Some standard content:
ICS03.120.20
National Standard of the People's Republic of China
GB/T27067—2006/ISO/IECGuide67:2004Conformity Assessment-Fundamentals of Product Certification certification (ISO/IEC Guide 67.2004, IDT)
2006-09-28 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
2007-05-01 Implementation
ISO/IEC Foreword
Normative references
3 Terms and definitions
3.1 Product certification system
3.2 Product certification scheme
4 Background of product certification
4.1 General principles
4.2 Objectives of product certification
4.3 Application of product certification
5 Basic principles of product certification
5. 1 General considerations
Selection (sampling)
Determination of…
5.4 Review and certification
5.5 Subcontracting
6 Elements and types of product certification systems
6.1 General considerations of elements
6.2 Matrix of elements and types of product certification systems 6.3 Description of types of product certification systems
References
GB/T27067—2006/ISO/IECGuide67:2004
GB/T27067--2006/IS0/IECGuide67:2004
This standard is equivalent to ISO/IECGuide67:2004 "Basics of conformity assessment product certification".
This standard is proposed and managed by the National Technical Committee for Certification and Accreditation of Standardization (SAC/TC261). The responsible drafting units of this standard are: Certification and Accreditation Administration of the People's Republic of China, Fangyuan Mark Certification Group Co., Ltd. The participating drafting units of this standard are: China National Accreditation Service for Conformity Assessment, China Quality Certification Center, China Standard Certification Center. The main drafters of this standard are: Zhang Wei, Xu Zengde, Lu Mei, Zhao Zhiwei, Cao Yabin, Chen Yunhua, Liu Xiaohong, Li Tienan, Fei Yang, Cao Gang.
GB/T27067—2006/IS0/IECGuide67:2004ISO/IEC Foreword
The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) have established a professional system for global standardization. The national member bodies of ISO and IEC participate in the formulation of international standards through technical committees established by ISO and IEC for specific areas of technical activities. The technical committees of ISO and IEC cooperate in areas of common interest. Other governmental and non-governmental international organizations that maintain contact with ISO and IEC also participate in the work. In the field of conformity assessment, the ISO Committee on Conformity Assessment (CASCO) is responsible for the formulation of international standards and guidelines.
International Standards are drafted according to the rules of Part 2 of the ISO/IEC Directives. Draft Guides adopted by the relevant committee or working group are submitted to the member bodies for voting. The draft Guide must be approved by at least 75% of the member bodies participating in the voting before it can be published as a Guide. ISO/IEC Guide 67 was prepared by the ISO Committee on Conformity Assessment (CASCO). GB/T27067-2006/ISO/IECGuide67:2004 Introduction
When products are designed, produced, sold, used and finally disposed of, they may cause social concerns. A common concern is whether the product is as described. Concerns about products may involve various characteristics of the product, such as safety, impact on health or the environment, durability, compatibility, suitability for intended use or specified conditions, etc. Addressing these concerns through product certification has the following two purposes:
a) It allows users and consumers to better choose products in the market; b) Suppliers can more effectively obtain market recognition by demonstrating conformity. The type of activities performed to demonstrate conformity of a product to requirements is often determined by the severity of the consequences of nonconformity. When the consequences are not significant or serious, society may rarely (require) or not expect to demonstrate conformity of a product because the problems caused may be easily dealt with or resolved after they occur. In these cases, statements from the supplier may be sufficient, although these statements may be supplemented by voluntary third-party product certification. However, if the consequences of nonconformity are significant, society may require that activities to demonstrate conformity of a product be completed before the product is allowed to enter the market, while the product is on the market, or both. One way to provide such assurance is to carry out product certification. The conformity assessment of a product can be carried out in a variety of ways by various parties (first-party, second-party and third-party). Product certification is a method by which a third party provides assurance that a product conforms to specific standards and other normative documents. This standard has been developed to provide a better understanding of the various functions and types of product certification.
This standard describes some of the activities of product certification, identifies the basic elements and types of product certification, and gives some methods for designing a product certification system incorporating these elements. The parties involved in product certification often view product certification only in terms of how it is implemented in their own specific context. Therefore, this standard emphasizes that there are many methods for product certification, and each method has its own rationality for application. This standard also identifies various activities that may be included in product certification under normal circumstances. The consideration of each element in this standard does not mean that all of these elements should be included in the product certification system, but is intended to propose the application method of each element. This standard provides various methods for selecting these elements to design a product certification system. The purpose of this standard is to promote a broad understanding of product certification as much as possible and to provide assistance to those who develop product certification systems for specific purposes and those who are responsible for evaluating these systems. 1 Scope
GB/T27067-2006/ISO/IECGuide67:2004 Conformity assessment
, product certification basis
This standard identifies various elements of product certification systems based on existing practices and provides guidance on product certification systems. This standard is intended for use by product certification bodies and other stakeholders who wish to understand, develop, establish or compare third-party product certification systems.
This standard does not aim to describe all existing forms of product certification. This standard does not involve first-party and second-party product conformity assessment.
Note 1: The term "product" has the broadest meaning in this standard, including processes and services; the term "standard\ includes other normative documents, such as specifications or technical regulations (see GB/T27065 for examples).
Note 2: Product certification is a third-party conformity assessment activity (see GB/T27000). 2 Normative references
The provisions of the following documents become the provisions of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document , the latest version of which applies to this standard. GB/T27000-2006 Vocabulary and general principles for conformity assessment (ISO/IEC17000:2004, IDT) 3 Terms and definitions
The terms and definitions established in GB/T27000-2006 and the following terms and definitions apply to this standard. 3.1
Product certification systemproductcertificationsystem Rules, procedures and management for implementing third-party product conformity assessment Note: Adapted from definition 2.7 of GB/T27000--2006. 3.2
Product certification schemeproductcertification Scheme Product certification system related to a specific product that is subject to the same specified requirements, specific rules and procedures Note 1: Adapted from definition 2.8 of GB/T27000-2006. Note 2: It is not necessary to distinguish between "product certification scheme" and "product certification system" at the national level. 4 Background of product certification
4.1 General
4.1.1 The first step to address concerns about the product is to formulate relevant product standards (or other normative documents), and the next step is to determine the method of product compliance with the standards.
Evaluating whether the requirements of standards or other normative documents are met is a technical means to address social concerns about products. 4.1.2 Product certification is an activity in which a third party provides written assurance that a product (including processes and services) meets specified requirements. In view of the widespread application of product certification throughout the world, this standard puts forward some views on the basic objectives that product certification should achieve. GB/T27067—2006/ISO/IECGuide67:20044.2 Objectives of product certification
4.2.1 Product certification is mainly applied to those social concerns whose importance requires the participation of independent organizations. The application of product certification confirms this view, because product certification is usually only used for important concerns (such as safety, health or environmental protection). Product certification may also be used by suppliers (manufacturers, retailers, warehouses, other service providers, etc.) to improve the market acceptance of their products.
4.2.2 Three basic purposes of product certification: 1. Product certification should gradually establish confidence for consumers, users and all stakeholders that the product meets the requirements, thereby addressing their concerns about the product; 1. Product certification can be used by suppliers to indicate to the market that there is third-party involvement; 1. Product certification should not require too many resources, resulting in product costs exceeding the limits that society is usually willing to bear. 4.2.3 In general, product certification should build confidence among parties concerned that a product meets requirements, and should provide sufficient value so that suppliers can market their products effectively. Product certification is most successful when it provides the required confidence using the fewest resources possible—maximizing value.
4.3 Applications of product certification
4.3.1 Product certification is applied in a variety of ways. For example, in some countries, governments may require certification for matters related to communications, food, and drugs; local government departments rely on product certification to ensure that technical areas such as electrical wiring and building products are suitable for use in construction projects; retailers of consumer goods use certification to prove that a third party has provided assurances about electrical safety, etc., thereby convincing people that the products they sell will not cause harm to consumers; and manufacturers may require suppliers to certify the goods they provide. 4.3.2 Each of the above situations involves different interested parties, each with specific interests. For example, governments have management and control responsibilities for matters that affect the interests and welfare of the general public. In many cases, the nature of the issues of concern transcends national boundaries. In these cases, governments often work together to set the basic rules and requirements. Examples include electromagnetic compatibility (EMC), terminal devices, and aviation.
4.3.3 Governments are also concerned with matters that are limited to their own country, such as highway construction or water supply. In the construction field, some countries may have national-level regulation, while others may have regulation at the provincial or state level or even at the local municipal level. At a more basic level, retailers and consumers are free to make their own choices. 4.3.4 While these examples illustrate the main differences in the application of certification, these brief overviews do not fully explain the details of certification in each case, nor do they cover all the application aspects of certification. 4.3.5 An individual's understanding and knowledge of certification will often depend on his or her own experience and familiarity with a particular field or application of certification. Because certification can be done in different ways, a single set of rules cannot be universally applicable to all applications and situations of certification, such as the choice and details of the system itself, or mutual recognition on a bilateral, multilateral or global basis. It is therefore necessary to understand who is involved, how they participate, and to what end (for details, see ISO/IEC Guide 68). 4.3.6 Certification is by its very nature a constraint, otherwise it would have no value. Therefore, engaging in product certification is a challenge. However, parties with common goals can work together to realize the value of certification without adding unreasonable burdens and constraints. 5 Basic principles of product certification
5.1 General considerations
5.1.1 Product certification, as a technical means to address concerns related to the design, production, sale, use and disposal of products, has been used for more than 100 years. Many effective forms of product certification can be found in the world. Although all forms of product certification may be very effective, the specific concerns that need to be addressed by product certification and the operating conditions of product certification (voluntary and mandatory) will limit the choice of the optimal combination of elements of a specific product certification system.
5.1.2 Product certification includes at least the following three functional stages: Selection (sampling):
-determination;
-review and certification (decision).
GB/T27067—2006/IS0/IECGuide67：20045.1.3 According to the product certification system and quality management system in Table 1, product certification may include various other elements (such as assessment of production processes and market sampling).
5.2 Selection (sampling)
In the selection (sampling) stage, it is necessary to determine the characteristics to be assessed, the requirements (the specified requirements on which the product's conformity assessment is based) and the procedures applicable to the assessment and sampling.
5.3 Determination
Determination in accordance with applicable specified requirements may include testing, measurement, inspection, design evaluation, service assessment and audit, which are examples of methods used to check whether the product meets the specified requirements. When determining characteristics, measurements (in order to determine the value or limit) and comparison of the measured value with the required value can be combined. Note: The concept of measurement is defined in the International Basic Vocabulary and General Terms of Metrology (VIM). 5.4 Review and Certification
Before a decision is made to authorize the use of a certificate or mark of conformity, the adequacy of the quantitative and qualitative evidence relating to the product needs to be reviewed and documented.
If sufficient information is available, a decision can be made whether a certificate can be issued or the use of a mark of conformity can be authorized. For a specific product, the certification decision should be made by a person who does not have the certification determination function. 5.5 Subcontracting
Some elements of a product certification system may be subcontracted, depending on the rules of each system, but certification decisions should not be subcontracted. 6 Elements and types of product certification systems
6.1 General consideration of elements
6.1.1 The basic elements of product certification are supported or supplemented by additional elements. Additional elements will be identified when further, more substantive and more specific consideration is given to the actual implementation of the basic elements in product certification. For example, a decision should be made on how to select appropriate standards. Standards should be applicable to the product certification scheme selected. In determining the appropriateness of standards, the methods used in the development, maintenance or interpretation of standards can be considered. The initial assessment of the opponent's products should determine how to obtain samples and what tests to perform. 6.1.2 Although it is impossible to explain all issues and more options within a limited framework, it is helpful to focus on those more common elements and explain how they can work together to form a product certification system. Through this structured explanation, it can be seen that no combination of elements can be used as the only combination and arrangement of elements to define product certification. On the contrary, it shows that in the design and implementation of product certification, it is necessary to carefully consider the various situations related to product certification needs that are recognized. 6.2 Elements and Types of Product Certification Systems The element matrix in Table 1 gives some of the more general and common elements of product certification. The matrix provides suggestions on how to combine these elements to establish a specific certification system. For ease of reference, a type number can be assigned to each combination. These elements can also be used in other combinations to establish other systems. Moreover, users can add other sub-elements according to their own preferences to further refine the matrix.
Note: The product certification system numbers used below are not exactly the same as those in reference [16]. System 1 in reference [16] corresponds to systems 1a and 1b in Table 1. In addition, the symbol N is added to Table 1 to indicate possible other unnumbered systems based on different elements. 3
GB/T27067-2006/IS0/IECGuide672004Table 1 Establishment of product certification system
Elements of product certification system
1) Selection (sampling), when applicable
Determination of "characteristics, when applicable, by the following methods: a) Testing (ISO/IEC17025)
b) Inspection (GB/T18346)
c) Design evaluation
d) Service assessment
Review (evaluation)
Certification decision
Approve, maintain, expand, suspend, cancel certification license (certification\)
Approve, maintain, expand, suspend, cancel the right to use the certificate or mark6) Supervision, when applicable, by the following methods: a) Sampling from the open market Testing or inspection
b) Testing or inspection by sampling from the factory
c) Quality system audit combined with random testing or inspection d) Assessment of production processes or services
Product certification system.
Where applicable, these elements can be combined with the initial review and surveillance of the applicant's quality system (ISO/IEC Guide 53 gives an example) or the initial review of the production processa
. The order in which these reviews are carried out may vary. b Product certification systems should contain at least the elements of 2), 3) and 4). ISO/IEC Guide 28 describes a frequently used and proven model of product certification system, which is the product certification system corresponding to system 5.
d For product certification systems involving specific products, the term "scheme" is used (see Note 2 to 3.2). Reference [16] mentions system 7 (batch testing) and system 8 (100% testing). These systems must contain at least the elements of 1a to be considered as product certification systems.
f Definitions are given in GB/T 27000.
In some systems, evaluation means determination, while in others it means review. e
6.3 Description of types of product certification systems
6.3.1 General
The following examples do not necessarily reflect all possible forms of product certification systems. They can be used with many types of requirements and a wider range of mechanisms can be used to show conformity. 6.3.2 System 1a
Involves testing; conformity is assessed on samples of product. The sampling of the product population may or may not be of statistically significant character.
This certification system includes:
a) samples required by the certification body;
b) determination of characteristics by testing or assessment; evaluation of test or assessment reports;
d) certification decision.
6.3.3 System 1b
GB/T27067—2006/IS0/IECGuide67:2004 includes testing; assessing the conformity of product samples. Sampling is based on all products. A certificate of conformity is issued for each product represented by the sample.
This certification system includes:
a) samples required by the certification body;
b) determination of characteristics through testing or assessment; evaluation of test or assessment reports;
d) certification decision;
e) issuance of a license.
6.3.4 System 2
Includes testing and market supervision. Implement factory supervision and assess the continued conformity of products sampled from the production site. This certification system includes:
Samples requested by the certification body;
Determination of characteristics by testing or assessment;
Initial review of the production process or quality system, where applicable; Evaluation of test and assessment reports;
Certification decision;
Issuance of license;
Surveillance through testing or inspection of samples taken from the market. NOTE: Although this system can determine the impact of the distribution chain on conformity, it may require considerable resources. Furthermore, when serious nonconformities are found, the effective preventive measures that can be taken may be limited because the product has already been placed on the market. 6.3.5 System 3
Includes testing and factory surveillance. Factory surveillance is carried out and the continued conformity of products sampled from the production site is assessed. This certification system includes:
Samples required by the certification body;
Determination of characteristics through testing or assessment;
Initial review of the production process or quality system, where applicable; Evaluation of test and assessment reports:
Certification decision;
Issuance of license;
Supervision through testing or inspection of samples taken from the factory and review of the production process. Note: This system does not provide an indication of the impact of sales channels on conformity. When serious non-conformities are found, there is still an opportunity to resolve the non-conformity if the product has not yet been put on the market in large quantities.
6.3.6 System 4
Includes testing and supervision of samples obtained from the factory or (and) the open market. This certification system includes:
a) Samples required by the certification body:
Determination of characteristics through testing or assessment:
Initial review of the production process or quality system when applicable; d)
Evaluation of test and assessment reports;
Certification decision;
Issuance of license;
Supervision through testing or inspection of samples taken from the factory and review of the production process; 5
GB/T27067--2006/IS0/IECGuide67:2004h) Supervision through testing or inspection of samples taken from the open market. Note: This system can not only indicate the impact of sales channels on conformity, but also provide a mechanism to identify and resolve serious non-conformities before products are put on the market. For products whose conformity is not affected during the sales process, a lot of duplication of work may be generated. 6.3.7 System 5
Includes testing and review of related quality systems. The quality system is implemented for monitoring and the continuous conformity of products taken from the market or (and) the production site is assessed.
This certification system includes:
Samples required by the certification body;
Determination of characteristics through testing or assessment;
When applicable, initial review of the production process or quality system; Evaluation of test and assessment reports;
Certification decision;
Issuance of license;
Monitoring the production process or (and) quality system of the organization; Monitoring through testing or inspection of samples taken from the factory or (and) the open market. Note that the implementation level of the three requirements in continuous monitoring can be adjusted according to specific circumstances. Therefore, this system provides great flexibility for continuous monitoring. System 6
Specially for the certification of processes and services.
The elements of this certification include the following:
Determination of characteristics through assessment of processes or services; initial review of the quality system, where applicable; evaluation;
Certification decision;
Issuance of licensing;
Supervision through audits of the quality system; Supervision through assessment of processes or services. GB/T27067-2006/IS0/IECGuide67:2004 References
［17GB/T19000-2000 Quality Management System Fundamentals and Vocabulary (idtISO9000:2000) [2] GB/T19011--2003 Quality and (or Environmental Management System Audit Guide (ISO19011:2002, IDT) [3]
GB/T18346-2001
General requirements for the competence of various types of inspection bodies (idtISO/IEC17020:1998) [4 www.bzxz.net
ISO/IEC17021:2006 Conformity assessment - Requirements for bodies providing management system audit and certification [5]
GB/T27024-2004 Basic requirements for certification bodies for conformity assessment personnel (ISO/IEC17024:2003, IDT) [6]
ISO/IEC17025:
General requirements for the competence of testing and calibration laboratories [7]GB/T27030--2006 General requirements for third-party conformity marks for conformity assessment (ISO/IEC17030:2003, IDT)
ISO/IECGuide2:2004 Standardization and related activities - Common vocabulary
[9]ISO/IECGuide23:1982 Third-party certification systems for indicating conformity Method ISO/IEC Guide 28: 2004 Guidelines for third-party product certification systems for conformity assessment [10]
GB/T 15483.1-1999 Proficiency testing using laboratory comparisons Part 1: Establishment and operation of proficiency testing schemes (idt ISO/IEC Guide 43-1: 1997) [12]
GB/T 15483.2-1999 Proficiency testing using laboratory comparisons Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies (idt IS ISO/IEC Guide 43-2: 1997) [13]
ISO/IEC Guide 53: 1988 Methods for using supplier quality systems in third-party product certification [14]
GB/T 27065-2004 General requirements for product certification bodies (ISO/IEC Guide 65: 1996, IDT) ISO/IEC Guide 68: 2002 Agreement on recognition and acceptance of conformity assessment results Conformity assessment and verification of standards and technical specifications. International Organization for Standardization (ISO) and International Electrical Certification and Related Activities -
International Electrical and Electronics Commission (IEC), 1992
VIM International General Terms of Basic Metrology. BIPMEC, FCC, SO, IUPAC, IUPAP, OIML, 1993[18] Websites related to product certification:
http://ts.nist.gov
http://iecee.org/cbscheme-http://wssn.net
1) To be published. (Revision of ISO/IEC17025:1999)
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