general requirements for the competence of testing and calibration laboratories
TRANSCRIPT
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MALAYSIAN STANDARD
GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES (FIRST EDITION)
(ISO/IEC 17025:2005; IDT)
Hadi Akbar Bin DahlanGraduate InternInstitute of Halal Research & ManagementUniversiti Sains Islam Malaysia
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1. SCOPE
2. NORMATIVE REFERENCE
3. TERMS & DEFINITIONS
4. MANAGEMENT REQUIREMENTS
5. TECHNICAL REQUIREMENTS
ISO/IEC 17025:2005
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ISO/IEC 17025:2005
2 Important Guideline:
1. MANAGEMENT REQUIREMENT
2. TECHNICAL REQUIREMENT
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1. ORGANISATION
2. MANAGEMENT SYSTEM
3. DOCUMENT CONTROL
4. REVIEW OF REQUEST, TENDERS AND CONTRACTS
5. SUBCONTRACTING OF TEST & CALIBRATIONS
6. PURCHASING SERVICE & SUPLLIES
7. SERVICE TO CUSTOMER
8. COMPLAINTS
9. CONTROL OF NON-CONFORMING TESTING AND CALIBRATING WORK
10. IMPROVEMENT
11. CORRECTIVE ACTIONS
12. PREVENTIVE ACTION
13. CONTROL OF RECORDS
14. INTERNAL AUDITS
15. MANAGEMENT REVIEWS
MANAGEMENT REQUIREMENT
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MANAGEMENT REQUIREMENT
1. ORGANIZATIONS
• The organization must have:
– Managerial Personnel
– Technical Personnel
• All personnel should have known the specified responsibility, authority and interrelationships between them.
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MANAGEMENT REQUIREMENT
2. MANAGEMENT SYSTEMS
• The organization should have a DOCUMENTED “Quality Manual” which include:
– Policies
– Systems
– Programs
– Procedures
– Instruction
To the extent of obtaining a Calibrated Result
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MANAGEMENT REQUIREMENT
3. DOCUMENT CONTROL
Establish Documents
Review and approve by authorized personnel
DocumentsChanges
Recorded, rectified and readily available for peruse
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MANAGEMENT REQUIREMENT
4. REVIEW OF REQUESTS, TENDERS & CONTRACTSCUSTOMER SUBMIT
SAMPLES (TENDERS/CONTRACTS)
ORGANIZATION ACCEPT TENDERS/CONTRACTS
Identify customer needs
Obtain desired result
Using suitable method of analysis
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MANAGEMENT REQUIREMENT
5. SUBCONTRACTING OF TEST & CALIBRATIONS
Organization Sub-Contract Subcontractor
Comply with Organization quality’s criteria
Customer
Approval in Writing
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MANAGEMENT REQUIREMENT
6. PURCHASING SERVICES & SUPPLIES
• Services & Supplies use by Organization’s must have quality that is on par with the Organization’s quality.
– Have record of Transaction documents ( purchase, receipt, invoice etc.)
– Organization have inventory control
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MANAGEMENT REQUIREMENT
7. SERVICES TO THE CUSTOMER
Include:
– Provide access to relevant area in the laboratory
– Provide preparation, packaging and dispatch of test sample to/from the customer
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MANAGEMENT REQUIREMENT
8. COMPLAINTS
Establish procedure:
Complain lodged
Records Corrective Action
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MANAGEMENT REQUIREMENT
9. CONTROL OF NON-CONFORMING TESTING / CALIBRATION WORK
Authority take action
(halt, withhold test report, etc.)
Evaluate non-conform result
significance
Corrective Action
If necessary, notify customer
Acceptable result
RepeatNot acceptable
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MANAGEMENT REQUIREMENT
10. IMPROVEMENT
Improve by means of; improving not due to a problem arising, but due to opportunity, including:
• Increasing Corrective Action efficiency
• Establish Preventative Action
• Audit result efficiency
• Management review
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MANAGEMENT REQUIREMENT
11. CORRECTIVE ACTION
Establish a policy/procedure:
Cause / Failure Analysis
Selection & Implementation of Corrective Actions
Monitoring corrective action
efficiency
Audit
DOCUMENTED
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MANAGEMENT REQUIREMENT
12. PREVENTATIVE ACTION
“Proactive” process to identify opportunities of improvement/preventing failure:
Opportunity Identified
Establish Action Plan
Implement, Monitor & Audit
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13. CONTROL OF RECORDS
MANAGEMENT REQUIREMENT
Any Documents
RECORDED
In Form of:
• Technical Reports• Quality Records• Results Reports
• Indexing• Ease of access• Storage• Maintenance
• Worksheets• Workbooks• Computing Systems
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14. INTERNAL AUDIT
Audit by qualified personnel annually.
If doubts occur, corrective action should be taken.
“Auditing is Fact Finding not Fault Finding”
MANAGEMENT REQUIREMENT
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15. MANAGEMENT REVIEW
MANAGEMENT REQUIREMENT
Organization updates; including laboratoryquality, testing activities, performance reviewetc.
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1. GENERAL
2. PERSONNEL
3. ACCOMODATION & ENVIROMENT CONDITIONS
4. TEST & CALIBRATION METHODS AND METHOD VALIDATION
5. EQUIPMENT
6. MEASURING TRACEABILITY
7. SAMPLING
8. HANDLING OF TEST & CALIBRATION ITEMS
9. ASSURING THE QUALITY OF TEST & CALIBRATION RESULTS
10. REPORTING THE RESULT
TECHNICAL REQUIREMENT
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TECHNICAL REQUIREMENT
2. PERSONNEL
• Hired personnel must be trained & Certified
• Trainee Personnel must be supervise
Have clearly define Job
Descriptions
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TECHNICAL REQUIREMENT
3. ACCOMODATION & ENVIROMENT CONDITIONS
• Lab conditions must not invalidate result / affect quality of measurement
• Effective separation between work bench; prevent cross contamination
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TECHNICAL REQUIREMENT
4. TEST & CALIBRATION METHODS AND METHODS VALIDATION
Lab Must have Working Instructions of every apparatus &
facility
Selection of Methods
Customer Preference
Lab Dev.
Non-Std.
If no preference; method depend on
Organization Judgment
Validation of Methods
All reports must be review by authorized
personnel in the organization
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TECHNICAL REQUIREMENT
5. EQUIPMENT
• All apparatus must be calibrated and operated by authorizing and trained personnel
• Defective equipment must be isolated and labelled before disposal.
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TECHNICAL REQUIREMENT
6. MEASUREMENT TRACEABILITY
CALIBRATION• Use SI unit• Calibrate
first before put into service
TESTINGValidate with:• Reference
Std.• Reference
Material
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TECHNICAL REQUIREMENT
7. SAMPLING
Establish a procedure:
Selection of Sample
Sampling plan
Sample preparation
Withdrawal of Sample
Extraction
Homogenous
Record Documented
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TECHNICAL REQUIREMENT
8. HANDLING OF TEST & CALIBRATION ITEMS
• Establish procedure for handling transportation, transaction documents, disposal of test items, sampling procedure.
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TECHNICAL REQUIREMENT
9. ASSURING THE QUALITY OF TEST & CALIBRATION RESULTS
Conduct Quality Control Assurance Program in Laboratory
Inter-Laboratory Comparison(Proficiency Testing)
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10. REPORTING THE RESULTS
TECHNICAL REQUIREMENT
Result Report
Test Report
Calibration Certificate
Detail of Sampling
Opinions & Interpretation
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How to Contact Me
• https://www.linkedin.com/pub/hadi-akbar/66/818/892
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