ISO 17025 vs ISO 9001: Key Differences for Calibration Labs
Confused about ISO 17025 and ISO 9001 for your lab? This guide clarifies the core differences, helping you choose the right standard for accreditation and
Soft Tech Serv Team
•
ISO 17025 vs. ISO 9001: Understanding the Key Differences for Laboratories
In the world of laboratory quality management, ISO 17025 and ISO 9001 are two prominent standards. While both aim to improve quality and efficiency, they cater to different aspects of laboratory operations. Understanding the distinctions between these standards is crucial for laboratories seeking accreditation, enhancing their quality management system, and ensuring reliable results. This article will explore the key differences between ISO 17025 and ISO 9001, helping you determine which standard, or combination of standards, best suits your laboratory's needs.
For calibration laboratories, the choice between ISO 17025 and ISO 9001 is not just about compliance; it's about demonstrating competence and building trust with clients. Achieving ISO 17025 accreditation signifies that a laboratory has the technical competence and management system necessary to deliver accurate and dependable results. This assurance is vital for industries where precision and reliability are paramount. Let's delve into the specifics of each standard to understand their unique requirements and benefits for calibration laboratories.
What is ISO 9001 and Why is it Important?
ISO 9001 is an international standard that specifies requirements for a quality management system (QMS). It is designed to help organizations consistently provide products and services that meet customer and regulatory requirements. ISO 9001 focuses on all aspects of a company's operations, not just those related to testing or calibration. Achieving ISO 9001 certification demonstrates a commitment to quality and customer satisfaction. PromoCell GmbH's EXCiPACT certification builds on their existing ISO 9001:2015 certification, demonstrating this point.
Key Principles of ISO 9001
ISO 9001 is based on several quality management principles, including:
Get ISO 17025 accredited calibration for your laboratory equipment from certified professionals. Fast turnaround, competitive pricing, and exceptional service.
Customer focus: Understanding and meeting customer needs and expectations.
Leadership: Establishing a clear vision and direction for the organization.
Engagement of people: Involving employees at all levels in the quality management system.
Process approach: Managing activities as interconnected processes.
Improvement: Continuously seeking ways to improve the QMS.
Evidence-based decision making: Making decisions based on data and analysis.
Relationship management: Building and maintaining relationships with suppliers and other stakeholders.
What is ISO 17025 and Why is it Crucial for Labs?
ISO/IEC 17025 is the international standard for testing and calibration laboratories. It specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers quality management system requirements, as well as the technical requirements necessary for a laboratory to consistently deliver technically valid test results and calibrations. Unlike ISO 9001, ISO 17025 is specifically tailored to the unique needs of laboratories.
ISO/IEC 17025 is the single most important standard for calibration and testing laboratories around the world. - Soft Tech Serv Expert
Key Requirements of ISO 17025
ISO 17025 encompasses a wide range of requirements, including:
Management system requirements: Policies, procedures, and documentation to ensure consistent quality.
Resource requirements: Ensuring adequate personnel, equipment, and facilities.
Process requirements: Controlling testing and calibration processes to ensure accuracy and reliability.
Management review: Regularly reviewing the effectiveness of the management system.
Technical requirements: Method validation, measurement uncertainty, and traceability.
ISO 17025 vs ISO 9001: Core Differences
While both standards aim to improve quality, their scope and focus differ significantly.
| Requirements | Broad, applicable to any organization | Detailed, specific to laboratory operations |
| Accreditation | Certification | Accreditation |
| Technical Competence | Not explicitly addressed | Explicitly addressed and assessed |
How to Choose the Right Standard for Your Lab
The choice between ISO 17025 and ISO 9001 depends on your laboratory's specific goals and needs. If your primary goal is to demonstrate technical competence and produce reliable results, ISO 17025 is the clear choice. If you need a broader quality management system that encompasses all aspects of your organization, ISO 9001 may be more appropriate. Some laboratories choose to implement both standards to achieve comprehensive quality management and demonstrate both technical competence and customer satisfaction. Consider that ISO 9001 risk management updates have placed risk at the forefront of quality management.
Benefits of ISO 17025 Accreditation for Calibration Services
ISO 17025 accreditation offers numerous benefits for calibration laboratories, including:
Enhanced credibility: Accreditation demonstrates to customers and stakeholders that the laboratory is competent and reliable.
Improved accuracy and reliability: Implementing ISO 17025 requirements helps to ensure the accuracy and reliability of test results and calibrations. This is particularly important for ensuring the quality of medical gases. (Source 2)
Increased customer confidence: Accreditation provides customers with confidence in the laboratory's services.
International recognition: ISO 17025 is an internationally recognized standard, making it easier to gain acceptance in global markets.
Competitive advantage: Accreditation can give a laboratory a competitive advantage over non-accredited laboratories.
Better risk management: ISO 17025 promotes a culture of continuous improvement and risk management, helping laboratories to identify and mitigate potential problems. Brainstorming can be a useful risk management tool. (Source 4)
Maintaining ISO 17025 Accreditation
Maintaining ISO 17025 accreditation requires ongoing effort and commitment. Laboratories must regularly conduct internal audits, address non-conformities, and continuously improve their practices. Preparing for an ISO 17025 accreditation assessment requires careful planning and attention to detail. (Source 1) Regular internal audits are essential for identifying areas where improvements are needed and ensuring ongoing compliance with the standard.
Practical Applications and Examples
Here are some practical examples of how ISO 17025 and ISO 9001 can be applied in a laboratory setting:
●Calibration of pipettes: An ISO 17025 accredited laboratory would follow strict procedures for calibrating pipettes, including using calibrated reference standards, documenting the calibration process, and calculating measurement uncertainty. This ensures that the pipettes are dispensing accurate volumes, which is critical for many laboratory applications.
●Testing of water samples: An ISO 17025 accredited laboratory would use validated methods for testing water samples, ensuring that the results are accurate and reliable. The laboratory would also participate in proficiency testing programs to demonstrate its competence.
●Manufacturing of pharmaceutical excipients: A company manufacturing pharmaceutical excipients might implement ISO 9001 to ensure that its products meet customer and regulatory requirements. The company might also seek EXCiPACT certification to demonstrate compliance with GMP standards. (Source 5)
Conclusion
ISO 17025 and ISO 9001 are valuable standards for laboratories seeking to improve quality and efficiency. ISO 17025 is specifically designed for testing and calibration laboratories and focuses on technical competence and valid results. ISO 9001 is a broader quality management system standard that can be applied to any organization. The choice between the two standards depends on your laboratory's specific goals and needs. For calibration services, ISO 17025 accreditation is a crucial demonstration of competence and reliability.
As the field of laboratory science continues to evolve, staying abreast of the latest standards and best practices is essential for maintaining a competitive edge. By understanding the key differences between ISO 17025 and ISO 9001, laboratories can make informed decisions about which standard, or combination of standards, will best support their goals and ensure the delivery of accurate and reliable results. Contact Soft Tech Serv today to learn more about our ISO 17025 accredited calibration services.