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QMSL – Vision28 LEAN Quality System

Vision28 professionals have experience developing and defending quality systems in companies whose sizes range from Fortune 100 world-wide companies to start-ups trying to get their first product approved by FDA.

What we have found over the years is that overly complex systems hamper the basic mission of the company and may expose the company to compliance risk! 

Vision28 QMSL is a complete 21 CFR 820 and ISO 13485:2016 compliant  quality system. Paper based, it is ideal for start-ups and growth phase companies who don’t want to spend significant dollars for a medical device quality system, and who want to get a system up and running in weeks instead of months. QMSL Standard Operating Procedures include:

0001-SOP Quality Manual Rev A
0002-SOP Product Development Rev A
0003-SOP Document Control Rev A
0004-SOP Purchasing Controls Rev A
0005-SOP Production and Process Control Rev A
0006-SOP Acceptance Activities Rev A
0007-SOP Nonconformance Rev A
0008-SOP Corrective and Preventive Action Rev A
0009-SOP Device Master Record Rev A
0010-SOP Device History Record Rev A
0011-SOP Quality Records Rev A
0012-SOP Complaint Handling Rev A
0013-SOP Risk Management Rev A
0014-SOP Statistical Techniques Rev A
0015-SOP Personnel and Training Rev A
0016-SOP Internal Audits Rev A
0017-SOP Management Review Rev A
0018-SOP Handling Storage and Distribution Rev A
0020-SOP Installation Rev A

Give us a call and learn how Vision28’s QMSL can help you!