In most major countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
The ISO/IEC 17025 standard itself comprises five elements:
- Scope – The scope of accreditation of a calibration laboratory is the official and detailed statement of the activities for which the laboratory is accredited. The formulation and assessment of the scope of accreditation represents the core of the accreditation process.
- Normative References – Indispensable conditions/elements used as reference for the application and implementation of ISO/IEC 17025 in the organization.
- A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.
- Terms and Definitions – the real meaning and intent of keywords and phrases in the standard.
- Management Requirements – primarily related to the operation and effectiveness of the quality management system within the laboratory.
- Technical Requirements – factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.
Why we need to do so?
Laboratories use ISO/IEC 17025 to implement a quality system aimed at:
- Improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
- High ability of meeting specific requirements for competence, and applies directly to those organizations that produce testing and calibration results.
- Acceptance by supplier and authorities with accredited testing, inspection and certification carried out in compliance with best practices can limit product failure and down time, and control manufacturing costs.
Stage 1 - Gap Analysis
Review the existing client current practice against ISO/IEC 17025 Requirements.
Stage 2 - Design and Development
Provide ISO/IEC 17025 Introduction and Requirements Training
Plan and development the documents that fully comply with ISO/IEC 17025 requirements
Provide Measurement uncertainty and calibration and ISO/IEC 17025 Internal Auditor Training
Stage 4 - Review Supports
Perform pre-compliance audit and corrective action advice.
Stage 5 - Close Out
Assure the Client obtain the ISO/IEC 17025 certificate and reply to Standards Malaysia audit report.