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Assuring quality : Infrastructure for conformity assessment

by B. S. P. Mendis

Market deman-ds and expectations with regard to quality of goods and services are translated into the form of standards and technical regulations. Standards are a technical language that businesses use the world over to create goods, services and systems in meeting such demands. Conformity assessment procedures used to verify that requirements of these standards are fulfilled form an integral part of the systems for assuring quality of goods and services in the marketplace. The national infrastructure for effective application of standards and conformity assessement procedures needs to be strengthened to assure quality of goods and services on offer and enhance national performance.

Standards and Technical Regulations for products, processes, production methods and systems adopted at International and National levels form the basis for Quality Assurance of products and services offered both in internal and external trade. Needs and expectations of the Consumers and users are identified, and are translated into the form of specific requirements. These are then written into technical regulations and standards. Effective application and implementation of these technical regulations and standards is the key basis through which the safety and quality of products and services are assured to the general public or to specific consumer groups and users.

Effective application and implementation of technical regulations and standards, directly involves the assessment of conformity of products processes and systems to the relevant technical regulations and standards at various stages of production and delivery processes. "Conformity assessment procedures" is defined as any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations and standards are fulfilled.

Assessment of conformity with technical regulations and standards may take a variety of forms. These include sampling, testing, inspection, certification, calibration, and other supporting activities. These conformity assessment activities may involve regulatory functions non-regulatory (voluntary) activities or support for business operations, and may be undertaken by organizations in the public or private sector.

Conformity assessments connected with regulatory functions arise from the implementation of technical regulations and other mandatory requirements supported within a legal framework. Conformity assessments connected with non-regulatory (voluntary) activities include inspection and certification of products, services and systems based on accepted standards by independent third parties and declarations provided by manufacturers on aspects of quality and conformity to standards. Such declarations and certifications provide information in the marketplace and makes it possible for consumers and users to make their choice of goods and services with confidence.

Conformity assessment systems

Thus the increasing demand on quality of products and services offered both in domestic and export markets necessitates compliance with technical regulations, standards, and other regulatory measures covering health safety and quality.

The increasing importance of conformity assessment procedures in trade and in provision of goods and services requires the development of national conformity assessment systems which are reliable, transparent and based on internationally accepted systems on accreditation, testing and certification. Only then the purchaser or consumer could rely on the information given by the seller supported by independent conformity assessment bodies.

With regard to international trade, the Agreement of the World Trade Organization on Technical Barriers to Trade (WTO/TBT Agreement) was established to ensure that technical regulations and standards, and the procedures for assessing conformity with them, do not create unnecessary obstacles to international trade. The TBT Agreement promotes the recognition of others' conformity assessment results as a way of reducing barriers to trade. It emphasizes that confidence in the continued reliability of conformity assessment results is a prerequisite for recognition of assessments.

An overview of the market and the needs for conformity assessment and accreditation is illustrated in the figure.

Institutional infrastructure for quality

In recent developments in conformity assessment procedures several new approaches have been adopted. These new approaches adopted worldwide demands that certification, testing and inspections are carried out by impartial and competent bodies which could demonstrate their competence and reliability in performance. The methodology used for declaring competence is known as accreditation and is performed by a national accreditation body, which functions in accordance with international standards and guidelines. The function of an accreditation body is to assess the competence of the conformity assessment bodies performing within the national quality infrastructure and declare their competence.

The primary objective of this global approach is to introduce transparency into the conformity assessment systems used in both regulated and non-regulated (voluntary) sectors. One of the main means of achieving this is to ensure that the competence and credibility of conformity assessment bodies could be objectively verified. This is intended to generate confidence and thus promote the mutual recognition and acceptance of the results (test reports, certificates etc.) issued by these bodies.

To support quality assurance activities, it is necessary to establish well defined national infrastructure for conformity assessment, which makes it possible to provide efficient and effective services to support all sectors on an equal basis. A national quality infrastructure consists of all activities necessary to secure quality of products and services ultimately leading to better quality of life of the community. This is manifested in an institutional infrastructure for quality and conformity assessment consisting of the following institutions:

. A National Accreditation Body,

. A National Standards Body,

. Metrology system consisting of a national metrology institution and calibration laboratories,

. Testing laboratories,

. Certification Bodies, and

. Inspection Bodies

International standards and guides have been developed for bodies conducting conformity assessments and these standards have been adopted by many countries as the basis for greater acceptance of these procedures. It is therefore necessary to establish and develop the competence of conformity assessment bodies and accreditation activities in line with these International principles and standards.

Accreditation

Providing access to an accreditation scheme for the conformity assessment bodies is essential to strengthen and expand the institutional infrastructure for quality at national level. Recognizing the need for strengthening the institutional infrastructure for conformity assessment the Government of Sri Lanka has already accepted in principle the need to establish a National Accreditation Board. Legislating necessary for the establishment of the NAB has been drafted and is under consideration by the Ministry of Economic Reform, Science and Technology.

The main function of the National Accreditation Board will be to carry out accreditation of conformity assessment bodies in accordance with established international and national standards. The NAB will supervise and accredit the activities of testing and calibration laboratories, Product and Systems Certification bodies, and certification bodies for personnel undertaking quality related activities, offered by both the private and public sector.

For International recognition of the conformity assessment procedures it is necessary that the National Accreditation Board of Sri Lanka enters into Mutual Recognition Agreements (MRAs) with National Accreditation Boards of other countries. This will facilitate the free flow of goods between Sri Lanka and her major trading partners.

In the institutional infrastructure for quality, the main function of a National Standards Body (NSB) is to promulgate national standards for products, processes, methods, systems etc. for guidance and use by industry trade and other economic operators. In this exercise International Standards are adopted as national standards wherever applicable. These standards could be used by industry and other service providers to declare and demonstrate conformity of their products and services to the consumers and users.

This may be done through independent third party certification or self-declaration supported by sound evidence through appropriate conformity assessment procedures. Regulatory bodies could use these Standards as the basis for regulatory activities to assure safety and quality of products and services in order to safeguard the general public and in national interest. The Sri Lanka Standards institution is the NSB in Sri Lanka fulfilling the above objectives.

Testing laboratories

Strengthening the conformity assessment systems for quality assurance activities involve the development of a network of accredited testing laboratories, calibration laboratories, inspection and certification bodies to meet the needs of industry, trade and regulatory bodies. It is therefore necessary for the state sector, with the participation of the private sector, to support these activities by harnessing all available resources and developing activities for conformity assessment in line with international principles.

Testing is the most commonly performed type of conformity assessment and in the broadest sense covers testing measuring, calibration, examining, identifying or checking of a material, a specimen, a component, a product or a system for conformity with technical regulations and standards. Testing also provides the basis for other forms of conformity assessment. For example, testing is the main approach used in product certification activities to determine that a product complies with a specific standards.

Establishment and development of national testing arrangements to support conformity assessment activities should consider the resources available nationally to perform testing activities required by various sectors. These facilities may be available in testing laboratories operated by a wide range of organizations including government agencies, academic and research institutions, commercial organizations and industrial enterprises.

To make maximum use of facilities available in such laboratories and to support conformity assessment activities it is essential that all steps are taken to maximize the confidence of data and test reports generated by these laboratories. This is secured through Accreditation of laboratories based on ISO/IEC 17025:1999 - "General requirements for the competence of testing and calibration laboratories." The ISO/IEC 17025 contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they are technically competent and are able to generate technically valid and reliable results.

Calibration laboratories

The concept of traceability of measurements is one basic mechanism, which is required to be established to support the acceptance of testing and inspection activities. In checking competence of conformity assessment bodies, specifically laboratories and inspection bodies, the procedures adopted to demonstrate traceability of measurements plays a vital role. All international trade and exchange of finished and semi-finished goods would be impossible without traceability of measurement. To support conformity assessment activities and assure reliability of measurements in industry and production activities it is necessary to provide calibration services through accredited calibration laboratories with traceability to International Measurement Standards.

Inspection and certification bodies

Accredited inspection and certification bodies to support regulatory and non-regulatory (voluntary) activities forms an integral part of the institutional infrastructure for quality and conformity assessment. Requirements for inspection and certification bodies performing various types of inspections and certification are covered in a series of ISO/IEC Standards. Management and operational requirements as well as technical requirements are covered in these standards. Accreditation of the conformity assessment bodies based on the relevant international standards ensures technical competence of these bodies and provides confidence in the impartiality and integrity of their operations.

Product certification is a procedure by which a third party gives written assurance that a product conform as to specified requirements in a standard or other normative document. Product certification involves testing, assessment of production methods and related quality management activities. Accredited product certification bodies will be necessary to support conformity assessment activities.

In response to needs to worldwide business community, International Standards covering Management Systems requirements have been established. Requirements for Quality Management Systems (QMS) are covered in ISO 9000 series of Standards, and requirements for Environmental Management Systems (EMS) are covered in ISO 14000 series of Standards. Several other management systems standards have been developed and are used in industry and trade. Hazard Analysis Critical Control Point System (HACCP) is a safety management system in food production and processing published as an International Standard by the Codex Alimentarius Commission.

Business enterprises and other Organizations are seeking third party certification against these standards to demonstrate their performance in safety, quality and environmental activities. These certification activities are carried out by accredited certification bodies specifically accredited for QMS, EMS, HACCP or other Certification based on competence. The Sri Lanka Standards Institution provides product and systems certification services to the industry and trade.

Supporting quality assurance activities

Through the establishment of an accreditation system, an effective mechanism is developed for all regulatory authorities to have the necessary conformity assessment and controlling functions performed by other bodies both in the public and private sector, where such bodies have been assessed for competence and credibility by the NAB. When Government regulatory authorities promulgate laws and technical regulations, it is necessary to carry out conformity assessment to ensure effective implementation of such regulations.

The regulatory bodies could delegate specific types of conformity assessment activities to other bodies (public and private sector) which are accredited for performing such activities. This system could be made use of by regulatory bodies for implementation of regulations avoiding the need for the regulatory bodies to set up their own mechanisms for conformity assessment. Internationally such arrangements have been proved to be more effective and efficient than the regulatory bodies (public sector) setting up their own mechanisms for such purposes. It is also possible for the Regulatory Bodies to make effective use of accredited Product and Systems Certification Schemes to assure quality of products and services where health, safety or critical quality issues are involved.

The Accreditation system could be effectively used in certain key areas to secure safety and reliability of services offered to the general public. For instance, there has been an increasing concern about the reliability of results and reports issued by medical testing laboratories. Reliability in these reports could only be assured through the use of reliable equipment and validated methods, competency of persons who carry out the tests, supported by well laid down management and operation systems in laboratories. Accreditation of these laboratories based on ISO 17025 will provide an effective mechanism for assuring reliability of these services and providing the necessary confidence in the system.

In conclusion, the strengthening of the conformity assessment systems for goods and services backed up by an accreditation scheme would support the industry in facilitating internal and external trade and would be an effective mechanism for assuring quality of goods and services for domestic markets and for exports. It will also promote and facilitate private sector participation in quality assurance and conformity assessment activities.

Regulatory bodies could use the services of conformity assessment bodies both in the public and private sector for effective implementation of relevant regulations. The industry and trade could use the system to demonstrate the conformity of their products and services to the relevant standards.

(The writer is Deputy Director General Sri Lanka Standards Institution)

Japan-Sri Lanka diplomatic relations

by Pelham Juriansz

"This year we celebrate 50 years of Japan-Sri Lanka diplomatic relations" said the President, Sri Lanka-Japan business Co-operation Committee, Das H. T. Wijeratne, at the 13th Joint Meeting of the Japan-Sri Lanka 21st Century Symposium held at the BMICH on November 25th and 26th.

"The previous time we met was in Sri Lanka about four and a half years ago in May 1997 for the 11th Joint meeting. When we met in Tokyo in 1999 for the 12th meeting,it was decided to hold the 13th Joint meeting in Sri Lanka in 2001. However, in view of the celebration of 50 years of diplomatic relations between Japan and Sri Lanka in 2002 it was mutually decided to defer the Joint meeting to 2002".

The speakers addressed issues such as the economic situation, investment policy, trade and industry and concentrate on a few specific product and service sectors such as tea, IT, Tourism and fisheries identified as having potential for expansion of commercial relations with Japan.

The Chairman at the 13th Joint Meeting of the Sri Lanka-Japan and Japan-Sri Lanka Business Co-operation Committees Minoru Murofushi said that he recalled that it was in May 1979 when the then Minister of Trade and Shipping Lalith Athulathmudali visited Japan, that in addition to holding a seminar on investment in Sri Lanka in Tokyo, the two countries agreed to establish a Business Co-operation Committee between the two countries.

The meeting was attended by about 125 delegates from both countries.

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