General

This International Standard outlines the requirements for a quality management system (QMS) that can be utilized by organizations involved in various stages of the life cycle of a medical device. This includes design and development, production, storage and distribution, installation, servicing, and the final decommissioning and disposal of medical devices, as well as the design and development or provision of associated activities (e.g., technical support). The requirements of this International Standard can also apply to suppliers or other external parties providing products (e.g., raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. These external parties may choose voluntarily to comply with the requirements of this International Standard or may be required to do so by contract.

Several jurisdictions have regulatory requirements for applying quality management systems by organizations at various stages of the medical device supply chain. Consequently, this International Standard expects organizations to:

• Identify their role(s) under applicable regulatory requirements.
• Identify the regulatory requirements that apply to their activities under these roles.
• Incorporate these applicable regulatory requirements into their quality management system.
  
  

The definitions of regulatory requirements vary from country to country and region to region.

Organizations must understand how the definitions in this International Standard will be interpreted in light of the regulatory definitions within the jurisdictions where the medical devices are distributed.

This International Standard may also be used by both internal and external parties, including certification bodies, to evaluate the organization’s ability to meet customer and regulatory requirements relevant to the quality management system, as well as its own internal requirements. It is important to note that the quality management system requirements in this International Standard complement the technical requirements necessary for the product to meet customer and applicable regulatory safety and performance standards.

Adopting a quality management system is a strategic decision for an organization. The design and implementation of the QMS are influenced by factors such as:

• The organizational environment, any changes within it, and how these influence the conformity of medical devices.
• The organization’s unique needs.
• The specific objectives of the organization.
• The type of product provided by the organization.
• The processes used by the organization.
• The organization’s size and structure.
• Applicable regulatory requirements.
  
  

This International Standard does not intend to enforce uniformity in the structure of different quality management systems, nor does it require uniform documentation or alignment of documentation with the clause structure of this Standard.

Given the wide variety of medical devices, certain requirements of this International Standard apply only to specific groups of medical devices, which are defined in Clause 3.