Medical Devices Quality Management System (ISO 13485)ere

What is ISO 13485?
ISO 13485 specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device (e.g. design and development, production, storage, distribution, installation, servicing, final decommissioning and disposal of medical devices) and design, development or provision of associated activities (e.g. technical support). The requirements of ISO 13485 can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices) and services (e.g. sterilization, calibration, distribution and maintenance services) to such organizations. The supplier or external party can voluntarily choose or as required by contract conform to the requirements of ISO 13485.
Who should implement ISO 13485?

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.

ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system related services to such organizations.

What are the key benefits of ISO 13485 Certification?
  • Enhances corporate image, credibility and competitiveness to get more business.
  • Helps to meet the customers, legal authorities and other interested parties requirements.
  • Helps to achieve continual improvement, defect prevention and reduction of variation and waste in the medical supply chain.
  • Reduces cost associated with defects, re-works, rejection, penalties, and recalls by doing the first time right.
  • Enhances quality performance by improving efficiency, effectiveness, and capabilities of processes.
  • Improves and maintains the quality of products and services.
  • Engages and motivates staff by implementing best quality practices.
  • Helps to establish and promote quality culture.
  • Provides guidelines to improve internal and external communications.
  • Helps to define the roles, responsibilities, authorities and accountability in the organization.
  • Provides guidelines for selection, performance evaluation and management of suppliers.