What is ISO 13485:2016?
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard, published in 2003, The current ISO 13485 effective edition was published on 1st March 2016, that represents the requirements for a comprehensive “management system for the design and manufacture of medical devices”. While it remains a stand-alone document, “ISO 13485” is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485:2016 requires only that they demonstrate the quality system is implemented and maintained.
ISO 13485:2016 provides a harmonized set of quality management system requirements for medical device manufacturers. Based on a process approach to quality management, it focuses on what the manufacturer does to provide safe and effective medical devices.
Your ISO 13485:2016 certificates can help you enter into EU market.
While it is based on ISO 9001:2008, ISO 13485:2016 does not include the customer satisfaction and continual improvement clauses – so an organization certified to ISO 13485:2016 does not automatically meet the requirements of ISO 9001 unless it is assessed against that standard separately. Compliance with ISO 13485:2016 also does not equate compliance with regulatory requirements, although in many cases it can facilitate the audit process for those requirements.
Why should my organization become certified to ISO 13485:2016?
Your quality system’s conformity with ISO 13485:2016 can help you reap the benefits of:
- Expanded market access
National regulatory authorities require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others. - Reduced cost of sales
your certification establishes your company’s credibility and commitment to quality from day one. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers’ trust and confidence. - Improved overall performance
Based on a uniform and widely accepted system of process control, your certified QMS helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners and customers, and give your business a real advantage in the marketplace.
Other specific differences include:
- The promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
- controls in the work environment to ensure product safety
- Focus on rick management activities and design transfer activities during product development
- specific requirements for inspection and traceability for implantable devices
- specific requirements for documentation and validation of processes for sterile medical devices
- Specific requirements for verification of the effectiveness of corrective and preventive actions.
- Full documentation and traceability of production processes
- Compliance with regulatory requirements in regard to EU, US and other national directives about medical devices (MD), in vitro Diagnostics (IVD) or medicinal products
- ISO 13485 compliant quality management system (QMS) is in line with the Food and Drug Administration’s (FDA) QSR standards
Key requirements of ISO 13485
ISO 13485 focuses strongly on the compliance of manufactured products and production processes with EU directives for MD or IVD such as:
- Provision of technical documentation (medical device file / technical product file)
- Specific design & development requirements
- Labelling, packaging and installation
- Sterile MD / IVD
- Implementation of a risk management process
- Health, safety and staff hygiene requirements
- Change management, market observations and procedures for product recall
The compliance with ISO 13485 is achieved through certification by an approved certification body and independent internal audits.
Reason for use
While it remains a stand-alone document, ISO 13485:2016 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485:2016 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.
Other specific differences include:
- Controls in the work environment to ensure product safety
- Focus on risk management activities and design control activities during product development
- Specific requirements for inspection and traceability for implantable devices
- Specific requirements for documentation and validation of processes for sterile medical devices
- Specific requirements for verification of the effectiveness of corrective and preventive actions
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