Inspection and testing agency qualification assessment work procedures must read for laboratories
2024-09-11
This review work procedure is formulated in accordance with the requirements of the "Administrative Measures for Qualification Accreditation of Testing and Inspection Institutions" and its purpose is to standardize the review process for qualification accreditation of testing and inspection institutions.
1. Review Type and Time Limit
The qualification accreditation review work of inspection and testing institutions is divided into: on-site review and written review.
1.1 On-site review
Types of on-site reviews include initial review, change review, re-examination review and other reviews.
Initial review: For inspection and testing institutions that have not obtained accreditation, after they have established and operated a management system, they apply for an on-site review by the accreditation department to confirm whether they meet the accreditation conditions.
Change review: If there are changes in the organizational structure, workplace, key personnel, technical capabilities, management system, etc. of an already accredited inspection and testing agency, the accreditation department will conduct an on-site review to confirm whether it meets the accreditation conditions.
Re-examination and review: For inspection and testing institutions that have obtained qualification certification, they shall apply for certificate renewal three months before the expiration of the qualification certification certificate. The qualification certification department shall conduct on-site confirmation and review to determine whether their qualifications continue to meet the qualification certification conditions.
Other reviews: For accredited inspection and testing institutions, due to the need for supervision by the accreditation department and handling of appeals and complaints, an on-site review is conducted to confirm whether the inspection and testing institutions meet the accreditation conditions.
1.2 Written Review
Types of written reviews include change reviews and self-declaration reviews.
Change review: For accredited inspection and testing institutions, if there are any changes in their name, legal nature, address, legal representative, top management, technical director, authorized signatory, inspection and testing standards, or if they voluntarily cancel their accreditation projects, the accreditation department will conduct a written review to determine whether the changes meet the accreditation requirements.
Self-declaration review: For the inspection and testing institutions that have obtained qualification certification, the qualification certification department will conduct a written review of their self-declaration. For the institutions that make self-declarations, the qualification certification department will check whether the contents of their declarations are true in the subsequent supervision and management. If it is found that the contents of the commitments are false, the qualification certification department will revoke the approval decision and record the relevant situation in the credit file.
1.3 Technical Review Time Limit
After the qualification certification department accepts the application, it shall promptly organize experts to conduct a review. The technical review shall be completed within 45 working days after the qualification certification department accepts the application (including submission of the review conclusion), except where it cannot be completed within the prescribed time limit due to the applicant's own reasons.
2. On-site review preparation
2.1 Determine the implementation department
After accepting the qualification certification application of the inspection and testing agency, the qualification certification department can organize and implement the review on its own. If it needs to entrust a professional technical evaluation organization to implement the review, the following materials should be transferred to the professional technical evaluation organization:
(1) Application submitted by the inspection and testing agency;
(2) Quality Manual and Procedure Documents of the inspection and testing agency (when applicable);
(3) Relevant description of the inspection and testing agency;
(4) Forms for qualification accreditation and review work.
2.2 Establishing the review team
(1) Composition of the review team
The qualification certification department or its entrusted professional and technical evaluation organization shall form an evaluation group according to the principles of professional coverage and proximity based on the inspection and testing items and professional categories for which the audited inspection and testing institution applies for qualification certification. The evaluation group shall consist of one group leader and one or more reviewers or technical experts. Under the leadership of the group leader, the members of the evaluation group shall independently carry out the qualification certification review activities in accordance with the review tasks issued by the qualification certification department or its entrusted professional and technical evaluation organization, and shall be responsible for the review conclusions.
(2) Responsibilities of the review team leader
① Take the lead in observing the review discipline and code of conduct, require the behavior of the review team members to comply with relevant regulations, provide necessary guidance to the review team members, and evaluate the on-site review performance of the review team members;
② Lead the review team to carry out on-site review work, and be responsible for the legality and standardization of on-site review activities and the accuracy, authenticity and completeness of the review conclusions;
③ Communicate with the reviewed inspection and testing institutions on behalf of the review team, coordinate and control the on-site review process, and adjudicate disagreements and other matters in the review work;
④ Coordinate the contact between the review team and the supervisory personnel sent by the qualification certification department.
⑤ Responsible for the planning before the on-site review, including: document review, review schedule arrangement, agreement on on-site test items, filling in the preliminary preparation records for the review, and matters that should be prepared before the review, etc.;
⑥ Before the first on-site review meeting, introduce the relevant work content and requirements of the review to the review team;
⑦ Responsible for proposing on-site review conclusions based on the actual situation of the reviewed inspection and testing institution and the opinions of the review team members;
⑧ Organize the acceptance of the rectification of the reviewed inspection and testing institutions;
⑨ Responsible for summarizing and organizing the review materials, and promptly reporting the review situation and conclusions as well as submitting the review materials to the qualification certification department or its entrusted professional technical evaluation organization.
(3) Responsibilities of the reviewer
① Comply with the review team's planned schedule and the review team's division of tasks, complete the review work of relevant content, obey the arrangements and dispatch of the review team leader, abide by the review discipline and code of conduct, and be directly responsible for the accuracy, authenticity and completeness of the review content and conclusions;
② According to the division of labor of the review team, do a good job in collecting information before the review. The reviewer responsible for management elements should assist the review team leader in the preliminary document review. The reviewer responsible for technical elements should assist the review team leader in determining the on-site test assessment items and be responsible for filling in the relevant records in the review report.
(4) Responsibilities of technical experts
① Comply with the review team's schedule, review discipline and code of conduct, obey the review team leader's arrangements and dispatches, and be responsible for the accuracy, authenticity and completeness of the review content and conclusions;
② In accordance with the division of labor of the review group, assist the review group leader or reviewers in determining on-site test assessment items, and assist reviewers in carrying out inspection and testing capability confirmation work.
2.3 Material Review
The review team leader shall review the application materials submitted by the inspection and testing agency with the cooperation of the reviewers or technical experts. By reviewing the submitted "Application for Qualification Accreditation of Inspection and Testing Agency", the work type, capability scope, inspection and testing resource allocation and scope of management system operation of the inspection and testing agency shall be understood, and in accordance with the "Criteria for Qualification Accreditation of Inspection and Testing Agency" and corresponding technical standards, the "Quality Manual" and "Procedure Documents" of the applicant shall be reviewed for document conformity, and the operation of the management system shall be preliminarily evaluated.
(1) Key points for reviewing the “Application for Qualification Accreditation of Inspection and Testing Institutions” and its attachments
① Review the certification materials of the legal person status of the inspection and testing agency and examine whether its business scope meets the requirements of impartial inspection and testing;
② Whether the inspection and testing agency has a fixed workplace;
③ Whether the items/parameters and the standards on which they are based in the "Application for Qualification Certification Inspection and Testing Capability Table" are correct and whether they fall within the scope of qualification certification;
④ Whether the configuration of instruments and equipment (standard substances) is filled in correctly, whether the listed instruments and equipment meet the inspection and testing capability requirements of the application items/parameters, and can be deployed and used independently;
⑤Whether the professional titles and work experience of the technical person in charge, authorized signatory and inspection and testing personnel in specific fields meet the requirements;
⑥ Is the organizational chart clear?
(2) Key points for reviewing the Quality Manual
① The clauses of the Quality Manual should include the relevant provisions of the Criteria for Accreditation and Review of Inspection and Testing Institutions;
② The quality policy is clear, and the quality objectives are measurable and operational;
③Quality functions are clear;
④ The management system is clearly described, the elements are concise and practical, and the interface relationship between documents is clear;
⑤Quality activities are under control; the management system can operate effectively and make self-improvements.
(3) Key points for reviewing the “Procedure Document”
① All elements that need to be described in procedure documents have been properly compiled into procedure documents;
② The procedure document is operational in light of the characteristics of the inspection and testing organization;
③ There is a clear connection between procedure documents and between procedures and quality manual.
(4) Processing of review results
The head of the review team shall complete the material review within 10 working days of receiving the application materials and feedback the review opinions to the qualification certification department or its entrusted professional and technical evaluation organization. When the materials do not meet the requirements, the qualification certification department or its entrusted professional and technical evaluation organization shall notify the applicant institution to make changes.
2.4 Issuance of review notice
After the materials are reviewed and approved, the accreditation department or the professional technical evaluation organization entrusted by it shall issue a "Notice of On-site Review of Inspection and Testing Qualification Accreditation" to the reviewed inspection and testing agency, and inform the review team to implement the review as planned.
2.5 Preparation of review plan
After receiving the on-site review task, the review team will compile the "On-site Review Schedule for Inspection and Testing Institutions". They will plan and arrange the review date, time, work content, and division of labor of the review team. They will also communicate with the reviewed inspection and testing institutions on the following issues:
(1) Determine the review schedule;
(2) Determine the field test items;
(3) Agree on transportation, accommodation and other arrangements.
3. Conduct technical review
3.1 Convene a preparatory meeting
The review team leader shall hold a preparatory meeting for all review team members before the on-site review. The meeting content shall include:
(1) The review team leader declares that the review work is fair, objective and confidential;
(2) Explain the purpose, scope and basis of this review;
(3) Introduce the document review of the inspection and testing agency;
(4) Clarify the requirements for on-site review and unify the relevant judgment principles;
(5) Listen to the work suggestions of the review team members and answer the questions raised by the review team members;
(6) Determine the division of labor among the review team members, clarify their responsibilities, and provide them with relevant review documents and on-site review forms;
(7) Determine the on-site review schedule;
(8) Request the inspection and testing agency to provide supplementary materials related to the review when necessary;
(9) When necessary, the team leader will provide necessary training and review experience exchange to newly certified assessors and technical experts.
3.2 First meeting
The first meeting shall be chaired by the review team leader. All members of the review team, the top management, technical director, quality supervisor and heads of the inspection and testing business departments of the inspection and testing institutions shall attend the first meeting. The content of the meeting is as follows:
(1) The team leader announces the meeting and introduces the members of the review team; the inspection and testing agency introduces the participants;
(2) The review team leader reads out the review notice issued by the accreditation department, explains the purpose, basis, scope and principles of the review, and specifies the departments and personnel involved in the review;
(3) Confirm the review schedule;
(4) Announce the division of labor among the review team members;
(5) Make a confidentiality commitment to the inspection and testing agency;
(6) Clarify relevant issues and specify restrictions (such as clean areas, dangerous areas, people with whom conversation is restricted, etc.);
(7) The inspection and testing agency shall assign accompanying personnel to the review team and determine the review team’s workplace and the resources required for the review work.
3.3 Inspection of inspection and testing institutions
After the first meeting, the accompanying personnel will lead the review team to conduct an on-site inspection to inspect the relevant offices and inspection and testing sites of the inspection and testing agency. The process of on-site visits is a process of observation and assessment. Some sites may not be inspected again after a one-time visit, and the maximum amount of information should be collected in a limited time. During the on-site visit, relevant questions should be asked in a timely manner, and the environmental conditions, instruments and equipment, and inspection and testing facilities should be observed purposefully to see whether they meet the requirements of inspection and testing, and records should be kept. The on-site visit should be completed within the time specified in the review schedule to prevent the subsequent review process from being affected by the overly detailed introduction of the accompanying personnel of the inspection and testing agency. Also, the time of other reviewers should not be delayed due to the in-depth investigation of a certain issue by individual reviewers.
3.4 Field trials
Whether the inspection and testing agency uses appropriate methods and procedures for inspection and testing should be assessed through on-site tests. Through on-site tests, the operating ability of the inspection personnel and the guarantee ability of the environment and equipment can be assessed.
(1) Selection of assessment items
The on-site test items for the first review must cover all major categories within the application scope, and may be reduced as appropriate based on specific circumstances during the re-evaluation.
(2) Methods of on-site test assessment
The on-site test assessment of inspection and testing institutions can be carried out through blind sample testing, personnel comparison, instrument comparison, witness testing and report verification.
(3) Application of field test results
① For blind sample tests, personnel comparison, instrument comparison, and process assessment, an inspection and testing report or certificate should be issued; for report or certificate verification, the original inspection record or inspection and testing report or certificate should be issued.
② During the on-site operation assessment, if the result data of the blind sample test, personnel comparison, and instrument comparison are unqualified, or deviate significantly from the known data, the inspection and testing agency should be required to analyze the reasons; if it is an accidental cause, the inspection and testing agency can be arranged to retest; if it is a systematic deviation, it should be deemed that the inspection and testing agency does not have the inspection and testing capabilities for this purpose.
(4) Evaluation of field tests
After the on-site test is completed, the assessor shall evaluate the test results. The evaluation contents are as follows:
①Whether the inspection and testing standards adopted are correct;
② Check whether the test results are accurate, clear and understandable;
③ Whether the inspection and testing personnel have relevant inspection and testing experience;
④ How proficient are the inspection and testing operations?
⑤Environmental facilities and suitability;
⑥ Whether the receipt, registration, description, placement, sample preparation and disposal of samples are standardized;
⑦ Check whether the debugging and use of testing equipment and test systems are correct;
⑧ Check whether the inspection and testing records are standardized.
(5) Questions from the audience
On-site questioning is part of the on-site review and is a form of qualification confirmation to evaluate whether the staff of the inspection and testing agency have received appropriate education and training and have the appropriate experience and skills. The top manager, technical director, quality supervisor, authorized signatory, personnel in various management positions and all personnel engaged in inspection and testing activities of the inspection and testing agency should accept on-site questioning.
On-site questions can be combined with on-site visits, operational assessments, record review and other activities, or they can be asked in forums and other occasions.
The questions asked on site can be basic questions, such as questions about laws and regulations, review criteria, system documents, inspection and testing standards, inspection and testing technologies, etc. You can also ask follow-up or clarification questions about problems found during the review or unclear issues. All questions should be recorded accordingly so that a reasonable review conclusion can be made.
(6) Review quality records
The records generated during the management system process and the records generated during the inspection and testing process are strong evidence for reproducing the management process and the inspection and testing process. The review team should evaluate the effectiveness of the management system operation and the correctness of the technical operation by verifying the quality records. The review of quality records should focus on the following issues:
① Whether the control of documents and materials, as well as the management of archives are applicable, effective, and in compliance with the requirements of control, and whether there are corresponding resources to ensure;
② Whether the operation records of the management system of the inspection and testing agency are complete and scientific, and whether they can effectively reflect the operation status of the management system;
③ The format and content of the original records, reports or certificates should be reasonable and contain sufficient information;
④ The records should be clear and accurate, and should include all information that affects the test results, such as charts, the entire process, etc.;
⑤The formation, modification and storage of records shall comply with the relevant provisions of the system documents.
(7) Fill in the on-site review record
The process of on-site review of the inspection and testing agency should be recorded in the review form of the "Inspection and Testing Agency Qualification Review Report". While reviewing the inspection and testing agency in accordance with the "Inspection and Testing Agency Qualification Review Criteria" and the review supplementary requirements, the reviewer should record in detail the basic compliance and non-compliance clauses and facts. The review conclusions are divided into "compliance", "basic compliance", "basic compliance (on-site review required)", and "non-compliance".
(8) On-site discussion
Through on-site discussions, we can assess the basic knowledge of the technical and management personnel of the inspection and testing institutions, understand the understanding of the inspection and testing personnel of the system documents, clarify some problems in the on-site observation, exchange ideas, and unify understanding. The discussion is generally attended by the following personnel: management cadres and management personnel at all levels, internal auditors, supervisors, major sampling, inspection and testing personnel, and new employees. The following questions should be asked and discussed during the discussion:
① Understanding of the “Evaluation Criteria”;
② Understanding of the system documents of the inspection and testing institutions;
③ The application of the "Evaluation Criteria" and system documents in actual work;
④ The understanding of the responsibilities of personnel in various positions;
⑤ Professional knowledge that various personnel should possess;
⑥ Some problems discovered during the review process and issues that need to be clarified with the reviewed party.
(9) Assessment of authorized signatories
The authorized signatory refers to the person nominated by the inspection and testing institution, who has passed the qualification assessment by the qualification certification department and issues the inspection and testing report and certificate. The authorized signatory shall meet the following conditions:
① Possess a professional title of intermediate level or above (including intermediate level) or equivalent ability as stipulated in the standards;
②Have relevant work experience;
③ Be familiar with or master the verification/calibration status of relevant instruments and equipment;
④ Be familiar with or master the corresponding technical standards and methods in the field of signature undertaken;
⑤Be familiar with the management of inspection and testing institutions and the review and issuance procedures of inspection and testing reports or certificates;
⑥ Have the ability to make corresponding evaluations of inspection and testing results;
⑦ Be familiar with the "Criteria for Accreditation and Review of Testing and Inspection Bodies" and the requirements of relevant laws, regulations and technical documents.
The assessment is chaired by the assessment team leader and participated by the assessment team members. Each authorized signatory shall fill out a "Evaluation Record Form for Authorized Signatories of On-site Assessment of Inspection and Testing Institutions". The contents of the record are as follows:
① The main questions raised in the assessment and the responses of the person being assessed;
②Examiner’s evaluation opinions.
(10) Determination of inspection and testing capabilities
Confirming the inspection and testing capabilities of the inspection and testing agency is the core link of the on-site review by the review team. Each reviewer should seriously review the capabilities of the inspection and testing agency and provide a true and reliable review conclusion for the administrative license of qualification certification. The approved inspection and testing capabilities must meet the following conditions:
① Standards on which the project is based. The inspection and testing standards on which the project is based must be currently valid; in the absence of national standards, industry standards, local standards, group standards, and international standards, the inspection and testing agency can formulate non-standard methods on its own, and the supporting documents for the formulation, verification, and confirmation process should be able to prove that the non-standard method is scientific, accurate, and reliable;
② The facilities and environment must meet the inspection and testing requirements;
③ The range and accuracy of all equipment required for the entire inspection and testing process must meet the expected use requirements;
④ All inspection and testing data should be traceable to the national metrology standards;
⑤ All inspection and testing personnel can correctly complete the inspection and testing work;
⑥ Ability to demonstrate corresponding inspection and testing capabilities through on-site trials, blind sample tests, etc.
The following issues should be noted when determining the inspection and testing capabilities:
① Inspection and testing capabilities are based on existing conditions and cannot be based on promises or speculations;
② Projects that temporarily borrow equipment cannot be used as inspection and testing capabilities;
③ The inspection and testing items shall be confirmed according to the scope of application, and the assessors shall not add items without authorization;
④ If the party being reviewed cannot provide inspection and testing standards, the inspection and testing personnel do not have the corresponding skills, there is no inspection and testing equipment or the inspection and testing equipment is not configured correctly, or the environmental conditions do not meet the inspection and testing requirements, they will be treated as not having the inspection and testing capabilities;
⑤ If only part of the same inspection and testing items meet the standard requirements, it should be noted in the "Limited Scope or Description" column;
⑥ Non-standard methods developed by the inspection and testing agency itself should be indicated in the "Limitation or Description" column: limited to commissioned inspection and testing agreed upon in specific contracts.
(11) Filling in the “Inspection and Testing Capabilities Confirmed by the Review Group”
The inspection and testing agency capability table in the review report should be filled in according to the inspection and testing agency capability classification standards.
(12) Internal meeting of the review team
During the on-site review, time should be arranged every day to hold an internal review team meeting. The main contents include: exchanging the review situation of the day, discussing the findings of the review, and determining whether there are non-conformities; the review team leader understands the progress of the review work, adjusts the reviewer's work tasks in a timely manner, organizes and controls the review process, and puts forward suggestions for handling some difficult problems of the reviewer.
The last internal meeting of the review group is chaired by the review group leader to summarize the review situation, determine the inspection and testing capabilities that have passed the review, propose non-conformities and rectification requirements, form review conclusions and keep review records. After the meeting, the review conclusions should be notified to the representatives of the reviewed party and the other party should be asked to comment on these results. If necessary, the questions of concern of the representatives of the reviewed party should be answered or the differences in the views of both parties should be resolved.
(13) Communication with inspection and testing institutions
After the review team forms its opinion, the review team leader should communicate with the top management of the reviewed inspection and testing agency, inform them of the non-conformities found during the review and the review conclusions, and listen to the opinions of the reviewed inspection and testing agency.
(14) Review conclusion
The review conclusions are divided into four types: "compliant", "basically compliant", "basically compliant but requiring on-site review", and "non-compliant".
(15) Review report
The review team leader is responsible for writing the review team's opinions, which mainly include:
The basis for on-site review, number of review team members, on-site review time, review scope, basic review process, evaluation of the effectiveness of the organization's system operation and its ability to undertake impartial third-party inspections, evaluation of personnel quality, instruments and equipment, environmental conditions and inspection reports, evaluation of on-site test operation assessments, number of projects recommended for approval of qualification certification, and other issues that need to be explained, non-conformities, and issues that need to be rectified.
The "Evaluation Report" should use the text uniformly printed and issued by the National Certification and Accreditation Administration, and the relevant personnel should sign in the corresponding column.
(16) Final meeting
The final meeting is chaired by the review team leader and attended by all review team members, including the principal of the reviewed unit. The content of the final meeting is as follows:
① Review status and problems found during the review;
② Read out the review opinions and review conclusions;
③ Propose rectification requirements for “non-conforming items and basically conforming items”;
④ The reviewed inspection and testing agency expresses its opinions on the review conclusions;
⑤Announce the completion of on-site review work.
4. Follow-up verification of rectification
After the on-site review is completed, the inspection and testing agency shall rectify the non-conformities raised by the review team within the agreed time, and the rectification time shall not exceed 30 days. After the rectification is completed, written materials shall be submitted to the review team leader for confirmation. After receiving the rectification materials from the inspection and testing agency, the review team leader shall complete the follow-up verification within 5 working days and report the review-related materials to the qualification certification department or its entrusted professional technical evaluation organization.
(1) For inspection and testing institutions whose review conclusion is "basically compliant", follow-up verification should be carried out through document review:
① The inspection and testing agency submits a rectification report and corresponding witness materials;
② The review team leader confirms whether the rectification is effective and meets the requirements based on the witness materials;
If the rectification meets the requirements, the review team leader shall fill in the "Rectification Completion Record" in the "Review Report" and submit it for approval.
(2) For inspection and testing institutions whose review conclusion is "basically compliant but requires on-site review", follow-up verification should be carried out through on-site inspection:
① The inspection and testing agency submits a rectification report and relevant witness materials;
② The review team leader organizes relevant reviewers to conduct on-site inspections of non-conformities that need to be rectified to confirm whether the rectification is effective;
③ If the rectification is effective and meets the requirements, the review team leader shall fill in the "Rectification Completion Record" in the "Review Report" and submit it for approval.
5. Summary and submission of review materials
The review team shall submit the following materials to the qualification certification department or the professional technical evaluation organization entrusted by it:
(1) Application form;
(2) Review report;
(3) Attachment to the certificate of qualification;
(4) Rectification report;
(5) All records of what happened during the review;
(6) CD-ROM (contents include: application form; review report; certificate appendix; text of rectification report; all records of the review process).
6. Termination of Review
In the following situations, the review team should consult the qualification certification department that issued the review task or the professional technical evaluation organization entrusted by it, and the review can be terminated with their consent.
(1) The inspection and testing agency has no legal status;
(2) Inspection and testing institutions are seriously understaffed;
(3) The inspection and testing agency's location seriously fails to meet the inspection and testing requirements;
(4) The inspection and testing institutions lack necessary instruments, equipment and standard materials;
(5) The management system of the inspection and testing institution is seriously out of control;
(6) The inspection and testing institutions have serious violations of laws and regulations.
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2024-09-11
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