PERKEMBANGAN ISO/IEC 17025 : 2017

Summary

This video discusses ISO 17025:2017, an international standard for laboratory competence, detailing its updates and key features. The video introduces ISO and IEC 17025, explaining how these standards set requirements for laboratories in terms of management and technical aspects. The 2017 revision emphasizes risk-based thinking, flexibility, and clear definitions for laboratories. It also covers key components such as laboratory scope, normative references, management and technical requirements, and how these updates improve laboratory competency, data consistency, and accreditation processes. Overall, the video provides essential insights into the significance and impact of the updated ISO 17025 standards.

Takeaways

• 😀 ISO 17025 is an international standard for testing and calibration laboratories, defining the general requirements for their competence.
• 😀 The standard is issued by two main organizations: ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission).
• 😀 ISO 17025 ensures that laboratories are competent, reliable, and provide consistent results in testing and calibration.
• 😀 The 2017 version of ISO 17025 introduced a risk-based thinking approach, emphasizing preventive actions as part of the routine risk management process.
• 😀 ISO 17025:2017 offers greater flexibility compared to previous editions, particularly in terms of procedural documentation and organizational responsibilities.
• 😀 The 2017 version also includes a new definition for 'laboratory,' providing clarity in terms of scope and application.
• 😀 The standard is divided into five main sections: laboratory scope, normative references, terms and definitions, management requirements, and technical requirements.
• 😀 Laboratories must comply with various management requirements, such as quality system operations, subcontracting control, and document management.
• 😀 Technical requirements address staff competence, measurement traceability, test methods, equipment, and sample handling.
• 😀 ISO 17025 ensures that all laboratories, regardless of size, maintain consistency and competence in their operations, offering formal recognition of their competency.
• 😀 The standard is intended to enhance laboratory reputation and data consistency, ultimately boosting confidence in the results provided by accredited labs.

Q & A

What is ISO 17025?

ISO 17025 is an international standard that specifies the general requirements for the competence of testing and calibration laboratories. It was developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

Who are the organizations behind ISO 17025?

ISO (International Organization for Standardization) is the world’s largest developer of international standards, and IEC (International Electrotechnical Commission) is responsible for preparing and issuing international standards for electrical and electronic technologies.

What are the main components of ISO 17025?

ISO 17025 consists of 15 management requirements and 10 technical requirements that laboratories must meet to demonstrate their competence in testing and calibration.

What changes were introduced in ISO 17025:2017 compared to earlier versions?

The key changes in ISO 17025:2017 include a risk-based thinking approach, greater flexibility in documentation and procedural requirements, and clearer definitions for laboratory operations and responsibilities.

What does 'risk-based thinking' mean in ISO 17025:2017?

'Risk-based thinking' involves identifying potential risks and opportunities within laboratory operations and making proactive adjustments to mitigate these risks. This approach helps laboratories not only prevent negative outcomes but also capitalize on positive opportunities.

How has the flexibility in ISO 17025:2017 improved laboratory operations?

The flexibility in ISO 17025:2017 allows laboratories more leeway in how they document processes, manage procedures, and define responsibilities. This allows laboratories to better adapt to their specific needs while maintaining high standards.

What is the significance of the definition of a 'laboratory' in ISO 17025:2017?

ISO 17025:2017 includes a clearer and more comprehensive definition of a 'laboratory' to ensure that the standard applies consistently across all types of laboratories, regardless of size, personnel, or accreditation.

What are the main sections covered under ISO 17025?

ISO 17025 covers five main areas: scope of the laboratory, normative references, definitions, management requirements for the laboratory environment, and technical requirements for laboratory operations.

What are the key management requirements under ISO 17025?

The management requirements include aspects such as organizational structure, subcontracting, control of non-conformities, documentation management, internal audits, and corrective actions.

What are the technical requirements for laboratories in ISO 17025?

The technical requirements focus on factors such as competency of laboratory personnel, equipment calibration and traceability, method validation, sample handling, and measurement traceability to international or national standards.