Identifying, developing and implementing the best solution for your organization is paramount.

In developing a QMS, SEAS will facilitate determining the regulations and guidance that need to be addressed, both from a compliance perspective and a cost benefit perspective.

Tailoring and applying the regulations and guidance provided by 21CFR§820, ISO13485, ISO14971, IEC 62304, CMMi, GAMP-5 and other Regulated Processes and "Best Practices" will provide you with a dynamic maintainable roadmap that not only makes strategic sense but also results in exceeding customer expectations.

Documents will be revised or written detailing the processes and procedures that function best for the organizational group being guided.

We (SEAS and Your Organization) will determine what the specific purpose of each Policy; what is trying to be accomplished.

The Policies will then be audited to ensue all regulations and guidance are addressed.

Each Procedure will be revised or written from a common sense perspective, detailing how each Policy will be executed. 

Procedure processes will be flowcharted and validated against the appropriate Policy/Policies.

Care will be taken in not being too verbose as well as not being too brief. 

Documents will be written fully expecting common sense enactment.

Successful documents need to be implemented and supported from a “We” attitude, not a “Me” attitude. Organization personnel need to accept accountability and responsibility for the final product. Quality and Compliance is a team effort, not an individual effort.

Next, reconciliation using Internal Audits will to be performed to assure that the QMS documents, (Policies, SOPs, and WIs) address and comply with external requirements and guidance and add real benefit.

Finally, SEAS will assist in or develop, conduct and record the training on all QMS documents.