This standard is a guide to the use of an organization's quality management system in product certification. This standard outlines a common approach for certification bodies to develop and implement the use of an organization's quality management system in product certification programs. The terms given in this standard are not requirements for the accreditation of product certification bodies, nor can they replace GB/T27065-2004 "General Requirements for Product Certification Bodies". GB/T 27053-2008 Guide to the use of an organization's quality management system in conformity assessment product certification GB/T27053-2008 Standard download decompression password: www.bzxz.net
This standard is a guide to the use of an organization's quality management system in product certification. This standard outlines a common approach for certification bodies to develop and implement the use of an organization's quality management system in product certification programs. The terms given in this standard are not requirements for the accreditation of product certification bodies, nor can they replace GB/T27065-2004 "General Requirements for Product Certification Bodies".
This standard is equivalent to ISO/IEC Guide 53:2005 "Guide to the use of an organization's quality management system in conformity assessment product certification" (English version).
This standard is a guide for using the quality management system of an organization in product certification.
Appendix A and Appendix B of this standard are informative appendices.
This standard is proposed and managed by the National Technical Committee for Certification and Accreditation Standardization.
The responsible drafting unit of this standard: China National Institute of Standardization.
Participating drafting units of this standard: National Certification and Accreditation Administration, China National Accreditation Service for Conformity Assessment, China Quality Certification Center, Fangyuan Mark Certification Group, China United Certification Center, Guangzhou Weikai Testing Technology Research Institute.
Main drafters of this standard: Zhu Chunyan, Xu Zengde, Chen Yunhua, Su Shenzhi, Zhang Wei, Xi Yongcai, Chen Zhitian, Wu Keqiu, Ge Hongmei, Li Boning, Min Jing, Jiang Jie.

The clauses in the following documents become the clauses 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 that reach 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 is applicable to this standard.
GB/T19000-2000 Quality Management System Fundamentals and Vocabulary (idtISO9000:2000)
GB/T27000-2006 Conformity Assessment Vocabulary and General Principles (ISO/IEC17000:2004, IDT)

Foreword III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Steps in a product certification scheme 1
4.1 Determine the scheme 1
4.2 Functional stages of implementing a product certification scheme 2
5 Selection 2
6 Determination 2
7 Review and certification 3
8 Supervision 3
9 Mark of conformity 4
Appendix A (Informative) Example 5 of a survey form for a product certification program using a small number of organizational quality management system requirements
Appendix B (Informative) Example 9 of a survey form for a product certification program using multiple organizational quality management system requirements
References 17

ICS03.120.20
National Standard of the People's Republic of China
GB/T27053-2008/IS0/IECGuide53:2005Conformity assessment-
Guidance on the use of an organization's quality management system in product certification(ISO/IECGuide 53:2005, IDT)
2008-05-12 Issued
Digital Anti-Counterfeiting
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
2008-12-01 Implementation
Normative Reference Documents
Terms and Definitions
Steps of Product Certification Scheme
Determine Scheme
Functional Stages of Implementation of Product Certification Scheme
Review and Certification
Conformity Mark
GB/T27053--2008/IS0/ IEC Guide 53: 2005
Appendix A (Informative Appendix) Example of Survey Form for Product Certification Schemes Using a Few Organizational Quality Management System Requirements Appendix B (Informative Appendix)
References
Example of Survey Form for Product Certification Schemes Using Multiple Organizational Quality Management System Requirements 5
GB/T 27053—2008/IS0/IEC Guide 53: 2005 Foreword
This standard is equivalent to ISO/IEC Guide 53: 2005 "Guidelines for the Use of Organizational Quality Management Systems in Conformity Assessment Product Certification" (English version).
This standard is a guide for the use of organizational quality management systems in product certification. Appendices A and B of this standard are informative appendices. This standard is proposed and managed by the National Technical Committee for Certification and Accreditation of Standardization. The responsible drafting unit of this standard: China National Institute of Standardization. The drafting organizations of this standard are: Certification and Accreditation Administration of the People's Republic of China, China National Accreditation Service for Conformity Assessment, China Quality Certification Center, Fangyuan Mark Certification Group, China United Certification Center, Guangzhou Weikai Testing Technology Research Institute. The main drafters of this standard are: Zhu Chunyan, Xu Zengde, Chen Yunhua, Su Shenzhi, Zhang Wei, Yongcai, Chen Zhitian, Wu Keqiu, Ge Hongmei, Li Boning, Min Jing, Jiang Jie.
GB/T27053—2008/IS0/IECGuide53:2005 Introduction
The use of the organization's quality management system in a product certification scheme is beneficial for the organization and the certification body to determine whether the product meets the specified requirements and to ensure continued compliance with these requirements.
In this type of scheme, product certification is based on the assessment of the organization's quality management system and whether the product meets the specified requirements. The product certification schemes within the scope of this standard include these two aspects of assessment that can be performed by the certification body. Product certification schemes can take many forms, including schemes that do not use the organization's quality management system. There is no distinction between good and bad product certification schemes. Furthermore, when the certification body has several product certification schemes for a particular product, the organization has the right to choose the scheme it deems appropriate. Note: The technical regulations of some countries predetermine the type of product certification scheme to be adopted. Interested parties using this standard to develop product certification schemes should be familiar with: - the principles and practices involved in the ISO9000 family of international standards; - the more general certification and supervision provisions for product certification systems developed in GB/T27067; - specific product requirements.
1 Scope
GB/T27053-2008/IS0/IECGuide53:2005 Guide to the use of an organization's quality management system in conformity assessment and product certification
1.1 This standard outlines a general approach for certification bodies to use an organization's quality management system in developing and implementing product certification schemes. The provisions given in this standard are not requirements for the accreditation of product certification bodies, nor can they replace the requirements of GB/T27065-2004. 1.2 The schemes contained in this standard are only suitable for product certification, and in any case, the following principles should be included: a) Assessment of the organization's quality management system and its ability to continuously and stably provide products that meet the specified requirements; b) Inspection, examination or comparison to confirm that the products meet the scheme criteria and specified requirements; c) Adoption of appropriate monitoring programs to ensure that the products provided by the organization continue to meet the specified requirements; d) Control of the certification body's conformity mark and/or logo. 1.3 In the product certification scheme, the certification body may take various methods to prove whether the specified requirements are met, including the assessment of the applicant's quality management system. Regardless of the form of product certification scheme established, the certification body has the right to decide whether to pass the certification. In addition to the criteria described in this standard, the certification body may also specify other scheme criteria as appropriate. 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all referenced documents with a month date, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to agreements based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced documents, the latest version shall apply to this standard. GB/T190002000: Fundamentals and Vocabulary of Quality Management Systems (IDT ISO9000:2000) 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/T19000 and GB/T27000 and the following terms and definitions apply to this standard. 3.1
Inspector
A qualified person assigned by a product certification body to inspect an organization alone or as a member of an inspection team. 4 Steps in a Product Certification Scheme
4.1 Determine the Scheme
In order to achieve the desired assurance of the product certification scheme, the scheme criteria should include: the quality management system requirements specified in GBT19001 or similar quality management system standards.
Note: Such quality management system requirements may be based on GB/T19001 and its applicable standards for a particular industry (e.g. GB/T18305 and ISO/TS29001) or similar quality management system standards. Product certification bodies should consider the possible risks and costs of applying the product certification scheme when determining how many quality management system requirements to include in the certification scheme.
If the risk level is high, the certification body should consider including more quality management system requirements in the certification scheme. 1
GB/T27053—2008/ISO/IECGuide53:20054.2 Functional phases of product certification scheme implementation Product certification schemes within the scope of this standard include the following functional phases: a) selection;
b) determination;
c) review and certification; bzxZ.net
d) supervision.
Note: These functions are consistent with the requirements specified in GB/T27065. GB/T27067 gives product certification schemes developed by certification bodies using this standard. For a description of the above functions, see GB/T 27000. Chapters 5 to 8 describe the activities of the above functions, which are related to the use of the organization's quality management system as part of the product certification program.
5 Selection
5.1 During the selection stage, the certification body should collect information to determine the degree of compliance with the requirements (see Chapter 6). 5.2 When the organization has implemented a quality management system, the certification body should review the documents to determine the organization's readiness for the quality management system, the extent to which the quality management system has been established and its ability to implement it. 5.3 To facilitate the review, the applicant needs to provide relevant information in the form of a program data record form. Appendix A and Appendix B provide two examples of program questionnaires, one is simpler and the other is more complex in terms of the number of quality management system requirements. 5.4 The certification body should ensure that the organization has a minimum experience in implementing a quality management system before submitting an application for product certification. This requirement depends on the type of product certification program and the extent to which the program uses the organization's quality management system. 5.5 The certification body may consider whether the scope of certification covered by the organization's existing quality management system certification includes: a) the product scope under consideration;
b) the location where the activities take place.
Note: It is also possible to consider recognizing the quality management system certification completed by the certification body that has been accredited and/or peer reviewed in accordance with relevant national and international standards (such as GB/T27021 and/or ISO17040). 5.6 The certification body should evaluate the information provided and request additional information if necessary to decide whether the certification work can enter the next stage, namely the determination stage.
5.7 The certification body should arrange for an on-site inspection of the applicant organization and set up an inspection team. The members of the inspection team should have the following capabilities: familiar with the applicable product requirements;
b) familiar with the corresponding inspection and/or inspection procedures and techniques; familiar with the conformity assessment procedures;
d) familiar with the quality management system requirements included in this plan; and familiar with the inspection methods recommended by GB/T19011
Note: For information on inspection activities, personal qualities, knowledge and skills of inspectors, please refer to GB/T19011. 6 Determination
6.1 The specific content of the on-site verification by the inspection team will vary greatly depending on the specific quality management system requirements included in the relevant product certification plan. However, the inspection team should normally take the following actions: a) determine the correctness and completeness of the information contained in the application; b) conduct inspections to determine that the organization is equipped with the necessary equipment, facilities and personnel to complete the tasks required of the organization in the product certification scheme;
Require the organization to demonstrate its ability to monitor and measure products to ensure compliance with specific product requirements specified in the product certification scheme. This may require the certification body to verify the inspection results or inspection reports; GB/T270532008/IS0/IECGuide53:2005d) Confirm that the organization has implemented the quality management system procedures as part of the certification scheme, and that the organization has made necessary planning arrangements to ensure that the quality management system procedures can be effectively implemented and maintained on a continuous basis. 6.2 After the inspection of the quality management system by the certification body inspection team, it is appropriate to prepare an inspection report based on the inspection results. The report should be submitted together with the complete application materials to the person or group in the certification body responsible for deciding whether to approve the certification and under what conditions. This condition is related to the degree of trustworthiness of the applicant's quality management system in ensuring the continuous production and supply of products that meet the specified requirements.
6.3 The organization shall be certified for new products when the certification body confirms that the organization's new products meet the specified requirements and, where applicable, completes an inspection of the quality management system directly related to the new products. 6.4 If required by the relevant product certification scheme, all sites involved in the product design process of the organization (whether or not part of the organization) should be included in the identification stage of the certification body. 6.5 When the organization's quality management system has been certified by an accredited or peer-reviewed certification body, the certification body should consider the total amount of inspection time.
Note: Recognition of quality management system certification completed by accredited and/or peer-reviewed certification bodies in accordance with relevant national and international standards (such as GB/T27021 and/or ISO17040) can also be considered. 7 Review and certification
7.1 The specific way to use an acceptable quality management system depends on the specific requirements of the relevant product certification scheme. The certification process should be completed as described in the certification scheme, and the acceptability of the organization's quality management system for each certified site covered by the product certification should also be included in the certification documents. 7.2 For example, a simple procedure might be based solely on the acceptability of test data provided by the organization's laboratory, that is, only those requirements relating to the organization's testing facilities and operations would be covered during the inspection (see Annex A). In this case, the certification body's inspector should inspect the laboratory on-site to:
a) witness all types of testing or inspection processes, including sampling; or b) witness certain types of testing or inspection processes; or c) review the organization's test results or inspection reports, which would be accepted if they meet the specified requirements. NOTE: For testing and calibration laboratories, ISO/IEC 10001 specifies both management system requirements and technical competence requirements. When products are certified to this standard, only the relevant quality management system requirements are checked, and ISO/IEC 10001 does not serve as the basis for laboratory quality management certification. 7.3 As another example (see Annex B), after the various processes of the organization's quality management system have been inspected and all other reviews required by the product certification scheme have been completed, the certification body authorizes the organization to use its mark for that product under continuous supervision. 7.4 Annexes A and B show examples of product certification schemes that make little (Annex A) and much (Annex B) use of the organization's quality management system requirements, respectively. In addition, certification bodies may use different combinations to meet different needs. NOTE: Product certification provided by a product certification scheme based on this standard does not mean that its associated quality management system is also certified. 8 Landu
The monitoring phase of a product certification scheme is to ensure that the certified products continue to meet the specified requirements for a specified period of time. The specific content of the monitoring may depend on the type of scheme, but the following principles should be followed: During on-site monitoring of the organization, the certification body's inspector shall ensure that all quality management system requirements described in the product certification scheme are implemented and that the products covered by the scheme continue to meet the specified requirements. Monitoring work usually also includes witnessing certain selected tests or inspections, verifying their records and inspecting products to determine whether they meet the requirements. b) During monitoring, the scheme criteria related to new or changed products within the approved product range should be considered. If it is determined that product changes may affect the use of the certification mark for new or changed products, the inspector should submit his opinions to the person or group in the certification body who has overall responsibility for the certification decision. 3
GB/T27053-2008/ISO/IECGuide53:2005The product certification scheme should specify the minimum frequency of supervision. All sites covered by the product certification scheme should be supervised. For example, c)
If the manufacture or supply of a product is not carried out at the same location as its design, testing and inspection, and all these activities are within the product certification scheme, then the relevant sites should be supervised (see also 6.4). Conformity mark
GB/T27030 has made corresponding provisions for the issuance and use of third-party conformity marks. For detailed guidance, please refer to GB/T27023-2008 "Methods for expressing conformity to standards in third-party certification systems" and GB/T27027-2008 "Guidelines for certification bodies to take corrective measures for misuse of their conformity marks".
Appendix A
(Informative Appendix)
GB/T27053-2008/ISO/IECGuide53:2005 Example of a questionnaire for a product certification scheme that utilizes a small number of organizational quality management system requirements A, 1 Introduction (not part of this scheme questionnaire) The following is an example of a scheme questionnaire that the certification body requires an organization applying for certification to complete, which requires the use of some or all of the inspection data generated by the organization's inspection laboratory to demonstrate compliance with applicable requirements. This example is based on the requirements of GB/T19001. In this example, the certification body's inspection of the organization's quality management system requirements in accordance with the certification scheme will involve: control of monitoring and measuring equipment (e.g. GB/T19001--2000, 7.6); and - monitoring and measurement of products (e.g. GB/T19001-2000, 8.2.4). The inspection of the organization's quality management system involves the following items: laboratory operating procedures or instructions;
the accuracy of all relevant measuring and testing equipment; environmental conditions for calibration;
environmental conditions for inspection;
measurement and inspection methods;
the effectiveness of measuring and testing equipment;
whether the resources required for inspection are sufficient;
the organization's equipment calibration procedures;
proof of the ability to conduct inspections in accordance with the requirements specified by the certification body. During the selection stage, the certification body may consider: a) jointly determining with the organization the designated representative and agent for certification liaison; evaluating the organization's understanding of the applicable requirements and how to maintain this understanding; b)
) checking whether product inspection personnel have the appropriate work capabilities, including the ability to conduct inspections in accordance with the requirements. Information related to the above items can be found in the program questionnaire (see Chapter A.2). A.2 Scheme Questionnaire (Sample)
Document:
Organization:
Introduction and Instructions
This form is intended to provide the certification body with information on: a) the organization's quality management system that ensures that all products bearing the certification body's mark conform to its applicable requirements; and b) the capabilities and responsibilities of the personnel in the organization responsible for the product certification scheme. For the following questions, the certification body requires documentation to confirm the answers given. The certification body shall retain a copy of it. This form shall be completed by the organization and submitted to the certification body together with supporting documents before the certification body's inspector inspects the organization. A separate form shall be completed for each new or additional site. Once completed, this form will be used as the basis for review together with relevant documents and the organization's conformity assessment scheme. If there are any changes to the organization, personnel, information or other content reported on this form, the organization shall promptly notify the certification body in writing so that certification under this scheme can proceed. The certification body's personnel will review the information contained in this form regularly during subsequent on-site inspections to determine and record changes.
GB/T270532008/IS0/IECGuide53:2005If there is not enough space on this form to accommodate the relevant application information, it is advisable to add a note in an appropriate place, such as "see the appendix dated". The required materials must be dated, identified and attached. Once completed, this form should be kept as a confidential document, and the certification body should do the same. Location and person in charge
Inspection or inspection site (full address): Person on site responsible for handling matters related to this product certification program a)
Name:
Position:
Location:
Telephone:
E-mail:
Fax:
This person should be authorized in writing to carry out the requirements of the certification body on behalf of the organization and make necessary modifications to the production inspection facilities and procedures in accordance with the requirements of the certification body's standards and relevant documents.
Is it authorized?
To whom should this person report? (Name and position) b)
Agent with the same responsibilities as 1a):
Production (or supply) site
Name (full name):
Address (full name):
Person responsible for capital product certification scheme matters at the production (or supply) site:Name (full name):
Position:
Telephone:
E-mail:
Fax:
Quality management system
Does the organization implement a quality management system standard that complies with GB/T19001 or an equivalent? If applicable, please specify the equivalent quality management system standard. 3.2 Has the quality management system been certified by a recognized certification body? 6
Yes No
Yes No
Yes No
GB/T27053-—2008/IS0/IECGuide53:20053.3 Does the scope of the quality management system certification cover the production (or supply) process of the products within the scope of the product certification? 3.4 Are all the sites responsible for production (or supply) covered by the quality management system certificate? If yes, please attach a copy of the latest quality management system certificate or the latest audit report. 4 Personnel
Yes No
Please attach the quality management system document that specifies the responsibilities and authorities of the personnel responsible for inspecting or checking whether the product conforms to the requirements and writing product monitoring and measurement records.
Please attach the relevant qualification documents of the above personnel and their resumes in terms of education, training, experience and skills. 5
Control of monitoring and measuring devices
Criteria: The quality management system should be able to effectively control the monitoring and measuring devices used to verify whether the product meets the requirements as specified in 7.6 of GB/T19001-2000 or equivalent quality management system standards (it is advisable to indicate the identification). 5.1 Which monitoring and measuring devices are used for inspection? List the serial number and quantity as appropriate, and provide the accuracy of each inspection. 5.2 Calibration cycle of monitoring and measuring devices? List the calibration cycle of each device.
5.3 Calibration status identification of monitoring and measuring devices? 5.4 Which reference equipment is used for calibration? 5.5 Are the calibration records of each relevant monitoring and measuring device permanently archived? 5.6 Is there a written calibration procedure?
5.7 Who is responsible for approving the release and implementation?
5.8 Describe how these reference equipment can be traced back to international standards or national standards. 6
Inspection procedures
1 Have documented inspection procedures been established for all product inspections? 6.1
6.2 Who is responsible for approval and release?
Yes? No?
GB/T27053—2008/IS0/IECGuide53:2005 Is the inspection procedure provided to all inspectors? 6.3
Do the inspectors understand the inspection procedures? Can they smoothly perform the required inspections? 6.4
Please list the relevant personnel who can perform the inspections. Does the documented control procedure include requirements for reviewing and approving the inspection methods when relevant requirements are changed? 6.5
Please explain in detail.
Are there records of inspection results or examination results for the products certified under this scheme? 6.6
If not, why? Please explain in detail. Yes? No
Yes? No?5 Are the calibration records of all relevant monitoring and measuring devices permanently archived? 5.6 Is there a written calibration procedure?
5.7 Who is responsible for approving and issuing the implementation?
5.8 Describe how these reference equipment are traceable to international or national standards. 6
Inspection procedures
1 Have documented inspection procedures been established for all product inspections? 6.1
6.2 Who is responsible for approving and issuing the implementation?
Yes No
GB/T27053—2008/IS0/IECGuide53:2005 Are the inspection procedures provided to all inspectors? 6.3
Do the inspectors understand the inspection procedures? Can they smoothly perform the required inspections? 6.4
Please list the relevant personnel who can perform the inspections. Does the documented control procedure include the requirement for reviewing and approving the inspection methods when the relevant requirements are changed? 6.5
Please explain in detail.
Are there any records of test results or inspection results for products certified under this scheme? 6.6
If not, why? Please explain in detail. Yes No
Yes No5 Are the calibration records of all relevant monitoring and measuring devices permanently archived? 5.6 Is there a written calibration procedure?
5.7 Who is responsible for approving and issuing the implementation?
5.8 Describe how these reference equipment are traceable to international or national standards. 6
Inspection procedures
1 Have documented inspection procedures been established for all product inspections? 6.1
6.2 Who is responsible for approving and issuing the implementation?
Yes No
GB/T27053—2008/IS0/IECGuide53:2005 Are the inspection procedures provided to all inspectors? 6.3
Do the inspectors understand the inspection procedures? Can they smoothly perform the required inspections? 6.4
Please list the relevant personnel who can perform the inspections. Does the documented control procedure include the requirement for reviewing and approving the inspection methods when the relevant requirements are changed? 6.5
Please explain in detail.
Are there any records of test results or inspection results for products certified under this scheme? 6.6
If not, why? Please explain in detail. Yes No
Yes No
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