ISO 13485 - Chapter 1

Original text

Expert opinion

This International Standard 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). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
The international standard is not restricted to medical device manufacturers, but applicable to all providers of services and process-related work impacting or affecting the life-cycle of a product.
Service providers can adopt the standard as well for cases where quality-relevant work is provided.

Requirements of this International Standard 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 ISO 13485 is not restricted to a size or type, meaning that a one-man business or start-up is in the same manner covered as large enterprises. Further, it does not stop at specific types of organizations and thus, the standard is applicable to institutes and non-profit organizations as well.

The processes required by this International Standard 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.

As with any standard, the field of application has to be justified and defined in writing.
Monitoring, maintaining and controlling the processes applicable is of major concern not only whether these are effective, but also whether they are complete and potentially need to extended over time.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls.
Conformity claims to the ISO 13485 can and should include any justifications for opt-out.
If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
Written justifications are needed if clauses are not applicable.

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