ISO 13485 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 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 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.
Since the publication of Annex SL - the standard that defines the high-level structure for all ISO management systems standards - all ISO management systems must be developed following this structure:
So, if your company have already a management system implemented don’t forget that clauses 4, 5, 7, 9, and 10, have a similar text, so it can be unified without compromising the individual standards. It is the beginning of integration!
ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system.
The ISO 9000 family of standards lays out the fundamentals and provides terminology, requirements and guidance for implementing, maintaining and improving an effective quality management system, that can be applied to all type of organizations with any size.
ISO 9000 is a quality management standard that presents guidelines intended to increase business efficiency and customer satisfaction. Based on ISO 9001, the goal of ISO 13485 is to embed a quality management system within an organization, increasing productivity, reducing unnecessary costs, and ensuring quality of processes and products.
Seven Quality Management Principles behind ISO9001 requirements: