Laboratory accreditation or ISO 9001 certification?
When looking for an organization to entrust with your testing, calibration and measurement tasks, you need to be sure that the organization will give you reliable and exact results.
Technical competence of a laboratory depends on various factors including:
- qualification, practical experience and skills of the personnel;
- appropriate equipment maintained in good condition and calibrated;
- appropriate control and quality assessment procedures;
- appropriate procedures of sample collection and preparation;
- certified testing/measurement techniques;
- precise registration of data, including protocols;
- appropriate testing conditions.
Until the lab proves it complies with all the above mentioned requirements, or gives you the opportunity to rate its condition by yourself, nobody can guarantee that the organization you’ve selected is competent.
What does it mean if the lab has an ISO 9001 certificate??
Laboratories can be inspected and certified according to the international quality management standard ISO 9001. This standard is commonly used by manufacturing and service providing organizations for the assessment of their goods and services quality management systems.
Being an effective instrument in terms of management systems assessment, ISO 9001 doesn’t contain criteria for the assessment of technical competence of a service provider. It means that the assessment of a supplier in terms of ISO 9001 doesn’t guarantee that your customers will get precise and reliable results of testing, measurement or calibration.
Then how can you be sure that the laboratory is technically competent?
Most countries nowadays rely on the process of laboratory accreditation as a source of independent assessment of the competence of the laboratory.
Unlike ISO 9001 certification, laboratory accreditation uses criteria and procedures directly aimed at defining technical competence. Experts and technical specialists rate all factors which can have an impact on the issued technical data. These criteria are based on the international ISO/IEC standard 17025 used for laboratory assessment all over the world. This standard focuses on the factors influencing the ability of the laboratory to get precise (correct) testing and measurement results including:
- technical competence of the personnel
- attested and relevant methods
- traceability of measurements and calibration to the national reference standards
- appropriate application of measurement uncertainty
- calibrated and properly working testing equipment
- appropriate testing conditions
- appropriate procedures of sample collection and preparation
- testing, measurement and calibration results quality assurance.
Laboratory accreditation also includes the corresponding elements of quality systems, just like ISO 9001. To conform compliance, accredited laboratories are regularly controlled. They might be asked to participate in regular qualification testing programs or intralaboratory comparative tests in order to demonstrate their competence via external evaluation.
How can I recognize an accredited laboratory?
Test or calibration reports issued by accredited laboratories are usually marked with some symbol or sign of recognition confirming their accreditation. You should also ask the lab about the list of particular types of testings, calibrations and measurements it is accredited to perform. It is usually mentioned in the accreditation scope register which the lab provides upon request.
Accreditation agencies of many countries issue the registers or lists of laboratories accredited by them containing the information of their contact persons and the scope of testing. The accreditation agency can help you choose an accreditation laboratory able to perform the required testing or calibration.
If you need to find an accreditation agency in your country, make an inquiry to your national standardization authority or the ministry of industry or technologies. If you have access to the Internet, visit the International Laboratory Accreditation Cooperation (ILAC) website www.ilac.org
and use its accreditation agencies registers and the lists of accredited laboratories in some countries.
What should I do with the data obtained from foreign laboratories?
Many countries have one or several organizations responsible for laboratories accreditation. Most of these accreditation agencies have adopted the ISO/IEC 17025 standard as a basis for the accreditation of testing and calibration laboratories. It allows for a common approach to defining the competence of the laboratories. It also urges the labs to use, if possible, the internationally recognized testing and measurement procedures.
Such an approach helps countries to conclude agreements based on mutual assessment and accreditation systems recognition. These international agreements, aka Mutual Recognition Arrangements (MRA), are of key importance for ensuring the possibility of mutual recognition of testing and calibration results by the countries. In fact, each participant country of such an MRA considers the laboratories accredited by the partner as accredited by this country itself.
About 45 accreditation agencies have signed the multilateral recognition agreement (ILAC). The list of member countries is available at ILAC website www.ilac.org
This international agreements system helps the labs to get international recognition and promotes the recognition of data accompanying the exported goods on the foreign markets. It reduces costs of both the manufacturer and the importer, as there’s no or small need to re-test products in another country.
Countries having no accreditation systems can accredit their laboratories abroad, thus making the results of these laboratories approved on the foreign markets. They can also create their own accreditation systems based on the structure and experience of the systems of other countries.
There’s the difference in the goals, criteria and accents of the ISO 9001 and ISO/IEC 17025 quality management standards.
ISO/IEC 17025 is a standard for laboratories wishing to confirm their technical competence together with the quality management system. Thus, the customers searching for competent laboratories should make sure these labs are accredited according to ISO/IEC 17025 standards and their testing scope is relevant and appropriately confirmed.
A laboratory, accredited according to the ISO/IEC 17025 standard, can, for some reasons, have the ISO 9001 quality management system, too. For example, many laboratories, which are independent legal entities, are involved in other forms of activity alongside testing, measurement and calibration. The laboratory’s accreditation scope doesn’t cover its extra functions. If the management system of an organization includes some forms of activity not related to testing, for example, project calculation, marketing, information services, educational activity, etc., it can be obliged or expected to certify these forms of activity according to the ISO 9001 standards.