ISO 13485
Quality management system for medical devices


What is ISO 13485?

ISO 13485 is the most widely used international quality management standard in the medical device industry. It is an effective solution to meet complex QMS requirements. The adoption of the ISO 13485 standard provides manufacturers with a practical basis for the implementation of the Medical Equipment Directive (MDD), the Medical Equipment Regulation (MDR) and other regulations, and also demonstrates a commitment to the safety and quality of medical products.

Requirements for the Quality Management System for medical devices

  • understand their external and internal problems and stakeholders
  • have a Quality Policy describing the obligations of top management - usually a one-page document declaring commitment to quality
  • to consider risks and opportunities throughout the business
  • to develop a Quality or Management Manual - documenting as much or less as you want, but usually briefly reviewing the sections of ISO 13485
  • develop procedures or work instructions - recipes for doing business; as much or less as you need; ideally, these are brief instructions for employees to follow
  • to develop and monitor quality objectives
  • to ensure that staff is competent and understands the quality management system
  • to ensure a clear understanding and compliance with customer requirements
  • under control to develop new products and services
  • monitor any outsourcing work and procurement of materials
  • monitor the work so that the final product or service meets the plan
  • monitor performance and customer satisfaction
  • take into account and monitor compliance with requirements specific to medical products
  • monitor nonconformities and nonconforming products
  • take measures to eliminate significant or recurring nonconformities
  • conduct internal audits of the quality management system
  • ensure that top management strategically analyzes the quality management system.

Documentation requirements:
  • Quality Policy
  • Procedures or work instructions
  • Forms
  • Quality improvement plan (monitoring of quality goals and objectives)
  • Registers are for nonconformities and corrective actions.
  • Additional requirements of the specifics of the standard (for medical products.appointments)

Benefits of an quality management system for medical devices:

  • increased efficiency
  • reduced costs
  • increased customer satisfaction and repeat business
  • increased staff morale and motivation
  • expanded company profile
  • confidence that the business will work as intended
  • ability to allow employees to continue working without direct supervision
  • compliance with customer requirements, prequalification or regulatory requirements
  • easily integrated with other management systems.

TQCSI Certification Process:
  • contact your TQCSI Office and ask for a quote or apply on-line - TQCSI will need to know what your business does, how many employees (full time equivalent) and what types of information security risks are applicable
  • to prevent delays, don’t wait until your quality management system for medical devices is fully implemented.

ISO 13485
Quality management system for medical devices

Below you can watch the recording of the webinar for a better acquaintance with the standard.

We are TQCSI Kazakhstan, the only international certification body that conducts free webinars aimed at raising awareness and understanding of international ISO standards.

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