ISO 13485:2003 - Management System Certification for Medical Device Manufacturers

Introduced by the International Organization for Standardization in July 2003, ISO 13485:2003 is recognized throughout the world as a quality management system standard designed specifically for medical device manufacturers.

Based on the same basic principles as ISO 9001:2008, ISO 13485:2003 is often seen as a crucial first step in ensuring manufacturing and design processes consistently produce quality products that meet regulatory requirements. ISO 13485:2003 is used to assist in the synchronization of quality management systems and medical device regulatory requirements. Because of this, the standard includes various requirements for medical devices and excludes various requirements of ISO 9001. As a result, those companies that are registered to ISO 13485:2003 cannot necessarily claim compliance with ISO 9001.

Manufacturers who assemble a combination of non-medical as well as medical products should also consider working to and meeting the requirements of ISO 9001:2000 with the possibility of registering to the standard.

Important Aspects of the Standard

  • ISO 13485:2003 was written as a model to meet the quality system requirements of various global regulations.
  • ISO 13485:2003 is compatible with other “non-quality” management systems, such as ISO 14001, or OHSAS 18001.
  • ISO 13485:2003 does not emphasize customer satisfaction as ISO 9001:2008 does because the standard was written as a model for regulatory requirements.
  • If a company meets ISO 13485:2003 requirements, it should easily be able to meet the FDA QSR requirements. Although ISO 13485:2003 has not been adopted by the FDA, the FDA participated in writing ISO 13485:2003 to ensure the requirements are aligned.
  • Risk management is a key element of ISO 13485:2003.
  • TR 14969 is a guidance document for the use and implementation of ISO 13485:2003.
  • ISO 13485:2003 was written as a tool for maintaining processes, not for a business improvement model.
  • Unlike ISO 9001:2008, ISO 13485:2003 will not allow manufacturers to rationalize documentation. In order to ensure companies meet regulatory requirements, ISO 13485:2003 is more prescriptive, and requires that certain procedures still need to be documented.
  • There is no significant relationship between ISO 13485:2003 and ISO 9004:2008.

Special Points and System/Process Requirements

The ISO 13485:2003 standard has eight sections. Three sections are general information for manufacturers about the standard and are not auditable. Certification focuses on the five key auditable sections:

  • Quality Management System
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis, and Improvement

ISO 13485:2003 consists of certain ISO 9001 requirements and newly defined requirements, specific to the medical device industry. Because ISO 13485:2003 is different from ISO 9001, manufacturers will find that ISO 13485 excludes ISO 9001’s requirements related to continual improvement because most medical device regulations require organizations to maintain their quality management systems instead of improving on them. Thus, while ISO 9001 emphasizes the importance of improving on quality management systems, ISO 13485:2003 emphasizes the importance of maintaining them. Customer satisfaction requirements have also been excluded from ISO 13485:2003 because these requirements tend to be too subjective.

Additional special points and system/process requirements of ISO 13485 include:

  • Focus on meeting regulatory requirements
  • Risk management systems
  • Clinic evaluations and trials
  • Product cleanliness and contamination controls
  • Requirements for implantable devices
  • Proper communication of advisory notices
  • Additional research and development requirements

Advantages of Registration to ISO 13485:2003

With ISO 13485:2003 registration, manufacturers are provided with a process-based model and approach to developing and improving effectiveness of a quality management system.

ISO 13485:2003 registration also assists in meeting customer and global regulatory requirements by:

  • Maintaining global recognition as the best quality practices from companies within the medical device industry
  • Enabling companies to work within various countries and organizations, meeting necessary regulations and obligations
  • Helping to create an organized framework in which companies can maintain and evaluate their processes and customer response
  • Providing a framework to ensure maintenance and improvement of the effectiveness of those processes with applicable requirements
  • Enabling improved performance, such as increased sales, increased timeliness in getting products to the global marketplace, reduced costs, fewer errors, less waste, better use of time and resources and a lower product failure rate
  • Demonstrating compliance with European Union Directives throughestablishment and independent assessment of the quality management system