Representatives from Smithers Quality Assessments will be on hand to answer questions and provide insight into the transition to AS9100 Rev. C. in a free March 8 Workshop sponsored by Purdue Manufacturing Extension Partnership.

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Through a mixture of presentations and discussions, participants will:

• Discover that as of July 1, 2011 ALL AS9100 audits will be to the new standard
• Learn the differences between AS9100 Rev. B and Rev. C
• Experience what an AS9100 Rev. C audit looks like from a registrar’s perspective

As an auditor for the ISO 13485:2003 standard for the design, manufacturing and distribution of Medical Devices, I can attest to the benefits of preparing for and documenting audit information in detail. Through the implementation of ISO 13485, companies increase the probability of making safe and effective medical devices, meeting regulatory requirements, and ultimately meeting customer expectations. Many times a client may not realize that a comprehensive internal audit needs to be conducted before a registrar like Smithers can perform an official audit.

An internal audit involves a management review and the use of workbooks and materials to build an internal audit schedule. Each of the identified processes should also contain associated objectives.

Detailed documentation of objective evidence during an internal audit also is helpful. For example, if you are reviewing a medical device Purchase Order, record the specific Order Number.

View the steps to ISO 13485:2003 certification here. If these basics were followed, most of our noncompliance findings could be avoided. In addition, the FDA website offers detailed information to help with a 13485:2003 audit such as:
- How to determine the class of a device and what type of controls must be in place.
- Past problems others encountered with the device (if not new) and how they were addressed.
- Requirements for everything from pest control to record storage.

As organizations enter compliance with AS9100 C, there are many steps you can take to streamline the internal audit and certification process. These include defining your process so it encompasses all business areas; understanding the roles and responsibilities of your management team in the certification process; and viewing the internal auditing process as a business asset, not a function, and staffing it appropriately.

A clear and effective development plan for the life of your Quality Management System (QMS) ensures effective implementation, maintenance and continued growth of your QMS. Having a plan ahead of time versus inventing it as you go is much easier on all parties involved.

Don’t limit your definition of “internal processes” to manufacturing processes only. Think of them as business processes that make up the key matrix, performance and importance to your internal and external customers. This will help you make clear improvements to your business as a whole, not just your QMS. It also provides an opportunity for total commitment and belief by levels throughout the organization that the quality management system can provide value and not something less.

Pre-certification training before you enter a Stage 1 audit for ISO 9001/AS9100, for example, can be very helpful. All management personnel ought to undergo a comprehensive, fundamental training or consulting, such as a session by a third party, of the requirements and or possibly roles and responsibilities management has to adhere and improve a QMS. Consider identifying the QMS as a Business Management System instead and embed this term throughout your organization!

Here’s a story to illustrate the importance of preparedness for your QMS. While performing an ISO 9001 recertification audit that didn’t get off to a good start, the management team asked if “they could pick the sample to audit, or provide product and data from two to three years ago as the sample to review during the audit, because back then, we were much better.” While this was a creative request, it certainly didn’t follow protocol. Had they performed an internal audit prior to the certification audit, they could have identified the non-conformances and fixed the processes.  Several months later, this organization still has a suspended certification!