CNAS Certification Answers Frequently Asked Questions about Laboratory Qualification Accreditation

Date：2022-12-27 15:51:28 Views：735

Laboratory accreditation is a procedure for the formal recognition of the testing/calibration laboratory and its personnel's ability to perform the specified type of testing/calibration by an authoritative accreditation body. China National Accreditation Service for Conformity Assessment (CNAS for short) is a national accreditation institution approved and authorized by the Certification and Accreditation Administration of the People's Republic of China in accordance with the Certification and Accreditation Regulations of the People's Republic of China. It is responsible for the accreditation of certification institutions, laboratories, inspection institutions and other relevant institutions. This paper collects and sorts out some materials, hoping to be of great reference value to all readers.

1. The internal laboratory of the enterprise has been recognized by CNAS. Can it issue a certificate report as a third party? A: CNAS accreditation is the recognition of laboratory capacity. Whether it can issue a certificate report as a third-party organization should also meet the requirements of national laws and regulations. For example, the national metrology law stipulates that the test report issued by a third-party testing agency must pass the metrological certification (CMA).

2. How to define "multi site laboratory"? In the same city, but the test sites are scattered in several locations, is it a "multi site laboratory"? A: There is a definition of "multi site laboratory" in CNAS-RL01, which can be viewed. Different addresses mean different places. Even in the same city, there are many places.

3. Should the laboratory be required to provide a copy of the method validation record to the accreditation committee for the initial and expanded project review applications? For smooth review. Answer: At present, the laboratory is only required to provide method validation records when applying for non-standard methods, while the application for standard methods does not require method validation records. Whether it needs to be provided in the future depends on the situation. When reviewing the application materials, the review team leader can ask the laboratory to provide them if necessary.

4. Can the first and second party laboratories recognized by CNAS carry out entrusted testing services for external customers? Do these laboratories think that they are qualified to issue test reports to the outside world after being recognized by CNAS laboratories? A: Laboratory accreditation is only the recognition of capabilities. Whether the laboratory can provide external testing services and testing reports should also meet the requirements of relevant national laws and regulations. It is not through laboratory accreditation that testing services can be carried out externally. (Please refer to Question 1)

5. If an enterprise sends a built laboratory (with qualified site, equipment and personnel) to a company, and there are written gift documents, the site is in the factory of the enterprise, the laboratory was originally an internal laboratory of the enterprise, which was used to control the production of products. Is it OK for the company to apply for approval? Answer: It can be recognized as long as the recognition conditions in CNAS-RL01 Laboratory Accreditation Rules are met. CNAS needs to judge the legal effect of the gift contract and its implementation.

6. The technical manager specified in CL10 does not have it. Is it not recognized in this field? A: Yes, it is not recognized in the chemical field.

7. CL10 regularly uses the calibration standard sample at the intermediate point to check the calibration curve, which may mislead the laboratory into thinking that making a calibration curve can be used for a long time as long as it meets the above requirements, and the method is incorrect! Does not meet the basic requirements of analytical chemistry! How to deal with it? Answer: CNAS accredited laboratories include domestic laboratories and overseas laboratories. CL10 stipulates the minimum requirements and also adopts international general rules. If specified in the corresponding national standard, the laboratory shall implement the national standard.

8. What if all the authorized signatories in the chemical field of the application fail to meet the requirements of CL10? Is it possible to recommend other authorized signatories who have chemical technology capabilities but have not recommended the chemical field? Answer: If there is no qualified authorized signatory in a certain field of the laboratory, the ability in this field will not be recognized.

9. The reference materials of the chemical laboratory shall be checked as planned according to CL10 requirements. However, in CL01, as long as the technical and economic conditions permit,... should be carried out, according to which requirements. Answer: The CL10 document should be implemented because the application instruction document is a clear and detailed statement of the requirements of the general acceptance criteria (CL01), allowing its requirements to be higher than those of the general acceptance criteria.

10. CL10's requirements for the technical director. In judicial authentication institutions, such as public security judicial authentication institutions, does the role require the technical director of the physical and chemical laboratory, or one of the technical directors of the institution? Answer: It is one of the technical management personnel of the recognized laboratory. If the physical and chemical laboratory is only one department of the judicial authentication institution, it should be one of the technical directors of the institution.

11. How to understand the testing experience in the approval instructions? For similar products, can the test items without experience be covered by the test items with experience? Answer: ① If the laboratory has never tested the product, it cannot be recognized even if it can be covered by other products. CNAS clearly stipulates that what is recognized is the testing activities frequently carried out by the laboratory. ② If the laboratory has tested the product before and has no testing experience in recent two years due to objective reasons only, and the laboratory can also provide evidence proving that the testing of other products with testing experience can cover the product, it can be regarded as experienced.

12. For the products or parameters that have been approved previously, if they have no testing experience and have not participated in the capability verification within the three-year validity period of approval, will they no longer maintain the approval qualification of relevant projects during the re evaluation? Answer: ① If the requirements of CNAS-RL02 cannot be met, approval cannot be maintained. ② If there is no capability verification available, judge whether it has carried out corresponding quality control according to CNAS-EL-01. If there is no quality control, the recognition will not be maintained.

13. With regard to test experience, if the test methods, test procedures, test equipment and test conditions for test objects with different matrices are roughly the same, but the sample pretreatment process is different, do you require that products with different matrices have test experience before they can be recognized? A: The products with different matrices can only be recognized if they have testing experience, because without testing experience, the method validation has defects. The sample pretreatment is directly related to the test results. If there is no test experience, it cannot prove that the laboratory has mastered the pretreatment method well.

14. Some units may not have tested a project for 3 years. The project must be retained as required, and the unit is fully capable of doing the project. How to review the project during supervision review and re evaluation. Answer: ① The laboratory should provide evidence to prove its ability to do so. ② Review according to the interpretation of RL01 in CNAS-EL-01. ③ During one approval cycle, on-site review shall witness at least one on-site test.

15. Does the laboratory need to confirm the verification certificate whose traceability conclusion is "qualified"? A: It needs to be confirmed. Because the instruments and equipment are qualified, but they may not meet the needs of detection/calibration.

16. Can the "test/detection" report issued by the testing laboratory recognized by CNAS and the "measurement" certificate issued by the calibration laboratory not be used for instrument traceability? Answer: It cannot be used for instrument traceability. Because of the difference between testing and calibration, testing is carried out using instruments and equipment according to relevant testing standards, and calibration is carried out using working standards traceable to national standards according to relevant calibration specifications. Calibration often requires stricter environmental facilities and equipment than testing. The calibration laboratory will generally issue the "measurement" certificate without calibration specifications, which is not within the scope of CNAS approval, so it can not meet the requirements of quantity traceability.

17. In the information security and software testing laboratories, the proportion of imported testing instruments used is high, and the upgrading is very fast, especially the network performance test, software efficiency test, etc., these imported equipment (software) have no institutions that can be calibrated, usually all that can be done is the comparison between laboratories, and there is no required uncertainty in the industry. How to evaluate the traceability and uncertainty of the measurement value in the laboratory evaluation? Answer: In this case, the laboratory is allowed to perform only functional verification. See the relevant application instructions for the requirements of uncertainty.

18. Internal calibration problem of the laboratory: the team leader has different ways to deal with the laboratory standards. Answer: ① Even if the laboratory establishes a standard, its internal calibration capability should still be reviewed during on-site review. ② CNAS project director and review team shall strictly implement CNAS-CL31 Internal Calibration Requirements, and assign corresponding calibration reviewers to review internal calibration capability during on-site review.

19. The content of the test report usually does not give the measurement uncertainty, can it. Answer: Whether the test report gives the uncertainty depends on the situation. The CNAS-CL07 Uncertainty Requirements specifies the conditions under which the test laboratory needs to give the uncertainty. Although the laboratory does not need to report the uncertainty on all test reports, the laboratory should have the ability to evaluate the uncertainty of each test result that issues a value.

20. Some laboratories, especially the laboratories of the first party, have no requirements on the "uncertainty description of test results" from customers. Since such evaluation is relatively complex, how to master it on site? Answer: According to the requirements of the guidelines, there should be personnel in the laboratory who have the ability to evaluate the measurement uncertainty, and they should be assessed during the on-site review. Even if the customer does not have such requirements, the laboratory should also have the ability to evaluate the measurement uncertainty, which is a standard requirement and cannot be defaulted.

21. Whether the report without CNAS approval mark has the unacknowledged standard without explanation, or the report is issued without the signature of the authorized signatory recognized by CNAS, which constitutes a nonconformity? A: It depends on the situation. If the report claims to have been approved by CNAS, but the items that have not been approved are not indicated or the personnel issuing the report are not approved, it constitutes a nonconformity. If the report does not claim to be recognized, it does not constitute a nonconformity.

22. After the standard change application has been submitted to CNAS, if there is no substantial change in the testing method, can you continue to use the CNAS logo after indicating it in the testing report? Answer: No. The approval mark can only be used on the test report after being approved by CNAS.

23. For the standard methods used beyond the predetermined scope, when expressing capabilities, what situations are expressed as standard methods and what situations are expressed as self prepared methods (SOP)? Answer: ① It can be expressed as a standard method when it can be tested/calibrated according to the standard method standard through method confirmation. ② If the standard method needs to be modified through confirmation, the operation instruction shall be prepared for approval.

24. In the approved standards or specifications, the contents are relatively simple, and other standards are quoted or implemented (implemented according to the project). Whether this implementation standard needs to apply for approval. Answer: Apply for approval.

25. If the product standard is used to apply for approval, do you still need to confirm how to evaluate the ability of other contents in the product standard in addition to the parameters applied in the product standard during the on-site review? Answer: The accreditation review is about testing/calibration capabilities. For product standards, what needs to be confirmed is also the content of testing capabilities involved in the product standards applied by the laboratory. For product standards that do not involve testing capabilities, it is not within the scope of accreditation review.

26. Can the following standards used beyond the scope be approved? Can the standard used beyond the scope be regarded as deviation? Should it be a non-standard method? The approved parameters are beyond those specified in the standard; The detection object is outside the scope specified in the standard; Replace with other instruments, such as ICP instead of atomic absorption. A: The above standards are used beyond the scope. In this case, the laboratory should confirm by non-standard methods. The review team should check the accuracy of the data confirmed by non-standard methods and conduct a comprehensive analysis of the technical reliability of non-standard methods.

27. Many foreign laws and regulations have been recognized. These laws and regulations are not related to the testing methods. The laboratory has bundled the laws and regulations with the selected testing methods for approval, suggesting that CNAS recognizes that the testing results of the bundled testing methods meet the requirements of the listed laws and regulations, while those testing methods do not specify which substances can be tested. Answer: At present, the regulations can be recognized together with the test method standards, but without test methods, the regulations cannot be recognized separately. When some regulations were issued, there was no specific testing method for some restricted substances, so the laboratory needs to select appropriate methods and confirm according to non-standard methods.

28. How to solve the problem of using standard methods in other fields in the application for recognition (such as the application for the ability to use American EPA standards in the chemical detection of environmental hazardous substances widely in the fields of textiles, toys, etc.) in this field. Answer: ① The laboratory shall confirm according to non-standard methods. ② If the standards in other fields are used by reference, the laboratory shall prepare operation instructions and conduct approval at the same time. 29. Can WI14-01 work instructions be used as the basis for determining non conformities/observations? Answer: No, because SOP is the document that the reviewers follow and implement during the review, is the requirement for the review, and is not the basis for the laboratory to establish the management system, nor is it the basis for the review.

30. For the physical and chemical testing laboratory, how to control the laboratory without sample preparation ability? Is there a need for restrictions or clarification? How to deal with the application of experimental projects involving welding and other early sample preparation when the laboratory has no welding ability? Because the welding process will affect the results of later tests. Answer: It is required to state in the limited range column that sample preparation is not required. 31. In the review, recognized projects (such as grade protection and risk assessment) are often encountered, but the laboratory does not have operation instructions and there is no restriction on the recognized projects (generally the fifth level). A: When the reviewer conducts on-site review, he/she should limit his/her capabilities. For example, IP grade, which cannot be recognized without corresponding equipment, shall be limited in the limit range. The review team has the right to limit the approved projects according to the on-site review results.

32. If the equipment and site of the main leasing enterprise are used for testing, or if the company cooperates with other institutions in testing projects in the way of business income sharing (such as making full use of others' equipment, site or even personnel), can the corresponding projects not be recognized? A: This situation cannot be recognized.

33. In the field review, it is found that there is a lack of instruments and equipment. Is it necessary to issue a nonconformity or cancel the corresponding parameters (not the whole project)? Whether it is OK to close materials and provide photos and copies of invoices of newly purchased equipment due to lack of testing equipment in the on-site review and non conformance? Some laboratories cheat. A: It depends on the specific situation. If the main equipment is missing, it will not be recommended for approval. If the auxiliary equipment is missing, and the laboratory can purchase instruments and equipment during the rectification period, and complete the corresponding work, the nonconformities can be opened, but the on-site tracking verification is required. If the above work cannot be completed within the rectification period, or the rectification acceptance is unqualified, the corresponding parameters will not be recognized. In case of lack of inconformity of equipment, rectification and acceptance cannot be completed only by photos and invoices, and on-site tracking and verification shall be carried out. If necessary, on-site tests shall be arranged.

34. The laboratory has set up more than one technical director or quality director, whose responsibilities are not clearly defined in the system documents. Is it allowed to issue nonconformities? Answer: It can be opened or not. Because each technical director has different fields and responsibilities, the laboratory should clarify their responsibilities. However, it is up to the laboratory to decide which level of document is responsible for.

35. If the reviewed unit's Quality Manual and procedures do not mention the application instructions, can the nonconformities be opened? Answer: If the application instructions are not mentioned, there is no problem. The key is to review whether the requirements of the application instructions are implemented in the system documents (regardless of the level).

36. The team leader's 20 days of document review is not enough, and the auditee still needs time to make amendments and supplements. It is recommended that the on-site review be carried out after the document review is basically qualified. Answer: 20 days refers to the time when the team leader reviews documents and gives review opinions, excluding the time for the reviewed organization to rectify. If the team leader finds that there are problems affecting the on-site review and the on-site review can only be carried out after the laboratory has rectified and passed the review, the team leader can choose "suspend the implementation of on-site review". If the existing problems do not affect the on-site review, the problems can be fed back to the reviewed organization for rectification after communication with the project director, and the rectification will be tracked during the on-site review.

37. The main management personnel or the site or internal structure of the laboratory were found to have changed on site, and the change procedures were not handled with CNAS. Answer: ① Management personnel and other changes have not been applied for, and non conformance items have been issued. ② If the change of site or environmental facilities is not applied for, the approval qualification shall be suspended.

38. Standards that have been revised and changed will appear in the review, but no update is proposed in the laboratory application, how to deal with it? A: First of all, we should understand why the laboratory did not apply for changes. Is it because there is a problem in the tracking of laboratory standards, or because the laboratory needs to use obsolete standards for special reasons. In case of the former, corresponding nonconformities shall be opened. If the laboratory puts forward change requirements on site, it shall be handled according to the relevant provisions of WI14-01 (6.5.1).

39. The key links in the operation instructions such as the direct reading spectrum of the laboratory are "omitted", and the operators cannot get all the instructions from the instructions. Answer: ① There was a dispute between the review team and the laboratory at that time. ② This is a non conformance. The operation instructions prepared according to the requirements of Article 5.4.1 of CNAS-CL01 shall not "omit" the technical requirements.

40. Overdue technical standards are found on site. Answer: ① Check whether there are reasonable regulations but problems occur in implementation, or whether the regulations are unreasonable, or whether there are problems in the new search path, or whether there are no regulations, and open non conformities. ② If the laboratory puts forward the change request on site, if the review team has the ability, it will confirm, otherwise it will not confirm, and the laboratory is required to submit the change application to CNAS.

41. Is there a proportional requirement for on-site test arrangement? Is the field test proportion of expanded items more than that of maintaining approval? Answer: There is no requirement on the proportion of field tests, but WI14-01 operation instruction specifies the requirements for selecting field tests. The field test shall cover all key detection technologies.

42. It is found that the operation of the laboratory personnel is not in accordance with the provisions of the technical standards or reflected from the records on the site. Answer: ① If the method is incorrect, the project is not recommended. ② In case of deviation from the method based on experience and non conformance, the laboratory is required to check the provisions of the document, go through necessary procedures and formulate internal operation instructions.

43. For the product standards newly applied for expansion, on-site test arrangement: should each product be arranged with on-site test witness or the same product (with the same main test parameters)? Answer: For similar products with the same main parameters, the product with the largest difficulty coefficient can be selected for experiments. The products with the greatest difficulty can cover the products with the least difficulty. At the same time, attention must be paid to the differences in the operation of the same parameters and the ability of special parameters between different products.

44. For laboratory expansion projects, if the laboratory fails to provide the "simulation test record report of new projects and the materials reviewed and approved by the unit, how to deal with it? A: If the laboratory has not verified the expansion projects, they will not be confirmed during the on-site review and will not be recommended for recognition.

45. If an authorized signatory is involved in multiple fields (chemistry, physics, nondestructive, etc.), how can he master his relevant profession and years? If you have worked for 10 years without a college degree, how can you handle multiple fields? If two fields require 20 years? Or only one field can be considered in 10 years?, 10 years of work experience is not enough in both fields? A: If the education background is not satisfied, the 10-year work experience should be in one field, not a combination of multiple fields. The authorized signatory must have corresponding experience in the field of authorization.

46. If the laboratory has only one authorized signatory and no agent, can we say that the laboratory personnel are insufficient? Answer: If the laboratory can prove that one authorized signatory is sufficient, it cannot be said that the laboratory is not staffed enough.

47. The application instructions require that the authorized signatory of the laboratory should have a bachelor's degree or above in chemistry, and have more than three years of relevant technical work experience. If you do not meet the above conditions, you should have enough testing experience in chemical related fields (at least ten years) - some small-scale testing room staff hardware does not meet the requirements, but has the ability, and only this person is the authorized signatory. If you do not recommend, you will not be able to issue a report. How to control this? Answer: The laboratory will not be recognized if there is no qualified authorized signatory. Because the recognition of the laboratory's technical ability is composed of two parts: testing/calibration ability and authorized signatory.

48. With the increase of laboratory business, some laboratories have established test bases outside their headquarters. If the laboratory business reception, report issuance, etc. are all in the headquarters, and the test base is close to the headquarters and only located in the place where the test is conducted, do the attached tables 1 and 2 of the review report need to be described separately? Answer: Since the report is issued at the headquarters, Schedule 1 does not need to be described separately. However, the test sites are different, and Schedule 2 must be described separately.

49. There are expanded items in the review, but the field has not changed. Whether the authorized signatory is assessed according to the expanded field during the assessment, how to fill in the remark column of the authorized signatory of the laboratory recommended for accreditation in Schedule 1, especially whether it is necessary to provide Schedule 1 during the supervision review. A: If there is an extension, the scope of authorization of the authorized signatory may change. Therefore, "Change in scope of authorization" can be filled in the "Remarks" column. During the supervision and review, if there is no change in the authorized signatory and the scope of authorization, Schedule 1 may not be filled in.

50. For supervision and review, can Schedule 2 be left blank and reported to CNAS? For expansion and change, it is only necessary to form a separate Schedule 2? Answer: During the supervision review, if the approved standards have not changed, you may not fill in the attached table 2 of the review report. If there is a change in the standard, or supervision+extension review is carried out, Schedule 2 can only fill in the content of the change and extension, but it should be noted in the "Description" column.