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ISO/IEC 17025 : 2005
General Requirements forthe 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
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
Accreditation orCertification ?
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
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 requirements
Section 4 : Management requirements , and
Section 5 : Technical requirements
Key Elements ForAccredited
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
The ISO 17025 Quality Manual
 Section 1 : Scope
An overview of the laboratory’s 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 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
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
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 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
EXTERNAL DOCUMENTS
ISO 17025
UKAS M3003
BIS/URN 14/902
UKAS Lab 1
UKAS Lab 3
UKAS Lab 5
Other UKAS LAB and TPS
documents as relevant .
International Standards
British 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
CustomerComplaints : 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 surveys
The minimumretention 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
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
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 froman
NMI (as opposed to an accredited laboratory) could
result in an improved uncertainty on its issued
certificates of calibration , by using that lower
Sampling : 5.7
This section is not relative to many UKAS laboratories
outside of the medical , analytical , orforensic 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 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
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 Results
Recognition of
Equivalence
Laboratory in Country B
(ISO 17025)
Calibration Results
Country A Country B
Mutual
Mutual Recognition Aggreements
Continued
FurtherInformation 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
Contact Details
PKQA Services
Pat Kilbane : MCQI CQP
QA Consultant and ISO17025 Auditor
Tel : 0116 2713867
Mobile : 07833 616839
Email : pat.kilbane@virginmedia.com
Website : www.pkqaservices.info
Also Available FromPKQA Services
ISO 17025 Internal Auditing Powerpoint Presentation
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Pkqa iso 17025 requirements

  • 1. ISO/IEC 17025 : 2005 General Requirements forthe Competence of Testing and Calibration Laboratories A Quality Management System(QMS) Presented by Pat Kilbane : PKQA Services
  • 2.  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 A Brief History of Accreditation in the UK
  • 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 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
  • 4. Accreditation orCertification ? 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
  • 5. 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 requirements Section 4 : Management requirements , and Section 5 : Technical requirements
  • 6. Key Elements ForAccredited 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
  • 7. The ISO 17025 Quality Manual  Section 1 : Scope An overview of the laboratory’s 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 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
  • 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) – if applicable  Handling of test calibration items (5.8)  Assuring the quality of test and calibration results (5.9)  Reporting the results (5.10)
  • 10. Sections 1 , 2 , and 3 of ISO 17025 General Requirements
  • 11. 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
  • 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 laboratory’s accreditation
  • 13. Section 3 : Terms and Definitions  The terms mentioned in ISO/ IEC guide 2 , ISO 17000 , and VIM are applicable to 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
  • 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 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 EXTERNAL DOCUMENTS ISO 17025 UKAS M3003 BIS/URN 14/902 UKAS Lab 1 UKAS Lab 3 UKAS Lab 5 Other UKAS LAB and TPS documents as relevant . International Standards British Standards .
  • 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. CustomerComplaints : 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. 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) .
  • 28. 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
  • 29. 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 minimumretention period required by UKAS is 6 years
  • 30. 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
  • 31. 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
  • 33. 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
  • 34. 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
  • 35. 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
  • 36. 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
  • 37. 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
  • 38. 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
  • 39. 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
  • 40. 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 froman NMI (as opposed to an accredited laboratory) could result in an improved uncertainty on its issued certificates of calibration , by using that lower
  • 41. Sampling : 5.7 This section is not relative to many UKAS laboratories outside of the medical , analytical , orforensic 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
  • 42. 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
  • 43. 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
  • 44. 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
  • 45. 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
  • 46. 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)
  • 48. 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
  • 49. 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 Mutual Recognition Aggreements (MRA’s)
  • 50. Accreditation Body in country A (ISO 17011) Accreditation Body in country B (ISO 17011) Recognition Laboratory in country A (ISO 17025) Calibration Results Recognition of Equivalence Laboratory in Country B (ISO 17025) Calibration Results Country A Country B Mutual Mutual Recognition Aggreements Continued
  • 51. FurtherInformation 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
  • 52. Contact Details PKQA Services Pat Kilbane : MCQI CQP QA Consultant and ISO17025 Auditor Tel : 0116 2713867 Mobile : 07833 616839 Email : pat.kilbane@virginmedia.com Website : www.pkqaservices.info
  • 53. Also Available FromPKQA Services ISO 17025 Internal Auditing Powerpoint Presentation Slides 1 to 4 of 28 Slides