Biomedical Engineering Reference
The rings would not exist on the real thing - they are there to help me clarify things:
Item 1 is the title of the procedure and its file name. The inclusion of a file name is
important in this electronic world.
Item 2 is the version number. It is worthwhile having a sheet in the quality manual, and
on a wall, that gives the most up-to-date version numbers of all procedures and controlled
Item 3 is the proof of sign off.
Item 4 is the record of changes. As each new version evolves something will change, and
this table enables that to be tracked. Obviously the table will grow and there is no need
to have all changes listed (or your procedure will be a small picture in a large table of
changes) but at least the last two/three changes should be logged. As the old procedures
are placed in your repository, this historical record will develop.
Item 5 is optional but is good practice. This statement should be produced by a red-ink
stamp that is held by one person only. In that respect they are the only people who are
able to print off this document. If someone tries to photocopy it the red text comes out
black - hence it is obvious that it is a copy. However, modern IT has superseded this and
most companies now have a secure FTP server where up-to-date (and only the up-to-
date) versions are kept; everyone has access and there is no excuse to not have the latest
In this chapter we met procedures. We saw how the procedures are used to demonstrate
meeting the requirements for design control in FDA CFR 21 and ISO 13485 and how they are
used to ensure that devices are designed right the first time - every time. We further saw that
the procedures ensure that all of the design documentation is controlled. While there has been
an attempt to provide procedures that are general in nature it is important for you to develop
your own procedures as this helps you to fully understand your company, your product line,
and your customers.
George, M. L., Maxey, J., Rowlands, D. T., & Upton, M. (2005). The lean six sigma pocket toolbook . McGraw
FDA (1997). Design control guidance for medical device manufacturers . FDA.
ISO (2003). BS EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for
regulatory purposes .
ISO (2007). ISO 14971:2007 Application of risk management to medical devices.