History of ISO/IEC 17025 :
ISO/IEC 17025, the international standard for laboratory testing and calibration, has a rich history spanning over three decades. Here’s a brief overview:
1980s:
- The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) recognized the need for a global standard for laboratory testing and calibration.
- By 1980, the specific standard ISO/IEC 17025 did not yet exist. Instead, the relevant standards of the time were ISO 25 and IEC 456.
- ISO 25: This standard, issued in 1983, was an early precursor to ISO/IEC 17025. It focused on general requirements for the competence of testing and calibration laboratories.
- IEC 456: This standard, released in the late 1970s, covered the competence of calibration laboratories.
- In 1986, the first edition of ISO/IEC Guide 25 was published, providing guidelines for laboratory accreditation
1990s:
- This edition introduced the concept of “competence” as a key aspect of laboratory accreditation.
- At that time, the quality management and competence requirements for testing and calibration laboratories were addressed through different standards ISO 9000 ,ISO 25 and IEC 456.
- ISO 9000: This series of standards, first published in 1987, focused on quality management systems. Laboratories were encouraged to adopt these standards to improve their quality management practices.
- ISO 25: In 1999, the second edition of ISO/IEC Guide 25 was released (published) incorporating feedback from users and accreditation bodies . It was an important precursor to ISO/IEC 17025, setting out requirements for laboratory practices and performance
- IEC 456: Published by the International Electrotechnical Commission (IEC), this standard dealt with the requirements for calibration laboratories.
- The formal ISO/IEC 17025 standard was published in 1999, combining elements from ISO 25 and IEC 456. This new standard was designed to provide a unified set of requirements for both testing and calibration laboratories, reflecting advancements in laboratory practices and aligning with the principles of quality management systems
2000s:
- ISO/IEC 17025 had been formally established. The standard was first published in 1999, representing a significant milestone in the field of laboratory accreditation. Here’s a brief overview of its history and context around that time:
- Publication: ISO/IEC 17025:1999 was published as a comprehensive standard for testing and calibration laboratories. It combined and updated requirements from earlier standards such as ISO 25 and IEC 456, creating a unified set of criteria to ensure laboratory competence and reliability.
- Purpose: The standard was designed to harmonize laboratory practices globally, emphasizing quality management, technical competence, and consistent results. It aimed to ensure that laboratories could produce valid and accurate results regardless of their location.
- Content: ISO/IEC 17025:1999 included requirements for quality management systems, technical competence, and the reliability of test and calibration results. It was structured to address both the management and technical aspects of laboratory operations.
- Adoption and Impact: The standard quickly gained acceptance worldwide as a benchmark for laboratory accreditation. It was recognized by national and international bodies and became a key tool for laboratories seeking to demonstrate their competence and obtain accreditation.
- In 2005, ISO/IEC 17025 has undergone revisions since its initial publication, with significant updates.
- This 1st edition introduced significant changes, including:
- Emphasis on risk management and uncertainty of measurement
- Clarification of laboratory management system requirements
- Introduction of a more detailed and structured approach to laboratory accreditation.
2010s
- In 2017, the third edition of ISO/IEC 17025 was published, featuring:
- Enhanced requirements for laboratory information management systems
- Increased emphasis on impartiality and conflict of interest
- Clarification of the role of the laboratory in the accreditation process
Present day:
- ISO/IEC 17025 continues to evolve, with ongoing revisions and updates to reflect advancements in technology, changes in industry needs, and feedback from users and accreditation bodies.
- The standard remains a cornerstone of laboratory accreditation, ensuring the competence and reliability of laboratory testing and calibration worldwide.
Throughout its history, ISO/IEC 17025 has played a crucial role in promoting laboratory excellence, facilitating international trade, and supporting scientific innovation.
Comparison of ISO/ISC 17025 Version 2005 & 2017
| Version 2005 | Version 2017 |
| Scope | Scope |
| Normative Reference | Normative Reference |
| Terms and Definitions | Terms and Definitions |
| Management Requirements | General Requirements |
| Technical Requirements | Structure Requirements |
| Resource Requirements | |
| Process Requirements | |
| Managements Requirements |
Changes and Updates:
- Risk Management: The 2017 version places greater emphasis on risk management and uncertainty of measurement.
- Laboratory Information Management System (LIMS): The 2017 version introduces requirements for LIMS, ensuring effective data management.
- Impartiality and Conflict of Interest: The 2017 version strengthens requirements for impartiality and conflict of interest, ensuring laboratory objectivity.
- Process Approach: The 2017 version adopts a more process-oriented approach, focusing on laboratory workflows.
- Management System: The 2017 version integrates laboratory management system requirements, aligning with ISO 9001.
- Technical Requirements: The 2017 version updates technical requirements, including calibration, testing, and sampling.
- Assessment and Validation: The 2017 version enhances assessment and validation requirements, ensuring laboratory competence.
- Reporting and Results: The 2017 version clarifies reporting and result requirements, ensuring transparency and accuracy.
Key differences:
- Structure and Format:
- 2005: Followed a format based on the ISO 9001:2000 quality management system, but it tailored specifically for laboratories.
- 2017: Adopted the High-Level Structure (HLS) aligned with other ISO standards, which includes a more standardized approach to clause organization and terminology.
- Risk-Based Thinking:
- 2005: Mentioned risk management but did not emphasize it strongly.
- 2017: Emphasizes risk-based thinking throughout the standard, requiring laboratories to identify and address risks and opportunities that could impact their operations and results.
- Management and Leadership:
- 2005: Focused more on quality management and administrative requirements.
- 2017: Places greater emphasis on leadership and management commitment, requiring top management to actively support and engage in the quality management system.
- Process Approach:
- 2005: Had some focus on processes but was less structured.
- 2017: Strongly adopts a process-based approach, requiring laboratories to manage and control their processes more explicitly.
- Documentation and Evidence:
- 2005: Required documented procedures and records but with less emphasis on the context and objectives of documentation.
- 2017: Focuses on ensuring that documentation serves the laboratory’s context and objectives, reducing the need for extensive documentation and focusing on what is necessary to demonstrate compliance.
- Impartiality and Confidentiality:
- 2005: Addressed impartiality and confidentiality in a general sense.
- 2017: Strengthens the requirements for maintaining impartiality and confidentiality, with more specific expectations for managing these aspects.
- Competence and Personnel:
- 2005: Addressed the competence of personnel but with less detail.
- 2017: Provides more detailed requirements for the competence of laboratory personnel, including specific qualifications and ongoing training.
Similarities:
- Core principles: Both versions maintain core principles of laboratory accreditation, ensuring competence and reliability.
- Technical requirements: Both versions cover essential technical requirements for laboratory testing and calibration.
The 2017 version of ISO/IEC 17025 builds upon the foundation established in the 2005 version, introducing enhancements and updates to ensure laboratories remain competent, reliable, and effective in their testing and calibration activities.
