iso17025 requirements

7/31/2019 ISO17025 Requirements

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What is ISO/IEC 17025


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What is ISO/IEC 17025

* used by laboratory to demonstrate its technicalcompetence globally

* used in confirming and recognizing thecompetence of laboratory by customer andregulatory authorities

* In Malaysia,

- manage by Standards Malaysia (DSM)

- commonly known as SAMM (Skim Akreditasi MakmalMalaysia)


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Process of ISO/IEC 17025 Accreditation

* Laboratory must document a qualitymanagement 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


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Submission of Application

- Application form

- Quality Manual

- SOPs- Test Methods

- CV for key personnel

- Copy of ROC

- Organization chart


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Assessment

Adequacy Audit

-A review of laboratorys quality manual and associated documents

Pre-assessment

- preliminary assessment of the laboratorys quality managementsystem and operation to determine its readiness for the

compliance assessment

Compliance

- assessment to establish whether the laboratory can competentlyperform the test for which it seeks accreditation


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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)


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ISO/IEC 17025 Requirements

Two Main Sections

Management Requirements

- relates to the operation and effectiveness of the qualitymanagement system within a laboratory

Technical Requirements

- address competence of staff, methodology and test


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Management Requirement

4.1 Organization- policies and involvement in activities to protect the

laboratorys integrity

- personnel are aware of their roles and how theycontribute to the achievement of the objectives

4.2 Management System

- document a quality policy- document a quality manual


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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 thework.


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4.5 Subcontracting of Tests

- If out-sourced laboratory work, ensure it goes to acompetent subcontractor

4.6 Purchasing Services and Supplies- ensure purchase of services and supplies that would

affect the quality of results are fit-for-purpose


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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 isinvestigated and the appropriate corrective action taken


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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


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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


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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


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4.15 Managment Review- top management need to periodically review the overall

effectiveness of their management system and update

changes


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5.2 Personnel

- staff performing tasks need to be competent andrecords of the authorization and competence

confirmed to be made available

5.3 Accommodation and EnvironmentalConditions

- ensure the facilities and environmentalconditions under which testing is done are fit forpurpose and in no way invalidate results


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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


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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).



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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.


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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.

iso17025 requirements

Documents