general requirements for the competence of testing and calibration laboratories
TRANSCRIPT
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
1. SCOPE
2. NORMATIVE REFERENCE
3. TERMS & DEFINITIONS
4. MANAGEMENT REQUIREMENTS
5. TECHNICAL REQUIREMENTS
ISO/IEC 17025:2005
ISO/IEC 17025:2005
2 Important Guideline:
1. MANAGEMENT REQUIREMENT
2. TECHNICAL REQUIREMENT
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
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.
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
MANAGEMENT REQUIREMENT
3. DOCUMENT CONTROL
Establish Documents
Review and approve by authorized personnel
DocumentsChanges
Recorded, rectified and readily available for peruse
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
MANAGEMENT REQUIREMENT
5. SUBCONTRACTING OF TEST & CALIBRATIONS
Organization Sub-Contract Subcontractor
Comply with Organization quality’s criteria
Customer
Approval in Writing
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
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
MANAGEMENT REQUIREMENT
8. COMPLAINTS
Establish procedure:
Complain lodged
Records Corrective Action
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
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
MANAGEMENT REQUIREMENT
11. CORRECTIVE ACTION
Establish a policy/procedure:
Cause / Failure Analysis
Selection & Implementation of Corrective Actions
Monitoring corrective action
efficiency
Audit
DOCUMENTED
MANAGEMENT REQUIREMENT
12. PREVENTATIVE ACTION
“Proactive” process to identify opportunities of improvement/preventing failure:
Opportunity Identified
Establish Action Plan
Implement, Monitor & Audit
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
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
15. MANAGEMENT REVIEW
MANAGEMENT REQUIREMENT
Organization updates; including laboratoryquality, testing activities, performance reviewetc.
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
TECHNICAL REQUIREMENT
2. PERSONNEL
• Hired personnel must be trained & Certified
• Trainee Personnel must be supervise
Have clearly define Job
Descriptions
TECHNICAL REQUIREMENT
3. ACCOMODATION & ENVIROMENT CONDITIONS
• Lab conditions must not invalidate result / affect quality of measurement
• Effective separation between work bench; prevent cross contamination
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
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.
TECHNICAL REQUIREMENT
6. MEASUREMENT TRACEABILITY
CALIBRATION• Use SI unit• Calibrate
first before put into service
TESTINGValidate with:• Reference
Std.• Reference
Material
TECHNICAL REQUIREMENT
7. SAMPLING
Establish a procedure:
Selection of Sample
Sampling plan
Sample preparation
Withdrawal of Sample
Extraction
Homogenous
Record Documented
TECHNICAL REQUIREMENT
8. HANDLING OF TEST & CALIBRATION ITEMS
• Establish procedure for handling transportation, transaction documents, disposal of test items, sampling procedure.
TECHNICAL REQUIREMENT
9. ASSURING THE QUALITY OF TEST & CALIBRATION RESULTS
Conduct Quality Control Assurance Program in Laboratory
Inter-Laboratory Comparison(Proficiency Testing)
10. REPORTING THE RESULTS
TECHNICAL REQUIREMENT
Result Report
Test Report
Calibration Certificate
Detail of Sampling
Opinions & Interpretation
How to Contact Me
• https://www.linkedin.com/pub/hadi-akbar/66/818/892
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