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GB/T 27029-2022Conformity assessment - General principles and requirements for validation and verification bodies (English PDF)

合格评定 审定与核查机构通用原则和要求

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

April 15, 2022

Implementation date

November 1, 2022

Scope

GB/T 27029-2022 is the English-translated version of 合格评定 审定与核查机构通用原则和要求.

GB/T 27029-2022 is the Chinese standard "Conformity assessment - General principles and requirements for validation and verification bodies". Its scope clause reads: This 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. Its clauses include terms and definitions.

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Document preview — GB/T 27029-2022

National Standard of the People's Republic of China

Classification
A 00

Issued by: State Administration for Market Regulation, China National Standardization Administration

Contents

  • Preface
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Principle
  • 4.1 General
  • 4.2 Principles of the Validation and Verification Process
  • 4.2.1 Evidence-based decision-making
  • 4.2.2 Documentation
  • 4.2.3 Tell the truth
  • 4.3 Principles for Validation and Verification Bodies
  • 4.3.1 Impartiality
  • 4.3.2 Capability
  • 4.3.3 Confidentiality
  • 4.3.4 Publicity
  • 4.3.5 Responsibilities
  • 4.3.6 Response to complaints
  • 4.3.7 Risk-based approach
  • 5 General requirements
  • 5.1 Legal entities
  • 5.2 Validation and Verification Statement Responsibilities
  • 5.3 Impartiality Management
  • 5.4 Legal liability
  • 6 Structural Requirements
  • 6.1 Organizational Structure and Top Management
  • 6.2 Operation Control
  • 7 Resource requirements
  • 7.1 General requirements
  • 7.2 Personnel
  • 7.3 Processes for managing human competencies
  • 7.4 Outsourcing
  • 8 Validation and verification options
  • 9 Process Requirements
  • 9.1 General requirements
  • 9.2 Preparation before signing
  • 9.3 Contracting
  • 9.4 Planning
  • 9.5 Validation and Verification Implementation
  • 9.6 Review
  • 9.7 Issue of Decision and Validation and Verification Statement
  • 9.7.1 Decision
  • 9.7.2 Issuance of Validation and Verification Statements
  • 9.8 Facts discovered after the validation and verification statement was issued
  • 9.9 Handling of complaints
  • 9.10 Handling of complaints
  • 9.11 Record
  • 10 Information Requests
  • 10.1 Public information
  • 10.2 Other information available
  • 10.3 Validation and Verification References and Use of Marks
  • 10.4 Confidentiality
  • 11 Management System Requirements
  • 11.1 General requirements
  • 11.2 Management Review
  • 11.3 Internal Audit
  • 11.4 Corrective Action
  • 11.5 Measures to address risks and opportunities
  • 11.6 Documented information
  • Appendix B (informative) Terms and concepts defined in this document
  • Appendix C (Informative) Application Notes for Validation and Verification

1 Scope

This 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 references

The 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 Definitions

ISO /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.

GB/T 27400 | GB/T 27207 | GB/T 27025 | GB/T 27030 | GB/T 27028 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 44 pages — is available in the English PDF.

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