In January this year, the China National Accreditation Committee for conformity assessment (CNAS) revised the B4 version of the guide for accreditation of laboratory accreditation, which has been implemented since March 1, 2016.
Requirements: from 201512 to 31 to March 1, 2016 as a transitional period, during the transition period, if the review team uses the B4 version of the laboratory accreditation report, it should use the B4 version of the laboratory accreditation guidance book. After March 1, 2016, the B3 version of the laboratory accreditation guidance book was stopped.
The main impact of this change on the laboratory is that there will be changes in the laboratory's on-site review process. The main changes are as follows: (a total of 17 points):
1, section 4.2.2, increase: D) the criteria used in the application confirmation have been applied for recognition or recognition.
2, sections 4.4.2 and 4.4.3, increase the "record of changes in laboratory capacity".
3, section 4.4.7 I) adding "items including change records".
4, because the measurement audit procedure will be revoked, so delete the sections 4.4.8 and 4.4.9, which are related to the on-site measurement audits.
5, increase: section 4.6.3.5.3 supervision and review and re evaluation, for the technical ability to change records, such as changes in technical capabilities, should also be confirmed by on-site testing.
6, increase: confirm the criterion of 4.6.10.
7. Section 5.4.1 adds "proficiency testing and interlaboratory comparison, which is verified by the review team in document review and on-site review, and its technical capability is judged".
8, section 5.4.3, delete C) 1, increase the "4" other field test methods, such as recovery and so on.
9, delete section 5.4.4.
10, adding 5.6.2, "the assessor should pay special attention to whether the certification certificate contains traceability information, and whether the laboratory can provide information on measurement uncertainty." Amendment 5.6.3 description.
11, increase: 5.21. The application standard involves the processing of general standards for instrumental analysis methods.
12, Section 6.2 increase. "The leader of the review team should ask the lab to provide quality manuals and procedures in advance for examination." In the downloading of the on-site review, there is an increase in the evaluation documents package and public documents that need to be used: the certificate annexes that have been recognized by the accreditation laboratory, and the form for review, including the evaluation report form.
13, section 6.3b) to increase the ability to handle changes in the form of filing.
14, adding "technical capability change record" in Section 7.3.
15, increase the "8.5 expansion" review, if the laboratory exists through the CNAS record of the technical ability change, the review group's scope of assessment should also cover the technical ability to change the record. And (sixth) and seventh articles shall be carried out at the same time as "extension 8.6 assessment and supervision review or review".
16, the rectification period for initial evaluation and expansion will be adjusted to 2 months.
17, amend the appendix A of the review report, and revise the evaluation report in accordance with the new evaluation report form.
(source: quality and certification of public address)
