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

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 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
 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 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
 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 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
 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)
 General Requirements

Sections 1 , 2 , and 3 of ISO 17025

 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 EXTERNAL DOCUMENTS
Quality manual ISO 17025
Calibration/test instructions UKAS M3003
Operational procedures BIS/URN 14/902
Equipment listing/database UKAS Lab 1
Approved sub-contractor UKAS Lab 3
list UKAS Lab 5
Approved supplier list Other UKAS LAB and TPS
Customer complaints form   documents as relevant .
Skills matrix International Standards
Operator training records British Standards .
Approved Signatory list
Schedule Of Accreditation
Accreditation Certificate
Audit Plan
 Contract Review : 4.4
 A procedure for the review of requests , tenders and
contracts
 Defining and documenting the methods to be used
 Capability and resources to meet the requirements.
 Ensuring that the appropriate test or calibration
method is capable of meeting the clients’
requirements
 Maintaining records of reviews and any significant
changes
 Any calibrations sub-contracted by the Laboratory
 Informing clients of any deviation from their contracts.
 A procedure for contract amendments
 Sub-contracting of Work : 4.5
 Laboratory policy on sub-contracting work
 Informing customer of any sub-contracted work , and
his approval to do so
 Use of accredited laboratories only
 Responsibility for sub contracted work
 Have a register of approved sub-contractors
 If the laboratory issues its own covering certificate ,
acknowledgement must be made that the calibration
has been sub-contracted and to whom
 Purchasing of Supplies : 4.6
 Laboratory policy on purchasing services and
supplies
 Checking of supplies critical to calibration work prior
to their use
 In the case of equipment service or repair , re-
commissioning/re-calibration prior to its ongoing use
 Approved suppliers list
 Service to the Client : 4.7
 Policy of the laboratory to cooperate with customers
and to verify the work performed
 Ensure client confidentiality ; become a perty to a
non-disclosure agreement if necessary
 Visits and/or audits of the laboratory
 Seek periodic customer satisfaction
surveys/questionnaires
 Customer Complaints : 4.8
 A procedure for the resolution of complaints
 Maintenance of records
 Corrective or Preventative actions (see relative slide
for specific details of these sections of the standard)
 Recall and/or re-calibration of any other work effected
 Non Conforming Work : 4.9
 Actions taken by the laboratory in the event of non-
conforming work
 Informing the customer
 Evaluating the significance (ie item is damaged , un-
useable , out of specification , etc)
 Possibility of halting further work until issues have been
resolved
 Improvements : 4.10
 Continual improvement of the QMS
 Audit results
 Corrective and preventative actions
 Quality Control (QC) checks/Operator proficiency tests
 Inter-laboratory comparisons
 Analysis of data
 Any actions from the annual Management Review
 Corrective Action : 4.11
 A procedure for Corrective Action
 Root cause analysis of the problem
 Selection and implementation of corrective action
 Monitoring and recording of the corrective action
 Recall of any other affected work
 Implementation of any preventative action necessary
 Preventative Action : 4.12
 A procedure for Preventative Action
 Improvements could come from the outcome of a
management review meeting
 A plan to implement and monitor preventative
actions .

Note : Some happenings cannot be prevented or

predicted , they only become apparent from a
customer complaint or corrective action .
Others , such as health and safety issues , good
housekeeping , servicing , repair , and maintenance
of equipment can all have an impact on Preventative
Action (both positive and negative) .
 Control of Records : 4.13
 A procedure for the storage and accessibility of
records
 Storage of technical data , including original
observations , derived data and sufficient information
to establish an audit trail
 Calibration records , staff records and a copy of each
calibration certificate issued
 Procedure for updating and alteration/correction of
records
 Backup procedure
 Control of Records : 4.13 (continued)
What constitutes a record :-
 Copies of all measurement records/worksheets etc
 Copies of every certificate issued
 Audit reports
 Equipment calibration history
 QC checklist and results
 Staff training matrix and training records
 Temperature control charts and data
 Customer complaints forms
 Customer satisfaction surveys
The minimum retention period required by UKAS is 6
years
 Internal Audits : 4.14
 A procedure and also an internal audit plan covering
each major section of ISO 17025 over a 12 month
period
 The availability of staff responsible for tests and
calibrations
 The auditor is ideally independent of the facility being
audited
 The actions to be taken when an audit casts doubt on
the effective operation of the laboratory
 A policy for recording the results of audit and any
corrective actions
 A follow up on the effectiveness of corrective actions
 Management Review : 4.15
 Meeting of the management team to review key
aspects of the quality system and calibration activities
 Typical attendees are managing director , head
and/or deputy head of laboratory , senior
technicians/operators , any relevant
consultants/auditors
 A defined agenda
 Minuteing of the management review meeting and
the scheduling/planning of actions arising from it
Technical Requirements

Section 5 of ISO 17025

 General : 5.1
Factors that can effect the reliability of calibrations
include :

 Human element factors

 Accommodation and environmental conditions
 Calibration methods and method validation
 Good housekeeping
 Equipment
 Measurement traceability
 Sampling (if relevant)
 The handling of calibration items
 Personnel : 5.2
 Management must ensure the competence of staff to
perform the work in the laboratory , and for their
supervision and training

 Access to be restricted to approved members of the

organisation who are directly employed to work in
laboratory

 Job descriptions for all Laboratory staff and key

support staff

 A skills matrix , and training records for all operatives

 Accommodation : 5.3
 The size of the laboratory should be such to prevent
overcrowding of equipment and staff , have statutory
lighting and ventilation levels , temperature control ,
designated work areas and employ general good
housekeeping practices
 Adequate and secure storage area , and a stabilisation
area
 Work carried out in the laboratory is under strict
environmental control . Temperature and relative humidity
are monitored and recorded , with cessation of work
should environmental control fall outside of the required
parameters and/or gradients
 The construction of the Laboratory should provide a stable
environment with secure access , airlock , isolated floor ,
filtering of sunlight , and be draught and vibration free
 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 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
 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

 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
 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

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
 Mutual Recognition Aggreements
(MRA’s)
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
Continued
Country A Country B
Accreditation Body in country A Accreditation Body in country B
(ISO 17011) (ISO 17011)
Mutual

Recognition

Laboratory in country A Laboratory in Country B

(ISO 17025) (ISO 17025)

Recognition of
Calibration Results Calibration Results
Equivalence
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
 Contact Details

PKQA Services
Pat Kilbane : MCQI CQP
QA Consultant and ISO 17025 Auditor

Tel : 0116 2713867

Mobile : 07833 616839

Email : pat.kilbane@virginmedia.com
Website : www.pkqaservices.info
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