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What Are The Requirements Of ISO 17025 Standard

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 revised 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 under clause number 4 and Technical Requirements under clause number 5.
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.

Clause 4: Management System Requirements

Clause 4: Management System Requirements

4.1 Organization:

This clause guides on the roles responsibility of the laboratory, permanent facilities, responsibilities of key personnel and policies and procedures about confidential information and proprietary rights , relationship between quality management , technical operations and support services and organization and management structure of the laboratory, its place in any parent organization.

4.2 Quality System:

This clause guides on the establishing, implementing and maintaining of a quality system appropriate to the scope of its activities.

4.3 Document control:

This clause guides on establish & maintain procedures to control all documents that form part of its Quality system ( internally generated or from external sources) , such as regulations standards, other normative documents , test and/or calibration methods , as well as drawings, software, specifications, instructions and manuals.

4.4 Review of requests, tenders and contracts:

This clause describes the requirement to establish and maintain Policies and procedures for the review of requests, tenders and contracts.

4.5 Subcontracting of tests and calibrations:

This clause tells about establish and maintain the policies and procedures for the subcontracts of work whether because of unforeseen reasons or on a continuing basis.

4.6 Purchasing services and supplies:

This clause describes the requirements of establish and maintain policy and procedures for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations.

4.7 Service to the client:

This clause guides on clients’ value the maintenance of good communication, advice and guidance in technical matters and opinions and interpretations based on results, communication with the client, especially in large assignments.

4.8 Complaints:

This clause guides on policy and procedure for the resolution of complaints received from clients or other parties

4.9 Control of Non-conforming testing and/or calibration work:

This clause guides on policy and procedures on identification of nonconforming work or problems with the quality system or with testing and/or with testing and/or calibration activities can occur at various places within the quality system and technical operations.

4.10 Improvements:

This clause tells how to ensure the effectiveness of the management system continually improved.

4.11 Corrective actions:

This clause guides on policy and procedure of implementation of corrective action when non-conforming work or departures in the quality system or technical operations have been identified through a variety of activities , such as control of nonconforming work , internal or external audits , management reviews , feedback from clients or staff observations.

4.12 Preventive action:

This clause guides on preventive action is a pro-active process to identify opportunities for improvement rather than reaction to identification of problems or complaints.

4.13 Control of records:

This clause tells about establish and maintain procedures to control of records through identification, collection, indexing, access, filling, storage, maintenance and disposal of quality and technical records.

4.14 Internal audits:

This clause guides on policy and procedure of internal Quality audit and implementation and effectiveness.

4.15 Management reviews:

This clause describes the procedures and consideration of related subjects at regular management meetings.

Clause 5.1: General

This clause tells about factors contribute to the correctness and reliability of the tests and/or calibrations performed by laboratory.

Clause 5.2 Personnel:

This clause guides on how to ensure that all laboratory personnel who can impact tests and calibration results are adequately qualified.

Clause 5.3 Accommodation and environmental conditions:

This clause describes the policy and procedure on accommodation and environmental conditions, such as to facilitate correct performance of the tests and/or calibrations.

Clause 5.4 Test and calibration methods and method validation:

This clause guides on policy and procedure of selection of methods, Laboratory developed methods, No-standard methods, validation of methods, estimation of uncertainty of measurement, control of data.

Clause 5.5 Equipment:

This clause describes the policy and procedure on sampling, measurement and test equipment required for correct performance of the tests and/or calibrations. The intention to make sure that the instruments are suitable for performing selected tests and/or calibrations and are well characterized, calibrated and maintained.

Clause 5.6 Measurement traceability:

This clause describes the procedure on system for selecting , using , calibrating , checking , controlling and maintaining measurement standards, reference materials used as measurement standards, and measuring and test equipment use perform tests and calibrations.

Clause 5.7 sampling:

This clause guides on selection, sampling plan, withdrawal and preparation of sample or samples from substance, material or product to yield the required information.

Clause 5.8 Handling of test and calibration items:

This clause describes how to ensure that sample integrity is maintained during transport, storage, and retention and those samples are disposed of safely.

Clause 5.9 Assuring the Quality of test and calibration results:

This clause guides on procedures for monitoring the validity of tests and calibrations through proficiency testing program or ILC , Measurement of uncertainty , regular use of certified reference materials and/or internal quality control using secondary reference materials and/or replicate tests and/or retesting and/or co-relation of results for different characteristics of an item.

Clause 5.10 reporting the results:

This clause guides on how results of each test, calibrations or series of tests or calibrations carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively and in accordance with any specific instructions in the test or calibration methods.

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Thanks to the dedicated team for their expertise!

Technical Director

Calibration laboratory - USA

As a calibration laboratory, maintaining the highest standards of accuracy and reliability is critical. Lakshy Management Consultant Pvt. Ltd. were instrumental in helping us achieve ISO/IEC 17025 accreditation. Their team meticulously reviewed our calibration procedures, ensured our equipment met the necessary requirements, and helped us establish traceability to national standards. We were particularly impressed with their practical approach and their ability to explain complex technical concepts in a clear and understandable way. We highly recommend their services to any calibration laboratory seeking accreditation

Lakshy Management excels in ISO 17025 accreditation guidance.

CEO

Electrical Test Lab

“Achieving ISO/IEC 17025 accreditation was a major goal for our materials testing laboratory, but the process seemed daunting. Lakshy Management Consultant Pvt. Ltd. guided us every step of the way. Their consultants were incredibly knowledgeable about the standard and helped us develop a robust quality management system. They provided practical advice, helped us optimize our testing procedures, and ensured our documentation was impeccable. Thanks to their expertise, we sailed through the accreditation audit and are now confidently providing accurate and reliable testing services to our clients.”

Lakshy Management eased ISO 17025 implementation seamlessly and efficiently.

Lab Director

The largest Pharma Company

We were struggling to meet the stringent requirements of ISO/IEC 17025 for our medical testing laboratory. Lakshy Management Consultant Pvt. Ltd. provided the expertise and support we desperately needed. Their consultants helped us improve our risk management processes, implement effective internal audits, and ensure the competency of our laboratory personnel. They were always available to answer our questions and provide guidance, making the entire accreditation process much smoother than we anticipated. We are now a fully accredited laboratory and are confident in our ability to provide high-quality testing services to our patients

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