Quality Tools & Templates

Process Description SIPOC

Click the link above for a template of a QMS Process Description. The selected approach is SIPOC, called out in ISO 9001:2015 0.3. Add your QMS header/footer and create your own process template. Define your own QMS process list and assign process owners. Once developed list in your Quality Manual and Process Interaction Illustration.

QMS Process Owner

Click on the icon above for an example of a work instruction for the role of a QMS Process Owner.

Letter of Delegation

Management Representative

Click on the link above for an example template for a letter of delegation for Management Representative

Key Performance Indicators

Click on the icon above for an example list of key performance indicators and some sample process names in the form of a KPIs tracker. Modify and use as you wish.

CAPA template using 8D problem-solving methodology

Click on the icon above to access an example of a CAPA form applying the 8D problem-solving methodology.

QMS Processes List & Process Interaction Illustration

Click on the icon above to get to an example of an illustration of QMS process interaction. Here you will then see a generic example list of QMS processes listed under Plan-Do-Check-Act. You may have other applicable processes such as Field Service or Clinical Operations or others that you should add.

Quality Management Review - QMS Process report-out template (4-blocker)

Click on the link above for an example template for process content to be presented at Quality Management Reviews.