ISO 17025

‍ISO 17025:2017 is a quality management system (QMS) standard that is applicable only to Testing and Calibration Laboratories. It specifies the general requirements for the competence, impartiality, and consistent operation of these laboratories.

The ISO standard ISO/IEC 17025 is a specific, sector-based quality management standard intended for institutions engaged in testing and calibration.

Frequently Asked Questions (FAQs) Associated with ISO 17025

The sources confirm its role as a specialized standard within the broader ISO quality management family and detail its application in compliance and documentation within a QMS ecosystem.

1. What is the scope of ISO 17025?

ISO 17025 defines the Quality Management System applicable only to laboratories that perform testing and calibration activities. These activities are critical for quality control across various industries.

2. How is ISO 17025 used in the context of compliance activities?

Organizations that operate laboratories use ISO 17025 as their quality framework. For instance:

• Testing of Materials: Documentation for new products sometimes requires information from testing laboratories, including the laboratory's name and location, and documentation showing that the laboratory is accredited by a nationally or internationally recognized external accreditation organization. Compliance with ISO 17025 is often the mechanism by which a laboratory demonstrates this accreditation and competence.
• Medical Device Support: Laboratories are among the specialized industries for which implementation products (toolkits and training) related to ISO 17025 are provided.

3. How does ISO 17025 relate to other Quality Management Standards?

ISO 17025 is typically listed alongside other common ISO standards, demonstrating its place as a specialized system that may be implemented concurrently with broader QMS frameworks:

• Documentation: Implementation products are available for laboratories that allow them to comply with ISO 17025 alongside ISO 9001 (Quality Management) and NIS 2 (cybersecurity for critical infrastructure).
• Auditor Expertise: Professionals engaged in quality management, such as lead auditors, maintain expertise in ISO 17025, in addition to standards like ISO 9001, ISO 14001, ISO 45001, and ISO 13485.

4. What resources are available for implementing ISO 17025?

Entities that provide QMS implementation support offer specific tools tailored for laboratory environments:

• Documentation Toolkits: An ISO 17025 Documentation Toolkit provides all required policies, procedures, and forms necessary to implement ISO 17025 in a laboratory.
• Software and Knowledge Bases: The standard is often supported within software platforms that offer toolkits for various ISO and regulatory requirements.

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