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management system
- Quality Manual - Quality management procedures
* Implement the quality management system * Implementation require several months to establish the records * Undergo ISO/IEC 17025 assessment by DSM
Submission of Application
- Application form - Quality Manual - SOPs - Test Methods - CV for key personnel - Copy of ROC - Organization chart
Assessment
Adequacy Audit
- A review of laboratorys quality manual and associated documents
Pre-assessment
- preliminary assessment of the laboratorys quality management system and operation to determine its readiness for the compliance assessment
Compliance
- assessment to establish whether the laboratory can competently perform the test for which it seeks accreditation
Accreditation
Granting of accreditation upon satisfactory discharge of all non-compliances raised during the assessment. SAMM certificate of Accreditation and Schedules of Accredited tests will be issued to laboratory The Certificate of Accreditation is valid for 3 years (Renewal every 3 years)
Management Requirements
- relates to the operation and effectiveness of the quality management system within a laboratory
Technical Requirements
- address competence of staff, methodology and test
Management Requirement
4.1 Organization
- policies and involvement in activities to protect the laboratorys integrity
- personnel are aware of their roles and how they contribute to the achievement of the objectives
Management Requirement
4.3 Document Control
- ensure documents are reviewed and authorized for use - ensure documents are kept current
Management Requirement
4.5 Subcontracting of Tests - If out-sourced laboratory work, ensure it goes to a
competent subcontractor
Management Requirement
4.7 Service to the Customer
- If required, allow customers to witness their tests while protecting confidentiality to other customers - to seek and analyzed customer feedback for continual improvement
4.8 Complaints
- any negative feedback from outside laboratory is investigated and the appropriate corrective action taken
Management Requirement
4.9 Control of Non-conforming Testing Work
- when non-conformity is made, fix the problem and consider any consequences of it.
4.10 Improvement
- ensure the effectiveness of management system a continuous improvement process
Management Requirement
4.11 Corrective Action
- if any problem could impart on results and could recur, identify the root cause of the problem and prevent it from happening again
Management Requirement
4.13 Control of Records
- ensure all needed records are legibly maintained for relevant durations - ensure technical records establish a complete audit trail
Management Requirement
4.15 Managment Review
- top management need to periodically review the overall effectiveness of their management system and update changes
Technical Requirements
5.2 Personnel
- staff performing tasks need to be competent and records of the authorization and competence confirmed to be made available
Technical Requirements
5.4 Test Methods and Method Validations
- select appropriate methods to meet customers requirement - ensure methods give valid results - Method validation encompasses: Selectivity, Linearity, Limit of detection, Precision, Reproducibility, Accuracy, Robustness, Ruggedness
Technical Requirements
5.5 Equipment
- ensure all necessary equipment is fit for use, maintain that way, and staff are aware of its operation status.
Technical Requirements
5.7 Sampling
- If the laboratory is responsible, ensure samples are taken, identified and preserved correctly.
Technical Requirements
5.9 Assuring the Quality of Test Results
- make use of appropriate internal QC and external proficiency programs, monitor the validity of the laboratorys results.