by Phil Smart

Because ISO 13485 is a stand-alone document, medical device manufacturers are not required to be additionally certified to the ISO 9001 standard. There will be companies who will meet this requirement and will decide to go no further. However, there is a growing movement to reach beyond minimum regulatory obligations, and to apply all of the eight principles of quality which the ISO 9001 is built upon.

Does this make sense for your organization? Perhaps. But let us review these important points before you decide.

Point 1: ISO 9001 was developed, taking into consideration the eight quality management principles, as stated in ISO 9000:2000. The principles are:

- Customer focus
- Leadership
- Involvement of people
- Process approach
- System approach to management
- Continual improvement
- Factual approach to decision making
- Mutually beneficial supplier relationships

Does your organization apply (or at least attempt to apply) these principles? Beware that these 8 principles are not specifically referred to in ISO 13485.

Point 2: A main objective of ISO 9001 is to provide framework for achieving customer satisfaction and continual improvement. These two concepts have been removed from ISO 13485. In fact, ISO 13485 states,
". . . some of the ISO 9001:2000 requirements that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001:2000 unless their quality management systems conform to the additional ISO 9001:2000 requirements."

Do you seek to improve? Do your customers seek satisfaction? Can you afford not to apply these principles in such a competitive market?

Point 3: ISO 9004 gives guidance for the continual improvement of an organization's overall performance and efficiency. It is recommended as a guide for top management wishing to "go to the next level", in pursuit of continual performance improvement. But, ISO 13485 does not provide for organizations seeking both regulatory compliance and business excellence.


Solution:

With the above points in mind, you may want to consider ISO 9001 for your medical device manufacturing organization. It will not be a regulatory requirement, but it may simply be the right thing to do for a winning company! Contact us to discuss an effective strategy for ISO 9001 that meets your needs:

On-site training of your key staff members and internal auditors to ensure thorough understanding of the process approach and requirements of the standards;

Documentation and system gap analysis to ISO 9001

Gap analysis and corrective actions to ensure compliance with both standards: ISO 13485 and ISO 9001

Internal auditing of your facility to ensure independence and ongoing compliance