· · UQC Global Certification - ISO 13485 · ·

ISO 13485

ISO 13485 is an International Organization Standardization (ISO) standard which was published in 2003 and also represents the requirement of Quality Management System for the manufacture of medical devices. The primary objective of ISO 13485 QMS International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. Specific requirements for manufacture, installation and servicing and calls are included in this standard for:

VDA has the following values:

  1. Effective product traceability and recall system.
  2. Risk management approach to product development and product realization.
  3. Validation of process.
  4. Implementation of Quality Management System with several enhancements.
  5. Compliance with statutory and regulatory requirements

This standard is applicable to all the organizations operating at any tier in the medical device and pharmaceutical supply chain. ISO basically consists of certain requirements of ISO 9001 and newly defined requirements related to the medical device industry. ISO-13485 and ISO-9001 both differ from each other in many ways. ISO-9001 has emphasis on giving importance to improve the quality system whereas ISO-13485 emphasizes on giving more importance of maintaining them. ISO-9001 Customer satisfaction requirements were also excluded because the committee members of ISO-13485 found them too personal.

Specific differences between both of them Include:

  1. Focus on risk management activities and activities of design control during the development of product.
  2. Controls in the work environment to ensure the safety of product.
  3. Specific requirements for inspection and traceability for implantable devices.
  4. Specific requirement for verification of effectiveness of corrective and preventive actions.
  5. Promotion and awareness of regulatory requirements as a management responsibility.
  6. Specific requirement for documentation and validation of processes for sterile medical devices.

Some key points adopted by the ISO-13485 include:

  • Focus on meeting regulatory requirements.
  • Focus on meeting customer requirements.
  • Maintenance of the effectiveness of quality management systems.
  • Use of process approach.
  • Maintenance of procedural documentation.

  • ISO 13485 certification offers following benefits:

  • Increased efficiency, better product quality and improved customer service.
  • Ease of access to new markets.
  • Increase the credibility of the company with potential customers.
  • Demonstrate to your consumers and partners a commitment to quality.

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