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Definition under “Accreditation” means the procedure by which an authoritative body gives formal recognition that a conformity assessment body in accordance to the standards and technical regulations is competent to carry out specific tasks as laboratory testing, calibration, certification, and inspection services. Accreditation means confirmation and recognition of technical competence.
Accreditation is a “third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks,” as defined by ISO/IEC 17011 Conformity Assessment-General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies. Accreditation is a formal recognition that a laboratory is competent to carry out specific tests or calibrations or types of tests or calibrations. Third party is defined as a body that is recognized as being independent of the parties involved, in this case independent of the laboratory or the laboratory’s parent organization.
Accreditation is reserved for those bodies performing some type of certification service. This might be an ISO/IEC 17025 accredited laboratory issuing an accredited calibration or testing certificate, an accredited certification body issuing an ISO 9001 (management system requirements) certificate, or an accredited product or personnel certifier whose responsibility is to certify a product.
Accreditation means the formal recognition of the technical and organizational competence of an authority (such as a testing laboratory) to execute a specific service as described in the scope of accreditation. Competence is the key to transparency, confidence and comparability. Accreditation is a confidence-building measure, which allows authorities, economy and society to judge, if testing, inspection or certification bodies (conformity assessment bodies) fulfill specific tasks with the demanded high reliability.
In addition to technical regulations and standards, conformity assessment procedures also fall within the scope of application of the TBT Agreement. Conformity assessment procedures are defined in Annex 1.3 of the TBT Agreement as: …any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled.
Conformity assessment procedures include, e.g., technical procedures for sampling, testing, verification, inspection, accreditation, and certification, which confirm that products fulfill the requirements laid down in regulations and standards.
As a complement to the obligation to notify, each WTO Member must set up a national enquiry point. This acts as a focal point where other WTO Members can request and obtain information and documentation on a Member's technical regulations, standards and test procedures, whether impending or adopted, as well as on participation in bilateral or multilateral standard-related agreements, regional standardizing bodies, and conformity assessment systems (See Article 10). Enquiry points are generally governmental agencies, but the relevant functions can also be assigned to private agencies. The obligation to set up enquiry points is particularly important for developing countries.
On the one hand, it is the first step by a developing country Member towards implementation of the TBT Agreement. On the other, developing countries can acquire information from other Members' enquiry points on foreign regulations and standards affecting products in which they have a trade interest.
GRP has attracted increasing interest in international trade fora as a tool for preventing unnecessary technical barriers to trade (TBTs). GRP is essential for the elaboration and enforcement of technical regulations. The goal of GRP is to produce quality regulation. GRP promotes awareness of trade and investment implications in regulatory decision making, encourages trade friendliness in regulatory approaches, and reduces discrimination against or impediments to foreign imports, ownership, and supply.The Major GRP principles include:
- transparency and openness of regulatory decision making,
- avoidance of unnecessary trade restrictiveness,
- use of internationally harmonized standards and technical regulations,
- high quality technical regulations,
- recognition by countries of others countries’ regulatory measures, and
- regulatory coordination and consistency
The WTO has stressed the importance of good regulatory practice (GRP) as a critical tool for preventing unnecessary technical barriers to trade (TBTs). A large portion of the issues addressed by the WTO agreement on TBT agreement are regulatory in nature, with discriminatory, overly restrictive, and nontransparent technical regulations and related conformity assessment procedures often serving as significant barriers to trade.
A QI promotes a sustainable economic development mainly by strengthening the private economy by improving competitiveness of enterprises, providing conditions for integration of partner countries into the global trade system, and establishing institutions and influencing the enabling environment at national level. The NQI is considered as the totality of the institutional framework required to establish and implement standardization, metrology (scientific, industrial and legal), accreditation and conformity assessment services (inspection, testing and product- and system certification) necessary to provide acceptable evidence that products and services meet consumer’s safety and market exigencies (TBT requirements, and/or SPS measures).
A functioning NQI is a prerequisite for access to regional and global markets and a key determinant of competitive advantage, and economic growth. Owing to the globalization of the markets and its relentless food safety exigencies, the government is carefully reconsidering the overall arrangement of its NQI. The establishment and development of a quality infrastructure is part of a trade-related technical cooperation. It should enable the partners to utilise the advantages of globalisation and to avoid disadvantages. It is more than ever mandatory to strengthen the NQI institutions; and to provide a national quality promotion strategy that builds on the NQI and assists the country’s efforts in becoming globally competitive.
The functions of the NSB should include the following as a minimum:
- Standards development,
- Information, sales and promotion,
- International, regional and sub-regional liaison,
- Training (which could fall under the information section) Assuming that there is a need and that the necessary resources exist, the following functions may also be considered :
- Conformity assessment
- Corporate services (HR, finance, IT, facilities management, etc.)
A successful performance of a laboratory in a proficiency test (or its effective correction of testing problems after an unsuccessful performance) may provide regulators and accreditation bodies with confidence in the laboratories whose data they endorse or otherwise recognize. The clear benefit for the laboratories is the continuation of their standing as competent organizations.
In order to monitor the reliability of its measurements, it is important for the laboratory to implement quality control measures. For laboratories that are accredited, or seeking accreditation, these measures are an important aspect of the requirements.
Standards can be used as the technical basis for trade in end-products and services between willing buyers and sellers, or as a means of facilitating compliance with technical regulations. They are also used extensively by companies in production, product, service and process environments.
They are developed by a transparent, open and consensus-based process, involving interested stakeholders, and define fitness for purpose in the case of standards for products, and good practice in the case of processes or services.
Harmonization to international standards is an effective way to reduce the duplication of compliance costs due to varying sets of standards in export markets. Standards harmonization may thus facilitate market access and enable countries with no or inefficient standards policies to acquire better practice. However, harmonization means compromising on governments’ ability to set national standards at the appropriate level that may fit better the needs of local industries and consumers. Harmonization also requires potentially important and costly adjustments, involving the alignment of the national standards infrastructure with international practice.
The WTO requires all signatories to the Agreement on Technical Barriers to Trade (TBT) to establish a national Enquiry Point and Notification Authority to gather and efficiently distribute WTO TBT notifications on trade-related standards, technical regulations, and conformity assessment procedures concerning non-agricultural products. The Role of the Inquiry Point:
- To distribute all WTO TBT notifications to industries, government, and trade stakeholders.
- To provide the full texts of the standards, technical regulations, and conformity assessment procedures (which are summarized in the notifications) to inform trade and export stakeholders of the legal basis for the proposed measures;
- To circulates government and WTO Member comments on standards, technical regulations, and conformity assessment procedures;
- To responds to technical inquiries on national and international standards- and trade-related topics
- To Provides training on best practices for Inquiry Point operations and information services to the global network of national WTO TBT Inquiry Points
STDF is a global partnership that supports developing countries in building their capacity to implement international sanitary and phytosanitary (SPS) standards, guidelines and recommendations as a means to improve their human, animal and plant health status and ability to gain or maintain access to markets. In achieving its aims, the STDF acts both as a coordinating and a financing mechanism.
STDF maintains close contacts with the Aid for Trade initiative. It complements this global scheme through projects and monitoring of aid flows at an operational, issue-specific level.
The difference between the two seemingly similar definitions lies in the fact that in the first case, the formal recognition of competence is based on proven technical knowledges and therefore requires the consultation of a technical expert for the scope to be accredited, while the second case primarily involves ensuring conformity with a given norm, e.g. a management system or a product.
Accreditation therefore relates to specific technical tasks such as those of a testing or calibration laboratory, or of a certification or inspection body, for which specific norms set out the required degree of competence.
For accreditation, the rules require that the accreditation process be carried out by third party organizations: that means not by peers, not by suppliers (first parties) and not by customers (second parties). Third party is defined as a person or body that is recognized as being independent of the parties involved, in this case independent of the laboratory or the laboratory’s parent organization.
Certification by an agency or organization, as defined by ISO, is a “procedure by which a third party gives written assurance that a product, process or service conforms to specified requirements” [ISO/IEC Guide 2]. ISO 15189 is intended as an accreditation standard and not for certification. Accreditation is a “procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks” [ISO/IEC Guide 2].
- clearly mapping out and prioritizing key needs for trade-related assistance and capacity building, including trade infrastructure, supply and productive capacity
- submitting these demands to the donor community of each country for accessing funding beyond the resources available in the Framework's own Trust Fund.
The GRP principle encouraging use of internationally harmonized standards and technical regulations may help bring down TBTs by reducing the need for redundant certification and testing, opening markets to trade, and saving time to market.
Complying with different foreign technical regulations and standards entails significant costs for producers and exporters. Such costs arise from the need to translate foreign regulations, hire technical experts to explain foreign regulations, and adjust production facilities to comply with the requirements. In addition, firms must demonstrate that exported products meet the foreign regulations, raising certification, testing, and other conformity assessment costs. When companies are able to produce to the same international standard, they may produce a single version of a product rather than having to produce different versions for the various markets in which they wish to compete. Further, exporters can reduce costs by developing a single regulatory management system to meet product manufacturing requirements.
Thus, by using technical regulations that reference harmonized standards, countries may reduce the trade impact of the technical regulations and prevent unnecessary trade barriers.
The technology or science of measurement. Metrology can be subdivided into scientific metrology (the development and organization of the highest level of measurement standards), legal metrology (the assurance of correctness of measurements where these have an influence on the transparency of trade, law enforcement, health and safety) and industrial metrology (the satisfactory functioning of measurement instruments used in industry, production and testing). The immediate outcome of the implementation of the quality policy will be the design and establishment of a world-class metrology, standardization, accreditation, inspection, testing and certification infrastructure, i.e. the NQI, and the support of the application of its techniques, practices and service provisions to demonstrably comply with international standards throughout. The necessary capacity building actions for the implementation of a proper national quality policy includes upgrading the NQI, and the establishment of a proficient national technical regulation framework. Improvements in reorganizing the country’s food safety system through the implementation of an adequate national quality policy is required to help reduce regulatory deficiencies (gaps, overlaps and duplication, etc.) and to leverage existing resources.
The major components of a national quality policy include the national quality infrastructure (NQI) and the national technical regulatory framework, which covers quality, food safety, environmental and ethical regulations, including theirenforcement. Primarily, the quality policy’s objective is to ensure that goods and services emanating from or traded in the country are designed, manufactured and supplied in a manner that matches the needs, expectations and requirements of the purchasers and consumers as well as those of the regulatory authorities in the local as well as in the export markets. In support of the primary objective, the implementation of the Quality Policy should raise quality consciousness amongst both the suppliers and the consumers, and it is an undertaking to introduce and maintain a quality culture in public life and throughout society
PT is the determination of laboratory testing performance by means of inter-laboratory comparisons conducted by an authorized third party. The basic purpose of PT is to assess performance of laboratories for their conduct of specific test, measurements or calibrations. Many laboratories operate in isolation from other laboratories and do not have ongoing opportunities to compare their data with others. Without such opportunities there are risks that a laboratory’s data may have errors, biases or significant differences compared to similar laboratories. A PT programme provides an opportunity to undertake such comparisons and to have an independent appraisal of the laboratory’s data compared to reference values (or other performance criteria) or to the performance of similar laboratories.
The results from participation in PT programme provide laboratory managers with either a confirmation that the laboratory’s performance is satisfactory or an alert that investigation of potential problems within the laboratory is required. A PT is seen as a risk management and quality improvement tool. A PT provider that operates according to ISO/IEC 17043 can be considered as competent.
ISO/IEC 17043:2010, Conformity assessment — General requirements for proficiency testing.
Stakeholders are parties that stand to benefit from voluntary, consensus-based standards and for whom the existence and content of standards play an important role. Key stakeholders include:
- Industry (including services)
- National, state/provincial and local government
- Consumers and consumer groups,
- Professional institutions, The quality/con-formity assessment sector
- Organized labour, Educational and research establishments
Publication of a formal document (standard), generally developed by consensus, containing the requirements that a product, process or service should comply with. Standards are considered essentially voluntary in themselves.
Standards are a critical issue for manufacturing competitiveness in global markets, as they can facilitate international trade or they may impede access to foreign markets.
Suppliers can therefore choose whether to use standards or not. It is only once they are called up in a contract, for example, or referenced in a technical regulation, that compliance with standards becomes a legally binding obligation.
Standards represent a quasi-regulatory means of pursuing important public policy objectives, such as environmental protection, consumer safety, quality of food, manufactured products and services, or compatibility between different apparatus and regulatory systems. Therefore the policy objective should not be to eliminate standards but to make them more efficient and cost effective.
The mean role of the TBT Notification Authority is:
- To review the regulatory proceedings to identify actions concerning standards, technical regulations, and conformity assessment procedures which meet these conditions:
- There are significant trade effects (e.g., a new labeling or packaging requirement is introduced, product requirements are introduced or changed)
- Does not conform to internationally-accepted standards, technical regulations, or conformity assessment procedures
- There are no internationally-accepted standards, technical regulations, or conformity assessment procedures in place
- To notify to the WTO standards, technical regulations, and conformity assessment procedures proposed for examination
An organization that performs tests and/or calibrations in a permanent, temporary, or remote location. When a laboratory is part of an organization that carries out activities additional to testing/calibration, the term laboratory then refers to only the part(s) of the organization involved in testing and/or calibration process.
Implementing an ISO/IEC 17025 laboratory management system is a means to ensuring efficiency and technical competency in calibration and testing laboratories. A laboratory that establishes a laboratory management system compliant with ISO/IEC 17025 joins the growing world partnership of accredited laboratories.
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories