Accreditation

Written by CROSQ Secretariat on . Posted in Accreditation

What is accreditation?

Accreditation is a procedure by which an authoritative body provides formal recognition that a body or person is competent to carry out specific tasks.

Accreditation and trade

The international trade environment largely influences the need for accreditation of CABs as governments increase technical barriers to trade in an effort to regulate their markets. Accreditation provides assurance to trading partners that an exporting country is competent to test, inspect or certify to the trading partners’ requirements, thus overcoming trade barriers by assuring compliance to the WTO/TBT Agreement.

Such an accreditation could be granted to different types of CABs such as inspection bodies, certification bodies (product, management systems and personnel) and laboratories. Laboratory accreditation, therefore, is the formal recognition of an organization’s technical competency to perform specific tests, types of tests or calibrations.

Accreditation of laboratories ensures that test results can be reproduced to a sufficient degree in any accredited laboratory. It is an independent method of monitoring laboratory competence and performance and it assures the validity of results to users. An accredited laboratory can establish Mutual Recognition Agreements (MRAs) with counterpart bodies. These agreements ensure equivalency of systems in different countries. There is automatic acceptance of test results from accredited laboratories, which are parties to a given MRA. Costs are reduced because there is no need for duplicate testing by both exporters and importers and this serves to eliminate technical trade barriers and facilitate trade.

Using accredited laboratories also facilitates economic growth. The accrediting process relies on a uniform approach to determining laboratory competence – an approach that has been accepted and implemented across many borders. Because of internationally accepted testing and measurement practices, data generated by an accredited laboratory may lead to the more ready acceptance of exported goods in overseas markets.

The ISO publication, “Building Trust: The Conformity Assessment Toolbox” (page 40), defines accreditation as: “...a conformity assessment technique specifically related to the assessment of the conformity of conformity assessment bodies by a third party body, generally known as an accreditation body”

Accreditation standards and criteria

Two international standards are used for the purposes of accreditation – ISO/IEC 17025 “General requirements for the competence of Testing and Calibration laboratories”, and ISO 15189 “Medical Laboratories – Particular requirements for Quality and Competence”.

Laboratory accreditation uses criteria based on the international standards specifically developed to determine technical competence. Specialist technical assessors contracted by accreditation bodies conduct a thorough evaluation of all factors in a laboratory that affect the production of the test and / or calibration data to ensure accurate and reliable results. These factors are:

  • technical competency of staff;
  • validity and appropriateness of test methods;
  • traceability of measurements and calibrations to national standards;
  • suitability, calibration and maintenance of test equipment;
  • testing environment;
  • sampling, handling and transportation of test items; and
  • quality assurance of test and calibration data.

Difference between accreditation and certification

While certification is a confirmation of conformance of a product, service or system to established standards or requirements, accreditation establishes, for instance, the competence of a laboratory including requirements for laboratory personnel and operations.

Benefits of accreditation for laboratories

A regular assessment by an accreditation body checks all aspects of a facility’s operations related to consistently producing accurate and dependable data. Areas for improvement are identified and discussed and a detailed report provided at the end of each visit. Follow-up action is monitored by the accreditation body so the facility is confident that it has taken the appropriate corrective action.

Accreditation has the following benefits:

  • test and/or calibration results from accredited labs provide confidence that supplies comply with specifications;
  • test and/or calibration data contribute to consistently high quality products;
  • users have confidence in the technical capability of the accredited lab;
  • users of calibration services have confidence in the accuracy of their measurements;
  • reliable test and/or calibration data aid the decision making process for tenders and contracts;
  • it can be used as a marketing tool;
  • it supports policies to keep abreast of new technological developments;
  • it promotes continuous improvement of the services offered; and
  • effective management of the laboratory quality system enhances staff discipline and development.

Recognition of technical competence

Accredited laboratories are able to issue test or calibration reports bearing the accreditation body’s logo or endorsement, as an indication of their accreditation. Clients are encouraged to check with the laboratory concerning the specific tests or measurements they are accredited for, and the ranges or uncertainties. This information is usually specified in the laboratory’s scope of accreditation. The description in the scope of accreditation enables customers to find the appropriate laboratory to test their products.

International recognition

Many countries have adopted ISO/IEC 17025 and ISO 15189 as the basis for accreditation which has helped towards a uniform and internationally accepted approach in determining laboratory competence. This approach allows countries to establish agreements among themselves, based on mutual evaluation and acceptance of each other’s accreditation systems. Such international agreements, called mutual recognition arrangements (MRAs), are crucial in enabling test and/or calibration data to be accepted between these countries. In effect, each partner in such an MRA recognizes the other’s accredited laboratories as if they had undertaken the accreditation themselves. This has allowed data accompanying exported goods to be readily accepted in overseas markets and effectively lowers costs for both the manufacturers and importers, as it reduces the need for products to be re-tested.

International recognition

Many countries have adopted ISO/IEC 17025 and ISO 15189 as the basis for accreditation which has helped towards a uniform and internationally accepted approach in determining laboratory competence. This approach allows countries to establish agreements among themselves, based on mutual evaluation and acceptance of each other’s accreditation systems. Such international agreements, called mutual recognition arrangements (MRAs), are crucial in enabling test and/or calibration data to be accepted between these countries. In effect, each partner in such an MRA recognizes the other’s accredited laboratories as if they had undertaken the accreditation themselves. This has allowed data accompanying exported goods to be readily accepted in overseas markets and effectively lowers costs for both the manufacturers and importers, as it reduces the need for products to be re-tested.

CROSQ’s role in regional accreditation

CROSQ is in the process of establishing a regional accreditation mechanism amongst its Member States, the objective of which is to create an approach that would facilitate co-ordination for laboratory accreditation regionally in a manner that leverages capacity, harmonises processes and procedures and ensure quality service is maintained while being cost-effective, internationally recognized and accepted globally.

Caribbean Cooperation for Accreditation (CCA) Scheme is envisaged as a regional approach in which the CCA will operate as a unit within CROSQ for the facilitation of cost-effective accreditation solutions for the region. The main objectives of CCA are to ensure that:

  • For clients and the National Accreditation Focal Points (NAFPs): Internationally recognized Accreditation Services are economical, affordable, convenient and readily accessible in the region.
  • For the regionally located National Accreditation Bodies (NABs): Opportunities will be afforded for market expansion and new product development, thereby assisting their growth and development in a sustainable manner.

There are certain guidelines that will be underlying any formulated option of CCA in order for it to operate efficiently and effectively:

  • It will be built against international accreditation standards so as to assure that accredited CABs within the region can obtain international acceptance of their test results, thereby achieving higher levels of competitiveness;
  • The resulting organizational structure for regional accreditation will ensure that there is acceptance of testing results between the regional partners, operating according to harmonized criteria.
  • CCA will offer recognitions on the mandatory sectors ruled by legislation of CARICOM countries;
  • The NABs need to attain international recognition by becoming an International Laboratory Accreditation Cooperation / International Accreditation Forum (ILAC/IAF) MRA signatory and sign a Memorandum of Understanding (MoU) with CROSQ which will outline the terms of the cooperation; and
  • CCA will concentrate as a centre for shared services e.g. regional requests, regional training etc.

The CCA system will be a regional accreditation service that would be available initially, for private and public sector clinical, testing and calibration laboratories within the Caribbean economies. It should be noted however, that in order to fully address the needs of all CABs within the Caribbean this scope will have to be eventually extended for the inclusion of existing certification and inspection bodies.

The International Laboratory Accreditation Cooperation (ILAC)/International Accreditation Forum (IAF) Mutual Recognition Arrangement (MRA) is based on the results of an intensive evaluation of each body carried out by peers and in accordance with the relevant rules and procedures.

This regional approach to accreditation envisages the two NABs of the region working in cooperation with CROSQ and the local NAFPs. The CCA Scheme will therefore include the following key stakeholders:

  • TTLABS of Trinidad and Tobago and JANAAC of Jamaica – both IAAC Full Member and ILAC Affiliate Member;
  • Any other regional NAB that may emerge;
  • NAFPs in each Caribbean Member State; and
  • CROSQ.

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