ISO 17025 - Testing & Calibration
ISO/IEC 17025 is the main standard used by testing and calibration laboratories. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds in the concept of competence to the equation. And it applies directly to those organizations that produce testing and calibration results. Since its initial release, a second release was made in 2005 after it was agreed that it needed to have its quality system words more closely aligned with the 2000 version of ISO 9001.
The standard was first published in 1999 and on 12 May 2005 the alignment work of the ISO/CASCO committee responsible for it was completed with the issuance of the reviewed standard. The most significant changes introduced greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with the customer.
The contents of ISO/IEC 17025 - The ISO/IEC 17025 standard itself comprises five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC 17025 are Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an Accreditation Body. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence.
A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.
Why Laboratory Accreditation?
The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration.
Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands.
Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories.The globalisation of Indian economy and the liberalisation policies initiated by the Government in reducing trade barriers and providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence.
Benefits of Accreditation
- Formal recognition of competence of a laboratory by an Accreditation body in accordance with international criteria has many advantages:
- Potential increase in business due to enhanced customer confidence and satisfaction.
- Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
- Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
- Increase of confidence in Testing / Calibration data and personnel performing work.
- Customers can search and identify the laboratories accredited by NABL for their specific requirements from the Directory of Accredited Laboratories.
- Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.
Scope of Accreditation
NABL Accreditation is currently given in the following fields:
Thermal & Optical
Haematology and Immunohaematology
Microbiology and Serology
Nuclear Medicine (in-vitro tests only)
Accreditation to a laboratory is given on the basis of its capability to perform test(s) / calibration(s) and provide accurate and reliable results. A laboratory may apply for accreditation from as little as one to as many tests / calibrations provided it is performing these in accordance with NABL criteria.
Classification of the Testing Laboratories has been done on the basis of basic fields of testing. The laboratories doing inter-disciplinary testing of products, for e.g. textiles, plastics, building materials, metallurgical products, shall have to apply in relevant field(s) separately depending upon to which field(s) the test(s) belongs.
The accreditation granted to a laboratory shall remain valid for a period of 2 years subject to satisfactory periodical (annual) surveillance. Laboratory also has an option to widen the scope of accreditation in terms of specific tests and calibrations. NABL has established policies and procedures for granting, suspending and withdrawal of accreditation of accreditation in accordance with ISO/IEC 17011:2004
Directory of NABL Accredited Laboratories is published at regular interval, which contains laboratories' contact details and information on their Scope of Accreditation.
The laboratories seeking accreditation are assessed in accordance with ISO/IEC 17025:2005 for testing and calibration laboratories and ISO 15189:2007 for medical laboratories.A laboratory wishing to be accredited by NABL must have a Quality Manual on its Quality System satisfying the requirements as described in various clauses of ISO/IEC 17025 or ISO 15189 standard. Quality System documentation and its implementation by the laboratories shall be verified by the Assessors for its compliance in accordance with ISO/IEC 17025 or ISO 15189 standard. The laboratory management shall demonstrate to the NABL Assessment Team that all requirements as laid down in the ISO/IEC 17025/ISO 15189 standard, Specific Criteria and other Guidelines / Requirements of NABL are being followed. All applications for accreditation shall have to be in accordance with ISO/IEC 17025 or ISO 15189 Standard.
Modifications to the Accreditation Criteria
If NABL modifies the accreditation criteria, it shall inform the laboratory of this in writing giving a transition period of at least 6 months to the laboratory to align in accordance with the modified criteria
All decisions regarding accreditation to laboratories shall be open to appeal to NABL by laboratories and their users. Decision by NABL after investigation of appeal shall be final.
Process of Accreditation
Prepare your laboratory's application for NABL accreditation, giving all desired information and enlisting the test(s) / calibration(s) along with range and measurement uncertainty for which the laboratory has the competence to perform. Laboratory can apply either for all or part of their testing / calibration facilities. Formats NABL 151,NABL 152 & NABL 153 are to be used by Testing, Calibration & Medical Laboratories respectively for applying to NABL for accreditation.
Laboratory has to take special care in filling the scope of accreditation for which the laboratory wishes to apply. In case, the laboratory finds any clause (in part or full) not applicable to the laboratory, it shall furnish the reasons.
Laboratories are required to submit three sets of duly filled in application forms for each field of testing / calibration along with two sets of Quality Manual and Application Fees.
NABL Secretariat on receipt of application will issue acknowledgement to the laboratory. After scrutiny of application for it being complete in all respects, a unique Customer Registration Number will be allocated to laboratory for further processing of application.
NABL Secretariat shall then nominate a Lead Assessor for giving Adequacy Report on the Quality Manual / Application submitted by the laboratory. A copy of Adequacy Report by Lead Assessor will be provided to Laboratory for taking necessary corrective action, if any. The laboratory shall submit Corrective Action Report.
After satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory will be organised by NABL. Laboratories must ensure their preparedness by carrying out its internal audit before Pre-Assessment.
NABL Secretariat shall organise the Pre-Assessment audit, which shall normally be carried by Lead Assessor at the laboratory sites.
The pre-assessment helps the laboratory to be better prepared for the Final Assessment. It also helps the Lead Assessor to assess the preparedness of the laboratory to undergo Final Assessment apart from Technical Assessor(s) and Total Assessment Man-days required vis-à-vis the scope of accreditation as per application submitted by the laboratory.
A copy of Pre-Assessment Report will be provided to Laboratory for taking necessary corrective action on the concerns raised during audit, if any.
The laboratory shall submit Corrective Action Report to NABL Secretariat.
After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory shall be organised by NABL.
NABL Secretariat shall organise the Final Assessment at the laboratory site(s) for its compliance to NABL Criteria and for that purpose appoint an assessment team.
The Assessment Team shall comprise of a Lead Assessor and other Technical Assessor(s) in the relevant fields depending upon the scope to be assessed.
Assessors shall raise the Non-Conformance(s), if any, and provide it to the laboratory in prescribed format so that it gets the opportunity to close as many Non-Conformance(s) as they can before closing meeting of the Assessment.
The Lead Assessor will provide a copy of consolidated report of the assessment to the laboratory and send the original copy to NABL Secretariat.
Laboratory shall take necessary corrective action on the remaining Non-Conformance(s) / other concerns and shall submit a report to NABL within a maximum period of 2 months.
After satisfactory corrective action by the laboratory, the Accreditation Committee examines the findings of the Assessment Team and recommend additional corrective action, if any, by the laboratory.
Accreditation Committee determines whether the recommendations in the assessment report is consistent with NABL requirements as well as commensurate with the claims made by the laboratory in its application.
Laboratory shall have to take corrective action on any concerns raised by the Accreditation Committee.
Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to NABL Secretariat.
Laboratories are free to appeal against the findings of assessment or decision on accreditation by writing to the Director, NABL.
Whenever possible NABL will depute its own technical personnel to be present at the time of assessment as Coordinator and NABL Observer. Sometimes, NABL may at its own cost depute a newly trained Technical Assessor as "Observer" subject to convenience of the laboratory to be accessed.
Accreditation to a laboratory shall be valid for a period of 2 years and NABL shall conduct periodical Surveillance of the laboratory at intervals of one year.
Laboratory shall apply for Renewal of accreditation to it at least 6 months before the expiry of the validity of accreditation.