CNAS-RL01 Lab Accreditation Rules

1. Recognition Criteria:

Applicants must voluntarily apply for recognition while adhering to national laws and regulations and maintaining honesty and trustworthiness. CNAS will conduct a review and make recognition decisions based on the relevant recognition criteria and other requirements. Applicants must meet the following conditions to obtain recognition:

a) Possesses a clear legal status and the ability to assume legal liabilities.

b) Complies with the recognition criteria and related requirements issued by CNAS.

c) Adhere to the relevant provisions of the CNAS-recognized standard documents and fulfill the corresponding obligations.

2. Acknowledgment Process

5.1Initial Approval

5.1.1 Letter of Intent Application

Applicants may express their intention to recognize in any manner, such as visits, phone calls, faxes, and other electronic communication methods. Upon the applicant's request, the CNAS Secretariat shall ensure they receive the recognized version of the standard and other relevant documents.

5.1.2 Formal application and acceptance

5.1.2.1 After the applicant self-evaluates as meeting the recognition criteria (specific requirements can be found in Rule 6 of this document), they shall provide the application documents as required by the CNAS Secretariat and pay the application fee.

5.1.2.2 The CNAS Secretariat reviews the application materials submitted by the applicant and makes a decision on whether to accept the application, notifying the applicant accordingly. 5.1.2.3 If necessary, the CNAS Secretariat will arrange an initial visit to determine if the application can be accepted, with the applicant bearing the costs incurred from the initial visit.

5.1.2.4 During the document review process, the CNAS Secretariat should notify the applicant of any discrepancies with the recognition criteria found, without consulting. The applicant shall clarify or modify the application documents within the specified period. If, starting from the first feedback to the applicant, the conditions for acceptance are still not met after exceeding 3 months, the application for recognition will not be accepted. 5.1.2.5 Generally, the CNAS Secretariat shall arrange for the review within 3 months after accepting the application, except for delays caused by the applicant. If, due to the applicant's own reasons, the on-site review cannot be accepted within 3 months after the application is accepted, CNAS may terminate the recognition process and refuse recognition.

5.1.3 Document Review

5.1.3.1 After the CNAS Secretariat receives the application, it will arrange for the review leader to examine the application documents.

5.1.3.2 On-site review can be scheduled only when the document review results are basically in compliance with requirements.

5.1.3.3 Issues identified during document review should be fed back to the applicant by the CNAS Secretariat.

5.1.3.4 If necessary, the CNAS Secretariat will arrange a preliminary review to determine the feasibility of scheduling an on-site review. Any resulting costs will be borne by the applicant.

5.1.4 Form a review panel

5.1.4.1 The CNAS Secretariat operates on the principle of fairness, assessing the applicant's scope of application (such as testing/calibration/verification)

Establish an evaluation team with the corresponding technical capabilities (including domain, laboratory location and scale), and obtain the applicant's consent. Unless there is evidence indicating a potential bias in a specific reviewer, the applicant may not refuse any reviewer.

5.1.4.2 For applicants who refuse to accept the arrangement of the CNAS assessment team without legitimate reasons, CNAS may terminate the recognition process and not grant recognition.

5.1.4.3 In case of necessity, the CNAS Secretariat may appoint an observer to the assessment team.

5.1.5On-site evaluation

5.1.5.1 The assessment team shall conduct on-site assessment of the applicant's technical capabilities and quality management activities within the scope of application, based on CNAS' recognition criteria, rules, requirements, laboratory management system documents, and relevant technical standards. The on-site assessment should cover all activities and related locations within the scope of application. The duration and number of personnel for the on-site assessment shall be determined based on the testing/calibration/verification scope of the application.

Quantity determination for location, project/parameters, methods, standards/regulations, etc.

5.1.5.2 Generally, the on-site audit process includes:

a) Conferences

b) On-site Visit (upon request)

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d) The evaluation team communicates the evaluation status with the applicant.

e) Final Meeting

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