FDA Registered
Contact Us
Telephone: 616-233-3000
1440 Front Avenue NW, Grand Rapids MI 49504

Quality System Documentation

Rose Medical’ Quality System Documentation

Our Quality System Documentation includes the following:

Clean Room Quality Inspection by LotLevel 1 Documentation – Quality Policy Manual (QPM) – establishes our policies and defines our approach regarding quality in our organization, including details of and justification for any exclusion.

Level 2 Documentation – Quality System Procedures (QSPs) – supports the policies declared in our Quality Policy Manual and defines the individual / functional responsibilities and authorities (who, what and when and how).

Level 3 Documentation – Work Instructions (WIs) – departmental instructions, which address in more detail how certain activities are performed. When required, the appropriate department develops work instructions.

Level 4 Documentation – Records and other documentation – forms, results, tags, charts, etc, which show that the system is operating.

Our quality system related documentation also includes externally supplied documentation, comparative profiles, industry standards and specifications.

<< Back to Quality Assurance