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Laboratory accreditation process
1. 1 application of intention

Applicants can express their approval intention to CNAS Secretariat by any means, such as visiting, telephone, fax and other electronic communication methods. The CNAS Secretariat shall provide the applicant with the latest version of the certification rules and other relevant documents.

1.2 Formal application

1.2. 1 The applicant shall provide the application materials as required by the CNAS Secretariat and pay the application fee.

⒈2.2 CNAS Secretariat shall review the application materials formally submitted by the applicant. If the materials submitted by the applicant are complete, clear and correct, and have a basic understanding of the relevant requirements of CNAS, the quality management system has been officially operated for more than 6 months, and a complete internal audit and management review have been carried out. The applicant's quality management system and technical activities operate stably, and the employed personnel meet the requirements of relevant laws and regulations. It can be formally accepted, and on-site review will be arranged within 3 months (except for the delay caused by the applicant); Otherwise, we should know more about the situation. If necessary, with the consent of the applicant, we can conduct an initial interview (at the applicant's expense), which will be published on CNAS-GL 0 1: Page 6 * * 13, June 0, 2006, and July 0 1 2006. If the applicant cannot be examined within 3 months, the formal acceptance of the application shall be suspended.

2.3 In the process of data review and interview, CNAS Secretariat shall inform the applicant of any situation that does not meet the registration conditions without consulting the applicant.

2.4 When the applicant applies for accreditation of testing, calibration or other capabilities, he must provide proof that he has participated in at least one appropriate capability verification plan, comparison plan or measurement audit. CNAS will accept the application only if the applicant proves that he has participated in the competency verification activities and performed satisfactorily.

1.3 review preparation

1.3. 1 CNAS Secretariat shall appoint the evaluation team on the principle of fairness and non-discrimination, and obtain the consent of the applicant. If the applicant rejects any member of the evaluation team on the grounds of fairness, the secretariat will verify it.

It should be adjusted.

3.2 The review team shall review the quality management system documents and related materials submitted by the applicant. When unqualified documents are found, the secretariat or the review team shall notify the applicant in writing to take corrective measures. According to the proposal of the head of the evaluation team, the secretariat can negotiate with the applicant for pre-evaluation when necessary. Pre-assessment is only to verify or further understand the problems found in the information review that need to be clarified, without consultation, but a written pre-assessment report must be submitted to the secretariat. After the applicant takes effective corrective measures to solve the main problems found, the review team leader can conduct on-site review.

3.3 After the documents are approved, the audit team leader and the applicant will agree on the specific time schedule and audit plan for on-site audit, which will be implemented after being approved by CNAS Secretariat.

3.4 CNAS may assign observers to participate in the review team when necessary.

1.4 on-site review

1.4. 1 The evaluation team conducts on-site evaluation on the technical ability and quality management activities within the applicant's application scope according to CNAS evaluation criteria, rules and requirements and relevant technical standards. On-site review, review all other places covered by the applicant's application scope and carry out one or more key activities.

4.2 In the on-site review of the applicant's testing, calibration, inspection or other capabilities, the situation and results of the applicant's participation in the capability verification activities should be referenced and utilized, and measurement audit should be arranged if necessary. CNAS will take the applicant's performance in competency verification as an important basis for whether or not to grant recognition. For institutions that have participated in CNAS and its approved competency verification and comparison programs with satisfactory results, simplified competency confirmation of related projects can be properly considered in various reviews of CNAS. However, the country has clear regulations and specific professional requirements. CNAS-GL 0 1: Page 7 of 2006 * * 13 was published on June 0, 20061,

4.3 The evaluation team shall also evaluate the authorized signatory of the applicant. CNAS requires authorized signatories to meet the following conditions:

A) Have the necessary professional knowledge and corresponding work experience, be familiar with the relevant detection, calibration, detection and calibration methods and procedures within the scope of authorized signature, be able to make a correct evaluation of the detection and calibration results, and understand the uncertainty of the detection results;

B) Be familiar with the accreditation rules and policies, accreditation conditions, especially the obligations of accreditation bodies, as well as the provisions on the use of testing and calibration reports or certificates with accreditation marks;

C) Be responsible for the correctness of the test and calibration results, and have corresponding management authority.

4.4 In the process of on-site audit, if the audit team finds that the auditee has violated relevant national laws and regulations or other circumstances that obviously damage CNAS' reputation and rights and interests in related activities, it shall report to CNAS in time. If the auditee has the above problems or fails to fulfill the obligations stipulated in Article 8.2, in serious cases, CANS has the right to suspend the accreditation procedure and take corresponding measures.

4.5 On-site audit conclusions are divided into three categories: conformity, basic conformity (corrective measures for nonconformities need to be tracked) and nonconformities, which are given by the audit team at the end of on-site audit.

4.6 The audit team leader shall submit an on-site audit report to the auditee at the last meeting of on-site audit.

4.7 After making clear the rectification requirements, the auditee shall formulate a corrective action plan and complete it within three months. For the supervision review, it should be completed within one or two months and submitted to the review team. The audit team shall verify the effectiveness of the corrective measures.

4.8 After the corrective measures are verified, the audit team leader will report the rectification and acceptance opinions together with the on-site audit data to CNAS Secretariat.

1.5 certification evaluation

1.5. 1 CNAS Secretariat is responsible for submitting evaluation materials and all other relevant information (such as capability verification, complaints, disputes, etc. ) to the jury, which will evaluate whether the applicant meets the certification requirements and make a decision. The evaluation results can be one of the following four types:

A) agree to recognize;

B) partial recognition;

C) not recognized;

CNAS-GL01:Page 8 of 2006 *** 13 was released on June 0, 2006 and implemented on July 0, 2006.

D) Supplementary evidence or information before evaluation.

5.2 After the review, the Secretariat shall go through relevant formalities.

1.6 accreditation

1. 1 CNAS issues the approval certificate, approval decision notice and approval mark signed by the authorized person of CNAS to the authorized institution, and defines the approval scope and authorized signatory. The validity period of the accreditation certificate is 5 years.

⒈2 CNAS Secretariat is responsible for including the authorized institutions and their scope of accreditation in the list of authorized institutions and publishing them. 2. 1 Expand the recognition range

Within the validity period of accreditation, an authorized institution may apply to CNAS to expand the scope of accreditation.

2.1.2 the national accreditation Committee shall, according to the situation, review the application for expanding the scope of accreditation in the supervision, review and review, or separately arrange the review for expanding the scope of accreditation according to the needs of authorized institutions. The registration procedure for expanding the scope of registration is similar to the initial registration, and it must be applied, reviewed, evaluated and approved. For the simple expansion of relevant capabilities within the original recognition scope, it does not involve new technologies and methods, and can be directly recognized after data review.

3. 1.3 The conditions for approving the extension of accreditation scope are the same as those for initial accreditation, and the accredited institution must have the technical ability and quality management requirements specified in the accreditation standards within the scope of applying for extension accreditation.

6.5438+0.4 Under appropriate circumstances, CNAS may require relevant authorized institutions applying for expanding the scope of accreditation to participate in the competency verification plan to verify their technical capabilities within the scope of accreditation.

2.2 Narrow the scope of recognition

2.2. 1 Conditions for narrowing the scope of recognition can lead to narrowing the scope of recognition under the following circumstances:

A) An authorized institution voluntarily applies for narrowing its original scope of accreditation;

B) The change of business scope makes the authorized institution lose part of its capacity within the original authorized scope;

C) The results of supervision review, re-review or capability verification show that the technical capability or quality management of some testing and calibration projects of the accredited institutions can no longer meet the accreditation requirements and cannot be restored within the time specified by CNAS.

2.2 The proposal to narrow the scope of registration is put forward by CNAS Secretariat, and the registration decision is made by the Secretary-General after being evaluated by the evaluation committee or authorized by CNAS Director. The Secretariat shall go through the corresponding formalities. CNAS-GL 0 1: Page 9 of 2006 * *13 was published on June 01July 012006. The purpose of monitoring and evaluation is to confirm that the accreditation institutions continue to meet the accreditation requirements within the validity period of accreditation, and to ensure that the relevant requirements are incorporated into the quality system in time after revising the accreditation rules and guidelines. All authorized institutions must accept the supervision and evaluation of CNAS. Supervision and review includes on-site supervision and review and other types of supervision activities:

(a) Asking authorized institutions about authorization;

B) Review the statements made by authorized institutions on the scope of accreditation;

C) Require authorized institutions to provide documents and records (such as audit reports, internal quality control results used to verify the effectiveness of services provided by authorized institutions, complaint records and management review records);

D) Monitor the performance of authorized institutions (such as the results of participating in competency verification).

3. 1 Regular monitoring and review

3. 1.65438+ For laboratories accredited by multiple sites, the supervision and evaluation shall cover all sites.

13.10.2 Regular supervision and evaluation can be applied without the approval of an accredited laboratory, and the relevant evaluation requirements and on-site evaluation procedures are the same as those of the initial accreditation. When nonconformities are found in the supervision, the auditee shall formulate and implement the corrective action plan after clarifying the rectification requirements. The completion period of corrective measures is generally 2 months, and the nonconformities involving technical capabilities should be completed within 1 month. CNAS Secretariat shall verify the effectiveness of corrective measures, and the expenses required for verification activities, including on-site audit fees, shall be borne by the audited laboratory. When the corrective measures fail to pass the verification, CNAS may decide to suspend, narrow the approval scope or revoke the approval at its discretion.

13.10.3 when conducting regular supervision and evaluation, we should consider the results of the previous evaluation and participate in the arrangement and implementation of capacity verification, especially the implementation of corrective measures when the results of capacity verification are not satisfactory. In addition, other quality assurance measures should be paid attention to in the technical field where the laboratory has no ability to verify.

3.2 Irregular supervision and review

When the accredited laboratory changes as described in Article 10. 1. 1 of these Rules, the accreditation requirements of CNAS change, or the CNAS Secretariat deems it necessary to investigate complaints or other circumstances, the CNAS Secretariat may arrange irregular supervision and evaluation or irregular visits at any time. 3. 1 An authorized institution shall submit an application for re-evaluation to CNAS six months before the expiration of the validity period of accreditation (three years). CNAS shall, before the expiration of the validity period of accreditation, organize a re-evaluation according to the application of the accreditation institution to decide whether to extend the accreditation to the next validity period.

2. Other requirements and procedures for re-evaluation are consistent with those originally approved, aiming at reviewing all approved scope and requirements. The audit team leader shall verify the effectiveness of corrective measures. When nonconformities are found in the second review, the auditee shall formulate a corrective action plan after clarifying the rectification requirements and submit it to the audit team. The rectification period is generally two months, and the nonconformities that affect the inspection results should be completed within one month. The audit team leader shall verify the effectiveness of corrective measures. 5. 1 Modification by authorized institution

5. Notice of change +0. 1 In case of any of the following changes, the authorized institution shall notify CNAS in writing within one month after the change:

(a) The name, address and legal status of the authorized institution have changed;

B) The senior managers, technicians and authorized signatories of the authorized institution change;

C) Significant changes have taken place in important testing equipment, environment, testing and calibration scope and testing items within the approved scope;

D) Other changes that may affect its activities and system operation.

5. 1.2 change handling

After CNAS receives the change notice and verifies the situation, according to the nature of the change, it can take the following measures:

A) Conduct supervision, review or review in advance;

B) Enlarging, shrinking, suspending or revoking the certification;

C) Examining candidates for authorized signatories of new applications;

D) register the change.

⒌2 Changes in certification rules and standards

5.2. 1 When the certification rules and standards change, CNAS will promptly notify the authorized institutions and related applicants that may be affected through CNAS website, e-mail and letters. Detailed description CNAS-GL0 1: Page12006 * * Page 13 released on June 0 1 2006, and the certification rules implemented on July 012006.

5.2.2 When the accreditation conditions and accreditation criteria change, CNAS shall formulate and publish the method and time limit for conversion to the new requirements, and listen to the opinions of all parties concerned before so as to allow authorized institutions enough time to adapt to the new requirements. CNAS can confirm that the authorized institution meets the new requirements through supervision and review or re-review, and can continue to be recognized after it is confirmed to be qualified.

5.2.3 Upon completion of the conversion, the authorized institution shall promptly notify CNAS. If the authorized institution fails to complete the conversion within the prescribed time limit, CNAS may revoke its accreditation. 1. indicates that it has the technical ability to carry out testing and calibration services according to the corresponding recognized standards;

3. Enhance market competitiveness and win the trust of government departments and all walks of life; 3. It is recognized by the recognized institutions of the countries and regions that have signed the mutual recognition agreement;

Have the opportunity to participate in bilateral and multilateral cooperation and exchanges recognized by international conformity assessment agencies;

5.CNAS national laboratory accreditation mark and ILAC international mutual recognition joint mark can be used within the scope of accreditation;

6. Be included in the list of authorized institutions for raising awareness.