Standard Operating Procedures (SOPs) for ISO 13485

Standard Operating Procedures by the Pound? 

SOPS Standard Operating Procedures (SOPs) for ISO 13485

“If you are thinking about purchasing Standard Operating Procedures (SOPs), instead of writing procedures yourself, it’s important to understand the intent of the author that wrote the procedures. Many buyers expect to “pay by the pound.” After writing hundreds of procedures, I found that it requires more work to write a short and effective procedure than a 50-page dust collector.

If a company has a mature quality system, procedures tend to be lengthy, because each time an auditor finds a problem, another section is added to “clarify” the procedure. I try to write standard operating procedures that are concise and meet the requirements for an early-stage medical device company. Larger companies do not ask me to write many procedures. They ask me to audit procedures and to edit their procedures, but they seldom want me to start from scratch.

When Medical Device Academy writes standard operating procedures, we use a standard template for the sections. Almost everyone does this, but our template contains three elements, including:

1.   monitoring and measurement requirements for the process

2.   training and retraining requirements for personnel

3.   application of risk management

That last element is especially important now that ISO 13485:2016 was released on March 1, 2016 of next year.

If you want to learn more about our procedure template, please read our blog about it:  http://bit.ly/12PartSOPTemplate or download our sample standard operating procedure at the upper right of this page. You can also search our blog archives for the term “SOP” or “procedure”.

productHighlightsBanner Standard Operating Procedures (SOPs) for ISO 13485

  • Written specifically for early stage medical device companies
  • Create a ready made off-the-shelf Quality System for your company
  • Includes free updates for the ISO 13485:2016 as they become available
  • Can be used for FDA 483 responses
  • Are audit ready
  • Incorporates risk management into each procedure
  • Includes monitoring and measurement requirements for the process
  • Includes training and retraining requirements for personnel
  • Written by highly experienced industry subject matter experts

 

 

 

medical device conference 24 1024x490 Standard Operating Procedures (SOPs) for ISO 13485

Click Here for our next live webinar

 

Follow

Get every new post on this blog delivered to your Inbox.

Join other followers:

Simple Share Buttons
Simple Share Buttons