CMA is the abbreviation of China inspection body and laboratory mandatory approval, that is, the qualification certification of inspection and testing institutions. It is an evaluation license implemented by the market supervision and administration department in accordance with the provisions of laws and administrative regulations on whether the basic conditions and technical capabilities of the inspection and testing institutions that issue data and results with proof to the public meet the statutory requirements. Laboratory partners who have participated in the on-site review of CMA qualification certification of the laboratory know that after each on-site review of CMA qualification certification, the review team leader will announce the review conclusion on behalf of the review team. Generally speaking, it will be "basically compliant". So is there only one type of review conclusion that is "basically compliant"? In fact, the review conclusion is divided into four types: conformity, basic compliance, basic compliance (on-site review is required), and non-conformity.
Let's explain in detail the meaning of these four review conclusions:
Match. Compliance means that the management system of the assessed institution meets the General Requirements for Inspection and Testing Institutions for the Evaluation of Qualification Accreditation Capabilities of Inspection and Testing Institutions (RB T 214-2017) and operates effectively, has the inspection and testing capabilities of the declared items or parameters and can issue valid results, and can directly recommend the approval of its qualification qualification and inspection and testing capabilities.
Basically compliant. Basic compliance means that the management system documents of the assessed institution comply with the General Requirements for Inspection and Testing Institutions for the Evaluation of Qualification Accreditation Ability of Inspection and Testing Institutions (RB T 214-2017), and the operation is basically effective, but the non-conformities are found in the review, and the rectification needs to be completed and the documents are reviewed before they can be submitted to the qualification certification department for qualification certification.
Basically compliant (subject to on-site review).
Basic compliance (on-site review required) refers to the non-conformities found in the review, which need to be rectified and on-site review before being submitted to the qualification certification department
1) Non-conformities that affect the validity of inspection and testing results and the integrity of the institution.
2) Non-conformities involving non-compliance with environmental facilities.
3) Involving instrument and equipment failures, some of the missing non-conformities.
4) Non-conformities that cannot confirm whether the rectification is effective only by conducting a written review of the rectification materials.
What are the main contents?
Non-compliance refers to the fact that the management system of the assessed institution does not meet the "General Requirements for Inspection and Testing Institutions for Qualification Accreditation Ability Evaluation" (RB T 214-2017) or that there is a large gap between the inspection and testing capabilities that are basically not operated or declared and the actual situation, and the qualification certification cannot be recommended.
For the "non-conforming" review conclusion, the review team should fully explain the reasons in the review report and communicate with the audited institution to give a conclusion.
Not true. Rectification methods.
1.For the rectification of non-conformities, corrective measures should be used, not just corrections.
2.Corrective action is to eliminate the cause of the non-conformance and develop measures to address the cause.
3.The analysis of the cause of non-conformity is the top priority, the cause analysis is solved, and the problem is solved.
Not true. Common causes.
The root cause is often not obvious, so all potential causes of the problem need to be carefully analyzed.
Potential causes may include:
1.Customer-requested products.
2.Specification. 3.Methods and procedures.
4.Skills and training of employees.
5.Consumables.
6.equipment and its calibration.
The usual method of cause analysis.
The laboratory documents do not prescribe:
The document is not stipulated, cannot be followed, the responsibility lies with the management department or leadership, the standard is not well understood, or the importance of not being documented is not realized.
There are files that are not executed:
If there are documents that have not been implemented, there is a law that has not been followed, and the responsibility is the problem of the executives.
Take corrective action:
It is necessary to further train and educate the relevant personnel, and conduct an assessment, after the assessment, track and verify whether there are similar problems again, if there are no similar problems again, close and unqualified.
If similar problems still occur, you need to re-analyze the cause and take new measures until no similar problems occur again and close the disqualified condition.