Accredited certification evidences your organization’s achievement. ISO 13485 and 9001 are quality management standards and certified compliance gives customers assurance in the reliability of your business and quality of your products. So which standard do you choose and what are the benefits of each program?
Key differences between ISO 13485 vs. 9001
1. Industry Focus
• ISO 9001: This standard is versatile and applies to any organization, regardless of the industries. Its goal is to help businesses to enhance customer satisfaction by establishing a well-structured QMS.
• ISO 13485: Specifically for the medical device industry, ISO 13485 focuses on ensuring safety and efficacy of medical devices, whilst also meeting applicable regulatory and organizational requirements.
2. Risk Management Requirements
• ISO 9001: Risk-based thinking is an important element, though it is balanced with opportunities for improvement for process improvement. Risk is evaluated in terms of the impact on customer satisfaction and process efficiency.
• ISO 13485: Risk management plays a central role in this standard, with a strong emphasis on risk identification, control, and mitigation throughout the lifecycle of medical devices. Detailed documentation is required to ensure risks are managed effectively.
3. Regulatory Compliance
• ISO 9001: Whilst ISO 9001 encourage organization to comply with applicable regulations, it does not mandate specific industry-regulations. The standard is broad and does not provide detailed frameworks for compliance.
• ISO 13485: The standard places a significant emphasis on complying with medical device regulations. Organizations must meet both local and international regulatory requirements (e.g., FDA, EU MDR) and maintain rigorous documentation and audits to ensure compliance.
4. Focus on Continual Improvement vs. Compliance
• ISO 9001: Continual improvement is a key focus of ISO 9001. Organizations are expected to regularly assess and enhance their processes to boost customer satisfaction and operational efficiency.
• ISO 13485: While continual improvement is still important, particularly for processes, ISO 13485 prioritizes maintaining compliance with regulatory standards and ensuring the safety and efficacy of medical devices over broader process optimization.
5. Documentation Requirements
• ISO 9001: Documentation requirements are relatively flexible and generally focus on internal processes, customer satisfaction, and ongoing improvement.
• ISO 13485: Documentation requirements are much more detailed and prescriptive, requiring records on risk management, product traceability, and compliance with safety and performance standards. This documentation is crucial for passing regulatory audits.
Can an Organization be Certified for Both ISO 9001 and ISO 13485?
Yes, organizations can be certified for both standards. Manufactures medical devices, for example, may choose to implement both ISO 9001 and ISO 13485 to ensure a comprehensive approach to quality management across all business areas. However, ISO 13485 certification is often mandatory for regulatory approval of medical devices.
How Do ISO 9001 and ISO 13485 Differ with Respect to Product Development?
ISO 9001 covers product development with a broad focus to meet the needs of multiple industries. In contracts, ISO 13485 is much more prescriptive, placing a heavier emphasis on the design and development stages of medical devices and requiring manufacturers to establish robust controls and maintain comprehensive documentation throughout the product lifecycle. This includes risk management, validation, and verification processes that assure medical devices safety and performance.
Which Certification is Best for My Organization?
• ISO 9001: Ideal for businesses across all industries that seek to improve quality management, efficiency, and customer satisfaction. This standard offers flexibility and provides a framework for continuous improvement in a variety of sectors. The standard includes key business strategies including contextualisation, evidence-based decision making, proportionate risk management, and compliance with legal and regulatory requirements.The business focus of ISO 9001 is valuable for top management in designing, developing and maintaining a robust business in all sectors. It is an indicator of a commitment to quality and is required by some purchasers.
ISO 13485: Essential for organizations that design, manufacture, or service medical devices, and beneficial for organisations in the MedTech sector. ISO 13485 is focused on regulatory compliance and risk management, making it a key certification for accessing global markets in the medical device sector.ISO 13485 is more product-focused, demonstrating a deep understanding of the documentation and quality requirements for components, services, and final products within the MedTech sector. In some regulatory jurisdictions, it is a mandatory requirement for legal manufacturers of medical devices. Since ISO 13485 certification also takes into account critical suppliers—potentially including them in the audit program—it provides an added layer of assurance in building supply chains. This can help reduce audit costs, making suppliers with ISO 13485 certification more likely to be selected over those without it.
The Certification Cycle
Both ISO 9001 and ISO 13485 certifications follow the requirements of ISO 17021-1, including an 2-stage initial audit. Whereas the ISO 9001 stage 1 audit is often remote, the ISO 13845 Stage 1 audit is preferably on site, and must be on-site for high-risk devices. To maintain certification both schemes require periodic surveillance audits and recertification every three years. The renewal process involves a comprehensive review of the QMS and adherence to the specific requirements of each standard.
Conclusion: ISO 13485 vs. 9001 - Choosing the Right Standard
In summary, both ISO 9001 and ISO 13485 are focused on quality management but serve different needs. ISO 9001 is generic, with more content on business development and less prescriptive requirements for the products and documentation. ISO 13485 is specifically tailored for the MedTech industry, with a stronger emphasis on safety, risk management, and regulatory compliance. For companies in the medical device sector, ISO 13485 is crucial for regulatory approval and market access. However, ISO 9001 can complement ISO 13485 to offer a more comprehensive quality strategy, encompassing the business elements. Indeed, even if your strategy is only to have ISO 13485 certification, it is worth considering adoption of some of the ISO 9001 tools to support business resilience. Selecting the right certification ensures both compliance and success, depending on your organization’s goals and industry.
ISO 13485 Certification
Don’t know where to start for your ISO 13485 compliance or certification? Contact us for more whitepapers and guidance documents to support your quality management system implementation or an obligation free quote for compliance assessment and certification services.
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Author
Claire Dyson
has a doctorate in rational drug design and over 10 years of experience in medical devices that interact with or deliver medicines or biological responses. Most of her career has been spent in industry, mainly in Switzerland. She moved into certification bodies in 2018 and has been involved in several transformative change projects, including new accreditations and designations.
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