1.1 General
Manufacture of measuring instruments license on-site assessment should adhere to the principle of independence, confidentiality and evidence-based approach.
The principle of independence is the basis for the impartiality of the assessment and the objectivity of the findings. On-site assessment process, the assessor should be independent of the assessment activities, without bias, without conflict of interest, and maintain an objective mind to ensure that the assessment of opinions and conclusions based only on the assessment of evidence.
The principle of confidentiality requires that appraisers should ensure that information obtained during appraisal activities is kept confidential. Ownership of this information should be protected.
The principle of an evidence-based approach is a rational method for arriving at credible appraisal conclusions in a systematic appraisal process. Appraisal evidence is capable of being substantiated. Because appraisals are conducted within a specified time frame and with limited resources, appraisal evidence is based on a sample of available information. The reasonableness of the sample is closely related to the credibility of the appraisal conclusions, and the appraisal should cover every item of the application for a license, as well as every requirement of the appraisal specification.
1.2 Organization of the appraisal
1.2.1 Duties of the head of the appraisal team
The appraisal team implements the responsibility system of the head of the appraisal team. The duties of the head of the appraisal team are: to be fully responsible for organizing the appraisal of production conditions; to be responsible for formulating the appraisal plan; to represent the appraisal team to contact the leaders of the appraised unit; to have the right to make the final decision on the appraisal results; and to be responsible for finalizing and submitting the appraisal report.
1.2.2 Formulation of the assessment plan
The head of the assessment team shall be responsible for the formulation of the on-site assessment plan based on further detailed review of the application materials and the formation of documents. The on-site appraisal plan shall include the following:
-- Purpose and scope of the on-site appraisal;
-- List of personnel with significant direct responsibility for the appraised organization;
--Assessment guidelines, including assessment specifications, licensing assessment requirements, measurement specifications and technical standards related to the application project, as well as the management system of the applicant organization;
--Division of labor among the members of the assessment team, and determination of the assessment procedures and methods;
--The work and rest time of the appraisal work and the schedule of the main appraisal activities;
--The schedule of the first meeting, the last meeting and other meetings with the leaders of the applicant unit;
--Requirements for maintaining confidentiality.
The head of the appraisal team shall notify the applicant unit and the members of the appraisal team of the appraisal plan. When the applicant unit has objections to the appraisal plan, the head of the appraisal team shall consult with the applicant unit and resolve them before the appraisal begins.
1.3 Preparation for appraisal
1.3.1 Preparation of the appraisal team
13.1.1 Preparation of working documents
The head of the appraisal team shall be responsible for the preparation of the working documents for on-site appraisal. Working documents include licensing assessment of the necessary conditions, on-site assessment of the original record sheet (format see Appendix B), manufacturing measuring instruments licensing assessment report (format see Appendix C) and manufacturing measuring instruments licensing on-site assessment feedback form (format see Appendix D) and so on.
1.3.1.2 Preparation of field test samples
In order to implement the factory inspection capabilities of the assessment, the assessment team leader should be based on the assessment of the project reasonably determine the necessary field test samples. Field test samples can be provided by the assessment team, can also be taken in the assessment site. Test samples provided by the assessment team should be used in the field test before the assessment by the authority of the calibration or calibration, the value of the traceability to the national or international standards of measurement.
1.3.2 Preparation of the applicant unit
On-site assessment, the applicant unit should maintain the normal production status of the project for which the license is applied for, and prepare the following information for the assessment team to check:
(1) the basic situation of the applicant unit and the organization chart;
(2) the documents (original) of the registration or registration in the local government according to the law (including the offsite Business license) and organization code certificate (original);
(3) Acceptance of the type approval certificate and type evaluation report of the application for permission;
(4) renewal of the license held by the applicant unit of the license (original);
(5) product standards and the original registration or filing of the product standards;
(6) the applicant unit of the assessment of the assessment specification and licensing assessment against the Required conditions of self-evaluation;
(7) measurement management system and quality management system, and the implementation of the record;
(8) quality management personnel, technicians, metrologists and inspectors list and appointment letters, employment contracts, etc.;
(9) production equipment, process equipment, testing equipment and factory inspection and measurement equipment list;
< p>(10) testing equipment and factory inspection and measurement equipment calibration / calibration records or certificates;(11) application for permission to apply for the project design documents (including design drawings, installation and use of instructions, etc.), process documents (including operating instructions, process procedures, process cards), calibration procedures or calibration specifications or test methods;
(12) the product factory inspection records;
(13) measurement standard assessment certificate (such as the establishment of the enterprise most of the measurement standard);
(14) a list of relevant laws and regulations and the corresponding standards, technical specifications;
(15) process flow diagrams and the location of the key control points (in order to be used during the on-site inspections);
(16) on-site assessment of the process of the other information required.
1.4 On-site assessment
1.4.1 Preparatory meeting
After the assessment team arrives at the assessment site of the applicant unit, a preparatory meeting will be held with the participation of the members of the assessment team and the main person in charge of the applicant unit as well as the relevant personnel. The main contents of the meeting are as follows:
(1) Consultation on the arrangement of the appraisal work;
(2) Consultation on the scope of participants in the first meeting and the meeting procedures.
1.4.2 The first meeting
The first meeting is chaired by the head of the assessment team, and the participants include all the members of the assessment team, the person in charge of the applicant unit, the person in charge of metrology management and quality management, and other relevant personnel.
The main contents of the first meeting are as follows:
(1) introduction of relevant personnel;
(2) assessment team leader explains the basis of the assessment work, scheduling, assessment of the content and requirements of the assessment, assessment of the work of discipline, the assessment of the group's staff division of labor;
(3) the applicant unit to introduce the basic situation, the production of measuring instruments products, measurement and quality management implementation Situation; replacement unit should be introduced during the license period.
1.4.3 Site inspection
Site inspection and acceptance of the project-related departments, sites, facilities and equipment, with a focus on the materials warehouse, parts warehouse, processing plant and processing equipment, tooling facilities, product testing sites and equipment, measurement laboratories, finished goods warehouse, as well as the production of various processes.
When conducting on-site inspections, the assessor should record the model of the trial (or manufacturing) product, the materials used, key parts and components marking, on-site metrology management and quality management system implementation as well as the implementation of the process and the relevant technical standards and norms.
1.4.4 Subgroup inspection
General assessment team can be divided into two assessment groups of software and hardware. Software group is mainly responsible for 4.2 measurement of legal management,
4.3 human resources, 4.7 technical documents and 4.8 management system and other four aspects of the assessment; hardware group is mainly responsible for 4.4 production sites, 4.5 production facilities, 4.6 inspection conditions, 4.9 after-sales service and 4.10 product quality and other five aspects of the assessment.
The appraisers carry out the assessment according to the division of labor and the contents specified. The specific assessment method for each requirement can be found in the relevant provisions of the Field Assessment and Evaluation Record Sheet in Appendix B.
In the assessment process, the assessor and the applicant unit should exchange views in a timely manner, find important issues to report to the head of the assessment team in a timely manner, and if necessary, should extend the scope of the assessment in order to find out the problem.
1.4.5 On-site test
The factory inspection personnel of the applicant unit with the factory inspection equipment to be assessed on the assessment of the measurement object specified by the assessor. On-site test, the assessor should be factory inspection of personnel, resources, methods, operating procedures and test results for assessment, comprehensive assessment of factory inspection conditions, and be recorded. For each application for permission to form a "factory inspection project field test assessment record sheet" (the format of the record see Appendix B in Table B.6).
1.4.6 Summary of the situation
After the completion of the on-site assessment work, the head of the assessment team should convene a meeting of the assessment team to exchange the problems found and the situation, and in accordance with the specification of the 5.6.1 and 5.6.2 provisions of the requirements of the assessment of all the items to be assessed. If necessary, the head of the assessment team shall reconfirm the problems found in the assessment. For each assessment for "non-conformity" of the project, should form a "non-conformity report", the report should include non-conformity with the description of the facts, non-conformity with the basis of assessment, non-conformity with the nature of the project and non-conformity with the project involved in the application for licensing and so on (the report format in Appendix C, see Annex 2).
1.4.7 Exchange of Opinions
The appraisal team exchanges with the leadership of the applicant unit and the relevant responsible persons on the problems identified in the appraisal work. The assessment team should explain to the applicant unit of the assessment team's comments and recommendations, consult the applicant unit of the views of the relevant personnel. The assessment team should be "manufacturing measuring instruments licensing on-site assessment feedback form" to the applicant unit, the applicant unit to fill out the direct submission to the organization of the on-site assessment of quality and technical supervision departments.
1.4.8 The next meeting
The last meeting is chaired by the head of the assessment team, all members of the assessment team, the person in charge of the applicant unit and the relevant responsible personnel to participate. The head of the appraisal team informs about the appraisal work and the appraisal results.
1.5 Appraisal Records
Records shall be formed for all activities of the appraisal process. The records shall include sufficient information to properly evaluate the appraisal activities so that each evaluation is based on evidence-based methodological principles and so that each piece of evidence is verifiable and traceable
The on-site appraisal shall result in the following original records:
(1) On-site appraisal and evaluation record form (see Table B.1 in Appendix B);
(2) Record of confirmation of the main production equipment form (see Appendix B Table B.2);
(3) key components inspection confirmation record sheet (see Appendix B Table B.3);
(4) key components use confirmation record sheet (see Appendix B Table B.4);
(5) factory inspection items and measurement equipment site confirmation record sheet (see Appendix B Table B.5);
(6) factory Inspection items on-site test assessment record sheet (see Appendix B Table B.6).
1.6 Conclusion of the examination
1.6.1 Classification of the examination program
This specification chapter 4 "examination requirements" in addition to 4.1 "General Provisions", the remaining 38 paragraphs are on-site examination program. Among them, 4.2.1, 4.2.3, 4.2.5, 4.4.1, 4.5.1, 4.6.4, 4.6.5, 4.7.2, 4.10.1, and 4.10.2*** counted 10 paragraphs for the veto, and the remaining 28 paragraphs for the non-veto items.
1.6.2 Assessment of appraisal items
There are three types of appraisal conclusions for appraisal items: "Conformity", "Non-conformity" and "Not Applicable".
(1) Items that meet the requirements of the assessment provisions are assessed as "conforming";
(2) Items that do not meet the requirements of the assessment provisions are assessed as "not conforming";
(3) Items that do not meet the requirements of the assessment provisions are assessed as "not conforming";
(4) Items that do not meet the requirements of the assessment provisions are assessed as "not conforming". 4.2.3, 4.2.6, 4.7.8 and 4.10.3 may not be applicable to a certain type of assessment. For example, 4.2.3 does not apply to the first assessment; 4.10.3 does not apply to measuring instruments that do not contain measurement software, the conclusion of the assessment is "not applicable".
1.6.3 Determination of assessment conclusions
The assessment conclusions are divided into "qualified", "assessment is basically qualified, the need for rectification" and "unqualified". "There are three kinds of conclusions.
(1) If the evaluation conclusions of the veto items and non-veto items are all "in line with", the evaluation conclusion is "appraisal pass";
(2) If the evaluation conclusions of the veto items are all "in line with
(2) If the assessment conclusions of the veto items are all "Conform" and the assessment conclusions of the non-veto items are "Not Conform" in no more than 5 paragraphs (including 5 paragraphs), the assessment conclusion shall be "The assessment is basically qualified, and rectification is required";
(3) If there are 1 or more veto items, the assessment conclusion shall be "Not Conform". Assessment of the conclusion that "does not meet" or non-denial items have 6 or more paragraphs assessed conclusion that "does not meet", the assessment concluded that "the assessment fails";
To Apply for permission to manufacture a number of measuring instruments, the assessment team should be licensed for each measuring instrument to make an assessment of the conclusion of the project.
1.7 Rectification measures
Assessment concluded that "the assessment is basically qualified, the need for rectification", the applicant should be in accordance with the "non-conformity report" of the issues raised, generally within one month to complete the rectification work, and in the completion of the rectification work will be rectified after the completion of the rectification report and rectification of the witness information to be submitted to the assessment team.
The appraisal team shall confirm the rectification report and the rectification witness information, and fill in the record of rectification confirmation on the Nonconformity Report, and if necessary, shall arrange for on-site confirmation of the rectification by the appraiser. After confirming compliance with the requirements, the appraisal report concludes that "after rectification, the appraisal is qualified". The applicant failed to complete the rectification within the specified time or confirmed that the rectification still does not meet the requirements, the conclusion of the assessment is "assessment failed".
1.8 Appraisal Report
After the on-site appraisal, the appraisal team shall submit an appraisal report to the quality and technology supervision department of the organization to make the appraisal conclusion.
The appraisal report shall include all the inspection results, the appraisal conclusions made on the basis of these results, and all the information necessary for understanding and interpreting these results. All such information shall be complete, accurate and clearly presented.
The appraisal report shall be prepared and issued by the appraisal team leader's organization.
1.9 Appraisal information
When the appraisal is fully completed, the head of the appraisal team will submit the application form, the appraisal report, all the original appraisal records, the rectification materials and other necessary supporting materials to the department that organizes the appraisal in accordance with the specified time.
2 follow-up assessment
2.1 New project assessment
If the new project belongs to the original licensing project other than the other measuring instruments, should be in accordance with the first application for permission to assess the procedures and requirements for assessment.
If the new items belong to the original licensing program to expand the range or improve the accuracy of measuring instruments beyond the original approval of the type of new products, should be re-approved for measuring instruments type approval. Manufacture of measuring instruments license on-site assessment can be simplified or taken in writing to confirm the way.
2.2 Changes in the conditions of the assessment
The production conditions due to the migration of production sites and other reasons for change, should re-apply for the manufacturing of measuring instruments license assessment. The focus of the assessment is 4.4, 4.5, 4.6 and 4.10 articles.
2.3 Expiration of the license renewal assessment
2.3.1 Examination procedures
License expiration review of the license renewal assessment of the requirements and work procedures and the first on-site assessment is basically the same.
2.3.2 focus on the assessment
Re-check and renewal of the license assessment work focuses on the assessment of the unit during the license period of changes in licensing conditions, the implementation of measurement laws and regulations, as well as the quality of products, the focus should be on the following:
(1) whether the licensing conditions have changed, and if so, whether to fulfill the licensing requirements to change the procedures;
(2) product quality continues to comply with the product, the quality of the product is not only the same, but also the quality of the product is not the same.
(2) product quality continues to comply with product standards and metrological verification procedures or calibration specifications;
(3) the consistency of the product type and the product type approval certificate;
(4) license validity to accept the quality supervision of product quality supervision and sampling by the quality supervision department;
(5) customer complaints about product quality and complaint handling;
(6) the implementation of measurement management and quality management system;
(7) whether the measurement verification/calibration certificate of the measuring equipment is within the validity period;
(8) whether the registration or filing of the product standard is within the validity period;
(9) whether there is a commissioning of production and processing of unlicensed units;
(10) whether there is alteration, forgery, transfer or sale of licenses, etc..
2.3.3 Appraisal Conclusion
The appraisal team shall give the appraisal conclusion in accordance with the requirements of clause 5.6. If it is found in the assessment that the applicant unit has entrusted the production and processing of unlicensed units or alteration, forgery, transfer or sale of licenses, the assessment team shall immediately report to the quality and technical supervision departments to organize the on-site assessment.