ISO 13485 - Medical devices quality management system
What is ISO 13485 QMS
ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices.
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers
Its primary objective is to facilitate harmonized medical device regulatory requirements.
The standard contains specific requirements for manufacture, installation and servicing and calls for:
Implementation of a Quality Management System with several enhancements
Risk Management approach to product development and product realisation
Validation of processes
Compliance with statutory and regulatory requirements
Effective product traceability and recall systems
ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.
Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.
13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and—pre-eminently—various global regulators. While being certified to 13485 does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, 13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements.
13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971: 2001, Application of Risk Management for Medical Devices. While 13485 states that a manufacturer’s management team is charged with the management of device-related risks and the development of risk management plans, 14971 defines a list of steps to be taken by management in order to fulfill risk-related requirements. While it is not mandatory that a manufacturer be 14971 certified in order to attain 13485 certification, being certified to the former standard can ease the attainment of certification to the latter.
Benefits of iso 13485
Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
Improved stakeholder relationships - including staff, customers and suppliers
Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
Improved risk management - through greater consistency and traceability of products and use of risk management techniques
Proven business credentials - through independent verification against recognized standards
Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector