17025 vs. 9001

Attribute	17025	9001
Scope	Specific to testing and calibration laboratories	Applicable to all types of organizations
Focus	Technical competence and quality of testing/calibration results	Overall quality management system
Documentation	Extensive documentation requirements for procedures and records	Documentation requirements for quality management system
Competence	Specific requirements for personnel competence and training	General requirements for competence and training
Equipment	Specific requirements for calibration and maintenance of equipment	General requirements for control of monitoring and measuring equipment

Introduction

ISO/IEC 17025 and ISO 9001 are two important international standards that organizations can implement to improve their quality management systems. While both standards focus on quality, they have different scopes and requirements. In this article, we will compare the attributes of ISO/IEC 17025 and ISO 9001 to help organizations understand the differences between the two standards.

Scope

ISO/IEC 17025 is specifically designed for testing and calibration laboratories. It provides requirements for the competence of testing and calibration laboratories, including technical competence, quality management system, and personnel. On the other hand, ISO 9001 is a generic standard that can be applied to any organization, regardless of its size or industry. It focuses on customer satisfaction, continuous improvement, and the effective implementation of a quality management system.

Focus on Processes

ISO/IEC 17025 places a strong emphasis on the processes involved in testing and calibration activities. Laboratories must establish and maintain procedures for all processes, including sampling, handling, transportation, and storage of test items. ISO 9001 also focuses on processes, but it is more general in nature. Organizations must identify and manage their key processes to ensure that products and services meet customer requirements.

Documentation Requirements

ISO/IEC 17025 has specific documentation requirements that laboratories must meet to demonstrate compliance with the standard. This includes documenting the quality manual, procedures, work instructions, records, and management reviews. ISO 9001 also has documentation requirements, but they are less prescriptive compared to ISO/IEC 17025. Organizations must document their quality policy, objectives, processes, and procedures, but the level of detail is left to the organization to determine.

Risk-Based Thinking

ISO 9001:2015 introduced the concept of risk-based thinking, which requires organizations to identify and address risks and opportunities that could affect the conformity of products and services. This proactive approach helps organizations prevent problems before they occur and improve their overall performance. ISO/IEC 17025 also requires laboratories to consider risks and opportunities in their operations, but the focus is more on technical risks related to testing and calibration activities.

Competence of Personnel

Both ISO/IEC 17025 and ISO 9001 require organizations to ensure the competence of their personnel. In ISO/IEC 17025, laboratories must have personnel who are competent to perform specific tasks, including testing, calibration, and evaluation of results. ISO 9001 also requires organizations to determine the necessary competence of personnel and provide training to ensure that employees are capable of performing their duties effectively.

Customer Focus

ISO 9001 emphasizes the importance of customer focus and meeting customer requirements. Organizations must determine and address customer needs and expectations, monitor customer satisfaction, and strive to exceed customer expectations. ISO/IEC 17025 also recognizes the importance of customer focus, but the focus is more on meeting the technical requirements of customers and providing accurate and reliable test results.

Continuous Improvement

Both ISO/IEC 17025 and ISO 9001 promote the concept of continuous improvement. Organizations must monitor, measure, analyze, and evaluate their processes to identify opportunities for improvement. They must also implement actions to address nonconformities and prevent their recurrence. Continuous improvement is a key principle of both standards and helps organizations enhance their performance and achieve their quality objectives.

Conclusion

In conclusion, ISO/IEC 17025 and ISO 9001 are two important standards that organizations can implement to improve their quality management systems. While both standards focus on quality, they have different scopes, requirements, and focuses. ISO/IEC 17025 is specifically designed for testing and calibration laboratories, while ISO 9001 is a generic standard that can be applied to any organization. By understanding the differences between the two standards, organizations can choose the one that best suits their needs and objectives.