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Overview of ISO 17025
ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories
The requirements for ISO 17025 are specific to testing and calibration laboratories only.
ISO/IEC 17025 provides testing and calibration laboratories with all the requirements that must be met to demonstrate that they operate a quality management system that is technically competent and capable of producing technically valid and reliable results.
Who Should Use ISO/IEC 17025?
Any organization that performs testing, sampling or calibration and wants reliable and valid results regardless of size or the extent of the scope of testing and calibration practices.
This includes all types of laboratories, (whether owned and operated by the government, industry, or any other organization), universities, research centres, government institutions, regulators, inspection bodies, product certification organizations, other conformity assessment bodies or, in fact, any other organization:
- Independent testing laboratories;
- Independent calibration laboratories;
- Test laboratories housed in corporate facilities as part of the functionality of the organizations; and
- Calibration laboratories housed in corporate facilities as part of the functionality of the organisations.
Why should you use ISO/IEC 17025? Or benefits of ISO/IEC 17025
Without the ISO/IEC 17025, regulatory authorities and suppliers might not accept calibration or test results from your testing or calibration lab.
Calibration and testing laboratories that comply with ISO/IEC 17025 will find international acceptance and recognition for their testing and calibration results, operate more efficiently and experience increased customer satisfaction.
The ISO/IEC 17025 standard provides calibration and testing laboratories with a significant competitive advantage as it is perceived as having a higher standard and better quality results.
By eliminating the requirement for third-party audits of individual suppliers, product retesting is avoided, saving significant time and operational capital.
ISO/IEC 17025 is a sustainable way for laboratories to demonstrate technical competence, build and earn trust among customers by developing the technical competence of laboratory staff to deliver correct and valid results:
- standardization of testing and calibration prevents duplication of procedures or waste of material;
- the standard validates test and calibration methods and ensures accurate results; and
- demonstrate your technical competence in measurement traceability and calibration to the highest standards: maintaining high-quality results and reducing measurement uncertainties and errors is critical to a testing or calibration lab’s success.
Validate your laboratory's performance, giving you an edge over your competitors and improving your international reputation.
You may face risks and lost opportunities due to non-compliance with ISO/IEC 17025 standards:
- where ISO 17025 may be a legal or contractual requirement; and
- you will potentially be eligible for more lucrative, large scale both government and private sector contracts that are only offered to laboratories with ISO/IEC 17025.
ISO/IEC 17025:2017 Requirements
Clause 4 General requirements
4.1 Impartiality
4.2 Confidentiality
Clause 5 Structural requirements
Clause 6 Resource requirements
6.1 General
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 Equipment
6.5 Metrological traceability
6.6 Externally provided products and services
Clause 7 Process requirements
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.2.1 Selection and verification of methods
7.2.2 Validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Ensuring the validity of results
7.8 Reporting of results
7.8.1 General
7.8.2 Common requirements for reports (test, calibration or sampling)
7.8.3 Specific requirements for test reports
7.8.4 Specific requirements for calibration certificates
7.8.5 Reporting sampling – specific requirements
7.8.6 Reporting statements of conformity
7.8.7 Reporting opinions and interpretations
7.8.8 Amendments to reports
7.9 Complaints
7.10 Nonconforming work
7.11 Control of data and information management
Clause 8 Management system requirements
8.1 Options
8.1.1 General
8.1.2 Option A
8.1.3 Option B
8.2 Management system documentation (Option A)
8.3 Control of management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.7 Corrective actions (Option A)
8.8 Internal audits (Option A)
8.9 Management reviews (Option A)
MLOK’s methodology and approach to making your company ISO/IEC 17025 complied for accreditation
We adopt four stages of the most practical and methodological process to help you accredited to ISO/IEC 17025.
Stage 1: Planning
Conduct Kick-Off Meeting to:
- establish implementation schedule and plan;
- appoint laboratory management system committee;
- establish an ISO/IEC 17015 laboratory management system documentation framework; and
- have a fundamental understanding of the requirements of ISO/IEC 17015.
Stage 2: Documentation
Drafting and writing documents to comply with ISO/IEC 17015 requirements:
- Laboratory Manual;
- Job Description;
- Laboratory Functional Procedures;
- Laboratory Supporting Process Procedures;
- Laboratory System Procedures; and
- Laboratory Forms, Work Instructions and others.
Stage 3: Implementation
- Guidance and advice on the implementation of the documented laboratory management system.
- To conduct ISO/IEC 17025 laboratory management system Internal Audit Training.
- To conduct an ISO/IEC 17025 laboratory management system Internal Audit.
- To conduct an ISO/IEC 17025 laboratory management system Management Review Meeting.
Stage 4: External Audit
• Adequacy Audit by the Accreditation Body.
• Rectification of Audit Findings issued by the Accreditation Body.
• Preassessment or Compliance assessment by the Accreditation Body.
• Rectification of NCRs issued by the Accreditation Body.
You will then receive your ISO/IEC 17025 certificate.
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