ISO/IEC 17025 : 2005
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Transcript of ISO/IEC 17025 : 2005
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ISO/IEC 17025:2005
General Requirements for the Competence of Testing and Calibration Laboratories
A Quality Management System (QMS)
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What is Accreditation ? ISO/IEC 17025 itemises the necessary criteria that a
laboratory needs to implement in order for it to perform its test and calibration work competently
Accreditation is an independent and formal recognition of the competence of a laboratory to perform specific tests and calibrations , that are traceable to the SI System of Units and/or National Standards . In the UK , these are realised by the National Physical Laboratory , and at other National Measurement Institutes (NMI’s) worldwide
Accreditation assures that a laboratory’s compliance with ISO/IEC 17025 is maintained via regular internal audits , and by an annual surveillance visit by UKAS themselves
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Accreditation or Certification ?Certification : Means compliance with a standard or specification . This generally refers to the ISO 9000/9001 series of standards (or ISO 16949 in the motor industry) , and covers management systems and products , including business strategy and planning . Certification Bodies in the UK include Lloyds Register , ISOS Certification , and UL Inc .Accreditation : This is the recognition of specific technical competence , and is the domain of ISO 17025 . It evaluates peoples skills and knowledge , and that the laboratory is competent to carry out Internationally recognised tests and calibrations . The sole Accreditation Body in the UK is UKAS .NOTE : Both Certification and Accreditation provide clients with assurance that management systems are independently audited and also re-assessed by an annual Body surveillance visit .
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Overview : Quality Systems UKAS is the primary body in the UK that an
organisation’s calibration laboratory be accredited by . To gain UKAS accreditation , the laboratory must be seen (and be proven by independent assessment and audit) to be operating to a recognised quality system
The internationally recognised standard for laboratory accreditation is ISO 17025 , the current revision of which was introduced in 2005
ISO 17025 covers every aspect of the operation of a laboratory , and is split into 3 main areas :-Sections 1 to 3 : General requirementsSection 4 : Management requirements , andSection 5 : Technical requirements
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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
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The ISO 17025 Quality Manual Section 1 : Scope
An overview of the laboratory’s operation and management system
Section 2 : Normative ReferencesAll relative National and International standards and collaborations
Section 3 : Terms and DefinitionsReference to conformity assessment documents
Section 4 : Management Requirements Relative to the laboratory’s quality management system .
These activities are generally conducted outside of the laboratory Section 5 : Technical Requirements These aspects are relative to the technical operation of the
laboratoryKeep it simple . The quality manual defines the aims of
ISO 17025 , but the procedures describe exactly how those aims are achieved .
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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)
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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)
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Sections 1 , 2 , and 3 of ISO 17025
General Requirements
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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
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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
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Section 3 : Terms and Definitions
The terms mentioned in ISO/ IEC guide 2 , ISO 17000 , and VIM are applicable to ISO 17025
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Management Requirements
Section 4 of ISO 17025
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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
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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
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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
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Document Control : 4.3 (continued)
INTERNAL DOCUMENTSQuality manualCalibration/test instructionsOperational proceduresEquipment listing/databaseApproved sub-contractor listApproved supplier listCustomer complaints form Skills matrix Operator training recordsApproved Signatory list Schedule Of Accreditation Accreditation Certificate Audit PlanQC checklist
EXTERNAL DOCUMENTS ISO 17025 UKAS M3003 BIS/URN 14/902UKAS Lab 1 UKAS Lab 3 UKAS Lab 5 Other UKAS LAB and TPS documents as relevant . International StandardsBritish Standards .
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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
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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
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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
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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
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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
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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
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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
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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
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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) .
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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
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Control of Records : 4.13 (continued)
What constitutes a record :- Copies of all measurement records/worksheets etc Copies of every certificate issued Audit reports Equipment calibration history QC checklist and results Staff training matrix and training records Temperature control charts and data Customer complaints forms Customer satisfaction surveysThe minimum retention period required by
UKAS is 6 years
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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
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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
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Technical Requirements
Section 5 of ISO 17025
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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
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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
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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
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Methods & Validation : 5.4
Nationally and Internationally recognised standard methods and procedure’s which meet the requirement of UKAS
The Methods must meet the needs of the customer . If the laboratory feels that a procedure required by the customer is incorrect , he should be informed (see Contract Review) . When the method is unspecified , the method should follow those described in International or National standards
A procedure covering the development of non standard or laboratory developed methods should also be in force
Method validation includes calibration of and/or the use of reference standards , comparison of results from other methods or inter-laboratory comparisons , assessment based on the scientific understanding of the theoretical principles of the measurement , and from practical experience of the measurement type
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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
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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
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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
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Measurement Traceability : 5.6
A calibration program providing traceability to National and/or International standards , and to the International System of Units (SI System) , by the use of other UKAS accredited laboratories or National Measurement Institutes (NMI’s)
Reference standards to be used only for calibration purposes , and a planned program for their periodic re-calibration
Secure and protective storage of reference standards
NOTE : A laboratory that derives its traceability from an NMI (as opposed to an accredited laboratory) could result in an improved uncertainty on its issued certificates of calibration , by using that lower uncertainty in its own uncertainty calculation
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Sampling : 5.7This section is not relative to many UKAS
laboratories outside of the medical , analytical , or forensic
fields .
A sampling plan or procedure for materials or products stating how and when the sample is taken and measured
The use of statistical techniques and their confidence probabilities
Any special requirements , ie health and safety etc
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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
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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
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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
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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
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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)
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Additionally
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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
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THANKS