ISO 13485:2016 demonstrates needs for a quality management system where a company requires to show its capability to supply medical instruments and concerning services that regularly meet customer satisfaction and related regulatory concerns. Such companies can be a part of supply chain in one or more phases of the product cycle for example in design and development phase, or in the manufacturing phase, warehousing and supplies, commissioning, or servicing of a medical product or service. ISO 13485:2016 can also be utilized by distributors or third parties parties that supply product, as well as quality management system-related services to these organizations.
Needs of ISO 13485:2016 are relevant to companies despite of their size and despite of their work in this sector exclusive for those where explicitly stated. Wherever needs are demonstrated as relevancy to medical devices, the needs are relevant likely to concerning services as offered by the organization.
The procedures needed by ISO 13485:2016 that are relevant to the organization, but are not executed by the company, are the binding of the company and are considered for in the company’s quality management system by observing & rechecking, sustaining, and controlling the industrial business processes.
If relevant regulatory needs allow exclusions of requirements of design and development, this can be utilized as a reason for their uncover-age from the quality management system. These regulatory needs can bestow other methods that are to be stated in the quality management system. It is the duty of the company to make sure that statements of conformity to ISO 13485:2016 show any exclusion of design and development processes.
If any need in ISO 13485:2016 Clauses 6, 7 or 8 is not relevant due to the processes made by the company or the inherent features of the medical device for which the quality management system is used, the company does not require to involve such a need in its quality management system. For any clause that is exhibited to be not relevant, the company state the reason as described in the clause 4.2.2 of ISO 13485:2016.