Introduction
ISO/IEC 17025 is a company-level accreditation that ensures that all the general requirements for the competence of testing and calibration laboratories are met effectively. As per International Organization for Standardization, the ISO/IEC 17025 applies to all organizations conducting laboratory activities, regardless of the company size. ISO/IEC 17025:2017 is the current, revised standard. The standard was published with collaboration between the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
This standard covers major sections like
- Management Requirements (primarily related to the operation and effectiveness of the quality management system within the laboratory)
- Structural Requirements (primarily defines the basic organizational components of a laboratory, its range of activities, and its commitment to an effective management system)
- Resource Requirements (primarily addresses the requirement for the laboratory to have available the personnel, facilities, equipment, systems, and support services necessary to perform its laboratory activities)
- Technical Requirements (primarily related to the competence of staff and calibration of equipment)
- Any other requirements related to Quality Management like documentation, corrective actions on non-conformities, etc.
This certification allows the laboratories around the world to demonstrate that they operate competently and generate valid results, thereby promoting confidence to the clients of their work both nationally internationally.
ISO/IEC 17025 is important as it assists in the harmonization of procedures and standard methods, facilitates cooperation between laboratories and other bodies, and promotes the acceptance of results between countries. It is important for the Laboratories to pass the audits to secure ISO 17025 accreditation. Passing the audits equates to proof of an effective Quality Management System (QMS).
Applicability (Which organizations can avail ISO/IEC 17025 certification)
Any organization conducting laboratory activities/operations
Benefits of ISO/IEC 17025 Certification
- Creates a proactive risk-based business and quality culture
- Assures your Laboratories’ Creditability
- Creates a professional working environment
- Increase your customer’s confidence
- Enhance Global Business
Focus Points – ISO/IEC 17025 Implementation
- Streamlining and Standardizing the Laboratory needs and its processes
- Formulating Quality Policy and Objectives of the laboratory processes
- Setting up a system for documentation and records.
- Documentation Review and Gap Analysis
- Management information system
- Risk management for the business
- Equipment and Calibration Procedure
- Customer Service Procedure
- Test and Calibration Method Procedure
- Calibration Report and Certificate Requirements Procedure
- Performance and sustainability
ISO/IEC 17025 Implementation Process by PQSmitra
ISO/IEC 17025 certification is important and demanding across the globe. The number of certified organizations in India is very less as compared to the number of organizations certified to other standards such as ISO 9001 etc. This certification requires 100% compliance to the standard and procedures laid down by the organization. Hence system implementation as per laboratory requirements requires a very systematic approach and errorless documentation approach.
PQSmitra has helped many organizations achieving this mark of excellence. The simple and practical method of system implementation helps organizations to set up a robust and effective system.
PQSmitra offers 100% support for documentation compliance in addition to onsite guidance for effective implementation. The implementation process is described below:
- Initial visits and review of the existing system
- Gap analysis and planning for the documentation (Records and Procedures)
- Training and Handholding/ support for implementation
- Identification of product technical requirements
- Corrective and Preventive Action
- Measurement Traceability and Calibration
- Handling of Test Items
- Quality Control and Verification
- Preparation, Review, and Issue of Test Certificates and Reports Features
- Internal audit for verification of implemented system
- Management review
- Closure of non-conformities
- Certification Reward to the organization