ISO/IEC 17025 : 2005

General Requirements for the Competence of Testing and Calibration Laboratories

A Quality Management System (QMS)

Presented by Pat Kilbane : PKQA Services

Conceived originally as the British Calibration Service (BCS) under the auspices of the National Physical Laboratory (NPL) in 1966 .

In 1985 BCS merged with NATLAS , the National Testing Laboratory Accreditation Scheme to form NAMAS , the National Measurement Accreditation Service .

NAMAS underwent a name change in 1995 to become the United Kingdom Accreditation Service - UKAS as we know it today .

UKAS , a company limited by guarantee , is the sole UK body for the accreditation of laboratory’s performing traceable calibrations .

UKAS accredited laboratories are re-assessed annually to ensure their continued compliance with ISO 17025 .

European Standard EN 45001 , ISO Guide 25 , and relevant sections of ISO 9000 formed the basis of ISO 17025 , first introduced in 2002 , and now at Issue 2 : 2005 .

A Brief History of Accreditation in the UK

What is Accreditation ? ISO/IEC 17025 itemises the necessary criteria that a

laboratory needs to implement in order for it to perform its test and calibration work competently

Accreditation is an independent and formal recognition of the competence of a laboratory to perform specific tests and calibrations , that are traceable to the SI System of Units and/or National Standards . In the UK , these are realised by the National Physical Laboratory , and at other National Measurement Institutes (NMI’s) worldwide

Accreditation assures that a laboratory’s compliance with ISO/IEC 17025 is maintained via regular internal audits , and by an annual surveillance visit by UKAS themselves

Accreditation or Certification ?Certification : Means compliance with a standard or specification . This generally refers to the ISO 9000/9001 series of standards (or ISO 16949 in the motor industry) , and covers management systems and products , including business strategy and planning . Certification Bodies in the UK include Lloyds Register , ISOS Certification , and UL Inc .Accreditation : This is the recognition of specific technical competence , and is the domain of ISO 17025 . It evaluates peoples skills and knowledge , and that the laboratory is competent to carry out Internationally recognised tests and calibrations . The sole Accreditation Body in the UK is UKAS .

NOTE : Both Certification and Accreditation provide clients with assurance that management systems are independently audited and also re-assessed by an annual Body surveillance visit .

Overview : Quality Systems UKAS is the primary body in the UK that an

organisation’s calibration laboratory be accredited by . To gain UKAS accreditation , the laboratory must be seen (and be proven by independent assessment and audit) to be operating to a recognised quality system

The internationally recognised standard for laboratory accreditation is ISO 17025 , the current revision of which was introduced in 2005

ISO 17025 covers every aspect of the operation of a laboratory , and is split into 3 main areas :-

Sections 1 to 3 : General requirementsSection 4 : Management requirements , andSection 5 : Technical requirements

Key Elements For Accredited Laboratories

Pre-requisites at a minimum are :- A quality manual referenced to each section of

ISO17025 An environmentally controlled laboratory with secure

access A designated Head of Laboratory responsible for its

operation , and having a complete understanding of its measurement procedures , the operation of its test equipment , and of its quality management system (QMS)

An appropriate range of reference standards each with a traceable calibration

A suitable range of test and measuring equipment A series of operational procedures A series of calibration instructions Uncertainty calculations for all accredited calibrations

or generic groups of calibration

The ISO 17025 Quality Manual Section 1 : Scope

An overview of the laboratory’s operation and management system

Section 2 : Normative ReferencesAll relative National and International standards and collaborations

Section 3 : Terms and DefinitionsReference to conformity assessment documents

Section 4 : Management Requirements Relative to the laboratory’s quality management system .

These activities are generally conducted outside of the laboratory Section 5 : Technical Requirements These aspects are relative to the technical operation of the

laboratory

Keep it simple . The quality manual defines the aims of ISO 17025 , but the procedures describe exactly how those aims are achieved .

The ISO 17025 Quality Manual (2)Management Sections :- Organisation (4.1) Quality system (4.2) Document control (4.3) Review of requests, tenders and contracts (4.4) Sub-contracting of tests and calibrations (4.5) Purchasing services and supplies (4.6) Service to the client (4.7) Complaints (4.8) Control of non-conforming testing or calibration work

(4.9) Improvements (4.10) Corrective action (4.11) Preventive action (4.12) Control of records (4.13) Internal audits (4.14) Management review (4.15)

The ISO 17025 Quality Manual (3)Technical Sections :-

General (5.1) Personnel (5.2) Accommodation and environmental (5.3) Test and calibration methods and method validation

(5.4) Equipment (5.5) Measurement traceability (5.6) Sampling (5.7) – if applicable Handling of test calibration items (5.8) Assuring the quality of test and calibration results

(5.9) Reporting the results (5.10)

Sections 1 , 2 , and 3 of ISO 17025

General Requirements

Section 1 : Scope Specifies the requirements applicable to both Testing

and Calibration Laboratories

Notes given in the standard are the aims of the laboratory’s quality management system (QMS)

The standard is for use by laboratories , but can also be used by its customers , accreditation and certification bodies , and auditors , both Internal and external

Compliance with ISO 17025 can also ensure compliance with certain managerial aspects of the ISO 9000/9001 series of standards , ie contract review , customer complaints , corrective and preventative actions

Section 2 : Normative References ISO 9001 : 2000 Quality Management System

ISO / IEC Guide 2 : General terms and their definitions concerning standardization

VIM : The International Vocabulary of basic and general terms in Metrology

ISO 17000 , Conformity Assessment

Other British and International standards and General Product Specifications (GPS) relative to the laboratory’s accreditation

Section 3 : Terms and Definitions The terms mentioned in ISO/ IEC guide 2 , ISO 17000 ,

and VIM are applicable to ISO 17025

Management Requirements

Section 4 of ISO 17025

Organisation : 4.1 The laboratory shall be an entity that is held legally responsible for its actions The laboratory will carry out activities to meet the requirements of this standard , its customers , and regulatory/certification / accreditation authorities Activities will comply with relevant standards and

guidelines Relative to permanent , off-site and mobile facilities The laboratory will have managerial and technical

personnel and a defined management structure It will also have defined authority , responsibility and

inter-relationship of personnel , with adequate supervision of testing and calibration staff

There will be a Quality Manger , howsoever named , and

deputies for key management positions

Management System : 4.2 Scope of quality system Activities to conform to relevant standards and

guidelines A quality policy statement and quality objectives

issued by senior management . Objectives should employ the SMART ideology , ie be Specific , Measurable , Achievable , Realistic , and Timely .

Supporting systems such as operating procedures , calibration and test instructions , uncertainty calculations , and computer software (if applicable)

Named person responsible for ISO17025 conformance

Document Control : 4.3

Approval and periodic review of all documentation Activities conforming to relevant standards and

guidelines Location of documentation The authority for issue and update of documents The review , update , and retention of obsolete items Control/access of staff authorised to view documents Backup of documentation

Document Control : 4.3 (continued)INTERNAL DOCUMENTSQuality manualCalibration/test instructionsOperational proceduresEquipment listing/databaseApproved sub-contractor listApproved supplier listCustomer complaints form   Skills matrix Operator training recordsApproved Signatory list Schedule Of Accreditation Accreditation Certificate Audit PlanQC checklist

EXTERNAL DOCUMENTS ISO 17025 UKAS M3003 BIS/URN 14/902UKAS Lab 1 UKAS Lab 3 UKAS Lab 5 Other UKAS LAB and TPS documents as relevant . International StandardsBritish Standards .

Contract Review : 4.4

A procedure for the review of requests , tenders and contracts

Defining and documenting the methods to be used Capability and resources to meet the requirements. Ensuring that the appropriate test or calibration

method is capable of meeting the clients’ requirements

Maintaining records of reviews and any significant changes

Any calibrations sub-contracted by the Laboratory Informing clients of any deviation from their contracts. A procedure for contract amendments

Sub-contracting of Work : 4.5

Laboratory policy on sub-contracting work Informing customer of any sub-contracted work , and

his approval to do so Use of accredited laboratories only Responsibility for sub contracted work Have a register of approved sub-contractors If the laboratory issues its own covering certificate ,

acknowledgement must be made that the calibration has been sub-contracted and to whom

Purchasing of Supplies : 4.6

Laboratory policy on purchasing services and supplies

Checking of supplies critical to calibration work prior to their use

In the case of equipment service or repair , re-commissioning/re-calibration prior to its ongoing use

Approved suppliers list

Service to the Client : 4.7

Policy of the laboratory to cooperate with customers and to verify the work performed

Ensure client confidentiality ; become a perty to a non-disclosure agreement if necessary

Visits and/or audits of the laboratory Seek periodic customer satisfaction

surveys/questionnaires

Customer Complaints : 4.8

A procedure for the resolution of complaints Maintenance of records Corrective or Preventative actions (see relative slide

for specific details of these sections of the standard) Recall and/or re-calibration of any other work effected

Non Conforming Work : 4.9 Actions taken by the laboratory in the event of non-

conforming work Informing the customer Evaluating the significance (ie item is damaged , un-

useable , out of specification , etc) Possibility of halting further work until issues have been

resolved

Improvements : 4.10 Continual improvement of the QMS Audit results Corrective and preventative actions Quality Control (QC) checks/Operator proficiency tests Inter-laboratory comparisons Analysis of data Any actions from the annual Management Review

Corrective Action : 4.11 A procedure for Corrective Action Root cause analysis of the problem Selection and implementation of corrective action Monitoring and recording of the corrective action Recall of any other affected work Implementation of any preventative action necessary

Preventative Action : 4.12 A procedure for Preventative Action Improvements could come from the outcome of a

management review meeting A plan to implement and monitor preventative

actions .

Note : Some happenings cannot be prevented or predicted , they only become apparent from a customer complaint or corrective action .

Others , such as health and safety issues , good housekeeping , servicing , repair , and maintenance of equipment can all have an impact on Preventative Action (both positive and negative) .

Control of Records : 4.13

A procedure for the storage and accessibility of records

Storage of technical data , including original observations , derived data and sufficient information to establish an audit trail

Calibration records , staff records and a copy of each calibration certificate issued

Procedure for updating and alteration/correction of records

Backup procedure

Control of Records : 4.13 (continued)

What constitutes a record :- Copies of all measurement records/worksheets etc Copies of every certificate issued Audit reports Equipment calibration history QC checklist and results Staff training matrix and training records Temperature control charts and data Customer complaints forms Customer satisfaction surveysThe minimum retention period required by UKAS is 6

years

Internal Audits : 4.14 A procedure and also an internal audit plan covering

each major section of ISO 17025 over a 12 month period

The availability of staff responsible for tests and calibrations

The auditor is ideally independent of the facility being audited

The actions to be taken when an audit casts doubt on the effective operation of the laboratory

A policy for recording the results of audit and any corrective actions

A follow up on the effectiveness of corrective actions

Management Review : 4.15

Meeting of the management team to review key aspects of the quality system and calibration activities

Typical attendees are managing director , head and/or deputy head of laboratory , senior technicians/operators , any relevant consultants/auditors

A defined agenda Minuteing of the management review meeting and

the scheduling/planning of actions arising from it

Technical Requirements

Section 5 of ISO 17025

General : 5.1

Factors that can effect the reliability of calibrations include :

Human element factors Accommodation and environmental conditions Calibration methods and method validation Good housekeeping Equipment Measurement traceability Sampling (if relevant) The handling of calibration items

Personnel : 5.2 Management must ensure the competence of staff to

perform the work in the laboratory , and for their supervision and training

Access to be restricted to approved members of the organisation who are directly employed to work in laboratory

Job descriptions for all Laboratory staff and key support staff

A skills matrix , and training records for all operatives

Accommodation : 5.3 The size of the laboratory should be such to prevent

overcrowding of equipment and staff , have statutory lighting and ventilation levels , temperature control , designated work areas and employ general good housekeeping practices

Adequate and secure storage area , and a stabilisation area

Work carried out in the laboratory is under strict environmental control . Temperature and relative humidity are monitored and recorded , with cessation of work should environmental control fall outside of the required parameters and/or gradients

The construction of the Laboratory should provide a stable environment with secure access , airlock , isolated floor , filtering of sunlight , and be draught and vibration free

Access to the laboratory only to approved staff

Methods & Validation : 5.4 Nationally and Internationally recognised standard

methods and procedure’s which meet the requirement of UKAS

The Methods must meet the needs of the customer . If the laboratory feels that a procedure required by the customer is incorrect , he should be informed (see Contract Review) . When the method is unspecified , the method should follow those described in International or National standards

A procedure covering the development of non standard or laboratory developed methods should also be in force

Method validation includes calibration of and/or the use of reference standards , comparison of results from other methods or inter-laboratory comparisons , assessment based on the scientific understanding of the theoretical principles of the measurement , and from practical experience of the measurement type

Measurement Uncertainty : 5.4.6

Sometimes referred to as Best Measurement Capability (BMC)

The use of the principles described in UKAS document M3003 are used to estimate both random and systematic uncertainties

The calculation applies to all measurements , whether made internally or taken from calibrations or measurements made by other externally accredited sources

A calculation for each individual item or generic group of items

A coverage factor to qualify the confidence probability of the calculation

Control of Data : 5.4.7

How calculations entered onto a certificate are checked

If spreadsheets and other computer software are used , how are they verified and documented

Backup procedures

Client confidentiality and protection of his personal data

Equipment : 5.5 Equipment must be suitable for the range of

calibrations Traceability to National Standards

An equipment calibration and re-calibration database

Approved staff permitted to use equipment

Identification and clear labelling of equipment

Retention of records for equipment

Action to be taken if equipment is suspected of being faulty or damaged

A service/repair plan

Measurement Traceability : 5.6 A calibration program providing traceability to National

and/or International standards , and to the International System of Units (SI System) , by the use of other UKAS accredited laboratories or National Measurement Institutes (NMI’s)

Reference standards to be used only for calibration purposes , and a planned program for their periodic re-calibration

Secure and protective storage of reference standards

NOTE : A laboratory that derives its traceability from an NMI (as opposed to an accredited laboratory) could result in an improved uncertainty on its issued certificates of calibration , by using that lower uncertainty in its own uncertainty calculation

Sampling : 5.7This section is not relative to many UKAS laboratories

outside of the medical , analytical , or forensic fields .

A sampling plan or procedure for materials or products stating how and when the sample is taken and measured

The use of statistical techniques and their confidence probabilities

Any special requirements , ie health and safety etc

Handling of Items : 5.8 A goods-in/booking-in and despatch system

How customers items are identified , ie jobsheets/worksheets etc

Recording of condition upon receipt and informing customer of any transit damage

How items are protected , transported , stored , and despatched

Precautions taken to prevent deterioration or damage to the customers items from receipt through to despatch , and for its safe and secure delivery back to him

Assuring the Quality of Results : 5.9 Random re-checks of both clients and own calibrations

Analysis of results from quality control (QC) checks and internal audits

Participation in inter-laboratory comparisons or operator proficiency testing programmes as required by UKAS

Measurement audits

Correlation of calibrations using different techniques for the same item

The use of the En system of results analysis

Reporting Results : 5.10

To issue the client with an unambiguous and accurate certificate that meets his requirements , and that is to a format approved by UKAS

Provides all of the data requested by the client

Certificate to be checked and signed by an Approved Signatory . Accompanying calibration labels to be supplied

Supplementary certificates (or amendments) must be identified as such and bear a unique certificate number

No recalibration date stated on the certificate or label unless it is at the clients request

Reporting Results : 5.10 (continued : 1)

A calibration certificate must show : Name and address of the Issuing laboratory Unique certificate number on each page The name and address of the client Identification of the method used Identification of the item and its serial number Calibration results and the units of measurement Signature and name authorising the certificate The environmental conditions Uncertainty of measurement A traceability statement of the measurements

made

Opinions and Interpretations :-•These must first be added as an Extension to

Accreditation using UKAS form AC SUPP

•A document stating how opinions and interpretation are used

•Certificate clearly marked as such

•Not to be confused with Inspection or Product Certification as defined in ISO/IEC 17020

•Any sub-contracted results must be clearly identified

Reporting Results : 5.10 (continued : 2)

Additionally

The Benefits of Accreditation Industrial , National , and International recognition

Enhances the organisations reputation

Improved customer satisfaction and confidence

A business edge over non-accredited competitors

A source of additional revenue

Known and accepted methods , procedures and practices are in place

On-going monitoring via internal auditing

Can improve a customers measuring capability by him taking account of known errors in his own measuring systems

The scope for continual improvements to be made

UKAS is recognised Internationally by way of Mutual Recognition Agreements in Europe with the European Co-operation for Accreditation (EA) , the International Accreditation Forum (IAF) , and the International Laboratory Accreditation Co-operation (ILAC) . These include , but not restricted to :-COUNTRY BODY COUNTRY BODY

Australia NATA Brazil INMETROBelgium BELAC Canada SCCChina CNAS Denmark DANAKGermany DKD France COFRACItaly SIT Hong Kong HKASMexico EMA New Zealand IANZNorway NA South Africa SANASSpain ENAC Sweden SWEDACSwitzerland SAS USA A2LA and NVLAP

Mutual Recognition Aggreements (MRA’s)

Accreditation Body in country A(ISO 17011)

Accreditation Body in country B(ISO 17011)

Recognition

Laboratory in country A (ISO 17025)

Calibration ResultsRecognition of

Equivalence

Laboratory in Country B(ISO 17025)

Calibration Results

Country A Country B

Mutual

Mutual Recognition Aggreements Continued

Further Information Can Be Obtained From :-

British and International Standards Institutionswww.bsigroup.co.uk or www.iso.org

United Kingdom Accreditation Service (UKAS)www.ukas.com

National Physical Laboratory (NPL)www.npl.co.uk

International Laboratory Accreditation Co-operation (ILAC)

www.ilac.org European Co-operation for Accreditation (EA) www.european-accreditation.org

Contact Details

PKQA ServicesPat Kilbane : MCQI CQP

QA Consultant and ISO 17025 Auditor

Tel : 0116 2713867Mobile : 07833 616839

Email : pat.kilbane@virginmedia.comWebsite : www.pkqaservices.info

Also Available From PKQA ServicesISO 17025 Internal Auditing Powerpoint Presentation

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