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

foreword

This 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.

Introduction

Validation 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 Bodies

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.