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Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 27029-2022: Conformity assessment - General principles and requirements for validation and verification bodies Status: Valid
Basic dataStandard ID: GB/T 27029-2022 (GB/T27029-2022)Description (Translated English): Conformity assessment - General principles and requirements for validation and verification bodies Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A00 Word Count Estimation: 26,253 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 27029-2022: Conformity assessment - General principles and requirements for validation and verification bodies---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. Conformity assessment -- General principles and requirements for validation and verification bodies ICS 03.120.20 CCSA00 National Standards of People's Republic of China Conformity assessment General Principles and Requirements for Validation and Verification Bodies (ISO /IEC 17029.2019, IDT) Published on 2022-04-15 2022-11-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Principle 3 4.1 General 3 4.2 Principles of the Validation and Verification Process 4 4.2.1 Evidence-based decision-making4 4.2.2 Documentation 4 4.2.3 Tell the truth 4 4.3 Principles for Validation and Verification Bodies4 4.3.1 Impartiality4 4.3.2 Capability 4 4.3.3 Confidentiality4 4.3.4 Publicity 4 4.3.5 Responsibilities 4 4.3.6 Response to complaints5 4.3.7 Risk-based approach5 5 General requirements5 5.1 Legal entities5 5.2 Validation and Verification Statement Responsibilities5 5.3 Impartiality Management5 5.4 Legal liability6 6 Structural Requirements 6 6.1 Organizational Structure and Top Management 6 6.2 Operation Control 6 7 Resource requirements7 7.1 General requirements 7 7.2 Personnel 7 7.3 Processes for managing human competencies7 7.4 Outsourcing 7 8 Validation and verification options8 9 Process Requirements 8 9.1 General requirements 8 9.2 Preparation before signing 8 9.3 Contracting 9 9.4 Planning 9 9.5 Validation and Verification Implementation 10 9.6 Review 10 9.7 Issue of Decision and Validation and Verification Statement 10 9.7.1 Decision 10 9.7.2 Issuance of Validation and Verification Statements 10 9.8 Facts discovered after the validation and verification statement was issued11 9.9 Handling of complaints11 9.10 Handling of complaints11 9.11 Record 12 10 Information Requests 12 10.1 Public information 12 10.2 Other information available 12 10.3 Validation and Verification References and Use of Marks 12 10.4 Confidentiality 13 11 Management System Requirements 13 11.1 General requirements 13 11.2 Management Review 13 11.3 Internal Audit 14 11.4 Corrective Action 14 11.5 Measures to address risks and opportunities 14 11.6 Documented information 15 APPENDIX A (INFORMATIVE) ELEMENTS OF THE VALIDATION AND VERIFICATION PROGRAMME16 Appendix B (informative) Terms and concepts defined in this document17 Appendix C (Informative) Application Notes for Validation and Verification 19 Reference 20 forewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. This document uses the equivalent ISO /IEC 17029.2019 "General Principles and Requirements for Conformity Assessment and Verification Bodies". Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed and managed by the National Certification and Accreditation Standardization Technical Committee (SAC/TC261). This document is drafted by. China Certification and Accreditation Association, China National Accreditation Center for Conformity Assessment, Shenzhen CTI International Certification Co., Ltd., Guangzhou Saibao Certification Center Service Co., Ltd., China Quality Certification Center, China Classification Society Quality Certification Company, Environmental Development of the Ministry of Ecology and Environment Center, Certification and Accreditation Technology Research Center of State Administration for Market Regulation, China Metrology Association, Zhonghuan United (Beijing) Certification Center Co., Ltd. Company, Fangyuan Mark Certification Group Co., Ltd., China Building Materials Inspection and Certification Group Co., Ltd., Anhui Provincial Institute of Quality and Standardization, Construction Building Materials Industry Technology Information Institute, China Railway Inspection and Certification Center Co., Ltd., Nanjing Zhongke Pharmaceutical Co., Ltd., Beijing United Zhiye Certification Ltd. The main drafters of this document. Wang Yaning, Li Xijun, Zhou Lu, Zhou Wenquan, Chen Chunyan, Huang Lijun, Zhou Caicai, Li Weihua, Liu Wenbo, Zhang Xi, He Zhaowei, Wang Xiaodong, Sun Zhihui, Shi Chenggang, Yang Siyuan, Fu Binyou, Luo Hui, Xue Jinghua, Shi Weiwei, Zhao Tianshi, Yan Haochun, Zhou Yajie, Song Bin.IntroductionValidation and verification, as conformity assessment activities, can be understood as activities to determine the reliability of the information declared in the claim. Others and Approval Terms related to the subject of verification assessment also include statements, statements, announcements, conclusions, forecasts or reports. The main difference between the two activities is the timing of the claims being evaluated. Validation for intended use or forecast for the future The claim of the test result (the determination of reasonableness), the verification is applicable to the claim of the thing that has happened or the result obtained (the determination of the authenticity). This document only specifies general requirements and needs to be used in conjunction with the programme for a specific validation or verification activity. These plans further stipulate Validation of definitions, principles, rules, procedures and requirements related to the verification process, as well as competency requirements for validators and verifiers in specific areas. Relevant programmes may be legal regimes, international, regional or national standards, global initiatives, industry requirements, or Validation and Verification Bodies and Clients agreement. Validation and verification can build confidence in the stakeholders involved by providing assurance. Differences that can be explicitly guaranteed in the scheme level, such as reasonable warranty, limited warranty, etc. According to ISO /IEC 17000, the functional method used to demonstrate that specific requirements are met specifies that conformity assessment consists of the following three basic functions. Can form. ---Select; ---Sure; --- Review and certification. For the relationship between the general terms and concepts defined in ISO /IEC 17000 and the terms and concepts specified in this document, see the section of this document. Table B.1. According to the functional approach, validation and verification as conformity assessment activities include the decision to validate a claim. Validation and verification agency declaration After a decision is made on whether the claim complies with the initially specified requirements, the claim is identified by issuing a validation and verification statement. stipulates that both It can be general or specific, but claims of material misstatement should be avoided. Applicable schemes may specify the validation and verification process additional steps. When determining whether a claim made by a client can be asserted, the validation and verification body needs to collect information on the fulfillment of specific requirements. information and develop a comprehensive understanding and awareness. Includes evaluation of data and plans, review of documents, implementation of alternative calculation methods, site visits or in-person visits staff interviews. The requirements specified in this document apply to both validation and verification activities. If there is a standard requirement that only applies to one of the activities, This document makes it clear. The validation and verification body may be an internal body of the organization that provides the claim (first party), the body that uses the claim (second party), or An institution (third party) independent of the organization or person providing the claim and not related to the interests of the user. Validation and verification is an identification activity, which is different from other conformity assessment activities. It neither carries out characterization (testing) nor provides Inspection (inspection) or certificate of conformity (certification) for a certain period of time. However, the application of validation and verification needs to be combined with the corresponding conformity assessment system. Laboratory-like test reports can be included in inspection activities, or manufacturer's management system audits can be used for product certification, validation Verification statements can also be used as input to other conformity assessment activities. Similarly, the results of other conformity assessment activities can also be used for validation and Check the input of the activity. According to the provisions of this document, the statement of conformity, when issued as a result of other conformity assessment activities, should not be used as a elephant. For example, according to the product standard provided by GB/T 27050, the supplier's declaration of conformity, according to the certification provided by GB/T 27021.1 certificate, or inspection activities carried out in accordance with GB/T 27020 such as design review and verification. In addition, this document does not apply only as inspection (GB/T 27020), testing (GB/T 27025, GB/T 22576.1), certification (GB/T 27021.1, GB/T 27065) Validation and verification activities of one of the process steps, the organization and implementation of these activities shall apply to other specialized door requirements. For example, method validation in a testing laboratory operating in accordance with GB/T 27025, or in a management system operating in GB/T 19001 Design validation and verification. Applicable cases for validation and verification as conformity assessment activities include claims related to greenhouse gas (GHG) emissions (e.g. based on ISO /IEC 14064-3), environmental labeling/product or footprint-related claims (e.g. according to GB/T 24020 and GB/T 24040, such as product declaration), sustainability or environmental reporting (e.g. according to ISO 14016), etc. Potential new application areas include those related to building technology, energy management, Financial Management, Industrial Automation Systems, Software and Systems Engineering, Artificial Intelligence, Information Technology, Health Products and Medical Devices, Mechanical Safety Safety, safety and design engineering and social responsibility claims. However, when the validation and verification activities in the relevant application areas do not belong to this document In the case of conformity assessment activities specified in the document, such validation and verification activities are not included in the scope of this document. In this document, the following textual expressions apply. --- "Should" indicates a requirement; --- "Should" means suggestion; ---"May" means allow; --- "Can" indicates possibility or ability. Conformity assessment General Principles and Requirements for Validation and Verification Bodies1 ScopeThis document specifies general principles and requirements for the competence, consistency and impartiality of validation and verification bodies. Organizations operating under this document may provide validation and verification as first-party, second-party, and third-party organizations. can be used as a separate agency or verification agency, or both. This document is applicable to validation and verification bodies in all industry sectors that make claims of conformity for their intended use (validation) or claims truthful Statements (verifications) provide corresponding assertions. At the same time, this document stipulates that the results of other conformity assessment activities (such as inspection, testing and certification) should not be used for It is the object of validation and verification. In addition, validation and verification activities that are process steps in other conformity assessment activities do not apply to this document. This document is applicable to all areas by combining it with an area-specific approach containing the requirements for validation and verification processes and work procedures. This document may be used for accreditation as an accreditation body, for peer review within a peer review group, as well as for other Other forms of recognition of Validation and Verification Bodies by departments, regulators, programme owners, industry organisations, companies, customers or consumers According to the document. Note. This document contains general requirements, independent of the various validation and verification programmes in operation. The requirements for the various application scenarios are attached to this document Require.2 Normative referencesThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. principles) Note. GB/T 27000-2006 Conformity Assessment Vocabulary and General Principles (ISO /IEC 17000.2004, IDT)3 Terms and DefinitionsISO /IEC 17000 and the following terms and definitions apply to this document. 3.1 claim Information declared by the customer (3.13). Note 1.Claims to be the subject of conformity assessment for validation (3.2) and verification (3.3). Note 2 to entry. Claims can be specific to a point in time or cover a period of time. Note 3 to entry. Claims should be clear and unambiguous, and can be evaluated or measured stably and consistently by the certification body (3.4) and the verification body (3.5) according to the specified requirements. Note 4 to entry. Claims can be presented in the form of reports, statements, project plans or consolidated data. 3.2 validation confirm The assertion (3.1) of a claim (3.1) that the specific intended future use requirements have been met by providing objective evidence. Note 1.Objective evidence can come from real or simulated situations. Note 2 to entry. Validation is considered a process for evaluating the plausibility of assumptions, limits and methods that have implications for future activity outputs claims are supported. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 27029-2022_English be delivered?Answer: Upon your order, we will start to translate GB/T 27029-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 27029-2022_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 27029-2022_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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