I. preparation before certification:
1. Unified thinking of the unit leadership, and clearly why the CMA/CNAS and CMA/CNAS certification leaders and certification process schedules are required.
2. Decide whether to hire a consulting company;
Assess whether CMA/CNAS certification conditions are available.
3. According to the actual situation of the unit, make clear the organizational structure, reasonable human resource allocation and personnel division of labor (technology, quality leader, authorized signer, equipment administrator, archivist, etc.)
4. Equipment calibration, ability verification and other work (special CNAS approval, must be done in advance, about 6 months)
2. CMA/CNAS certification process.
1. According to the actual situation of the unit, compile the actual quality manual, procedure document, work instruction (or SOP) and record form of the unit.
2. Run quality system and improve various records.
3. Conduct internal audit.
4. Conduct management review.
5. Submission of application
6. Perfect system
7. On-site review
8. Take corrective measures and get the certificate.
3. Problems and experiences needed to be solved in CMA/CNAS system (combining CMA/CNAS system)
1. The organization
Need to pay attention to the question: whether the independent legal person, bank accounts, tax registration, contract, social security, equipment contract, the venue contract, etc., key positions and the appointment of the file, is clear about the responsibility and the agent;
Impartiality, whether the customer confidentiality rules, whether to form a record file.
2. Management system
Attention problem: establish management system, form documents, communicate to relevant personnel, and carry out;
Quality objectives and guidelines;
The management system continues to improve effectively.
3. Document control:
Attention problem: the uniqueness and validity of the file number;
Controlled management of documents;
Document approval, release, change record;
Documents shall be issued, recovered, reissued, amended, invalidated, reviewed and destroyed.
4. Contract review
Note: establishment of program files;
Scope and content of contract review (person, machine, material, method, loop, value traceability, quality control, etc.);
Subcontracting, deviation and contract modification must form a record file and notify the relevant personnel.
5. The subcontract
Matters needing attention: subcontracting reason;
Customer agrees;
The subcontractor's capability survey and assessment;
Subcontractor registration and other records.
6. Procurement of services and supplies.
Precautions: supplies (equipment, reagents, consumables);
Service (calibration verification, maintenance, waste liquid solid waste recovery), whether there is acceptance work instruction;
Purchase requisition, acceptance (specification model, appearance, quantity, blank test), enrollment registration;
Qualified supplier evaluation, qualified supplier list (note validity) and other records.
In the environmental protection company of recycling waste liquid, for example, need what materials: company qualification, whether in the environmental protection bureau for the record system, the handover records, wastewater treatment receipts (environmental protection bureau affix one's seal), and other materials.
7. Service customers
Note: customers can enter the laboratory without violating other customer confidentiality.
Registration of aliens;
Customer satisfaction survey, customer feedback and other records.
8. Complaint:
Note: the complaint is the attitude towards the service;
Representations are the result of testing;
Complaint/complaint handling.
9. Nonconformance
Note: non-conformance identification;
Classification of nonconformance items;
Non-conformity information source;
Not conforming to the judgment and record, rectification and corrective measures.
Improvement 10.
Note: management, quality and technical improvements.
11. Corrective measures 12.
Precautions: the difference between improvement, correction, corrective action and preventive measures;
Tracking verification
13. Control of records:
Notes: classification of records (quality records and technical records);
Record format and filling requirements;
The number of records;
Revision of records;
Collecting, archiving, reviewing, storing conditions, saving time and final destruction shall be documented.
The backup of electronic files, the computer sets the password to prevent the modification.
14. Internal audit:
Matters needing attention: the training, appointment and authorization of the internal auditor;
Internal audit plan, internal audit implementation plan, audit scope, internal audit report (top priority);
15. Management review
Note: management review content;
Management review plan;
Review cycle;
Input and output of management review;
The management review report (top priority) is not very good at internal audit and management review, but it is extremely important, mainly reflected in the internal audit report and management report, which can be communicated later.
16. General rules:
17.
Note: contracts, technical personnel files (qualification, to prove competent), license (equipment, test items), authorized personnel (sampling, inspector, equipment operators, self-calibration, authorized signatory, interpreter, etc.);
Training plan, personnel training, training effect assessment and other records;
Record of new entrants and quality supervision of personnel;
18. Facilities and environmental conditions.
Matters needing attention: identify the places and facilities that need to control environmental conditions;
Work instruction (SOP) for facilities and environment;
Effective isolation of incompatible activities;
Do well in laboratory work and safety management (water and electricity, health, drama drugs, fire fighting, anti-theft, etc.);
Environmental factors that need to be controlled (temperature and humidity, UPS, lighting, dust, electromagnetic, vibration, etc.) and environmental monitoring conditions record.
Especially for the instrument room, sample room, balance room, sample room, refrigerator, etc.
For CMA special attention to environmental protection: whether waste liquid is classified, solid waste treatment, waste gas treatment, and three waste disposal procedures.
19. Test method and method confirmation.
Note: set up the operation instruction (SOP) of the test method;
Select the appropriate detection method (national standard, ISO, line standard, landmark, enterprise standard, non-standard);
Method confirmed record (top), the effective method, novelty search records (once half a year), method of deviation (man, machine, material, method, ring, quantity traceability and quality control, etc.);
An uncertain assessment report (top priority);
Data control (effective number, retention number, data modification rule), computer management (set password, software verification, strictly prohibited access to Internet, electronic data backup regularly)
20. Equipment management
Precautions: reasonable configuration of testing equipment;
Operating instructions for equipment operation;
Equipment maintenance plan;
Equipment calibration, equipment calibration confirmation, equipment operator training, authorization record;
The "tricolor identification" of the equipment;
Equipment general list, equipment purchase application, contract, acceptance, equipment file card, equipment use record, maintenance record, maintenance, deactivation record;
Calibration of the use of the correction factor, and during the period of verification work instruction;
Relevant information is easy to read.
21. Traceability of measurement values.
Matters needing attention: the range of measurement traceability -- equipment, standard material, reference material;
Calibration plan (range, calibration parameters), calibration verification (parameters) can meet the detection requirements of precision, calibration qualified supplier evaluation (metrology institute of qualification, projects, and the period of validity), figure quantity traceability transmission;
Standard material numbering rules, procurement, acceptance, warehousing, use of registration records;
Standard solution preparation record;
Checking operation instruction (equipment, standard substance) during the period;
During the period of the verification plan and the verification record;
Preservation of standard substances (environmental records);
Can not trace the source to national benchmark, need to provide laboratory comparison, ability verification results;
22. The sampling:
Matters needing attention: the training, assessment, authorization and certification of the sampling personnel;
Sampling operation instruction;
Sampling work plan;
Sampling site record;
Quality control on site;
Sampling safety measures
23. Inspection and disposal of standard items (samples).
Matters needing attention: receiving, numbering, registration, warehousing, storage, distribution and disposal records of samples;
Sample storage condition record;
Sample identification, retention sample, sample deviation.
Chemical reagent: application, acceptance (grade, quantity, specification, appearance, reagent blank experiment), warehousing, registration record, etc.
24. Quality assurance of test results.
Matters needing attention: quality control means (reference material, laboratory comparison, ability verification;
Sample retest, method comparison, correlation between the different characteristics of the sample, parallel sample, label recovery and password sample;
Evaluation of laboratory comparison and capability verification;
Write quality control report.
Quality supervision - supervision personnel's qualification, authorization, supervision scope, especially for new personnel and supervision of personnel.
25. Results report
Note: the format and content of the test report;
Unique number;
Opinions and explanations;
A statement solely responsible for the sample;
Signature of authorized signatory;
Report changes.
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