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This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed by and is under the jurisdiction of the Certification and Accreditation Administration of the People's Republic of China.?
Introduction
The inspection body and laboratory shall be subjected to qualification authentication before they are engaged in inspection and testing activities within the territory of the People's Republic of China that issue evidentiary data and results to the society.
The qualification authentication of inspection body and laboratory is an administrative licensing system to ensure the truthfulness, objectivity and accuracy of inspection and testing data and results.
This standard is a general requirement for the qualification authentication of inspection body and laboratory to assess their competence. For inspection body and laboratory in different fields, reference shall be made to the supplementary requirements of corresponding fields issued according to this standard.
Competence assessment for inspection body and laboratory mandatory approval—
General requirements for inspection body and laboratory
1 Scope
This standard specifies the general requirements in terms of organization, personnel, site environment, equipment and facilities, and management system when assessing the competence of mandatory approval of inspection body and laboratory.
This standard is applicable to the competence assessment of the mandatory approval of inspection body and laboratory that issue evidentiary data and results to the society, and also to the self-assessment of inspection body and laboratory.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19000 Quality management systems—Fundamentals and vocabulary
GB/T 27000 Conformity assessment―Vocabulary and general principles
GB/T 27020 Conformity assessment—Requirements for the operation of various types of bodies performing inspection
GB/T 27025 General requirements for the competence of testing and calibration laboratories
JJF 1001 General terms in metrology and their definitions
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 19000, GB/T 27000, GB/T 27020, GB/T 27025, JJF 1001 as well as the following apply.
3.1
inspection body and laboratory
professional and technical organizations, which are established in accordance with the laws for inspection and testing of products or specific objects stipulated by laws and regulations according to the relevant standards or technical specifications using instruments and equipment, environmental facilities and other technical conditions and professional skills
3.2
mandatory approval
appraisal permit carried out by the Certification and Accreditation Administration of the People's Republic of China and the provincial quality and technical supervision departments in accordance with the provisions of relevant laws, regulations, standards and technical specifications for compliance of the basic conditions and technical capabilities of inspection body and laboratory with the statutory requirements
3.3
assessment of mandatory approval
examination and assessment of compliance of basic conditions and technical capabilities of inspection body and laboratory with Standards for accreditation of qualification of inspection body and laboratory and the supplementary requirements for accreditation carried out by the Certification and Accreditation Administration of the People's Republic of China and provincial quality and technical supervision departments or by their entrusted professional technical evaluation institutions to organize reviewers according to the relevant provisions of the Administrative Permission Law of the People's Republic of China
3.4
impartiality
no conflict of interest in inspection and testing activities
3.5
complaint
action of any person or organization to express dissatisfaction with its activities or results to the inspection body and laboratory and expect a reply
3.6
proficiency testing
testing of the participants' competence according to pre-established criteria by the means of the comparison between inspection bodies and laboratories
3.7
decision rule
rule describing how to consider the measurement uncertainty when inspection body and laboratory needs to make a declaration of compliance with specifications or standards
3.8
verification
provision of objective evidence to prove compliance of a given project with the specified requirements
3.9
validation
verification of whether the specified requirements meet the intended use
4 Requirements
4.1 Inspection body and laboratory
4.1.1 The inspection body and laboratory shall be legal persons or other organizations established according to laws and able to bear corresponding legal responsibilities. The inspection body and laboratory or their organizations shall have a clear legal status, be responsible for the inspection and testing data and results issued by them, and bear corresponding legal responsibilities. The inspection body and laboratory without independent legal personality shall be authorized by their legal entities.
4.1.2 The inspection body and laboratory shall clarify their organizational structure and the relationship among management, technical operation and support services. It shall be equipped with personnel, facilities, equipment, systems and support services required for inspection and testing activities.
4.1.3 The inspection body and laboratory and their personnel engaged in inspection and testing activities shall abide by the provisions of relevant national laws and regulations, follow the principles of objectivity, independence, fairness and justice, honesty and credit, abide by professional ethics and assume social responsibilities.
4.1.4 The inspection body and laboratory shall establish and maintain procedures for maintaining their fairness and integrity. The inspection body and laboratory and their personnel shall not be subject to pressure and influence from internal and external, improper commercial finance and other aspects, and ensure the truthfulness, objectivity, accuracy and traceability of inspection and testing data and results. The inspection body and laboratory shall establish a long-term mechanism to identify fair risks. If the impartiality risk is identified, the inspection body and laboratory shall be able to prove that the risk is eliminated or reduced. If the organization where the inspection body and laboratory is located is engaged in activities other than inspection and testing, measures shall be identified and taken to avoid potential conflicts of interest. The inspection body and laboratory shall not use personnel who work in two or more inspection bodies and laboratories at the same time.
4.1.5 The inspection body and laboratory shall establish and maintain procedures for protecting the secrets and ownership of customers, which shall include requirements for protecting electronic storage and transmission of result information. The inspection body and laboratory and their personnel shall have the obligation to keep confidential the state secrets, commercial secrets and technical secrets they know in the inspection and testing activities, and formulate and implement corresponding measures to keep confidential.
4.2 Personnel
4.2.1 The inspection body and laboratory shall establish and maintain personnel management procedures to standardize the management of personnel qualification confirmation, appointment, authorization and ability maintenance. The inspection body and laboratory shall also establish employment relationship with their personnel, and clarify the job responsibilities, job requirements and working relationship of technical personnel and management personnel, making them meet the job requirements and have the required power and resources, and perform the duties of establishing, implementing, maintaining and continuously improving the management system. All personnel in the inspection body and laboratory who may affect the inspection and testing activities, whether internal or external, shall behave impartially, be supervised, be competent for their work, and perform their duties according to the requirements of the management system.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Inspection body and laboratory
4.2 Personnel
4.3 Site environment
4.4 Equipment and facilities
4.5 Management system
Bibliography
