ISO17025 Requirements
Transcript of 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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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 thework.
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Management Requirement
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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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 isinvestigated and the appropriate corrective action taken
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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
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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
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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
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Management Requirement
4.15 Managment Review- top management need to periodically review the overall
effectiveness of their management system and update
changes
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Technical Requirements
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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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
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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).
Technical Requirements
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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.
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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.