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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