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 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

• hadiakbar1591@rocketmail.com

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