How to get certified to ISO 13485, ISO9001, AS9100 and/or AS9120
The process is straight forward with many successful businesses, small and large, benefiting from the advantages of a systematic approach to managing the business, its processes and when its done correctly brining improvements to both. It does take effort, ongoing commitment and you need to know which standard(s) are the right ones for you, customers often drive this decision. Here’s a simplified guide:
1. Which standard do I need ?
This can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). It can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilisation services, calibration services, distribution services, maintenance services) to such organizations.
The supplier or external party can voluntarily choose to conform to the requirements of this International Standard or can be required by contract to conform. It must be emphasized that the ISO13485 requirements are complementary to the technical requirements for product that are necessary to meet customer and applicable regulatory requirements for safety and performance.
2. Can I do it myself or do I need external support?
You can do the preparation work yourself but a certification body will be needed to assess your Quality Management System (QMS) and award the certificate, I recommend the use of an accredited certification body such as NQA as their methods and results are monitored by an independent authority usually backed the government, in this case UKAS.
Regarding the preparation work, yes you can do all this yourself, but there’s a greater risk of mis-interpreting the standard which could lead to non-conformances (getting it wrong) at the stage 1 and stage 2 elements of the certification process and even the need to repeat the stage. A competent QMS consultant can help you and your organisation with this.
3. What are the steps?
Once you have decided upon the standard to go for and got the basics of the QMS developed e.g. process maps, manuals/procedures (if required depending on the standard you go for) methods for internal audits, management review meetings, handling non-conformances plus a fair bit more, here’s the process: