ISO 13485

Quality Management Systems

Top Image for ISO 13485 ServiceHelps you with: Quality control, risk management, legal compliance, traceability and recall, process improvement, product improvement, operational efficiency.

What is ISO 22301?

There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. ISO 13485 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.

The standard contains specific requirements for manufacture, installation and servicing and calls for:

  • Implementation of a Quality Management System with several enhancements
  • Risk Management approach to product development and product realization
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems.

Certification to ISO 13485:2003 is not only used by medical device manufactures as the foundation to their management system, it is also used by non-medical device companies as a first step to gaining new business opportunities within the medical device community.

What are the benefits of certification?

Customer satisfaction. Deliver products that consistently meet customer requirements.

Improved stakeholder relationships. Improve the perception of your organization with staff, customers and suppliers.

Improved risk management. Gain a greater understanding of organizational risks; focus on consistency and traceability of products to help prevent problems.

Proven business credentials. Independent verification against recognized standards speaks volumes.

Open doors to win more business. Procurement specifications often require certification as a prerequisite for suppliers, particularly in a highly regulated sector.

Changing industry landscape and expectations

The industry landscape is always changing. These changes have impacts to your customer needs and require the evolution of your management system.

Considerations include:

  • Changing Regulatory Needs
  • Global Outsourcing
  • Evolving Customer Requirements
  • Shorter Delivery Deadlines
  • Integrity Threats in the Supply Chain

We have written this ISO 13485 Guidance Document to help you understand the registration process.

Download a PDF file of the ISO 13485 Registration Services

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Page last updated on 1/15/2015