ISO 13485 Criteria

ISO 13485 – normative document developed by international attestator. The updated version was released in 2016 and became mandatory for all businesses in 2019. This act includes ensuring full openness and regulating procedures accessibility of medical equipment circulation.

Manufacturers must meet it if they want maintaining certification. To this end, it is checked whether your QMS is capable of continuously monitoring and managing equipment life cycle and related activities. Unlike ISO 9001, for example, the emphasis is not so much on continuous or continuous improvement as on product safety. Particular attention is paid to risk control. This means new standard poses challenges for medical equipment producers and for service providers.

How does ISO 13485 help?

  1. Manage risks.
  2. Comply with the rule of law.
  3. Improve the product.
  4. Have good operational efficiency, etc.

ISO 13485 is needed and appreciated in medical market as it guarantees:

  • conditions for preventing mechanisms from entering the domestic market that do not meet efficacy demands;
  • joining a self-regulatory establishment, which is obliged controlling law demands compliance and be in charge of violations;
  • timely and sufficient provision of public and private medical institutions, as well as citizens with modern devices;
  • reducing harm causing risks to life and health of citizens, state and municipal property, the environment;
  • availability of regulatory documents at the enterprise (SOPs, orders for the recruitment of employees, job descriptions, registers with supplier assessments, instructions (safety, electrical safety, fire safety), etc.;
  • other QMS availability at enterprise;
  • products list, production lines;
  • manufacturing operation types performed in production.

ISO 13485 benefits

  1. Lower Operational Costs – uninterrupted procedures betterment and operational efficiencies generate cost savings.
  2. Building relationships with stakeholders – will improve perception of organization by employees, customers and suppliers.
  3. Legal Compliance guarantees a good impact on the company.
  4. Proven Business Qualities – independent verification of compliance with internationally recognized industry standards provides many privileges.
  5. A chance to win business in regulated sectors – obtaining certification will help win business specifically where procurement specifications require certification as a condition for supply in a highly regulated sector.
  6. Improved Risk Management – improved consistency and traceability of products and services means problems are easier to avoid and fix.

Facts about changes to ISO 13485

This act is designed to help companies improve their administration systems and focus on improving their own approach to risk control and compliance. It complies with ISO 9001: 2008, not 2015. This discrepancy happened because two standards revision ends in parallel, and because ISO 9001: 2015 is invalidated for equipment.

Company top members must clearly represent near plans. If intended market for medical products sale is countries of European Economic Union, then for an effective competitive advantage and the fulfillment of a number of legislative requests, it is enough to develop and certify QMS in accordance with ISO 13485 by any local by an authorized certification representative.

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