What is ISO/IEC 17025

What is ISO/IEC 17025

* used by laboratory to demonstrate its technical competence globally * used in confirming and recognizing the competence of laboratory by customer and regulatory authorities * In Malaysia,
- manage by Standards Malaysia (DSM) - commonly known as SAMM (Skim Akreditasi Makmal Malaysia)

Process of ISO/IEC 17025 Accreditation

* Laboratory must document a quality

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)

ISO/IEC 17025 Requirements

Two Main Sections

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

4.2 Management System

- document a quality policy - document a quality manual

Management Requirement
4.3 Document Control
- ensure documents are reviewed and authorized for use - ensure documents are kept current

4.4 Review of Requests, Tenders and Contracts

- ensure customers requirements are adequately defined, documented, and the laboratory has the capacity to do the work.

Management Requirement
4.5 Subcontracting of Tests - If out-sourced laboratory work, ensure it goes to a
competent subcontractor

4.6 Purchasing Services and Supplies

- ensure purchase of services and supplies that would affect the quality of results are fit-for-purpose

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

4.12 Preventive Action

- if potential problems are identified, prevent them from occurring

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

4.14 Internal Audits

- periodically monitor conformance to, and the effectiveness of the laboratorys management system - identify any needed improvement

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

5.3 Accommodation and Environmental Conditions

- ensure the facilities and environmental conditions under which testing is done are fit for purpose and in no way invalidate results

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.

5.6 Measurement Traceability

- ensure equipment affecting results is calibrated. - calibrations need to be traceable to SI units or to certified reference materials (or equivalent).

Technical Requirements
5.7 Sampling
- If the laboratory is responsible, ensure samples are taken, identified and preserved correctly.

5.8 Handling of Test Items

- maintain the integrity and identity of test sample while under the laboratory custody.

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.

5.10 Reporting of Results

- ensure customers received reports that provide them with results that are clear, unambiguous and objective.