The laboratory shall establish, implement and maintain a “Management System” appropriate to the scope of its activities.
The management system’s policies , programs , procedures and instructions ; including a quality policy statement , shall
be defined in a “ Quality Manual ”. The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued by top management.
4.2 Management system Quality and Technical Records Quality Policy and Objectives Quality Manual Management System Policies and Procedures Technical Procedures, Programs, Instructions, Test Methods, Specifications Evidences Technical documentation System Level procedures Overall summary and structure of quality system Commitments to quality Level V Level IV Level III Level II Level I
The “Quality Manual” shall include or make reference to the supporting procedures including technical procedures.
The role and responsibilities of technical management and quality manager shell be defined in the “Quality Manual”.
In the “Quality Manual” it is described that how requirements pertaining to each clause and sub-clause of the standard are meet.
4.3 Document control Regulatory documents Procedural documents Contractual documents Technical documents External document control Change control Distribution control Obsolete document control Review & approval
4.4 Review of requests, tenders and contracts Receipt of request or tender document Preparation of quotation/ proposal/contract
Review of request
Capability and recourses
Test of calibration method
Review of contract
difference with request
Terms and conditions
Any subcontracted work
Signing of contract Ok? Yes P R O C E D U R E R E C O R D S End No
4.5 Subcontracting of test and calibration Register of subcontractors Client notification & approval Laboratory responsibility Competent subcontractor
4.6 Purchasing services and supplies Laboratory Receiving verification
Supplier Review & approval Purchase order Selection and evaluation of suppliers
4.7 Services to the customer Laboratory C U S T O M E R R e q u i r e m e n t s Clarify requests Provide access C U S T O M E R S a t i s f a c t i o n Preparation, Analysis and calibration of items Surveys Review of results
4.8 Complaints Receipt of complaint Enter into complaint log Review of complaint Justified? P R O C E D U R E R E C O R D S Take immediate remedial measure Notify the customer Root cause analysis and corrective action Update the log & close out Yes No
4.9 Control of nonconforming testing and/or calibration work Control of non-conformity Notifying the customer and recalling the work Correction of nonconformity Evaluation of significance Identification of nonconforming work Records Policy and Procedure
4.10 Improvement OBJECTIVES define targets for improvement MONITORING & MEASUREMENT ANALYSIS OF DATA study the trends QUALITY REVIEWS review the achievement of objectives CORRECTIVE ACTION/ PREVENTIVE ACTION Revision
4.11/4.12 Corrective and Preventive Action Identify the problem Investigation the root causes Propose solutions Implement solution Evaluate the effectiveness of solution CORRECTIVE ACTION Action taken to eliminate the problems occurred to avoid their recurrence PREVENTIVE ACTION Action taken to eliminate the potential problems to avoid their occurrence
4.14 Internal audits P R O C E D U R E R E C O R D S Corrective Action And Follow-up Audit Execution Audit Planning Audit Reporting AUDIT CYCLE
4.15 Management review Management Review Meeting Suitability of policies/procedure Results of Internal audits Corrective/preventive actions Assessment by external bodies Results of proficiency tests Changes in volume & type of work Customer feedback/complaints Improvement suggestions Resources needs Revision of policy Revision of objectives Corrective/Preventive Action Improvement Actions INPUTS OUTPUTS
Procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items; including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer.
Identification system for proper identification of test and calibration items.
Checking at receipt of test and/or calibration item regarding any abnormality and record.
Procedures and appropriate facilities to avoid deterioration, loss or damage to the test or calibration items, during storage, handling and preparation.
5.9 Assuring the quality of test and calibration results
Established quality control procedures for monitoring
the validity of tests and calibrations performed.
Recording of data in way of trend indication.
Application of statistical techniques for data review.
Planned and reviewed monitoring which may include:
Regular use of certified reference materials and secondary reference materials.
Inter-laboratory comparisons and proficiency-testing