What conditions do CNAs certified laboratories need to meet? How to rectify the nonconformities?

Date：2021-07-22 13:48:24 Views：4107

Applying for CNAs accreditation by the laboratory is a long cycle and complex thing. If the process is unclear, the preparation data is insufficient, or the personnel and equipment do not meet the requirements, it will greatly affect the acceptance and review progress, ranging from a few months to a new year, or even fail directly. Since the laboratory is recognized by CNAs, it is of such great significance. Therefore, it is particularly important to understand and clarify the necessary conditions for applying for CNAs recognition. The seven necessary conditions for the laboratory to apply for CNAs accreditation and how to rectify the nonconformities? The following is a detailed description of the core detection center.

1. The laboratory has a clear legal status, and its activities should meet the requirements of national laws and regulations

(1) the laboratory has a clear legal status, which means that if the laboratory is an independent legal entity or a part of an independent legal entity and is established with the approval of the legal entity, the legal entity can bear relevant legal liabilities for the activities carried out by the laboratory.

(2) its activities shall comply with the requirements of national laws and regulations, which means that the laboratory shall carry out its work within the business scope permitted by its legal person license.

2. The management system meeting the recognition requirements has been established and has been officially and effectively operated for more than 6 months

(1) compliance means that the management system of the laboratory should meet the requirements of the basic accreditation criteria, such as CNAS-CL01, and also meet the requirements of the accreditation rules documents, such as cnas-rl02, the requirements documents and the instructions of the basic accreditation criteria in the professional application field, such as the calibration laboratory should meet cnascl25, etc.

(2) formal operation refers to the laboratory that establishes the management system for the first time. Generally, it shall enter the trial operation stage, adjust and improve the management system through internal audit and management review, and then formally operate.

(3) effective operation means that all elements involved in the management system have been operated and relevant records have been kept.

(4) after 6 months of formal and effective operation of the management system, complete internal audit and management review covering the whole scope and all elements of the management system shall be carried out.

3. The applied technical capability meets the requirements of cnas-rl02 capability verification rules

As long as there is an available capability verification, each sub field for which the laboratory applies for accreditation for the first time should have participated in at least one capability verification and obtained satisfactory results (the capability verification participated in within 3 years before the date of application for accreditation is valid).

4. The laboratory has sufficient resources to carry out testing / calibration activities within the scope of application

(1) personnel: there are personnel who meet the requirements of CNAs, and the number of personnel and work experience match the workload and activities of the laboratory. The main management personnel of the laboratory and all personnel engaged in testing or calibration activities shall have a long-term fixed labor relationship with the laboratory or its legal institution, and shall not engage in similar testing or calibration activities in other laboratories of the same type.

(2) environment: the testing / calibration environment of the laboratory can continuously meet the requirements of corresponding testing standards and calibration specifications.

(3) equipment: the laboratory has sufficient instruments and equipment and reference materials that match its business and workload, and the laboratory has full use right of the instruments and equipment.

5. The measurement traceability of the instruments and equipment used shall meet the relevant requirements of CNAs

(1) for instruments and equipment that can be traced to SI units, the calibration organization selected by the laboratory shall be able to meet the provisions of cnas-cl06 requirements for traceability of measurement results.

(2) equipment for internal calibration shall comply with cnascl31 internal calibration requirements.

(3) for those that cannot be traced to SI units, it shall meet Article 5 of CNAS-CL01 accreditation criteria for the competence of testing and calibration laboratories 6. 2. 2.2 requirements.

6. The technical capability applied for approval has corresponding testing / calibration experience

(1) the test / calibration items applied for approval by the laboratory must have corresponding test / calibration experience (the test / calibration experience does not necessarily require the test report / calibration certificate issued externally).

(2) the test / calibration items applied for approval by the laboratory shall be the main items frequently carried out, mature and within the main business scope of the laboratory:

① Do not accept the laboratory, only apply for non business projects;

② The laboratory is not allowed to apply for non main test items of a certain product, such as appearance;

③ The laboratory is not allowed to apply only for sampling (sampling) ability, and the sampling (sampling) ability shall be applied for approval together with the corresponding testing ability;

④ The laboratory is not allowed to apply only for judgment standards, but also apply for approval together with the corresponding testing ability (standard);

⑤ It is not acceptable for the laboratory to apply only for the general rules of instruments and methods, and apply for approval at the same time with the corresponding sample pretreatment capacity (standard);

⑥ For unapproved standards / specifications (including the draft of standard for approval), it is not accepted to apply for approval as a standard method. However, after confirmation, it can apply for approval according to the non-standard method.

7. CNAs has the ability to carry out accreditation for the testing / calibration ability applied by the laboratory

The ability applied by the laboratory shall be within the scope of CNAs's review ability.

How to rectify the non conformance of CNAs certified laboratories? CNAs handles the nonconformities in the initial evaluation, Supervision Review and re evaluation differently, as well as the general nonconformities and serious nonconformities. We classify them to explain:

preliminary assessment:

1. Handling measures for serious nonconformities:

If the review team finds serious nonconformities, the review team can make the following recommendations according to the overall findings of the review:

a. On site tracking verification;

b. It is not recommended to approve relevant testing or calibration items;

c. Approval is not recommended.

d. If integrity problems are found in the laboratory during the review, the review team shall submit the review report to the CNAs Secretariat immediately after the review.

2. Handling measures for general nonconformities;

The laboratory shall complete the correction and corrective measures within 3 months.

Supervision or review:

1. Handling measures for serious nonconformities

a. The laboratory is required to complete the correction and corrective measures within one month, and conduct on-site tracking verification;

b. Suspend or cancel relevant testing or calibration items;

c. Suspension or revocation of accreditation.

For the recommendation on suspending or revoking some recognized projects or recognized qualifications, the review team shall immediately inform the CNAs Secretariat of this information after the review.

2. Handling measures for general nonconformities

For general nonconformities, CNAs requires the laboratory to complete rectification within 2 months.

If the laboratory fails to complete the rectification within the specified time limit, the review team shall explain the situation in the review report, and may suggest suspending the recognition of the organization or part of the ability until it completes the corrective measures and verifies the effectiveness.

The above is all about what conditions CNAs certified laboratories need to meet? How to rectify non-conforming items. Chuangxin testing can undertake a variety of testing projects such as electronic component testing and verification, IC true and false identification, product design, material selection, failure analysis, function testing, factory incoming material inspection and tape weaving. You are welcome to call us for advice.