ISO 13485 - Change? Do I Have To??

Accordingly, many companies have a conundrum if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The array of opportunity may not be as broad in terms of rationalizing how to do business as an outlier.

The ISO 13485 quality management standard for medical devices is now at a new level of application based on these three points:

1. Any actions taken by a business must be measures for controlling risk
2. Critical factors must be evaluated as risk and opportunistic (R&O) driven outcomes
3. As a result of 1&2 it is explicitly imperative to make planning a tangible and documented activity with appropriate review and actions at executive-level decision-making.

Due to global markets in the life science industry, businesses are intertwined through such conditions as outsourcing as a result of core business objectives. Overlap and integration of OEM and tiered supply chain makes it imperative to facilitate such global alignment and immersion. The implementation of new concepts is now explicit in the changing standards.