What is ISO/IEC 17025:2017 TESTING AND CALIBRATION LABORATORIES?

Summary

This session from TNV Academy provides an in-depth overview of ISO/IEC 17025:2017, the international standard for laboratory competence. The video covers the importance of accreditation for testing and calibration laboratories, the process of obtaining ISO 17025 certification, and the benefits for organizations. Key topics include the structure of the standard, the steps to becoming accredited, and available training and certifications. The session emphasizes the importance of quality management, risk-based thinking, and continual improvement in laboratory operations, helping organizations ensure their results are valid and reliable across various industries.

Takeaways

• 😀 ISO/IEC 17025:2017 is the international standard for the competence of testing and calibration laboratories.
• 😀 The standard emphasizes the importance of competence, impartiality, and consistency in laboratory operations to ensure valid and reliable results.
• 😀 Accreditation to ISO/IEC 17025 demonstrates that a laboratory can produce valid results, with personnel competent in their roles.
• 😀 Laboratories need to meet both management and technical requirements, including activities to ensure scientific validity and technical competence.
• 😀 The 2017 revision of ISO/IEC 17025 included changes like scope, resource, process, and management system requirements.
• 😀 ISO/IEC 17025 accreditation is beneficial for increasing customer confidence, ensuring the use of current technologies, and creating a risk-based quality culture.
• 😀 The steps to becoming ISO/IEC 17025 accredited involve obtaining the standard, training personnel, performing gap analysis, documenting activities, and completing internal audits.
• 😀 The application process for accreditation includes meeting the accreditation body’s requirements, documenting processes, and having a third-party audit.
• 😀 ISO/IEC 17025 training and certification options are available for personnel, including lead auditor courses and method validation training.
• 😀 Accreditation according to ISO/IEC 17025 is recognized internationally, and it helps laboratories provide results that are accepted across countries and industries.
• 😀 Laboratories must plan actions to address risk, define quality objectives, and ensure continuous improvement to maintain accreditation and competence.

Q & A

What is ISO/IEC 17025:2017?

ISO/IEC 17025:2017 is an international standard that sets out the general requirements for the competence, impartiality, and consistent operation of laboratories. It ensures laboratories can produce valid and reliable test and calibration results.

What are the key differences between ISO/IEC 17025:1999 and ISO/IEC 17025:2005?

The key differences between ISO/IEC 17025:1999 and ISO/IEC 17025:2005 include an increased focus on senior management responsibilities, continual improvement of the management system, improved communication with customers, and a closer alignment with the 2000 version of ISO 9001.

What are the main elements of ISO/IEC 17025:2017?

ISO/IEC 17025:2017 consists of management requirements, technical requirements, and process requirements. These address the organization, resources, process validation, and the management system needed for laboratories to produce reliable results.

Why is accreditation to ISO/IEC 17025 important for a laboratory?

Accreditation to ISO/IEC 17025 demonstrates that a laboratory is competent to perform testing and calibration with consistently valid results. It also boosts customer confidence, supports regulatory compliance, and enhances the laboratory's reputation.

What is the accreditation process for ISO/IEC 17025?

The accreditation process involves obtaining a copy of the standard, training staff, defining the laboratory's activities, performing a gap analysis, documenting processes, and then applying to an accreditation body. After a review and audit, accreditation is granted.

What is the purpose of performing a gap analysis during the accreditation process?

The purpose of the gap analysis is to identify any discrepancies between the laboratory's current practices and the requirements of ISO/IEC 17025. This helps in determining what improvements need to be made to meet the standard.

What are the benefits of ISO/IEC 17025 accreditation?

The benefits of ISO/IEC 17025 accreditation include increased customer confidence, a proactive risk-based approach to operations, improved quality management, international recognition, and a sense of professionalism and pride within the organization.

What is the role of management in ISO/IEC 17025 accreditation?

Management plays a crucial role in ISO/IEC 17025 accreditation by ensuring the laboratory has the necessary resources, maintaining a culture of continual improvement, and overseeing the implementation of quality objectives and risk management processes.

What types of training are necessary for laboratory personnel under ISO/IEC 17025?

Laboratory personnel should undergo training on the ISO/IEC 17025 standard, risk-based thinking, process approach, internal auditing, and specific technical training such as method validation and measurement uncertainty evaluation.

How does ISO/IEC 17025 help with international cooperation?

ISO/IEC 17025 helps with international cooperation by harmonizing testing and calibration procedures across countries, ensuring results are recognized and accepted globally, thus fostering greater trust and facilitating cross-border business and regulatory activities.