Several ISO standards apply to prosthetic components, including standards for ensuring quality of the design and manufacturing process and others that are specific to structural testing of components in a laboratory environment. Conformity with these standards should therefore be evaluated.
ISO 9001:2015 and ISO 13485:2016 on manufacturing standards are the most acquired ISO certifications (see table 42). ISO 9001 provides specifications for a quality management system that can be applied at any organization regardless of company size, industry, product, or service. ISO 13485 is a comprehensive management system for medical devices. ISO 13485 appears more commonly required for international procurement as it has more specific requirements. For example, it includes medical device terminology, requirements for clinical and performance evaluations and a fundamental framework infused with risk management to ensure patient safety. 140
Table 42: ISO manufacturing standards
ISO 9001: 2015 | Global standard for quality management. Helps organizations of all sizes and sectors to demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system. It is the most used quality management standard in the world. i |
ISO 13485: 2016 | Specifies quality management system for suppliers of medical devices and related services. Organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ii |
iISO 9001:2015 - Quality management systems — Requirements [https://www.iso.org/standard/62085.html] ↩︎
iiISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes [https://www.iso.org/standard/59752.html] ↩︎