When selecting a laboratory to fulfill your testing, calibration or measurement needs, you need to be sure that they can supply you with accurate and reliable results. The technical competence of a laboratory depends on a number of factors including:
- The qualifications, training and experience of the staff
- The right equipment – properly calibrated and maintained
- Adequate quality assurance procedures
- Proper sampling practices
- Appropriate testing procedures
- Valid test methods
- Traceability of measurements to national standards
- Accurate recording and reporting procedures
- Suitable testing facilities
All these factors contribute to a laboratory being technically competent to do your testing.
Why is a laboratory’s technical competence so critical to you as a manufacturer, supplier, exporter or customer?
- Minimize Risk: throughout the world today, customers seek reassurance that the products, materials or services they produce or purchase meet their expectations or conform to specific requirements. This often means that the product is sent to a laboratory to determine its characteristics against a standard or a specification. For the manufacturer or supplier, choosing a technically competent laboratory minimizes the risk of producing or supplying a faulty product.
- Avoid Expensive Retesting: testing of products and materials can be expensive and time consuming, even when they are done correctly the first time. If not done correctly, then the cost and time involved in re-testing can be even higher if the product has failed to meet specifications or expectations. Not only do costs go up, but your reputation as a supplier or manufacturer can go down. You can also be held liable for any failure of your product, particularly if it involves public safety or financial loss to a client. Choosing a technically competent laboratory minimizes the chance of retesting being required.
- Enhance Your Customers’ Confidence: confidence in your product is enhanced if clients know it has been thoroughly evaluated by an independent, competent testing facility. This is particularly so if you can demonstrate to them that the laboratory itself has been evaluated by a third party. Increasingly customers are relying on independent evidence, rather than simply accepting a supplier’s word that the product is “fit for purpose”.
- Reduce Costs and improve acceptance of your goods overseas: through a system of international agreements (see below) technically competent, accredited laboratories receive a form of international recognition, which allows their data to be more readily accepted on overseas markets. This recognition helps to reduce costs for manufacturers and exporters that have their products or materials tested in accredited laboratories, by reducing or eliminating the need for retesting in the importing country.
What if the Laboratory has ISO 9001 Certification?
Laboratories can be audited and certified to an international management systems standard called ISO 9001. This standard is widely used in manufacturing and service organizations to evaluate their system for managing the quality of their product or service. Certification of an organization’s quality management systems against ISO 9001 aims at confirming the compliance of the management system to this standard, but does not specifically evaluate the technical competence of a laboratory.
How Then Can You be Sure That a Laboratory is Technically Competent?
Throughout the world, many countries now rely on a process called laboratory accreditation as a means of determining technical competence. Laboratory accreditation uses criteria and procedures specifically developed to determine technical competence. Specialist technical assessors conduct a thorough evaluation of all factors in a laboratory that affect the production of test or calibration data. The criteria are based on the internationally accepted standards ISO/IEC 17025, or ISO 15189 for medical laboratories, which are used for evaluating laboratories throughout the world. Laboratory accreditation bodies use this standard specifically to assess factors relevant to a laboratory’s ability to produce precise, accurate test and calibration data, including the:
- Technical competence 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
- Quality assurance of test and calibration data
Laboratory accreditation also covers the quality systems elements addressed in ISO 9001 certification. To ensure continued compliance, accredited laboratories are regularly re-examined to check that they are maintaining their standards of technical expertise. These laboratories may also be required to participate in regular proficiency testing programs as an on-going demonstration of their competence.
Laboratory accreditation thus provides a means of evaluating the competence of laboratories to perform specific types of testing, measurement and calibration. It also allows a laboratory to determine whether it is performing its work correctly and to appropriate standards. Manufacturing organizations may also use laboratory accreditation to ensure the testing of their products by their own in-house laboratories is being done correctly.
Very importantly, laboratory accreditation provides formal recognition to competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services able to meet their needs.
How Can You Tell if a Laboratory is Accredited?
Accredited laboratories usually issue test or calibration reports bearing some type of symbol or endorsement indicating their accreditation. You should also check with the laboratory as to what specific tests or measurements they are accredited for, and for what ranges or uncertainties. This is normally specified in their Scope of Accreditation, which may be supplied by the laboratory upon request.
Accreditation bodies in many countries publish lists or directories of the laboratories they have accredited, together with laboratories’ contact details and information on their testing capabilities. If necessary, you can contact the accreditation body and find out whether there are any accredited laboratories that can perform the tests or calibrations you require.
To find out if your country has one or more laboratory accreditation bodies, try contacting your national standards body or your ministry for industry or technology. Alternatively, if you have access to the internet, you can visit the website of the International Laboratory Accreditation Cooperation (ILAC) at www.ilac.org and use the directory of laboratory accreditation bodies available on this website. You will also find directories of accredited laboratories for certain countries on this website.
What About Data From Overseas Laboratories?
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 adopted ISO/IEC 17025 as the basis for accrediting their country’s testing and calibration laboratories, or ISO 15189 for accrediting medical 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.
This uniform approach allows countries to establish agreements among themselves, based on mutual evaluation and acceptance of each other’s laboratory accreditation systems. Such international agreements, called mutual recognition arrangements (MRAs), are crucial in enabling test data to be accepted between these countries. In effect, each partner in such an MRA recognizes the other partner’s accredited laboratories as if they themselves had undertaken the accreditation of the other partner’s laboratories.
Over 40 laboratory accreditation bodies have signed a multilateral 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 at www.ilac.org.
This system of international MRAs between accreditation bodies has enabled accredited laboratories to achieve a form of international recognition and allowed data accompanying exported goods to be more readily accepted on overseas markets. This effectively reduces costs for both the manufacturer and the importers, as it reduces or eliminates the need for products to be retested in another country.
Countries without viable accreditation systems can seek to have their laboratories accredited by established accreditation systems so that their test data and associated goods can be accepted on foreign markets. These countries can also endeavor to develop their own accreditation system based on the structure and experience of established systems in other countries.
Where Can I Get More Information?
For more information contact:
The ILAC Secretariat,
PO Box 7507, Silverwater NSW 2128, Australia
Fax +61 2 9743 5311
Email: [email protected]