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ISO 9001 Drastically Revised

Should You Keep Your Quality Manual?
The ISO 9001:2015 standard eliminates the requirement for a quality manual, but there is still a requirement to define how you meet the requirements of the standard. Therefore, I recommend maintaining a quality manual. A quality manual will also be required as part of the revised ISO 13485 standard (i.e., ISO 13485:2015).

If you have only an ISO 9001 certification, you might consider reorganizing and rewriting your manual to match the revised standard. However, if you have both ISO 13485 and ISO 9001, then you should probably maintain your existing organization of the quality manual because ISO 13485 has not changed in structure of the clauses. If you have both quality certifications, then you should probably add a cross-reference table at the end of your manual to indicate how you meet all the documentation requirements of ISO 13485 and 9001. Some of the 53 requirements for documented information will be procedures, and there are many more procedural requirements in ISO 13485, 21 CFR 820 and the European Medical Device Directive. The requirements for documented information that you meet by maintaining records can be addressed in a separate document for control of records or records retention.

Conclusions / Recommendations
The ISO 9001:2015 standard is a major revision that will require significant time and resources to determine the best way to implement the revised quality system. Most companies will need all three years of the transition period for compliance, and each medical device company is likely to develop their own solutions due to changes in ISO 13485.

Overall I do not see ISO 9001:2015 as an improvement. I believe that a risk-based approach is needed, but the way that it is being introduced in this Standard appears to be too radical of a departure from the current structure of the Standard.

If your company is a medical device contract manufacturer that does not have ISO 13485, you might consider updating your quality system to comply with ISO 13485 and drop your ISO 9001 certification. If you choose this approach, the revisions to your quality system will be much easier for employees to understand and implement in one year. You may even want to inquire with each of your customers in the next 6 months to see what their strategy will be. I already know of two clients that have dropped ISO 9001 and a third that is planning to drop ISO 9001 certification.

Rob Packard is a regulatory consultant with 20 years of experience in the medical device, pharmaceutical and biotechnology industries. Mr. Packard served in senior management at several medical device companies, including President and CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing and maintaining ISO 13485 and ISO 14971 certification. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. His specialty is regulatory submissions for high-risk medical devices for CE Marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

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