ISO-9000 Structure Template | Process Street ISO-9000 Structure Template – Process Street

How to use this template

Edit this template to remove or change the text in this section

This template is designed to help you easily build standard operating procedures which adhere to ISO-9001:2015 Quality Manual

Add this template to your organization in Process Street and you can export it to word and save as PDF once you have completed it.

Throughout each section, you will find concise instructions to complete your SOPs. You can select "Edit template" to change the text within each section. 

You are able to add new text, images, and subchecklists into this template by using the widgets on the right-hand side of the editing screen.

The ISO-9001:2015 requirements can vary between industries. If you need to view the specific standards and differences between industries, check this page of the ISO website.

More detailed information on how to work with ISO-9001:2015 can be found here.

Introduction:

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[Quality Manual Document Title]

Revision:
Date:
Doc Number:

Conforms to ISO-9001:2015

Amendments:

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Revision and Approval
  • [revision number] - [date] - [nature of changes] - [approved by]
  • [revision number] - [date] - [nature of changes] - [approved by]
  • [revision number] - [date] - [nature of changes] - [approved by]
  • [revision number] - [date] - [nature of changes] - [approved by]

Purpose:

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Welcome

[Include welcome text about the company here]

Quality Policy

[Include your quality policy here]

Responsibilities:

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Context of the Organization

[Include your context of the organization text. This should cover internal and external issues which could impact strategic direction]

Interested Parties

[List your interested parties here. This requires stakeholders who receive products/services, are impacted by products/services, or may otherwise have a significant interest in the company]

Scope:

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Scope of the Quality Management System

[Include your scope statement here. This must include a description of products/services. This will appear on any resulting ISO-9001 certificate. Consult with your certification body]

Locations

[List all physical locations with their full address where the business operates]

Exclusions

[List any locations which have exclusions from the QMS and identify which specific procedures are excluded]

Procedures:

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Process Management Methodology

[Explain your process methodology]

Top Level Processes
  1. Process 1
  2. Process 2
  3. Process 3
Complete Company Procedures

Procedure 1 [rename section titles in relation to procedure]

This is an example procedure. Edit this template to change the text in this section

Summary
  • This procedure defines the requirements for...
  • The ____ is responsible for the implementation and management of this procedure
Revision and Approval
  • [revision number] - [date] - [nature of changes] - [approved by]
Procedure
  1. Step 1
  2. Step 2
  3. Step 3
    1. Subtask 1
    2. Subtask 2
    3. Subtask 3
  4. Step 4

Procedure 2

This is an example procedure. Edit this template to change the text in this section

Summary
  • This procedure defines the requirements for...
  • The ____ is responsible for the implementation and management of this procedure
Revision and Approval
  • [revision number] - [date] - [nature of changes] - [approved by]
Procedure
  1. Step 1
  2. Step 2
  3. Step 3
    1. Subtask 1
    2. Subtask 2
    3. Subtask 3
  4. Step 4

Procedure 3

This is an example procedure. Edit this template to change the text in this section

Summary
  • This procedure defines the requirements for...
  • The ____ is responsible for the implementation and management of this procedure
Revision and Approval
  • [revision number] - [date] - [nature of changes] - [approved by]
Procedure
  1. Step 1
  2. Step 2
  3. Step 3
    1. Subtask 1
    2. Subtask 2
    3. Subtask 3
  4. Step 4

Procedure 4

This is an example procedure. Edit this template to change the text in this section

Summary
  • This procedure defines the requirements for...
  • The ____ is responsible for the implementation and management of this procedure
Revision and Approval
  • [revision number] - [date] - [nature of changes] - [approved by]
Procedure
  1. Step 1
  2. Step 2
  3. Step 3
    1. Subtask 1
    2. Subtask 2
    3. Subtask 3
  4. Step 4

Overview:

Process Sequence

[Upload a process diagram or flow chart if you have one]