ISO/IEC 17011:2004 Section 4: Accreditation Body APLAC Lead Evaluator /17011 … · 2019. 6. 18. · 3 Page 3 13 ISO/IEC 17011:2004 Section 4.3: Impartiality 4.3.1 Objectivity and

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APLAC APLAC Lead Evaluator /17011Lead Evaluator /17011

WorkshopWorkshopTokyo, 22Tokyo, 22--24 April 200524 April 2005

Barry Ashcroft (IANZ)Barry Ashcroft (IANZ)

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 4: Accreditation BodySection 4: Accreditation Body

4.14.1 Legal responsibilityLegal responsibility4.24.2 Structure of the ABStructure of the AB4.34.3 Impartiality requirements and Related Impartiality requirements and Related

BodiesBodies4.44.4 ConfidentialityConfidentiality4.54.5 Liability and financesLiability and finances4.64.6 Accreditation activities and extensionAccreditation activities and extension

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 4.1: Legal responsibilitySection 4.1: Legal responsibility

4.14.1 Legal ResponsibilityLegal ResponsibilityØ registered legal entity?

Note:Note: Is the governmental AB identified in Is the governmental AB identified in such a way that no conflict of interest such a way that no conflict of interest with governmental CABs can occur?with governmental CABs can occur?

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 4.2: StructureSection 4.2: Structure

4.24.2.1.1 Does the structure and operation Does the structure and operation give confidence in its give confidence in its accreditations?accreditations?

•• Do you and your team have confidence in the AB’s Do you and your team have confidence in the AB’s accreditations?accreditations?

•• If not, is it because of the structure? Or the If not, is it because of the structure? Or the operation?operation?

•• You will need more than just this (supporting) You will need more than just this (supporting) clause!clause!

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4.2.24.2.2 Does the AB have both the Does the AB have both the authorityauthority and responsibility for its and responsibility for its accreditation accreditation decisionsdecisions??

Accreditation decisionsAccreditation decisions defined as granting, defined as granting, maintaining, extending, reducing, suspending and maintaining, extending, reducing, suspending and withdrawal.withdrawal.

•• Does the AB really make the decision? Or is some Does the AB really make the decision? Or is some other interested party making it for them? other interested party making it for them?

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4.2.34.2.3 Legal status Legal status descriptiondescription??Ø Names of owners/controllers?

•• Are nonAre non--governmental ABs transparent over governmental ABs transparent over their status?their status?

•• Are you and your team clear over who has Are you and your team clear over who has governance authority and responsibility?governance authority and responsibility?

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4.2.44.2.4 Duties, responsibilities and Duties, responsibilities and authorities documented for …authorities documented for …

Ø senior AB management?Ø other personnel associated with the

AB who could affect the quality of the accreditation?

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Top managementTop managementØ Job descriptionsØ Specified in process procedures

Other personnel Other personnel –– who are these people?who are these people?•• AssessorsAssessors•• Technical committees (criteria setters)Technical committees (criteria setters)•• Peer reviewers/decision makersPeer reviewers/decision makers

Ø Specified in terms of reference, process procedures, appointment documentation and the like

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4.2.54.2.5 Identified management having Identified management having authority and responsibility for …authority and responsibility for …

Ø Operational policyØ Supervising implementation of policy and

proceduresØ Financial supervisionØ Accreditation decisionsØ ContractsØ Delegations for defined activities

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4.2.64.2.6 Access to Access to expertiseexpertise for advice for advice directly directly relating to accreditationrelating to accreditation

ØØ Is the AB operating in a vacuum?Is the AB operating in a vacuum?ØØ Does it have a mechanism for technical and Does it have a mechanism for technical and

administrative input from stakeholders and administrative input from stakeholders and interested parties?interested parties?

ØØ Is this input competent and valid? Is this input competent and valid? ØØ Does it cover the scope of accreditation activity?Does it cover the scope of accreditation activity?

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4.2.74.2.7 CommitteesCommitteesØØ Formal rules for appointmentFormal rules for appointmentØØ Terms of referenceTerms of referenceØØ Rules of operationRules of operationØØ All members identifiedAll members identified

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4.2.84.2.8 Documented structureDocumented structureØØ EntireEntire structurestructure

• AB entity, committees, assessors, related bodies, relationship to Government

ØØ Clear lines of Clear lines of authorityauthority and responsibilityand responsibility• Authority and responsibility not necessarily the

same• Requires a combination of organisation chart

and specified authorities and responsibilities (clause 4.2.4, 4.2.5)

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 4.3: ImpartialitySection 4.3: Impartiality

4.3.14.3.1 Objectivity and impartiality Objectivity and impartiality safeguardedsafeguarded

ØØ by the way it is organisedby the way it is organisedØØ by the way it is operated by the way it is operated

• The rest of 4.3 gives guidance on what this actually means

• Evaluation teams are going to need concise evidence arising from the operation of the AB to cite this clause in evaluation findings

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4.3.24.3.2 Involvement of interested Involvement of interested parties(1)parties(1)

Ø Does the structure (4.2.8) allow for this?Ø Are the interested parties identified? e.g.

• Accredited CABs• Organisations representing CABs• Direct customers of CABs• Regulators/Government• etc.

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Ø Is there a balanced representation from all stakeholders in the particular accreditation activity?

• The accreditation system must not be used to progress the “agenda” of any particular party, thereby rendering it partial.

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Ø Are the interested parties given the opportunity to effectively contribute to …

• operational policy development and maintenance?

• maintenance of impartiality?

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4.3.34.3.3 NonNon--discriminatory …discriminatory …Ø policies and proceduresØ in actual operation

Within the declared scope of accreditation Within the declared scope of accreditation services (4.6.1) and AB rules …services (4.6.1) and AB rules …Ø All applications acceptedØ Independent of size, affiliation, # of already

accredited CABs

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4.3.44.3.4 AB personnel and committeesAB personnel and committees(includes assessors)(includes assessors)

Ø … shall act objectivelyØ … shall be free from undue pressures that

could compromise impartiality

• Difficult to evaluate and even more difficult to detect with objective evidence.

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4.3.54.3.5 Accreditation decisions Accreditation decisions by …by …Ø competent personsØ different from the assessment team

• What sort of competencies? Technically matched to the applicant (like the assessment team)?

• Performance and competencies will need to be monitored (6.3.1).

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4.3.64.3.6(a)(a) No No CAB CAB activity …activity …Ø not offered nor provided, which affects its

impartiality• CAB defined (s3.10) as providing services that can

be the object of accreditation• Scope (s1) further defines as testing, inspection,

certification (x3), calibration• MR001 (s3.2.1.7) defines as covered by an ILAC or

IAF MRA; related bodies excepted (s3.2.1.8)

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4.3.64.3.6(b)(b) No consultancyNo consultancyØ nor linked to any consultancy

• So where does this leave training services?• Consultancy defined (s3.11) and suggests direct

participation of CAB activities and/or specific (rather than generic) advice or training.

• Many ABs push this to the limit in their day to day activities.

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4.3.74.3.7 Related bodies … (1)Related bodies … (1)Ø … who are separate legal entities, linked by

common ownership or contractual arrangements to the AB, or

Ø … for a governmental AB, is a separate part of government, and

Ø … whose activities do not compromise the confidentiality, objectivity and impartiality of the AB

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4.3.74.3.7 Related bodies … (2)Related bodies … (2)Ø …may offer consultancy or be an accredited

CAB if …• different top management to the AB (for

s4.2.5)• different personnel to the accreditation

decision makers• cannot influence assessment outcomes• different name, logo and symbols

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4.3.74.3.7 Related bodies … (3)Related bodies … (3)Ø The AB must, with the involvement of

interested parties (s4.3.2), …• identify, analyse and document …• related body relationships to determine all

possible conflicts of interest …• and action where these are identified.

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4.34.3 Impartiality Summary (1)Impartiality Summary (1)Ø The AB must a clearly defined legal entity,

structurally and legally separated from its related bodies.

Ø The AB itself cannot provide testing, calibration, inspection, or certification activities, nor consultancy.

Ø The AB must be transparent in its relationships with its related bodies.

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4.34.3 Impartiality Summary (2)Impartiality Summary (2)ØØ Possible difficulties in interpretation …Possible difficulties in interpretation …

• Accreditation decision vs. signing the accreditation certificate?

• What is “a separate part of government”?• What is an accreditable conformity assessment

activity and what isn’t?• … and many more!!!

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4.34.3 Impartiality Summary (3)Impartiality Summary (3)ØØ Evaluation teams will need to place priority Evaluation teams will need to place priority

on collecting facts, and if necessary, allow on collecting facts, and if necessary, allow the MRA Council to establish interpretation the MRA Council to establish interpretation through precedence.through precedence.

ØØ Rash decisions by impartiality idealists may Rash decisions by impartiality idealists may have wide reaching, and possibly have wide reaching, and possibly unnecessary, implications.unnecessary, implications.

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 4.4: ConfidentialitySection 4.4: Confidentiality

4.44.4 Confidentiality (of information obtained)Confidentiality (of information obtained)Ø …adequate arrangements …at all levels• committees• external bodies (interested parties)• individuals (AB staff, external assessors)Ø … no disclosure without written consent of

CAB• except where law requires

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 4.5: Liability and financingSection 4.5: Liability and financing

4.5.14.5.1 Liability Liability Ø … arrangements to cover liabilities arising

from its activities.• “… arrangements” could amount to anything?• Evaluation teams are not asked to judge

adequacy of these “arrangements”.

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 4.5: Liability and financingSection 4.5: Liability and financing

4.5.24.5.2 FinancesFinancesØ description of source of incomeØ documents to show the AB has the financial

resources required to operate

• Difficult to evaluate without knowledge of the costs of doing business in the domestic economy.

• Are they going broke? Are accreditation activities not being done through lack of resources?

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 4.6: Accreditation activitySection 4.6: Accreditation activity

4.6.14.6.1 Accreditation activities descriptionAccreditation activities descriptionØ … with reference to the accreditation

standards• MR001: 17025, 15189, 17020• Should include other domestic standards (e.g.

regulatory), or international standards (e.g. WADA, Bluetooth), where relevant

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4.6.24.6.2 Application/guidance documentsApplication/guidance documentsØ … prepared by competent personsØ … interested party participationØ … international documents encouraged

• Non-mandatory, but where used should not be prepared in isolation without competent stakeholder input

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4.6.34.6.3 Extension of activities …Extension of activities …Ø including responding to interested party

requirementsØ have established procedures e.g.• analysis of current resources in new field• access to expertise elsewhere• application/guidance document requirements• assessor selection, training• AB staff training

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ISO/IEC 17011 Section 5 Management

Peter UngerA2LA President

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ISO/IEC 17011:2004Section 5: Management

5.1 General

5.2 Management system

5.3 Document control

5.4 Records

5.5 Nonconformities and corrective actions

5.6 Preventive actions

5.7 Internal audits

5.8 Management reviews5.9 Complaints

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ISO/IEC 17011:2004Section 5.1: General

5.1.1 Maintain a management system and continually improve its effectiveness

• How do we measure continual improvement and what happens if improvement is not continual?

5.1.2 Procedures documented based on formulated policies whenever suitable

• Who determines suitability?

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ISO/IEC 17011:2004Section 5.2: Management system

5.2.1 Top management defines policies and objectives; ensure effective communication with interested parties; ensure policies are understood; objectives should be measurable

• What is effective communication?• How do we determine whether policies are understood?• What are some objectives one might find and how do we

measure them?• What if signatories do not refer to MRA obligations in

their policies?

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ISO/IEC 17011:2004Section 5.2: Management system

5.2.2 Operate an appropriate system; accessible to its personnel; ensure effective implementation of procedures

• Who defines “appropriate”?

• What is the scope of “personnel” that need access?

5.2.3 Top management appoints manager who shall have authority and responsibility to: ensure procedures for the management system are established; report to top management on any need for improvement

• Does this manager have to have his/her authority and responsibility defined in a job description?

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ISO/IEC 17011:2004Section 5.3: Document control

5.3.1 Procedures to control all internal and external documents:

a) approve for adequacy prior to issue

b) review and update

c) changes are identified

d) relevant versions are available

e) documents are legible and readily identifiable

f) prevent unintended use of obsolete documents

g) safeguard confidentiality

• Can anyone ever have a perfect document control system on a continual basis?

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ISO/IEC 17011:2004Section 5.4: Records

5.4.1 Procedures for ID, collection, indexing, accessing, filing, storage maintenance and disposal of records

5.4.2 Procedures for retaining records; access consistent with confidentiality arrangements

• Can we have one procedure for all records?

• What does “indexing” mean?

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ISO/IEC 17011:2004Section 5.5: Nonconformities and

corrective actions5.5 Procedures for management of NCs in its

own operations; where necessary, eliminate causes; corrective actions appropriate to the impact of problems

• When is it ever not “necessary” to eliminate causes of NCs?

• How do we determine “appropriateness” of corrective action?

• What is “timely” corrective action?

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ISO/IEC 17011:2004Section 5.6: Preventive actions

5.6 Procedures for ID of opportunities for improvement and to take preventive action to eliminate preventive actions appropriate to the impact of problems

• How do we determine “appropriateness” of preventive action?

• Do we conclude that preventive action is not effective if a previously envisioned potential NC actually does occur?

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ISO/IEC 17011:2004Section 5.7: Internal audits

5.7.1 Establish internal audit procedures to verify conformity to 17011 requirements and implementation of management system

• Any questions about this simple requirement?

• Is it OK to have one documented procedure for both internal audits and management review?

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5.7.2 Internal audit normally performed annually; frequency can be reduced if system is effectively implemented and stable; audit programme shall be planned, taking into consideration importance of each activity and results from previous audits

• What evidence could be used to establish “proven stability”?

• Do all areas of the management system have to be covered at least annually if prior audits indicate only minor nonconformities but good stability?

• Is it OK to simply audit all areas once per year and not take into account the importance and stability of each area?

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5.7.3 The AB shall ensure:a) qualified personnel conduct audits;

b) different from those who perform activity;c) personnel involved are informed of outcome;

d) actions taken are in a timely and appropriate manner; ande) opportunities for improvement are identified.• What evidence of qualifications could be used?

• What is the expectation with regard to “timely and appropriate manner”?

• What if no “opportunities for improvement” are identified during a given audit?

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ISO/IEC 17011:2004Section 5.8: Management reviews

5.8.1 Establish procedures to review its management system at planned intervals to ensure it continued adequacy and effectiveness; should be conducted normally at least once a year

• If there is evidence of management system NCs, does this automatically justify an NC against this clause as well?

• What would constitute an unacceptable “planned interval”?

• What is one to conclude if management reviews are not conducted once per year?

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5.8.2 Inputs to reviews, where available, current performance and improvement opportunities related to the 12 items listed.

• How do we determine whether a management review considered all 12 items, where relevant?

• What could be considered matters re “fulfilment of objectives”?

• Noting the definition of “appeals” is it sufficient to only review appeals to final decisions?

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5.8.3 Outputs to reviews shall include actions related to:

a) Improvement of system and its processes;

b) Improvement of services and accreditation process;c) need for resources;

d) defining/redefining policies, goals and objectives

• How do we determine improvements of services and accreditation process?

• What is the difference between a “goal” and an “objective”?

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ISO/IEC 17011:2004Section 5.9: Complaints

5.9 Establish procedures for dealing with complaints. The AB shall:

a) Decide on validity of the complaint;b) Where appropriate, ensure the complaint is first addressed

by CAB;c) Take appropriate actions and assess their effectiveness;

d) Respond to the complainant• Who decides on what is a “valid” complaint? Can we

second guess?• When is it not “appropriate” to have the CAB address the

complaint?• What would be expect to find re assessment of

effectiveness of the “appropriate actions” ?

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 6: Human ResourcesSection 6: Human Resources

6.16.1 Associated with the ABAssociated with the ABØ Includes AB staff and external

personnel6.26.2 Involved in the accreditation Involved in the accreditation

processprocess6.36.3 Monitoring of personnelMonitoring of personnel6.46.4 RecordsRecords

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 6.1: AB & assoc. personnelSection 6.1: AB & assoc. personnel

6.1.16.1.1 … sufficient number of … sufficient number of competent competent personnel … for the type, range and personnel … for the type, range and volume of work (1)volume of work (1)

ØØ Internal Internal (AB staff)(AB staff)• management• administrative• technical (assessors, experts, committees)• permanent/temporary; full/part time

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ØØ External External personnelpersonnel• Technical (assessors, experts, committees)• Generally contracted (temporary, part time)

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ØØ Competent?Competent?• Education and training• Technical knowledge, accreditation knowledge• Skills and experience• MR001, s3.2.1.3 – experienced management

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6.1.16.1.1 … sufficient number of … sufficient number of competentcompetentpersonnel … for the type, range and personnel … for the type, range and volume of work (4)volume of work (4)

ØØ Sufficient number?Sufficient number?• Depends on mode of operation of the AB• Assessments/assessor/year/field of technology• AB staff turnover• External assessor/expert recruitment• Expansion of accreditation activities

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ØØ Type, range and volume of work?Type, range and volume of work?• Restrict yourself to scope of evaluation• Types/technologies of testing/inspection• Number of CABs in each• Typical assessment length and frequency in

each

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6.1.26.1.2 … sufficient … sufficient assessorsassessors for all for all activities.activities.Ø Lead AssessorsØ AssessorsØ Experts• Can be internal AB staff or external• Analyse as per 6.1.1

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6.1.36.1.3… clear indication of extent/limitations … clear indication of extent/limitations of duties, responsibilities and of duties, responsibilities and authoritiesauthorities

ØØ Each/all persons Each/all persons (associated with the AB)(associated with the AB)•• Internal Internal –– management, administrative, management, administrative,

assessors/assessors/expertsexperts/committees /committees e.g. job e.g. job descriptions, procedure manualsdescriptions, procedure manuals

•• External External –– assessors/assessors/expertsexperts/committees e.g. /committees e.g. contracts, terms of referencecontracts, terms of reference

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6.1.46.1.4 … signed declaration of compliance … signed declaration of compliance with AB rules e.g.with AB rules e.g.

ØØ confidentialityconfidentialityØØ independence/impartiality/conflicts of interest, independence/impartiality/conflicts of interest,

including associations (past or present) with including associations (past or present) with the CABthe CAB

•• Internal Internal –– management, administrative, technicalmanagement, administrative, technical•• External External –– assessors/assessors/expertsexperts//committeescommittees

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 6.2: Acc. Process & PeopleSection 6.2: Acc. Process & People

6.2.16.2.1 “… each activity in the accreditation “… each activity in the accreditation process …”(1) process …”(1) includes:includes:

ØØ Application and reviewApplication and reviewØØ Subcontracting (where applicable)Subcontracting (where applicable)ØØ Assessment team and arrangementsAssessment team and arrangementsØØ Document reviewDocument reviewØØ OnOn--site assessmentsite assessmentØØ Reporting and followReporting and follow--upupØØ Accreditation decision and granting/continuationAccreditation decision and granting/continuation

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6.2.16.2.1“… each activity in the accreditation “… each activity in the accreditation process …”(2)process …”(2)Ø a description of qualifications, experience

and competence required• i.e. a position description for technical

administrators, assessors/experts, decision makers

Ø a description of initial and on-going training required

• applying to all personnel in the process, not just assessors/experts

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6.2.26.2.2 For assessors and For assessors and expertsexperts, , procedures for …procedures for …Ø selectionØ trainingØ formally approving• suggests experts need to be trained?• level of training not specified (defined by the

procedures required?)

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6.2.36.2.3 For assessors and experts, For assessors and experts, specific scopes to be able to assessspecific scopes to be able to assess::Ø are identified• How specific are “specific scopes”?Ø have demonstrated competence• How is competence to be demonstrated? To

what level?

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6.2.46.2.4 For assessors For assessors and expertsand experts, must , must have (1) …have (1) …Ø familiarity with process/procedures, criteria,

other• Which are relevant for experts?Ø relevant accreditation assessor training• Needed for assessors, but is it relevant for

experts?• What training is relevant?

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6.2.46.2.4 For assessors For assessors and expertsand experts, must , must have (2) …have (2) …Ø thorough knowledge of relevant

assessment methods• Needed for assessors, but is it relevant for

experts?Ø written and oral communicationØ appropriate personal attributes• How to evaluate this?

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 6.3: MonitoringSection 6.3: Monitoring

6.3.16.3.1 Monitor performance Monitor performance and and competence …competence …Ø of the assessment personnel (s6.3.2)Ø of the decision-making process personnel• How to do this?Ø by established proceduresØ to identify training needsØ … and to ensure overall satisfactory

performance of the process

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 6.3: MonitoringSection 6.3: Monitoring

6.3.26.3.2 AssessorAssessor performance monitoringperformance monitoringØ by on-site observation (minimum 3 years,

unless evidence to show otherwise satisfactory)

• What other evidence?Ø and/or e.g. assessment report peer reviews,

CAB feedback, monitoring by non-AB peersØ requires feedback loop to improve

performance• What about experts? Formal on-site monitoring not

required?

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 6.4: Personnel RecordsSection 6.4: Personnel Records

6.4.16.4.1 For each person in accreditation For each person in accreditation processprocess (1) ….(1) ….Ø Includes all involved in …• Application and review• Subcontracting (where applicable)• Assessment team and arrangements• Document review• On-site assessment• Reporting and follow-up• Accreditation decision and granting/continuation

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6.4.16.4.1 For each person in accreditation For each person in accreditation processprocess (2) ….(2) ….Ø relevant qualifications, training, experience

and competence• competence records in decision making?Ø up-to-date training, experience and

monitoring records• to demonstrate implementation of s6.3

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6.4.26.4.2 For assessors For assessors and expertsand experts (1)(1)Ø Name, address, position in organisation

(internal or external)Ø QualificationsØ Work experienceØ Training• Management (quality) systems• Assessment (audit) techniques• Calibration/testing/inspection

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6.4.26.4.2 For assessors For assessors and expertsand experts (2)(2)Ø Specific scope/task competenciesØ Assessment experienceØ Monitoring results

Ø Are they up-to-date?

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 8: AB & CAB ResponsibilitiesSection 8: AB & CAB Responsibilities

4.14.1 Obligations of the CABObligations of the CAB4.24.2 Obligations of the ABObligations of the AB4.34.3 Reference to accreditation and use of Reference to accreditation and use of

symbolssymbols

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 8.1: CAB ObligationsSection 8.1: CAB Obligations

8.1.18.1.1 Acc./applicant CABs must: (1) Acc./applicant CABs must: (1) Ø commit to continually fulfil accreditation

requirements• within accreditation scope• includes adapting to changes

Ø accommodate and cooperate with AB for verification purposes• includes all site where activities take place

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8.1.1 8.1.1 Acc./applicant CABs must: (2)Acc./applicant CABs must: (2)Ø provide access to information as necessary

for verification purposes, including• Information on related bodies w.r.t.

independence, impartiality

Ø arrange witnessing when requestedØ pay fees

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8.1.1 8.1.1 Accredited CABs must: (3)Accredited CABs must: (3)Ø claim accreditation only within scopeØ not use accreditation to bring the AB into

disrepute

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8.1.28.1.2 Accredited CABs must inform the Accredited CABs must inform the AB …. (1)AB …. (1)

Ø without delay• What does this mean?Ø of significant changes w.r.t. …• And what is significant?

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8.1.28.1.2 Accredited CABs must inform the Accredited CABs must inform the AB of changes to …. (2)AB of changes to …. (2)

Ø its legal status, commercial status, ownership status, organisational status

Ø its organisation, senior management, key personnel

Ø its main policiesØ its resources and premises

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8.1.28.1.2 Accredited CABs must inform the Accredited CABs must inform the AB of changes to …. (2)AB of changes to …. (2)

Ø its scope of accreditationØ anything that may affect ability to fulfil

accreditation requirements

Show me an accredited laboratory or inspection Show me an accredited laboratory or inspection body who remembers what they’ve agreed!body who remembers what they’ve agreed!

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 8.2: AB ObligationsSection 8.2: AB Obligations

8.2.18.2.1 Accreditation DirectoryAccreditation DirectoryØ Publicly availableØ Up-to-dateØ Name and addressØ Date of granting and/or expiry date

• as applicable

Ø Accreditation scope• in full or condensed (with access to full scope)

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8.2.28.2.2 Measurement traceability Measurement traceability informationinformation

Ø shall be availableØ w.r.t. accreditation scope offered

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8.2.38.2.3 International arrangements International arrangements informationinformation

Ø shall be provided when involved and where applicable

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8.2.48.2.4 Notice of changes to accreditation Notice of changes to accreditation requirementsrequirements

Ø shall consider views of interested partiesØ decision on precise form and effective date

of changes must be publishedØ shall give due notice

• How long is “due notice”?Ø shall verify each accredited CAB has

implemented the changes• When should this take place?

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ISO/IEC 17011:2004ISO/IEC 17011:2004Section 8.3: Accreditation & SymbolsSection 8.3: Accreditation & Symbols

New DefinitionsNew Definitions::•• AB AB logologo = used by the AB to identify itself= used by the AB to identify itself•• SymbolSymbol = issued by the AB and used by = issued by the AB and used by

accredited laboratories and inspection bodies accredited laboratories and inspection bodies to indicate their accredited statusto indicate their accredited status

•• MarkMark = e.g. as used in product certification= e.g. as used in product certification

However, ILAC still refers to a “mark” in the However, ILAC still refers to a “mark” in the licensing of its combined laboratory MRA symbol. licensing of its combined laboratory MRA symbol.

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8.3.18.3.1 Accreditation symbolAccreditation symbolØ policy governing protection and useØ accompanied by clear indication of which

activity is accredited• testing laboratory• calibration laboratory• inspection bodyØ used on reports/certificates within

accredited scope

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8.3.28.3.2 AB shall take effective measures to AB shall take effective measures to ensure accredited bodies … (1)ensure accredited bodies … (1)

Ø abides by rules for claiming accreditation status in media, documents & advertising

Ø uses symbols only for premises specifically within accreditation scope

Ø make no misleading/unauthorised statements w.r.t. its accreditation

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8.3.28.3.2 AB shall take effective measures to AB shall take effective measures to ensure accredited bodies … (2)ensure accredited bodies … (2)

Ø takes due care that reports/certificates or part thereof are used in misleading manner

Ø discontinue advertising its accreditation status upon suspension/withdrawal

Ø do not use its accreditation to imply approval by the AB of a product, process, system or person.

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ØØ Other points of note:Other points of note:Ø What are “effective measures”?

• Review during assessment, including contract documents?

• Review of the popular press?• Effective action on complaints (self policing)?

Ø For “… imply that a … person is approved by the AB”, where does this place ABs use the concept of an Approved Signatory to reports/certificates?

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8.3.38.3.3 AB shall take suitable action on AB shall take suitable action on nonnon--conformity with 8.3.2conformity with 8.3.2

Ø Suitable action defined in Note• request for corrective action• accreditation withdrawal• publication of transgression• legal action

4

Page 4

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ILACILAC--G14:2000 (1)G14:2000 (1)ØØ Mandated under MR001; to be used in Mandated under MR001; to be used in

evaluationsevaluationsØØ Currently under review within ILAC with a Currently under review within ILAC with a

view to it becoming an ILAC Pview to it becoming an ILAC P--documentdocumentØØ Any new issue will not address Any new issue will not address

inspection inspection –– what to do?what to do?

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ILACILAC--G14:2000 (2)G14:2000 (2)ØØ Includes added detail onIncludes added detail on

• Logo (symbol) reproduction• Approved/authorised signatories• Reporting non-accredited activities• Subcontracted results• Reporting compliance with specifications

and opinions and interpretations

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ILACILAC--G14:2000 (3)G14:2000 (3)ØØ Includes added detail on (contd.)Includes added detail on (contd.)

• Calibration certificates and labels• Electronic endorsed reports/certificates• MRA claims

Documents

ISO/IEC 17011:2004 Section 4: Accreditation Body APLAC Lead Evaluator /17011 … · 2019. 6. 18. · 3 Page 3 13 ISO/IEC 17011:2004 Section 4.3: Impartiality 4.3.1 Objectivity and