ISO 17025 Consultants - Testing and Calibration of Laboratories

Introduction

ISO/IEC 17025 is the global recognized standard that was developed specifically for testing and calibration laboratories that intended seeking accreditation. It is also the basis for accreditation from an accreditation body. The current release was published in 2017. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

There are two main clauses in ISO/IEC 17025 – Management Requirements and Technical Requirements. Management requirements are related to the operation and effectiveness of the quality management system within the laboratory, and this clause has similar requirements to ISO 9001. Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory namely competence of staff; environment control; testing methodology; equipment and measurement traceability; and reporting of test and calibration results.

Laboratories that can demonstrate compliance with ISO/IEC 17025 at assessment have demonstrated they operate using sound management practices and are technically competent to perform specific tests, calibrations and/or measurements as well as at the same time are able to generate technically valid results for which they hold accreditation. To maintain this recognition, laboratories are re-evaluated periodically by the accreditation body to ensure their continued compliance with requirements, and to check that their standard of operation is being maintained. The laboratory may also be required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence.

Accredited laboratories usually issue test or calibration reports bearing the accreditation body’s symbol or endorsement, as an indication of their accreditation.

Clients are encouraged to check with the laboratory as to what specific tests or measurements they are accredited for, and for what ranges or uncertainties. This information is usually specified in the laboratory’s scope of accreditation, issued by the accreditation body. The description in the scope of accreditation also has advantages for the customers of laboratories in enabling them to find the appropriate laboratory or testing and calibration service. Laboratory accreditation bodies publish the scopes of accreditation for their accredited laboratories in either hardcopy directories or on the internet.

Overview

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. A second release of the standard was made in 2005 after it was agreed that it needed to be more closely aligned with the 2000 version of ISO 9001 in term of its quality system words which include 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.

In the current global scenario, an essential pre-requisite of trade is that any product or service is accepted formally in one economy, must also be free to circulate in other economies without having to undergo extensive re-testing. WTO recognises that non-acceptance of test or calibration results and measurement data is a Technical Barrier to Trade. Thus, accreditation is considered as the first essential step for facilitating mutual acceptance of test or calibration results and measurement data. In seeking of recognition, laboratories need to demonstrate full compliance with both sections of ISO/IEC 17025 namely Management and Technical requirements and successfully go through the third party assessment i.e by accreditation body.

Many countries around the world have one or more organizations responsible for the accreditation of their nation’s laboratories. Most of these accreditation bodies have now adopted ISO/IEC 17025 as the basis for accrediting their country’s testing and calibration laboratories. This has helped countries employ a uniform approach to determining laboratory competence. It has also encouraged laboratories to adopt internationally accepted testing and measurement practices, where possible. In order for accreditation bodies (at various part of the world) to recognise each others' accreditations, the International Laboratory Accreditation Cooperation (ILAC) worked to establish methods of evaluating accreditation bodies against another ISO standard (ISO/IEC Guide 58 - which became ISO/IEC 17011). Around the world, geo-political regions such as the European Community, and Asia-Pacific, the Americas and others, established regional cooperations to manage the work needed for such mutual recognition. These regional bodies (all working within the ILAC umbrella) include European Accreditation Cooperation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), Southern Africa Accreditation Cooperation (SADCA) and the Inter-American Accreditation Cooperation (IAAC).

Though, the Management Requirements of ISO/IEC 17025 has similarity with ISO 9001, it cannot be interpreted to be the same as certification against the ISO 9000 series Standards. Confidence in accreditation can only be obtained by a transparent system of control over the accredited laboratories and an assurance given by the accreditation body that the accredited laboratory constantly fulfils the accreditation criteria. Thus, demonstration of compliance with Management and Technical Requirements will allow the laboratories to operate a quality management system for their testing and calibration activities that also meets the principles of ISO 9001 and at the same time has the people, with the skills and knowledge, the environment with the facilities and equipment, the quality control and the procedures that are required to produce valid results.

Is ISO/IEC 17025 relevant to your organization?

This International Standard is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. The standard is also applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities.

In addition to the use of this international standard by laboratories in developing their management system for quality, administrative and technical operations, laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. However, this International Standard is not intended to be used as the basis for certification of laboratories.

Global adoption

Following the increasing number of accreditation bodies representing various countries around the world joining as member of ILAC or APLAC by signing Mutual Recognition Agreements (MRAs) and continue efforts by ILAC and APLAC in promoting the acceptance of laboratories accreditation schemes across countries, the accreditation numbers to ISO/IEC 17025 has been steadily increasing.

As of to date, over 40 laboratory accreditation bodies have signed a multi-lateral recognition agreement called the ILAC Arrangement, which greatly enhances the acceptance of data across the national borders of the signatory countries. Full details for the ILAC Arrangement and the list of signatories can be found on the ILAC website.

Benefits

  • Increase of confidence in Testing/ Calibration data and of personnel performing work.
  • Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
  • Potential increase in business due to enhanced customer confidence and satisfaction.
  • Customers can search and identify the laboratories accredited by The Accreditation Member Body for their specific requirements from their website or 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.
  • Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
  • Improved national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.

Auditing

Two types of auditing are required to become accredited to the standard: auditing by an external accreditation body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment especially on demonstration of technical competency, to verify that the system is working as it's supposed to, find out where it can improve and to correct or prevent problems identified.

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