In a world characterised by constant innovation and technological advances, laboratories play a crucial role in ensuring quality, accuracy and reliability in various industries. ISO 17025 is an internationally recognised standard that defines the requirements for the competence of testing and calibration laboratories. It provides a framework for the establishment and maintenance of quality management systems to ensure the accuracy and reliability of test and calibration results.
WHAT IS ISO 17025?
ISO/IEC 17025 is a standard developed by the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC). It specifies the requirements for the competence of testing and calibration laboratories and includes both technical and management-related requirements. The standard applies to all types of laboratories, regardless of their size or the scope of their activities.
WHY IS ISO 17025 IMPORTANT?
ISO 17025 plays a crucial role in ensuring the quality and reliability of test and calibration results. By complying with this standard, laboratories can:
- Gain the confidence of their customers and other stakeholders by demonstrating the accuracy and reliability of their results.
- Improve the comparability of test results between different laboratories.
- Increase the efficiency and effectiveness of their processes.
- Reduce the risks of errors and misinterpretations.
- Ensure compliance with legal and regulatory requirements.
WHAT ARE THE MAIN REQUIREMENTS OF ISO 17025?
ISO 17025 covers a wide range of requirements relating to various aspects of laboratory operations. The most important requirements include
- Management requirements: These include setting quality objectives, documenting procedures, training staff and continuously improving laboratory performance.
- Technical requirements: These include the validation of test and calibration procedures, the monitoring and control of measuring equipment, the handling of test and calibration objects and the reporting of results.
- Quality assurance measures: This includes internal audits, external assessments, interlaboratory comparisons and participation in international comparison programmes to ensure the quality and reliability of test and calibration results.
HOW IS ISO 17025 IMPLEMENTED?
The implementation of ISO 17025 requires a thorough analysis of existing laboratory practices and the development and implementation of a quality management system that meets the requirements of the standard. The steps that laboratories should follow when implementing ISO 17025 include
- Documentation and evaluation of current practices: Laboratories should review their existing procedures and processes to determine if they meet the requirements of ISO 17025.
- Development of a quality management system: Based on the requirements of the standard, laboratories should develop and implement a quality management system that covers all relevant aspects of laboratory operations.
- Staff training: Employees should be trained in the requirements of ISO 17025 and understand how to implement them in their daily work.
- Conduct internal audits and reviews: Laboratories should conduct regular internal audits to review the effectiveness of their quality management system and identify potential areas for improvement.
- External assessment and accreditation: Laboratories can undergo external assessment and accreditation to demonstrate compliance with ISO 17025 and build the confidence of their customers and other stakeholders.
- Senior management commitment: senior management should make clear the commitment to asset management and allocate resources for implementation.
- Analysis and evaluation of current practices: Organisations should review their existing asset management practices and identify where adjustments are needed to meet the requirements of ISO 55000.
- Develop an asset management system (AMS): Based on the requirements of ISO 55001, an AMS should be developed and implemented that covers all relevant aspects of asset management.
- Training and awareness raising: Employees at all levels should be informed about the importance of asset management and receive training to support the implementation of the standard.
- Monitoring and continuous improvement: Organisations should regularly monitor their asset management systems, track key performance indicators and implement continuous improvement measures to ensure that objectives are met.
ISO 55000 provides organisations with a clear and standardised method to effectively manage their assets and maximise value throughout their lifecycle. By implementing this standard, companies can strengthen their competitiveness, minimise risks and ensure long-term success. It is therefore advisable that organisations wishing to improve their asset management practices integrate the ISO 55000 guidelines into their business strategy.
PeRoBa Quality Management from Munich - Individual quality management and ISO 55000 consulting
Consulting, implementation, audits and QM tools from a single source
PeRoBa GmbH Munich is a service provider with many years of experience in quality management, especially in automotive and
mechanical engineering. We help with all important standards (ISO 9001, ISO 55000, VDA6.3, IATF 16949,...) on the way to certification or
re-certification. We also work closely with universities and research institutes. Managing Director Dr. Scherb teaches as a lecturer,
for example, at the Hamburger Fern-Hochschule, the FOM in Munich and is also a speaker at the TÜV-Süd Akademie, the Bildungswerk der
Bayerischen Wirtschaft and many other institutions.
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