ISO 13485 2016
ISO 13485 Certification | Quality management system for medical devices
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such 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). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
THE EIGHT BENEFITS OF A CERTIFIED ISO 13485ENERGY MANAGEMENT SYSTEM
As an organisation, you can always choose to work in accordance with the ISO 13485standard, but you can also choose to be certified by an independent party (such as a certification body). In practice, we see eight major benefits in choosing a certified ISO 13485Quality management system for medical devices:
- You have objective proof that your organisation attaches great importance to Quality management system for medical devices and that you have it checked regularly by an independent party. This commitment increases confidence in your organisation.
- You achieve higher operating efficiency. Organisations that consider quality management to be an integral part of their business operations usually achieve a higher operating efficiency than those that do not.
- A certified ISO 13485Quality management system for medical devices increases the quality of your services and raises your staff’s awareness.
- A certified ISO 13485Quality management system for medical devices ensures clear processes and (communication) structures, tasks and responsibilities throughout the entire organisation. This increases the involvement of your staff, which improves the working atmosphere and reduces the pressure of work.
- You can detect and identify problems in good time, which means that you can quickly take steps to avoid the same mistakes in the future.
- You make it clear to your staff, your partners, your clients and the outside world that customer satisfaction is at the core of your business.
- A certified ISO 13485Quality management system for medical devices gives you a positive company image, raising you up to the level of your competitors or perhaps even a level higher.
- It is possibly also in your commercial interest, seeing that more and more clients demand that their suppliers work in accordance with a certified ISO 13485Quality management system for medical devices.