ISO 13485:2003 represents the requirements that medical device manufacturers must incorporate into their management systems. ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
When identifying and determining the applicable ISO guidelines, the company seeking certification bears the following responsibilities in regards to the QMS:
The standard is applicable to any organization that wishes to eliminate or minimize risk to employees and other stakeholders who may be exposed to OH&S risks associated with its activities. Many organizations will have elements required by OHSAS 18001 already in place, which can be supplemented to provide a more cohesive management system to meet the requirements of the standard. Organizations that implement OHSAS 18001 have a clear management structure with defined authority and responsibility, clear objectives for improvement, with measurable results and a structured approach to risk assessment. This includes the monitoring of health and safety management failures, auditing of performance and review of policies and objectives.
- To identify those processes that are vital to the system
- To determine the appropriate sequences and interactions of such processes
- To determine appropriate criteria and methods, thereby making process effectiveness certain
- To determine the availability of required resources
- To track, gauge, and analyze the processes necessary to reach the intended results
- To ensure that any outsourced activities comply with the standard
To identify appropriate guideline requirements, it may be helpful in some instances to employ the services of a quality system registrar that’s authorized to conduct ISO 13485 compliance audits.