General requirements for the competence of testing and calibration laboratories

MALAYSIAN STANDARD
GENERAL REQUIREMENTS FOR THE
COMPETENCE OF TESTING AND CALIBRATION
LABORATORIES (FIRST EDITION)
(ISO/IEC 17025:2005; IDT)
Hadi Akbar Bin Dahlan
Graduate Intern
Institute of Halal Research & Management
Universiti 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

1. ORGANIZATIONS
• The organization must have:
– Managerial Personnel
– Technical Personnel
• All personnel should have known the specified
responsibility, authority and interrelationships
between them.

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

3. DOCUMENT CONTROL
Establish
Documents
Review and
approve by
authorized
personnel
Documents
Changes
Recorded, rectified and
readily available for peruse

4. REVIEW OF REQUESTS, TENDERS & CONTRACTS
CUSTOMER SUBMIT
SAMPLES
(TENDERS/CONTRACTS)
ORGANIZATION ACCEPT
TENDERS/CONTRACTS
Identify
customer needs
Obtain desired
result
Using suitable
method of analysis

5. SUBCONTRACTING OF TEST & CALIBRATIONS
Organization Sub-Contract Subcontractor
Comply with Organization
quality’s criteria
Customer
Approval in
Writing

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

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

8. COMPLAINTS
Establish procedure:
Complain
lodged
Records Corrective
Action

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

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

11. CORRECTIVE ACTION
Establish a policy/procedure:
Cause / Failure
Analysis
Selection &
Implementation of
Corrective Actions
Monitoring
corrective action
efficiency
Audit
DOCUMENTED

12. PREVENTATIVE ACTION
“Proactive” process to identify opportunities of
improvement/preventing failure:
Opportunity
Identified
Establish
Action Plan
Implement,
Monitor & Audit

13. CONTROL OF RECORDS
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”

15. MANAGEMENT REVIEW
Organization updates; including laboratory
quality, testing activities, performance review
etc.

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

2. PERSONNEL
• Hired personnel must be
trained & Certified
• Trainee Personnel must be
supervise
Have clearly
define Job
Descriptions

3. ACCOMODATION & ENVIROMENT CONDITIONS
• Lab conditions must not invalidate result /
affect quality of measurement
• Effective separation between work bench;
prevent cross contamination

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

5. EQUIPMENT
• All apparatus must be calibrated and operated
by authorizing and trained personnel
• Defective equipment must be isolated and
labelled before disposal.

6. MEASUREMENT TRACEABILITY
CALIBRATION
• Use SI unit
• Calibrate
first before
put into
service
TESTING
Validate with:
• Reference
Std.
• Reference
Material

7. SAMPLING
Establish a procedure:
Selection of
Sample
Sampling plan
Sample
preparation
Withdrawal of
Sample
Extraction
Homogenous
Record Documented

8. HANDLING OF TEST & CALIBRATION ITEMS
• Establish procedure for handling
transportation, transaction documents,
disposal of test items, sampling procedure.

9. ASSURING THE QUALITY OF TEST &
CALIBRATION RESULTS
Conduct Quality Control
Assurance Program in Laboratory
Inter-Laboratory Comparison
(Proficiency Testing)

10. REPORTING THE RESULTS
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
• hadiakbar1591@rocketmail.com

General requirements for the competence of testing and calibration laboratories

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