CMA certification process

First, the preparatory work before certification:

1. The leaders of the unit unified their thinking and made clear why they should pass CMA, as well as the person in charge of CMA certification and the timetable of the certification process.

2. Decide whether to hire a consulting company; Evaluate whether CMAS certification conditions are met.

3. According to the actual situation of the unit, clarify the organizational structure, rational allocation of human resources and division of labor (technical quality director, authorized signatory, equipment manager, file manager, etc.). ).

4. Equipment calibration, capability verification, etc.

Second, the process of CMA certification

1. According to the actual situation of the unit, prepare quality manuals, program documents, work instructions (or SOPs) and record forms that conform to the actual situation of the unit.

2. Run the quality system and improve all kinds of records.

3. Conduct internal audit

4. Conduct management review

Submit application

6. Improve the system

7. on-site review

8. Rectification measures and licensing.

Third, the audit focus

1. Organization

Problems needing attention: whether it is an independent legal person, bank account, tax registration, personnel contract, social security, equipment contract, venue contract, etc. , and whether the post documents of key positions clarify the post responsibilities and agents of personnel; Whether fairness and customer confidentiality are stipulated, and whether records and files are formed.

2. Management system

Attention: Establish management system, document it, communicate it to relevant personnel and implement it; Quality objectives and policies; The management system has been continuously and effectively improved.

3. Document control:

Note: uniqueness and validity of document number; Controlled management of documents; Records of approval, release and change of documents; Records of the issuance, recovery, reissue, revision, invalidation, acquisition and destruction of documents must be filed.

4. Contract review

Matters needing attention: establish procedure documents; Scope and content of contract review (personnel, machinery, materials, methods, environment, quantity traceability, quality control, etc.). ); Subcontracting, deviation and contract modification must form records and documents, and notify relevant personnel.

5. Subcontracting

Matters needing attention: reasons for subcontracting; Customer consent; Investigation and evaluation of subcontractor's ability; Subcontractor registration and other records and documents.

6. Procurement of services and supplies

Precautions: supplies (equipment, reagents, consumables); Services (calibration and verification, maintenance, waste liquid and solid waste recovery), whether there is an acceptance work instruction; Purchase application, acceptance (specification, model, appearance, quantity, blank test) and warehousing registration; Records and documents such as qualified supplier evaluation and qualified supplier list (indicate the validity period). Take an environmental protection company recycling waste liquid as an example, what materials are needed: company qualification, whether it is filed with the Environmental Protection Bureau, waste liquid handover record, waste liquid treatment receipt (sealed by the Environmental Protection Bureau) and other materials.

7. Serve customers

Note: customers can visit the laboratory without violating the confidentiality of other customers; Registration of foreigners; Customer satisfaction survey, customer feedback information and other records.

8. Complaints and statements:

Note: the complaint is about the attitude towards service; Indicates that it is aimed at the test results; Handling of complaints/statements

9. Unqualified

Matters needing attention: identification of nonconformities; Classification of unqualified products; Unqualified sources of information; Non-conformance judgment and record, rectification and corrective measures

10. Improvement

Attention: improvement in management, quality and technology.

1 1. Corrective measures 12 Precautionary wording

Matters needing attention: the difference between improvement, correction, corrective measures and preventive measures; Tracking verification

13. Record control:

Matters needing attention: classification of records (quality records and technical records); Format and filling requirements of records; Number of the record; Modification of records; Collection, archiving, access, storage conditions, storage period and final destruction shall be recorded and archived. For the backup of electronic files, the computer has set a password to prevent it from being modified.

14. Internal audit:

Matters needing attention: training, appointment and authorization of internal auditors; Internal audit plan, internal audit implementation plan, audit scope and internal audit report (most important);

15. Management Review

Matters needing attention: management review content; Management review plan; Review cycle; Input and output of management review; Management review report (highest priority)

Internal audit and management review are not easy to write, but they are extremely important, mainly reflected in the internal audit report and management report, and can be exchanged in the future.

16. General:

17. Personnel Department

Matters needing attention: personnel contract, technical personnel file (qualification to prove ability), employment certificate (equipment and testing items), and personnel authorization (sampler, inspector, equipment operator, self-proofreader, authorized signatory, translator, etc.). ); Training plan, personnel training, training effect evaluation and confirmation records; Quality supervision records of new employees and interns;

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Matters needing attention: determine the places and facilities that need to control environmental conditions; Operating instructions (SOP) related to facilities and environment; Effective isolation of incompatible activities; Do a good job in laboratory housekeeping and safety management (water and electricity, health, medicine, fire protection, prevention

Thieves, etc. ); Records of environmental factors to be controlled (temperature and humidity, uninterruptible power supply, lighting, dust, electromagnetism, vibration, etc.). ) and environmental monitoring conditions. Especially instrument room, standard sample room, balance room, sample room, refrigerator, etc. , is the key inspection place.

Pay special attention to the environmental protection of CMA: whether waste liquid is collected separately, solid waste treatment, waste gas treatment and three wastes treatment procedures.

19. detection method and method confirmation

Matters needing attention: establish the operating procedures (SOP) of detection methods; Select appropriate detection methods (national standard, ISO, line standard, landmark, enterprise standard, non-standard); Methods Confirm the record (most important), whether the current method is effective, the method is updated every six months, and the deviation of the method (people, machines, materials, methods, environment, quantity traceability, quality control, etc.). ); Uncertain evaluation report (highest priority); Data control (effective digits, reserved digits, data modification rules), test computer management (password setting, software verification, no internet access, regular backup of electronic data).

20. Equipment management

Precautions: Reasonable configuration of testing equipment; Equipment operation instruction; Equipment maintenance plan; Equipment calibration, equipment calibration confirmation, equipment operator training and authorization records; "Three-color identification" of equipment; Equipment master table, equipment purchase application, contract, acceptance, equipment file card, equipment use record, maintenance record, maintenance record and shutdown record; Use calibration correction factors to guide the verification work; Relevant information is easy to read.

2 1. Traceability of value

Matters needing attention: the scope of traceability of values-equipment, reference materials and reference materials; Calibration plan (scope, calibration parameters), calibration confirmation (whether the parameters can meet the accuracy of the test requirements), calibration qualified supplier evaluation (qualification, project and validity period of the measuring institution), and value traceability transfer diagram; The numbering rules, purchase, acceptance, warehousing and use registration records of reference materials; Standard solution preparation record; Check the work instructions (equipment, standard materials) during the period; During the verification plan, during the verification record; Preservation of reference materials (record of environmental conditions); If it cannot be traced back to the national standard, it is necessary to provide laboratory comparison and ability verification results;

22. Sampling:

Matters needing attention: training, assessment, authorization and certification of sampling personnel; Sampling operation instruction; Sampling work plan; Field records of sampling; Site quality control; Sampling safety measures

23. Handling of test and standard items (samples)

Matters needing attention: records of sample receiving, numbering, registration, warehousing, storage, distribution and disposal; Records of sample storage conditions; Identification, retention and deviation of samples

Chemical reagents: application, acceptance (grade, quantity, specification, appearance, reagent blank experiment), warehousing, registration records of recipients, etc.

24. Quality assurance of test results

Matters needing attention: quality control means (reference material, laboratory comparison, capability verification,; Sample reinspection, method comparison, personnel comparison, correlation of different characteristics of samples, parallel samples, standard recovery, coded samples); Evaluation of laboratory comparison and capability verification results; Prepare quality control report

Quality supervision-the qualification, authorization and supervision scope of personnel, especially the supervision of new personnel and personnel under training.

25. Results report

Matters needing attention: the format and content of the test report; Unique number; Comments and explanations; A statement that only samples are responsible; Signature of authorized signatory; Revision of the report.

Matters needing attention in external audit

On the day before receiving the review notice, everyone was waiting for the arrival of the blind sample that night. Because of the blind sample evaluation, Luo Gong and Liang Gong contacted the review team leader to determine the project of field experiment. Everyone else is waiting in the lab. When they get the samples at night, they will start to be blind. Business people will fill in the power of attorney, and other people will help find the standard, so they can't be idle.

Judging from the on-site assessment items, generally 10% does routine experiments, 10% does sample retest, and 10% does on-site demonstration, standard recovery and blind sample assessment (because 30% is required to do on-site experiments).

After the project is determined, all the samples should be found out and the sample entrustment form should be filled in. Those that don't need live demonstrations and label recycling are all done at night.

At 8 am, the first meeting will be held. The content of the meeting is very simple, mainly to introduce the summary of some experts and our company, as well as the work arrangement of the review team for two days. In half an hour, we will return to our respective laboratories and wait for the battle. After the first meeting, the software team looked at the materials and the hardware team looked at the scene.

The evaluation experts called the teacher up and said to take out all the materials you want to evaluate (the so-called materials are five items of people and physical environment). He said to print out the list of items to be evaluated this time and the list of field experiments sent to you last night for him to confirm.

Chapter 2: Review.

First, why do you want to measure certification?

According to the provisions of the Metrology Law, all laboratories that issue certification data to the society must be certified by metrology.

Second, what is the basis of measurement certification?

People's Republic of China (PRC) and the national metrology law, standardization law, product quality law and laboratory qualification accreditation criteria.

3. What is the quality policy of your laboratory?

Objective and fair, accurate results, scientific and standardized, continuous improvement

What is the quality goal of the laboratory?

The qualified rate of report delivery 100%, and the timely rate of report ≥98%. The effective version rate of technical standards and specifications is 100%, the customer complaint rate is ≤ 1%, the complaint and complaint handling rate is 100%, the customer satisfaction rate is over 98%, the employee training rate is 100%, and the examination pass rate is ≥98%.

5. What is the laboratory quality system document?

It is divided into four levels: quality manual, procedure document, work instruction and record form. How to supervise the quality of intransitive verbs laboratory (what is the key to quality supervision). First, we appointed a quality supervisor, then determined the key and error-prone testing links according to our company's testing projects, made a monitoring plan, and then supervised according to the monitoring plan. When non-conformance is found during monitoring, a Non-conformance Report shall be issued.

7. What is the basis of laboratory internal audit?

Laboratory qualification accreditation criteria, quality system documents, testing standards and related testing laws and regulations.

Eight, how to conduct internal audit laboratory (or internal audit process)

First, make an internal audit plan. According to the plan, set up an internal audit team, determine the internal audit team leader, and issue an internal audit notice before the internal audit. Then the internal audit team prepares the internal audit list. During internal audit, the first internal audit meeting should be held, and then the internal audit checklist should be implemented in all departments. The Internal Audit Checklist shall be truthfully filled in during the audit, and the non-conformance report shall be issued when any nonconformities are found. After all departments and posts are audited, the last internal audit meeting will be held, and the internal audit team will give feedback on the internal audit. After the last meeting, the internal audit team leader shall prepare the internal audit report and organize the rectification and verification of nonconformities.

Nine, the difference between internal audit and supervision (or the difference between internal auditors and supervisors)

1. Internal audit focuses on management and supervision focuses on detection technology.

2. Internal audit is to check whether the operation of the laboratory system conforms to the evaluation criteria and system documents. And supervision is to judge whether the inspection and operation procedures of personnel meet the standards.

3. Internal audit is generally regular, while supervision is daily and can be carried out at any time.

4. The internal auditor should be trained and obtain the internal auditor certificate, and be familiar with the operation of the management system; The supervisor is appointed by the laboratory, so he must be familiar with the test methods, procedures and purposes, and know how to evaluate the test results.

5. The internal auditor can't audit the department, but the supervisor can only supervise the department.

X. What are the contents of management review input?

1. Results of recent internal audit

2. Personnel training and assessment;

3, personnel, equipment, facilities and other resource allocation;

4. Complaints and complaints from customers

5. Quality control report;

6. Comparison and capability verification;

7. Review by external agencies

8, supervisor supervision report;

9. Changes in workload and type of work;

10. Suitability of laboratory policy.

XI。 The difference between internal audit and management audit

1, with different purposes.

The purpose of internal audit is to verify whether the operation of management system conforms to standards and system documents, find out nonconformities and take corrective measures.

Positive measures. The purpose of management review is to evaluate whether the quality management system is suitable for our company and make necessary changes and improvements.

2. Different participants

The internal audit is audited by the internal audit team, and the management audit is attended by the main management personnel of the laboratory.

3. Different organizers

The internal audit shall be presided over by the internal audit team leader. The management review shall be presided over by the top management.

4. Different methods

From internal audit to on-site audit, the main methods are watching, sampling and asking questions, while management audit is discussed and studied in the form of meetings, and finally a resolution is formed.

Thirteen, how to self-calibration in the laboratory?

First of all, we should formulate self-calibration methods and draw the traceability map of self-calibration values. Then according to the self-calibration method, self-calibration equipment, consumables, etc. Configured, equipment verified and personnel trained in self-calibration. Make a good record of self-calibration in the process of self-calibration. 14. What is temporary verification? Intermediate verification refers to the verification of the technical indicators of the equipment in the middle of the two verifications of the equipment to confirm that the equipment meets the requirements.

15. Why do you want to check during the period?

Timely prevent and find unqualified instruments, avoid misuse, ensure the continuous accuracy and effectiveness of test results, and reduce the deviation caused by the change of instrument stability.

16. What are the verification methods?

1, verification of standard substance 2, comparison between instruments 3, verification with reference standard 4, verification with the tested sample with relatively stable performance as verification standard.

17. Why should the laboratory carry out quality control?

In order to find the systematic deviation of the test results in time and ensure the accuracy and scientificity of the test process and results. Eighteen, what are the methods of quality control?

1, using standard materials for quality control, such as using cement standard samples regularly for control.

2. The samples should be reinspected, and the samples with stable performance should be reinspected regularly.

3. Repeat the detection of the same sample with the same or different methods.

4. Participate in the comparison or capability verification organized by the Management Department.

5. Compared with other laboratories.

6. Internal personnel comparison

7. Analyze the correlation of different parameters of the sample.

1. How did the authorized signatory (or the concept of authorized signatory) come into being?

Laboratory authorization, application, review by the evaluation team and approval by the issuing agency (the person who approves the issuance of the test report shall be legally responsible for the test report).

Second, the role of the authorized signatory.

It is the last stage of the report, and it is approved to issue the test report and bear legal responsibility for the test report.

Three, how to authorize the signatory to review the report (or what to read when signing the report? )

When issuing the test report, the authorized signatory shall review the format, information content, test content, data and conclusions, legal measurement units, basic standards and the use of CMA. It is not necessary and impossible for the authorized signatory to recheck the data of each test report, but if the data is in doubt and the value is at the boundary value, it is necessary to recheck or conduct spot checks. Attention should be paid to possible suspicious values, miscalculated values and abnormal values that do not conform to statistical laws in the report.

Fourth, the technical director's responsibilities

1. Confirmation of certification test methods and approval of work instructions

2, responsible for personnel training and assessment.

3, responsible for the review of new projects.

4. Be responsible for the review of special and major contracts.

5, responsible for laboratory quality control

6, responsible for the audit of purchasing plan.

5. What is the procedure for forming your company's report?

After the inspection, the inspector will hand over the original records to the business office, and the business office will prepare the inspection report according to the original records. After the report is completed, the input personnel and proofreaders check and sign it, and then submit it to the inspectors for preliminary examination and signature (that is, preliminary examination). After the first trial, the director of the supervision office will review and sign (i.e. the second trial), and after the review, the authorized signatory will sign the final trial (i.e. the third trial), and the authorized signatory will sign and seal it.

6. As the person in charge of quality (technology), what did you mainly do when preparing for metrology certification?

As the person in charge of quality, I mainly assist the top management to establish the quality system and ensure the effective operation of the management system. To this end, I have mainly done the following work: First, organize the preparation of the company's version A quality system documents, and review the quality manual and program documents. The second is to organize the publicity of system documents and evaluation criteria, and assist the technical director to evaluate and evaluate the training effect. The third is to organize the first internal audit of our company, the fourth is to organize daily supervision, and the fifth is to participate in laboratory quality control.

As the technical person in charge, I have mainly done the following work: First, I have assisted the quality person in compiling quality system documents and approving work instructions; Secondly, I organized the company's personnel training, especially the technical training on testing standards and equipment operation, and presided over the assessment and evaluation of personnel. The third is to organize the evaluation of all new projects in our company, and the fourth is to organize the quality control of test results and the comparison between laboratories.

What do you think is the core of the operation quality system?

I think the core of the operation quality system is full participation, which can find the defects of the system operation in time and take corrective and preventive measures, and has a self-improvement mechanism.

Chapter III: Metrological Certification and Evaluation

Metrological certification and review

I. Terminology and definitions

1. 1 CMA

The English abbreviation of "China Metrology Certification" stands for Metrology Certification, which refers to the system in which the quality and technical supervision departments at or above the provincial level make compulsory evaluation on the metrological verification of laboratories providing notarized data to the society, the working performance of testing equipment, the working environment and the operating skills of personnel, the measures to ensure uniform and accurate values, and the ability of the management system to detect fair and reliable data.

1.2 card

The abbreviation of "China Accredited Laboratory" stands for approval (acceptance), which refers to the compulsory means by which the quality and technical supervision department at or above the provincial level establishes the laboratory according to law or the government authorizes it, defines the task scope, evaluates the testing ability and finally authorizes it (acceptance).

1.3 management system

Establish policies and objectives and the system for achieving these objectives (GB/T 19000-2008). In ISO/IEC 17025:2005, it refers to the quality, management and technical system for controlling the operation of laboratories.

Note: The qualification certification mentioned below refers to the integration of measurement certification and approval (acceptance), and the laboratory is equivalent to the product quality inspection institution, and testing, inspection and testing are equivalent.

Second, the origin and development of measurement certification/approval (acceptance)

Three. Development trend of metrological certification/examination and approval (acceptance)

Four. Evolution and development of relevant management institutions

Five, the implementation of measurement certification/approval (acceptance) procedures.

5. 1 Work Procedure Diagram

5.2 Description

5.2. 1 application materials