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ISO 17025 Requirements

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Title: ISO 17025 Requirements


1
  • 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

2
A Brief History of Accreditation in the UK
  • 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
    laboratorys 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 .

3
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 also at other National Measurement Institutes
    (NMIs) worldwide
  • Accreditation assures that a laboratorys
    compliance with ISO/IEC 17025 is maintained via
    regular internal audits , and by an annual
    surveillance visit by UKAS themselves

4
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 surveillance visit .

5
Overview Quality Systems
  • UKAS is the primary body in the UK for which an
    organisations calibration laboratory can 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 requirements
  • Section 4 Management requirements , and
  • Section 5 Technical requirements

6
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

7
The ISO 17025 Quality Manual
  • Section 1 Scope
  • An overview of the laboratorys operation and
    management system
  • Section 2 Normative References
  • All relative National and International
    standards and collaborations
  • Section 3 Terms and Definitions
  • Reference to conformity assessment documents
  • Section 4 Management Requirements
  • Relative to the laboratorys 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 .

8
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)

9
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) may not be applicable to most
    labs
  • Handling of test calibration items (5.8)
  • Assuring the quality of test and calibration
    results (5.9)
  • Reporting the results (5.10)

10
General Requirements
Sections 1 , 2 , and 3 of ISO 17025
11
Section 1 Scope
  • Specifies the requirements applicable to both
    Testing and Calibration Laboratories
  • Notes given in the standard are the aims of the
    laboratorys 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

12
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 laboratorys accreditation

13
Section 3 Terms and Definitions
  • The terms mentioned in ISO/ IEC guide 2 , ISO
    17000 , and Vocabulary of International Metrology
    (VIM) are applicable to , and invoked within ISO
    17025

14
Management Requirements
Section 4 of ISO 17025
15
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

16
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
    ideally 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

17
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

18
Document Control 4.3 (continued)
INTERNAL DOCUMENTS Quality manual Calibration/test
instructions Operational procedures Equipment
listing/database Approved sub-contractor
list Approved supplier list Customer complaints
form   Skills matrix Operator training
records Approved Signatory list Schedule Of
Accreditation Accreditation Certificate Audit
Plan QC checklist
EXTERNAL DOCUMENTS ISO 17025 UKAS M3003
BIS/URN 14/902 UKAS Lab 1 UKAS Lab 3 UKAS Lab
5 Other relevant UKAS LAB and TPS documents ,
plus British and International standards , with
monthly (UKAS) and 6 monthly (BSI) website checks
to ensure current versions are held on file .
19
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

20
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

21
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

22
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

23
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

24
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

25
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

26
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

27
Corrective Action 4.11 Contd
Fault Identified
Corrective Action Completed
Results Fully Documented
Root Cause Identified
YES
NO
Corrective Action Effective ?
Corrective Action Planned
Corrective Action Implemented
28
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) .

29
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

30
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 surveys
  • The minimum retention period required by UKAS is
    6 years

31
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

32
Internal Audits 4.14 (Continued)
  • Measurement Audits and Inter-Laboratory
    Comparisons
  • Uses the En Ratio to analyse the performance
  • En Ratio Difference in results
    (operator/laboratory)
  • Uncertaiinty1²
    Uncertainty2²
  • Note An En Value of 1 is required for an
    acceptable result

33
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

34
Technical Requirements
Section 5 of ISO 17025
35
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

36
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

37
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

38
Methods Validation 5.4
  • Nationally and Internationally recognised
    standard methods and procedures 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

39
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

40
Measurement Uncertainty 5.4.6 Contd
  • The concept of Traceability -

International Bureau of Weights and Measures
BIPM , Paris
National Metrology Institute (NMI)
UKAS Accredited Laboratory
Standards Rooms and Measurement Labs in Industry
41
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

42
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

43
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 (NMIs)
  • 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

44
Sampling 5.7
  • This 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

45
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

46
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

47
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

48
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

49
Reporting Results 5.10 (continued 2)
  • 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

50
Additionally
51
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

52
Mutual Recognition Aggreements (MRAs)
  • 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 INMETRO
  • Belgium BELAC Canada SCC
  • China CNAS Denmark DANAK
  • Germany DKD
    France COFRAC
  • Italy SIT
    Hong Kong HKAS
  • Mexico EMA New Zealand IANZ
  • Norway NA South Africa SANAS
  • Spain ENAC Sweden
    SWEDAC
  • Switzerland SAS USA A2LA and NVLAP

53
Mutual Recognition Aggreements Continued
Country A
Country B
Accreditation Body in country A (ISO 17011)
Accreditation Body in country B(ISO 17011)
Mutual
Recognition
Laboratory in country A (ISO
17025)
Laboratory in Country B(ISO 17025)
Recognition of Equivalence
Calibration Results
Calibration Results
54
Further Information Can Be Obtained From -
  • British and International Standards Institutions
  • www.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
  • Bureau International de Poids et Mesures (BIPM)
  • www.bipm.org

55
Contact Details
PKQA Services Pat Kilbane MCQI CQP QA
Consultant and ISO 17025 Auditor Tel 0116
2713867 Mobile 07833 616839 Email
pat.kilbane_at_virginmedia.com Website
www.pkqaservices.info
56
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