Standard Operating Procedure (SOP) Template (ISO 13485, ISO 9001, 21CFR part 820)

Kickstart your business' SOP creation with this fully editable SOP Template. This template is intended to be used to derive other SOP documents and to incorporate seamlessly into your Quality Mangement System (QMS). It allows you to input your own document numbers and document change request (DCR) numbers all while streamlining your SOP creation into a few easy to organize categories!

Note: This SOP template can be used or edited to fit a wide variety of industries, but it is currently intended for biotech, drug, biologic, and medical device companies that require compliance to standards: ISO 13485, ISO 9001, and/or 21 CFR part 820.

Categories include:

• Purpose
• Scope
• References
• Responsibilities
• Materials
• Procedure
• Revision History (template and SOP)
• Plus room for more!

How to Use: (refer to your business protocols first prior to use)

1. Enter your company name in the document header.
2. Internally at your company, assign this template a document number, version, and a DCR number. Follow your business protocol(s) for this process.
3. Design your SOP template using what is already written as a guide. Use blue, italicized text to signify instructions to future SOP writers that will use this template. Remember, this is a template and not intended to be an actual SOP itself. So will want to explain to the user as clearly as possible how they will use this template to create their SOP for particular process. This step may vary wildly depending on what type of SOP you are writing - whether it's for equipment, software, laboratory procedures, etc.
4. Enter all appropriate information into the Template Revision History EXCEPT for the Approver signatures.
5. If you have a paper-based QMS system, print off a paper copy of the template and obtain approver signatures. Store the signed template per your protocols. If you have a digitally-based QMS system, you may obtain seperate, digital approval if your business allows it and delete the approval signature section from this template.
6. Your SOP template should now be ready for use!

Again, you can use this for a wide variety of industries, but it is intended for use in medical device, drug, biologic, and biotech companies that require compliance to standards: ISO 13485, ISO 9001, and/or 21 CFR part 820.