ISO 13485:2016 is the internationally recognized standard for quality management systems in the medical device industry.
The standard provides the framework to implement and manage a quality management system that allows the organization to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements and medical device directives.
The standard is designed for organizations that are involved in one or more of the stages of the product life cycle, from design and development to production, installation, storage, servicing and sales of medical devices. It also applies to suppliers of external parties that provide product such as raw materials or services.
The primary objective of ISO 13485 is to facilitate a framework of harmonized medical device regulatory requirements for quality management systems. This regulatory framework specifies the need for the organization to identify and comply with requirements that also includes meeting regulatory requirements as defined by each country, industry or discipline.
Regulatory requirements are often more specific than the prescripts of the ISO 13485 standard, particularly in the areas of complaint handling, labeling control etc. and must be included in the structure of the quality management system to provide evidence of compliance.
ISO 13485 is a standalone standard that is largely based on the business orientated structure of ISO 9001, with the additional focus on some specific requirements relating to medical devices such as product and process orientated risk analysis, sterile manufacturing and traceability.
ISO 13485 Certification does not indicate conformity to ISO 9001.
The MCC has published the regulatory requirements and recommendations to register for the license to manufacture, import, export or distribute Class B, Class C and Class D medical devices & IVDs.
The requirements speak to the implementation of a quality management system in line with the requirements of the ISO 13485 standard with some prescribed additional controls such as complaint handling, recall controls etc.
The registration requirements also calls for detailed product registration protocols to be followed.
SEMQ can assist with the implementation of a ISO 13485 Quality Management System that also addresses the prescripts as required by the MCC regulations. SEMQ, does however not provide product registration services, but can assist in recommending qualified third party consultants to assist.