An overview of laboratory accreditation.
Testing is the process of getting information and data. It is a technical operation that determines one or more characteristic or performance of a given product, material, equipment, organism, physical phenomenon, process or service according to the specified method. The accuracy, reliability and credibility of these play a very important role for decision making. Test results are used by the customers either for the decisions that may affect the acceptance or rejection of the product, process and the business contract. The test result may also serve as evidence to determine compliance or noncompliance to a statement of requirements, basis for regulatory authorities to initiate action, acceptance or rejection of liability claims on insurance agencies through legal means. Thus, laboratory results have greater impact on the society with respect to commercial transactions, social interactions, economic development, environment, health care, etc.
Customer requirements and traders compliance
Customers need objective evidence, which is the valid test/ measurement data and is produced by a reliable laboratory, that the specifications are met. Due to an open market, the lack of international acceptance of test/measurement data is a significant obstacle to trade. This led the World Trade Organization (WTO) to adopt two new agreements to insure that technical requirements do not restrict the trade. These agreements are on Technical Barriers to Trade (TBT) and on Sanitary and Psytosanitary (SPS).
Valid test/measurement data and their importance
Internationally, the conformity assessment process is used to promote, among others, the acceptance of test/measurement data across borders. This process of assessment assures whether a product or system meets the requirements of a technical regulation or specification. A third party conformity body issues reports or certificates for the following:
* Testing--by using scientific method of test or measure specifications;
* inspection--by using visual means or simple equipment to check specifications;
* product certification--by certifying that the product meets particular standards; and
* system certification--by certifying that quality management environmental management systems meet particular standards.
Accurate test/measurement results are vital for regulatory approval. Product certification decisions may be based on data from laboratories in several different countries. An objective assessment of laboratory competence is therefore a vital issue. As a result, accreditation of such laboratories through internationally agreed criteria is an effective way of demonstrating competence. Accreditation of a manufacturer's laboratory by a competent and authorized body gives such assurance of competence.
Ways of accepting test/measurement data internationally include:
* by accepting overseas data without question;
* by accepting a foreign laboratory through regulator or custom;
* by approving a foreign laboratory through evaluation or recommendation by a third party in the other country, and through an MRA (mutual recognition arrangement) between laboratory accreditation bodies in both countries; and
* the reliable mechanisms for accepting test/measurement data are those through inter-comparisons and discussions at the laboratory level with those confident in technical matters. This is mainly because technical confidence is earned through knowledge and trust.
Test data are acceptable globally only when produced in a competent laboratory. Competency of the laboratory can be achieved by establishing and maintaining effectively a sound quality system during its operation. Otherwise, competency can be judged conventionally by evaluating the results of a particular test/measurement by participating in the proficiency/inter-laboratory program and followed by a comparison of results by different statistical techniques.
Accreditation is formal recognition that an organization is competent to carry out specific tasks. A laboratory is accredited to issue specific types of test reports or calibration reports. The specific areas of competence are specified in the scope of accreditation. Accreditation is granted after detailed assessment of the competence of the organization and its staff against technical and management system criteria defined in ISO/IEC 17025 Standard. This assessment is conducted by accreditation authority staff in association with experts from the particular technology being assessed. Accredited organizations are subjected to regular review by their national accreditation authority.
Parameters considered while choosing a laboratory
When selecting a laboratory to fulfill testing, calibration or measurement needs, one needs to be sure that the laboratory can supply accurate and reliable results. The technical competence of a laboratory depends on a number of factors, including:
* The qualification, training and experience of the staff;
* the right equipment--calibrated and maintained;
* adequate quality assurance procedure;
* proper sampling practices;
* appropriate testing procedures;
* valid test methods;
* traceability of measurements to national standards;
* accurate recording and reporting procedures; and
* suitable testing facilities.
Considerations in judging a lab's technical competence
Throughout the world, 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 a 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.
A void expensive re-testing
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 costs go up, but reputation as a supplier or manufacturer can go down. Choosing a technically competent laboratory minimizes the chance of re-testing being required.
Enhance customers' confidence
Confidence in a product is enhanced if clients know it has been thoroughly evaluated by an independent, competent testing facility. This is particularly so if anyone 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."
Cost optimization and improvement in acceptance of goods in overseas markets
Through a system of international agreements, technically competent, accredited laboratories receive a form of international recognition, which allows their data to be more readily accepted in 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 re-testing in the importing country.
A recognition of testing competence
Laboratory accreditation provides formal recognition to competent laboratories, thus providing a ready means for customers to identity and select reliable testing, measurement and calibration services. 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.
A marketing advantage
Accreditation is an effective marketing tool for testing, calibration and measurement organizations, and a passport to submit tenders to contractors that require independently verified laboratories. Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence. Many accreditation bodies also publish a directory of their accredited laboratories, which includes the laboratories" contact details plus information on their testing capabilities. This is another means of promoting a laboratory's accredited services to potential clients.
A benchmark for performance
Laboratory accreditation benefits laboratories by allowing them to determine whether they are performing their work correctly and to appropriate standards, and provides them with a benchmark for maintaining that competence. A regular assessment by an accreditation body checks all aspects of a facility's operations related to consistently producing accurate and dependable data. Manufacturing organizations may use laboratory accreditation to insure that the testing of their products by their own in-house laboratories is being done correctly.
Judgement about the technical competence of a laboratory
Throughout the world, laboratory accreditation is used as a means of determining technical competence of the laboratory. 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 an international standard called ISO/IEC 17025, which is 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:
* 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; and
* quality assurance of test and calibration data.
Laboratory accreditation and its role in data acceptance
ILAC (International Laboratory Accreditation Cooperation) has laid down agreed international procedures for the operation of an accreditation system. The most important document is ISO/IEC 58, a criteria set out to assess an accreditation body. Similarly, another important document is ISO/IEC 17025, a set of criteria for assessing a laboratory. The National Accreditation System in each country (in India it is NABL: National Accreditation Board for Testing and Calibration Laboratories) judges the competency of the test and calibration laboratory. The liberalization of trade and industry policy of the government provides a greater thrust to export. The WTO identified the acceptability of the test results as a technical barrier to trade across the border. Identification of an authoritative body/bodies for executing the accreditation process nationally and establishing and fulfilling mutual recognition agreements (MRA) through international bodies like ILAC and APLAC, between different nations, is required in order to remove these technical barriers. Data produced from the accredited laboratories will automatically be accepted internationally through MRA. The assessment structure includes:
* Adoption of the international standard that helps countries to adopt a uniform approach for determining laboratory competence;
* allowing countries with similar accreditation systems to establish agreements between themselves, based on mutual evaluation and acceptance of each other's accreditation systems, called mutual recognition agreements (MRA); and
* enabling test data to be accepted between these countries. In effect, each partner in such an agreement recognizes the other partner's accredited laboratories as if they themselves had undertaken the accreditation of the other partner's laboratories. This developing system of international mutual recognition agreements between accreditation bodies has enabled accredited laboratories to achieve a form of international recognition, and allowed test data accompanying exported goods to be more readily accepted in overseas markets. This effectively reduces costs for both the manufacturer and the importer, as it reduces or eliminates the need for products to be re-tested in another country.
Authoritative accreditation body in India-NABL
In 1982, the National Coordination of Testing and Calibration Facilities (NCTCF) was formed under DST, taking ISO Guide 25 as the base document. In 1991, a European Expert (EC) visited to study various standardization systems being practiced in India and recommended that NCTCF be aligned with EN45000 and achieve international recognition. In 1992, NCTCF was renamed NABL under DST and given the time-bound program to achieve the above. In 1999, NABL became an autonomous body under the Quality Council of India (QCI) which is established by the government of India and three prime industry associations. In June 2000, NABL became a member of APLAC and ILAC and signed MRA. At present, about 700 testing laboratories and 300 calibration laboratories have been accredited by NABL, and this figure is increasing in a geometric fashion.
The Standard ISO/IEC 17025:1999
This is the general requirement for the competence of testing and calibration laboratories, replacing earlier ISO/IEC Guide 25 and EN45000, and demonstrates the following:
* Technical competence;
* operation of an effective quality system; and
* ability to generate technically valid calibration and test results.
Scope of the standard
This international standard specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods and laboratory-developed methods. It is applicable to all organizations performing tests and/or calibrations. This includes first, second and third party laboratories where testing and/or calibration forms part of inspection and product certification. It is used by the laboratories in developing their quality, their administrative and technical systems that govern their operations. Laboratory clients, regulatory authorities and accreditation bodies may also use this standard in confirming or recognizing the competence of laboratories. This standard does not cover the compliance with regulatory and safety requirements on the operation of laboratories. This standard is divided into two parts; one is the management requirement and the other one is the technical requirement. The management requirements (4.0) are:
* Organization (clause 4.1);
* quality system (clause 4.2);
* document control (clause 4.3);
* review of requests, tenders and contracts (clause 4.4);
* subcontracting of tests and calibrations (clause 4.5);
* purchasing services and supplies (clause 4.6);
* service to the client (clause 4.7);
* complaint (clause 4.8);
* control of nonconforming testing and/or calibration work (clause 4.9);
* corrective action (clause 4.10);
* preventive action (clause 4.11);
* control of records (clause 4.12);
* internal audits (clause 4.13); and
* management reviews (clause 4.14).
The technical requirements (5.0) include:
* General (clause 5.1);
* personnel (clause 5.2);
* accommodation and environmental conditions (clause 5.3);
* test and calibration methods and method validation (clause 5.4);
* equipment (clause 5.5);
* measurement traceability (clause 5.6);
* sampling (clause 5.7);
* handling of test and calibration items (clause 5.8);
* assuring of quality of test and calibration result (clause 5.9); and
* reporting the results (clause 5.10).
NABL international linkages
NABL maintains its linkages with the international bodies like International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC). NABL is a full member of both ILAC and APLAC. NABL is a signatory to ILAC as well as APLAC Mutual Recognition Arrangements (MRA), which are based on mutual evaluation and acceptance of other MRA Partner laboratory accreditation systems. Such international arrangements facilitate acceptance of test/calibration results between countries to which MRA partners represent.
Present scenario in rubber and allied industries
In India, only a few laboratories have been accredited so far in relation to rubber and allied industries, e.g., HASETRI, Hi-Tech Carbon and Sri Ram Research Institute. A few more laboratories are preparing themselves for accreditation. The major concerns with respect to accreditation in Indian rubber industries are as follows:
* Competent manpower:
* adequate and calibrated equipment in order to make the measurement traceable to national or international standards;
* quality control in testing and calibration activities including proper proficiency testing; and
* uncertainty measurement of testing.
In the international context, information on accreditation about laboratories like Smithers Scientific Services and Akron Rubber Development Laboratory (ARDL) in the U.S. is also available.
The global trade scenario in the open market is such that technical requirements are becoming more stringent. For products to be accepted internationally, manufacturers and producers must prove that their products and services meet these technical requirements. As a result, they must be able to show the laboratory/measurement reports which conform to the technical standard, so the product reports/certificates produced by the accredited laboratories will be accepted to the importing country quickly and freely through a formal mutual recognition arrangement.
Table 1--accreditation vis-a-vis certification Accreditation Certification Laboratory accreditation uses The ISO 9001 standard is criteria and procedures specifi- widely used in manufacturing tally developed to determine and service organizations to technical competence. evaluate their system for managing the quality of their product or service. Specialist technical assessors Certification of an organiza- conduct a thorough evaluation tion's quality management of all the factors in a laborato- system against ISO 9001 aims ry that affect the production of at conforming the compliance test or calibration data. of the management system to this standard. Such certifica- tion does not make any state- ment about the technical com- petence of a laboratory. Accreditation is highly specif- Certification is very generic ic, and it is dependent on the in nature. type of laboratory. The laboratory accreditation The certification process process gives emphasis on the gives emphasis on the quality technical competency of the system alone. laboratory performing specific testing or calibration jobs. Accreditation of any laborato- Certification does not cover ry covers only the tests or cali- the product of the organiza- bration performed by the labo- tion. ratory, which in turn is the product of a laboratory.
1. ISO/IEC 17025:1999 Standard and IS 14874:2000 Standard.
2. S.K. Mandot Project Report on "The new ISO quality system and laboratory, accreditation criteria: Their implication, interpretations, implementations and effectiveness with special reference to HASETRI (a case study)," submitted for fulfillment of MBA degree from IGNOU, New Delhi, 2001.
3. Course material on laboratory quality management system and internal auditor: A course conducted Sept. 2002 by HASETRI at Jaykaygram, Kankroli Rajasthan.
4. S.L. Agrawal, S.K. Mandot, S. Bandyopadhyay, A.S. Deuri and R. Mukhopadhyay, "Accreditation and present scenario in rubber industry," paper presented at Asia RUB TECH EXPO, New Delhi, India, Nov. 2002.
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|Title Annotation:||Tech Service|
|Date:||Oct 1, 2004|
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