ogy
test
s fo
r re
sear
ch u
se o
nly
(eg.
ce
ll vi
abili
ty te
st, g
ene
expr
essi
on a
naly
sis)
.
No
SEN
oO
rgan
ised
scr
eeni
ng
for a
sym
ptom
atic
w
omen
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue
hist
olog
y, m
olec
ular
bi
olog
y m
etho
ds, I
m-
mun
ohis
tolo
gy m
eth-
ods,
flow
cyt
omet
ry
No
Follo
w-u
p an
d
man
agem
ent o
f re
curr
ence
s
Annex III: Tables | 85
Table 3. (cont.)
ISO
sta
ndar
dCo
untr
ies
usin
g
the
stan
dard
The
who
le b
reas
t ca
ncer
pat
hway
Scre
enin
gD
iagn
osis
Trea
tmen
tSu
rviv
orsh
ip
and
follo
w-u
p
Clin
ical
Pa
thol
ogy
Accr
edit
atio
n st
anda
rd
UK
No
No
Aspi
ratio
n of
flui
d an
d su
bseq
uent
test
ing,
bi
opsy
and
tiss
ue
hist
olog
y
No
Follo
w-u
p an
d m
an-
agem
ent o
f re
cur-
renc
es, T
he s
ampl
ing
and
exam
inat
ion
of
aspi
rate
s an
d bi
opsi
es
durin
g fo
llow
-up
sur-
veill
ance
act
iviti
es
Imag
ing
Se
rvic
es
Accr
edit
atio
n Sc
hem
e
UK
No
No
Sym
ptom
atic
scr
een-
ing,
dia
gnos
tic m
am-
mog
raph
y, d
iagn
ostic
ul
tras
ound
and
oth
er
imag
ing
and
inte
r-ve
ntio
nal r
adio
logy
se
rvic
es
No
Follo
w-u
p an
d m
an-
agem
ent o
f re
cur-
renc
es, p
erio
dic
imag
-in
g an
d in
terv
entio
nal
radi
olog
y sc
reen
ing
to d
etec
t pot
entia
l re
curr
ence
86 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 4. Specific items of the screening stage addressed by the standard in place.
Questions:
• ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care.
• Is the screening stage addressed by the standard.• Items of the screening stage addressed by the standard.
Annex III: Tables | 87
Table 4. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
the
stan
dard
Is t
he s
cree
ning
sta
ge a
ddre
ssed
by
the
sta
ndar
dAr
e th
ese
item
s ad
dres
sed
by t
he s
tand
ard
Org
anis
ed s
cree
ning
fo
r as
ympt
omat
ic w
omen
O
ther
ISO
15
189:
2012
BE
No
NR*
–
CZN
oN
R*Co
lore
ctal
can
cer,
cerv
ix c
ance
r, pr
osta
te c
ance
r
DE
No
NR*
–
EEN
oN
R*–
ESYe
sYe
s–
FIN
oN
R*–
FRN
oN
R*–
GR
No
NR*
–
HR
No
NR*
–
IEN
oN
R*–
NL
No
Not
kno
wn
–
RSYe
sN
ot k
now
nG
enet
ic s
tudi
es-o
ne la
b is
acc
red-
ited
(exa
min
atio
n of
mut
atio
ns in
BR
CA-1
and
BRC
A-2
gene
)
SEYe
sYe
s–
UK
No
NR*
–
ISO
/IEC
1702
0:20
12D
EN
oN
R*–
FRYe
sN
R*Ac
cred
itatio
n of
insp
ectio
n bo
dies
fo
r med
ical
dev
ices
(mam
mog
ra-
phy)
ext
erna
l qua
lity
cont
rol
ISO
/IEC
1702
1:20
11AT
Yes
Not
kno
wn
–
BGN
oN
R*BA
S do
es n
ot h
ave
info
rmat
ion
rela
ted
to th
e to
pic
CZ
Yes
Yes
Colo
rect
al c
ance
r, ce
rvic
al c
ance
r, pr
osta
te c
ance
r
ES
Yes
Yes
–
FIYe
sYe
s–
GR
Yes
Yes
–
88 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 4. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
the
stan
dard
Is t
he s
cree
ning
sta
ge a
ddre
ssed
by
the
sta
ndar
dAr
e th
ese
item
s ad
dres
sed
by t
he s
tand
ard
Org
anis
ed s
cree
ning
fo
r as
ympt
omat
ic w
omen
O
ther
ISO
/IEC
1702
1:20
11(c
ont.)
ITYe
sYe
s–
LTYe
sYe
s–
PLYe
sN
ot k
now
n–
SEYe
sYe
s–
UK
No
NR*
–
ISO
/IEC
1702
5:20
05ES
No
NR*
Ther
e is
one
lab
orat
ory
accr
ed-
ited
for c
alib
ratio
n of
the
stan
dard
us
ed fo
r the
rapy
leve
ls, G
amm
a ra
diat
ion
of C
obal
t 60,
0,8
1 G
y/m
in, C
MC=
0,8
%
FIN
oN
R*–
GR
No
NR*
–
SEYe
sYe
s–
Clin
ical
Pa
thol
ogy
Accr
edit
atio
n st
anda
rd
UK
No
NR*
–
Imag
ing
Se
rvic
es
Accr
edit
atio
n Sc
hem
e
UK
No
NR*
–
* N
R: N
ot R
epor
ted.
Rel
evan
t dat
a w
as n
ot p
rovi
ded
or th
at th
e qu
estio
n w
as n
ot re
leva
nt ta
king
into
con
side
ratio
n th
e an
swer
s to
pre
viou
s qu
estio
ns.
Annex III: Tables | 89
Table 5. Specific items of the diagnosis stage addressed by the standard in place.
Questions:
• ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care.
• Is the diagnosis stage addressed by the standard.• Items of the diagnosis stage addressed by the standard.
90 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 5. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rdIs
the
dia
gnos
is
stag
e ad
dres
sed
by
the
sta
ndar
d
Scre
enin
g
Aspi
ratio
n of
flui
d an
d su
bseq
uent
tes
ting
Bi
opsy
and
tis
sue
hist
olog
yO
ther
ISO
15
189:
2012
BEYe
sN
ot k
now
nYe
sM
olec
ular
test
ing
to d
etec
t any
mut
atio
ns
caus
ing
brea
st c
ance
r or i
nflue
ncin
g tr
eatm
ent
(for
exa
mpl
e: H
ER2/
Neu
FIS
H: i
f po
sitiv
e, a
tr
eatm
ent w
ith h
erce
ptin
will
be
star
ted)
.
CZYe
sN
oYe
s–
DE
Yes
Yes
NR*
–
EEYe
sYe
sYe
sBR
CA1,
BRC
A2 te
sts
ESYe
sYe
sYe
sM
olec
ular
Pat
holo
gy: e
.g.;
HER
2
FIYe
sYe
sYe
s–
FRYe
sYe
sYe
s–
GR
Yes
Yes
Yes
Bloo
d m
arke
r tes
ts fo
r CA
15.3
, CA1
25, C
EA
(car
cino
embr
yoni
c an
tigen
)
HR
No
NR*
NR*
–
IEYe
sYe
sYe
s–
NL
Yes
Not
kno
wn
Yes
–
RSYe
sN
R*Ye
sCy
topa
thol
ogic
al e
xam
inat
ion
of b
iops
y-m
ono c
lona
l ant
ibod
y (1
lab)
SEYe
sYe
sYe
sM
olec
ular
bio
logy
met
hods
–Im
mun
o hi
stol
gy
met
hods
–Fl
ow c
ytom
etry
UK
Yes
Yes
Yes
–
ISO
/IEC
1702
0:20
12D
EYe
sN
R*Ye
s–
FRN
oN
R*N
R*–
ISO
/IEC
1702
1:20
11AT
Yes
Not
kno
wn
Not
kno
wn
–
BGN
oN
ot k
now
nN
ot k
now
nBA
S do
es n
ot h
ave
info
rmat
ion
rela
ted
to
the
topi
c
CZYe
sYe
sYe
s–
ESYe
sYe
sYe
sYe
s
FIN
oN
R*N
R*–
GR
Yes
Yes
Yes
–
Annex III: Tables | 91
Table 5. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rdIs
the
dia
gnos
is
stag
e ad
dres
sed
by
the
sta
ndar
d
Scre
enin
g
Aspi
ratio
n of
flui
d an
d su
bseq
uent
tes
ting
Bi
opsy
and
tis
sue
hist
olog
yO
ther
ISO
/IEC
1702
1:20
11(c
ont.)
ITYe
sYe
sYe
s–
LTYe
sYe
sYe
s–
PLYe
sN
ot k
now
nN
ot k
now
n–
SEYe
sYe
sYe
s–
UK
No
NR*
NR*
–
ISO
/IEC
1702
5:20
05ES
No
NR*
NR*
–
FIYe
sYe
sYe
s–
GR
Yes
No
No
Labo
rato
ry’s
equ
ipm
ent c
alib
ratio
n.
SEYe
sYe
sYe
sM
olec
ular
bio
logy
met
hods
–Im
mun
o hi
stol
gy
met
hods
–Fl
ow c
ytom
etry
Clin
ical
Pa
thol
ogy
Accr
edit
atio
n st
anda
rd
UK
Yes
Yes
Yes
–
Imag
ing
Se
rvic
es
Accr
edit
atio
n Sc
hem
e
UK
Yes
No
No
–
* N
R: N
ot R
epor
ted.
Rel
evan
t dat
a w
as n
ot p
rovi
ded
or th
at th
e qu
estio
n w
as n
ot re
leva
nt ta
king
into
con
side
ratio
n th
e an
swer
s to
pre
viou
s qu
estio
ns.
92 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 6. Specific items of the treatment stage addressed by the standard in place.
Questions:
• ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care.
• Is the treatment stage addressed by the standard.• Items of the treatment stage addressed by the standard.
Annex III: Tables | 93
Table 6. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rdIs
the
tre
atm
ent
stag
e ad
dres
sed
by
the
sta
ndar
d
Are
thes
e it
ems
addr
esse
d by
the
sta
ndar
d
Surg
ery
Brea
st
reco
nstr
ucti
onRa
diot
hera
pyCh
emot
hera
py a
nd
horm
onal
the
rapy
Oth
er
ISO
15
189:
2012
BEN
oN
R*N
R*N
R*N
R*–
CZN
oN
R*N
R*N
R*N
R*PE
T Ce
ntre
s
DE
No
NR*
NR*
NR*
NR*
–
EEN
oN
R*N
R*N
R*N
R*–
ESN
oN
R*N
R*N
R*N
R*–
FIN
oN
R*N
R*N
R*N
R*–
FRN
oN
R*N
R*N
R*N
R*–
GR
Yes
No
No
No
Yes
Bloo
d ce
ll co
unts
: w
hite
blo
od c
ells
, re
d bl
ood
cells
, he
mog
lobi
n, h
e-m
atoc
rit, p
late
lets
, bl
ood
chem
istr
y,
leve
ls o
f liv
er
enzy
mes
, le
vels
of
pot
assi
um,
chlo
ride,
and
ure
a ni
trog
en le
vels
, ca
lciu
m le
vels
, bl
ood
suga
r lev
els,
de
term
inat
ion
of d
rug
leve
ls in
bl
ood,
blo
od m
ark-
er te
sts
for C
A 15
.3, C
A125
, CEA
(c
arci
noem
bryo
nic
antig
en),
FISH
Tes
t (F
luor
esce
nce
In
Situ
Hyb
ridiz
atio
n),
mol
ecul
ar te
sts
for
mut
atio
n an
alys
is
(eg.
real
tim
e PC
R,
ARM
S PC
R, N
GS)
94 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 6. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rdIs
the
tre
atm
ent
stag
e ad
dres
sed
by
the
sta
ndar
d
Are
thes
e it
ems
addr
esse
d by
the
sta
ndar
d
Surg
ery
Brea
st
reco
nstr
ucti
onRa
diot
hera
pyCh
emot
hera
py a
nd
horm
onal
the
rapy
Oth
er
ISO
15
189:
2012
(con
t.)
HR
Yes
NR*
NR*
NR*
Yes
–
IEN
oN
R*N
R*N
R*N
R*–
NL
No
NR*
NR*
NR*
NR*
–
RSYe
sYe
sN
ot k
now
nYe
sYe
s–
Imm
unoc
hem
i-ca
l met
hods
(CA
15-3
; CEA
) (7
labs
)–
Cyto
path
olog
ical
ex
amin
atio
n of
bi-
opsy
-mon
oclo
nal
antib
ody
(1 la
b)
SEN
oN
R*N
R*N
R*N
R*–
UK
No
NR*
NR*
NR*
NR*
–
ISO
/IEC
1702
0:20
12D
EN
oN
R*N
R*N
R*N
R*–
FRN
oN
R*N
R*N
R*N
R*–
ISO
/IEC
1702
1:20
11AT
Yes
Not
kno
wn
Not
kno
wn
Not
kno
wn
Not
kno
wn
–
BGN
oN
ot k
now
nN
ot k
now
nN
ot k
now
nN
ot k
now
nBA
S do
es n
ot h
ave
info
rmat
ion
re-
late
d to
the
topi
c
CZYe
sYe
sYe
sYe
sYe
s–
ES
Yes
Yes
Yes
Yes
Yes
–
FIYe
sYe
sYe
sYe
sYe
s–
GR
No
NR*
NR*
NR*
NR*
–
IT
Yes
Yes
Yes
Yes
Yes
–
LT
Yes
Yes
Not
kno
wn
Yes
Yes
–
PL
Yes
Yes
Not
kno
wn
Yes
Yes
–
SE
Yes
Yes
Not
kno
wn
Not
kno
wn
Yes
–
UK
No
NR*
NR*
NR*
NR*
–
Annex III: Tables | 95
Table 6. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rdIs
the
tre
atm
ent
stag
e ad
dres
sed
by
the
sta
ndar
d
Are
thes
e it
ems
addr
esse
d by
the
sta
ndar
d
Surg
ery
Brea
st
reco
nstr
ucti
onRa
diot
hera
pyCh
emot
hera
py a
nd
horm
onal
the
rapy
Oth
er
ISO
/IEC
1702
5:20
05ES
Yes
NR*
NR*
Yes
NR*
Ther
e is
one
lab
o-ra
tory
acc
redi
ted
for c
alib
ratio
n of
th
e st
anda
rd u
sed
for t
hera
py le
vels
, G
amm
a ra
diat
ion
of C
obal
t 60,
0,8
1 Gy
/min
, CM
C=0,
8 %
FIN
oN
R*N
R*N
R*N
R*–
GR
Yes
No
No
No
No
Mol
ecul
ar a
nd c
ell
biol
ogy
test
s fo
r re
sear
ch u
se o
nly
(eg.
Cel
l via
bilit
y te
st, G
ene
expr
es-
sion
ana
lysi
s)
SEN
oN
R*N
R*N
R*N
R*–
Clin
ical
Pa
thol
ogy
Accr
edit
atio
n st
anda
rd
UK
No
NR*
NR*
NR*
NR*
–
Imag
ing
Se
rvic
es
Accr
edit
atio
n Sc
hem
e
UK
No
NR*
NR*
NR*
NR*
–
* N
R: N
ot R
epor
ted.
Rel
evan
t dat
a w
as n
ot p
rovi
ded
or th
at th
e qu
estio
n w
as n
ot re
leva
nt ta
king
into
con
side
ratio
n th
e an
swer
s to
pre
viou
s qu
estio
ns.
96 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 7. Specific items of the survivorship and management of recurrence stage addressed by the standard in place.
Questions:
• ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care.
• Is the survivorship and management of recurrence stage addressed by the standard.• Items of the survivorship and management of recurrence stage addressed by the standard.
Annex III: Tables | 97
Table 7. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rdIs
the
surv
ivor
ship
and
man
agem
ent
of r
ecur
renc
e st
age
addr
esse
d by
the
sta
ndar
d
Are
thes
e it
ems
addr
esse
d by
the
sta
ndar
d
Follo
w-u
p
and
man
agem
ent
of r
ecur
renc
e
Psyc
hoso
cial
ca
reSu
rviv
orsh
ip
supp
ort
Palli
ativ
e ca
re
and
end-
of-li
fe
care
Oth
er
ISO
15
189:
2012
BEN
oN
R*N
R*N
R*N
R*–
CZN
oN
R*N
R*N
R*N
R*–
DE
No
NR*
NR*
NR*
NR*
–
EEN
oN
R*N
R*N
R*N
R*–
ESN
oN
R*N
R*N
R*N
R*–
FIN
oN
R*N
R*N
R*N
R*–
FRN
oN
R*N
R*N
R*N
R*–
GR
Yes
Yes
No
No
No
–
HR
No
NR*
NR*
NR*
NR*
–
IEN
oN
R*N
R*N
R*N
R*–
NL
No
NR*
NR*
NR*
NR*
–
RSYe
sN
ot k
now
nN
oN
oN
o–
SEYe
sYe
sN
oN
oN
o–
UK
Yes
Yes
No
No
No
–
ISO
/IEC
1702
0:20
12D
EN
oN
R*N
R*N
R*N
R*–
FRN
oN
R*N
R*N
R*N
R*–
ISO
/IEC
1702
1:20
11AT
N
oN
R*N
R*N
R*N
R*–
BGN
oN
ot k
now
nN
ot k
now
nN
ot k
now
nN
ot k
now
nBA
S do
es n
ot h
ave
info
rmat
ion
re-
late
d to
the
topi
c
CZYe
sYe
sN
ot k
now
nN
ot k
now
nYe
s–
ESYe
sYe
sYe
sYe
sYe
s–
FIN
oN
R*N
R*N
R*N
R*–
GR
No
NR*
NR*
NR*
NR*
–
ITYe
sYe
sYe
sYe
sYe
s–
LTN
oN
ot k
now
nN
ot k
now
nN
ot k
now
nN
ot k
now
n–
98 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 7. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rdIs
the
surv
ivor
ship
and
man
agem
ent
of r
ecur
renc
e st
age
addr
esse
d by
the
sta
ndar
d
Are
thes
e it
ems
addr
esse
d by
the
sta
ndar
d
Follo
w-u
p
and
man
agem
ent
of r
ecur
renc
e
Psyc
hoso
cial
ca
reSu
rviv
orsh
ip
supp
ort
Palli
ativ
e ca
re
and
end-
of-li
fe
care
Oth
er
ISO
/IEC
1702
1:20
11(c
ont.)
PL
Yes
Not
kno
wn
Yes
No
No
–
SEYe
sYe
sN
ot k
now
nN
ot k
now
nN
ot k
now
n–
UK
No
NR*
NR*
NR*
NR*
–
ISO
/IEC
1702
5:20
05ES
No
NR*
NR*
NR*
NR*
–
FIN
oN
R*N
R*N
R*N
R*–
GR
No
NR*
NR*
NR*
NR*
–
SEYe
sYe
sN
oN
oN
o–
Clin
ical
Pa
thol
ogy
Accr
edit
atio
n st
anda
rd
UK
Yes
Yes
No
No
No
The
sam
plin
g an
d ex
amin
atio
n of
asp
irate
s an
d bi
opsi
es d
urin
g fo
llow
-up
surv
eil-
lanc
e ac
tiviti
es
Imag
ing
Serv
ices
Ac-
cred
itat
ion
Sche
me
UK
Yes
Yes
No
No
No
Perio
dic
imag
ing
and
inte
rven
tiona
l ra
diol
ogy
scre
enin
g to
det
ect p
oten
tial
recu
rren
ce
* N
R: N
ot R
epor
ted.
Rel
evan
t dat
a w
as n
ot p
rovi
ded
or th
at th
e qu
estio
n w
as n
ot re
leva
nt ta
king
into
con
side
ratio
n th
e an
swer
s to
pre
viou
s qu
estio
ns.
Annex III: Tables | 99
Table 8. STransversal items of breast cancer addressed by the standard in place.
Questions:
• ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care.
• Transversal items covered by the standard.
100 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 8. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rd
Mammography
Ultrasound
MRI
Pathology
Laboratory tests
Medication man-agement
Communication
Information sys-tems
Quality management
Proficiency testing
Personal compet- ence requirements
Hygiene
Safety
Research
Oth
er
ISO
15
189:
2012
BEN
oN
oN
oYe
sYe
sYe
sN
oN
oYe
sN
oYe
sN
oN
oN
oN
o
CZN
oN
oN
oYe
sYe
sN
ot
know
nN
oN
oN
oN
oN
oN
ot
know
nN
ot
know
nN
oN
o
DE
NR*
NR*
NR*
NR*
Yes
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
–
EEN
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*–
ESN
oN
oN
oYe
sYe
sN
oN
ot
know
nYe
sYe
sYe
sYe
sYe
sYe
sN
oN
o
FIN
oN
oN
oYe
sYe
sN
oYe
sYe
sYe
sYe
sYe
sYe
sYe
sN
oN
o
FRN
oN
oN
oYe
sYe
sN
oN
oN
oN
oN
oN
oN
oN
oN
o–
GR
No
No
No
No
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
–
HR
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
–
IEN
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*–
NL
NR*
No
No
No
No
No
No
No
Not
kn
own
Yes
No
Not
kn
own
Not
kn
own
Not
kn
own
No
RSN
oN
oN
oYe
sYe
sN
ot
know
nN
oN
oN
oYe
sYe
sYe
sYe
sYe
s–
SEYe
sYe
sN
ot
know
nYe
sYe
sYe
sN
ot
know
nYe
sYe
sN
ot
know
nYe
sYe
sN
ot
know
nN
ot
know
nN
o
UK
No
No
No
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
ISO
/IEC
1702
0:20
12D
EN
R*N
R*N
R*Ye
sN
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*N
R*–
FRYe
sN
oN
oN
oN
oN
oN
oN
oN
oN
oN
oN
oN
oN
oN
o
ISO
/IEC
1702
1:20
11AT
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
Not
kn
own
–
BGN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nBA
S do
es n
ot
have
info
rma-
tion
rela
ted
to
the
topi
c
Annex III: Tables | 101
Table 8. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rd
Mammography
Ultrasound
MRI
Pathology
Laboratory tests
Medication man-agement
Communication
Information sys-tems
Quality management
Proficiency testing
Personal compet- ence requirements
Hygiene
Safety
Research
Oth
er
ISO
/IEC
1702
1:20
11(c
0nt.)
CZYe
sYe
sYe
sN
ot
know
nN
ot
know
nN
ot
know
nN
oYe
sYe
sN
oN
oN
ot
know
nN
ot
know
nN
oN
o
ESYe
sYe
sYe
sYe
sYe
sN
ot
know
nN
ot
know
nN
ot
know
nYe
sN
ot
know
nYe
sYe
sYe
sN
ot
know
n–
FIYe
sN
oN
oN
oN
oYe
sYe
sYe
sYe
sN
oYe
sYe
sYe
sN
oN
o
GR
Yes
Yes
Yes
No
Yes
No
No
No
Yes
No
Yes
Yes
Yes
No
No
ITYe
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sN
o
LTYe
sYe
sYe
sN
ot
know
nYe
sYe
sYe
sYe
sYe
sN
ot
know
nYe
sN
ot
know
nN
ot
know
nN
ot
know
n–
PLYe
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sN
ot
know
nYe
sYe
sYe
sYe
s–
SEYe
sYe
sN
ot
know
nYe
sYe
sYe
sN
ot
know
nYe
sYe
sN
ot
know
nYe
sYe
sN
ot
know
nN
ot
know
nN
o
UK
(und
er
ISO
900
1)N
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nYe
sN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
nN
ot
know
n–
UK
(und
er
ISO
270
01)
No
No
No
No
No
No
Not
kn
own
Yes
No
No
No
No
No
No
No
ISO
/IEC
1702
5:20
05ES
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
NR*
–
FIN
oN
oN
oYe
sYe
sN
oYe
sYe
sYe
sYe
sYe
sYe
sYe
sN
oN
o
GR
No
No
No
No
Yes
No
No
No
Yes
Yes
Yes
No
No
Yes
Equi
pmen
t ca
libra
tion
and
met
rolo
gica
l tr
acea
bilit
y
SEYe
sN
oN
oYe
sYe
sN
oN
ot
know
nN
oYe
sYe
sYe
sN
oN
ot
know
nN
ot
know
nN
o
102 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe
Table 8. (cont.)
ISO
sta
ndar
dCo
untr
y us
ing
th
e st
anda
rd
Mammography
Ultrasound
MRI
Pathology
Laboratory tests
Medication man-agement
Communication
Information sys-tems
Quality management
Proficiency testing
Personal compet- ence requirements
Hygiene
Safety
Research
Oth
er
Clin
ical
Pa
thol
ogy
Accr
edit
atio
n st
anda
rd
UK
No
No
No
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Sam
plin
g an
d te
stin
g m
ay b
e do
ne
spec
ifica
lly a
s a
poin
t-of
car
e ac
tivity
Imag
ing
Se
rvic
es
Accr
edit
atio
n Sc
hem
e
UK
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
The
stan
dard
is
des
igne
d to
be
app
lied
to
all c
urre
ntim
agin
g m
odal
ities
and
to in
terv
entio
nal r
adio
logy
ser
vice
s: g
ener
al x
-ray
; ultr
asou
nd; c
ompu
ted
tom
ogra
phy;
inte
rven
tiona
l rad
iolo
gy; m
agne
tic
reso
nanc
e im
agin
g ; d
ual e
nerg
y x-
ray
abso
rptio
n; ra
dion
uclid
e im
agin
g; s
ympt
omat
ic b
reas
t mam
mog
raph
y. N
on-i
mag
ing
aspe
cts
of N
ucle
ar
Med
icin
e (in
clud
ing
radi
opha
rmac
y) a
nd a
sym
ptom
atic
bre
ast s
cree
ning
ser
vice
s ar
e no
t cur
rent
ly in
clud
ed in
the
scop
e of
this
sta
ndar
d
* N
R: N
ot R
epor
ted.
Rel
evan
t dat
a w
as n
ot p
rovi
ded
or th
at th
e qu
estio
n w
as n
ot re
leva
nt ta
king
into
con
side
ratio
n th
e an
swer
s to
pre
viou
s qu
estio
ns.
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European Commission
EUR 27382 EN – Joint Research Centre – Institute for Health and Consumer Protection
Title: Report of a survey on accreditation and conformity assessment in the field of breast cancer in Europe
Author(s): Aslı Ulutürk, Silvia Deandrea, Donata Lerda, Jesús López Alcalde, Luciana Neamtiu, Zuleika Saz-Parkinson
Luxembourg: Publications Office of the European Union
2015 – 102 pp. – 21.0 x 29.7 cm
EUR – Scientific and Technical Research series – ISSN 1831-9424 (online) – ISSN 1018-5593 (print)
ISBN 978-92-79-50318-4 (pdf)
ISBN 978-92-79-50334-4 (print)
doi:10.2788/15049
JRC Mission
As the Commission’sin-house science service,the Joint Research Centre’smission is to provide EUpolicies with independent,evidence-based scientificand technical supportthroughout the wholepolicy cycle.
Working in closecooperation with policyDirectorates-General,the JRC addresses keysocietal challenges whilestimulating innovationthrough developing newmethods, tools andstandards, and sharingits know-how withthe Member States,the scientific communityand international partners.
Serving societyStimulating innovationSupporting legislation
LB-NA-27382-EN
-N
doi:10.2788/15049ISBN 978-92-79-50318-4