Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization.
Part of both ISO 13485 and QMS
Internal audits are required as part of ISO 13485 and the FDA’s Quality System Regulation (QMS). However, these procedures are quite complicated for many professionals in the medical device industry. They are often confusing and cumbersome, mainly because of the jargon and regulatory language they contain. Many organizations find it difficult to get the import of these words while wading through them all the way to a successful internal audit.
A tad complicated
Another couple of complicating factors come into play: Since the FDA does not look at the content of internal audits; many medical device organizations do not get feedback on the true effectiveness of their internal audit system from the FDA during the time of FDA inspections.
Secondly, while on the other hand ISO 13485 auditors do look at internal audits; they are most concerned with the process. For them, a proper definition of a process that meets the requirements of the standard and the assurance that the company is following these are more important than anything else.
Auditor training is necessary
Both these regulations require that the medical device manufacturer define Auditor training. But there is a catch, because auditor training sometimes just requires reading the company’s procedure, while most external auditors will look for more than this.
How does a medical device company extricate itself out of this quagmire? The solution to all these vexing questions will be offered at a two-day seminar from GlobalCompliancePanel, a globally known provider of regulatory compliance trainings.
At this seminar to enroll for which you need to just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900601SEMINAR; the Director, Betty Lane, who is Founder and President, Be Quality Associates, LLC, will explain all the issues relating to these aspects of external and internal supplier audits, in a way that is comprehensible and easy to implement.
In the process of explaining what makes for efficient and effective internal and supplier quality systems auditing for medical devices; she will also offer an explanation of best practices for creating and managing a value-added auditing process that will meet both company business needs and regulatory requirements.
At this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion; Betty will get participants to review all the quality management system requirements of FDA and ISO 13485 and then allow them to learn how to set up and manage an audit system that complies with these requirements, yet is risk-based so that their organization makes the most efficient use of auditing resources for both internal and supplier audits.
She will also include interactive exercises at this two-day session, which will help to strengthen the fundamentals of conducting and documenting quality system audits. The auditing principles taught in this seminar will be based on ISO 19011:2011 Guidelines for auditing management systems.