$85.99

Quality Manual – Ready-to-Edit Template
The Quality Manual is a document that allows organizations to demonstrate how they meet the requirements of ISO 13485:2016 and fulfils commitments to their customers. It is often one of the first documents reviewed by auditors or regulators. This template is ideal for small to medium sized businesses who are looking for an easy to edit template to comply to the requirements of Clause 4.2.2 of ISO 13485.
$85.99
The Quality Manual serves as a simple document that:
- Provides employees with guidelines on how to go about their work, which procedures to consult and what should be checked to produce a high-quality product and / or service
- Helps employees find information quickly when there are questions about certain aspects of the processes provided by the organization
- Sets clear expectations for customers so they understand what to expect from the organization
What’s included?
The Quality Manual template includes:
- A section for the description of the Quality Management System
- An overview of the document structure within the organization
- Prompts that guide you on how to complete each section of the template
- Prompts that require you to reference relevant procedures and / or system documents in your Quality Management System
- A section addressing each section of the ISO 13485:2016 standard
We’ve also titled each section of the Quality Manual to correspond with the relevant sections of the ISO 13485:2016 standard. This makes it easier for auditors / regulators to ensure compliance is met.
Purchase your simple ready-to-edit Quality Manual template today!

Quality Manual – Ready-to-Edit Template
The Quality Manual is a document that allows organizations to demonstrate how they meet the requirements of ISO 13485:2016 and fulfils commitments to their customers. It is often one of the first documents reviewed by auditors or regulators. This template is ideal for small to medium sized businesses who are looking for an easy to edit template to comply to the requirements of Clause 4.2.2 of ISO 13485.
$85.99