What is a Quality Manual and Do You Really Need One? – Ledge Inc.

How to Write a Quality Manual and What You Should Include

When creating a quality manual, it is important to tailor it to your organization and outline the policies and procedures that fulfill applicable ISO requirements.

Writing Tips

When it comes to creating your own system with a tailored ISO 9001 quality manual, the process will likely vary for every business. Taking the right steps from the beginning will help you stay organized and ensure you have everything you need to meet your quality objectives.

Here are a few tips to get started on writing a quality manual that properly sets expectations:

• Identify the structure and format your manual will have
• Create an outline
• List out the policies you will need to write
• Write down relevant policies, procedures, and terminology
• Draft your manual
• Get input on the draft from all departments
• Maintain an attitude of continuous improvement and make revisions
• Arrange for the certification body of your choice to evaluate your manual and your performance against ISO standards
• Obtain formal approval and release

Recommended Inclusions

The specific contents of your manual and QMS will depend on which of the ISO standards you are striving to meet and the nature of your business. However, there are many common elements that tend to appear in quality manuals, such as:

• Organizational chart
• Policy statements for applicable standard requirements
• A detailed explanation of how your company structures documentation
• Operating procedures
• Definitions of industry-relevant terminology
• Internal audits
• External audits
• Management reviews
• Company context (regarding company culture and community involvement)
• Areas of improvement (and demonstrations of corrective action)
• Your quality policy, including its purpose and scope

When you write your performance manual, you may find that its contents vary from this list; the important thing to keep in mind is that your quality manual should ultimately fulfill its purpose in providing the proper documentation to meet your ISO standard of choice.

Updating a Quality Manual

A quality manual should be reviewed and updated regularly to ensure that it remains up-to-date. The frequency of reviews and updates will depend on the changes that occur within the organization. Generally, your manual should be reviewed at least once per year.

Improve Your Quality Standards With Ledge

In order to meet ISO quality standards, you will need to undergo both internal and external audits from a qualified auditor. You can outsource internal audits to the Ledge team to ensure your QMS and quality manual meet ISO regulations before your registrar comes to complete the certification/surveillance audits.

When assessing your QMS, we’ll dive deep to uncover any areas of improvement so you can take corrective action before you are visited by your registrar. We’ll help you ensure your QMS thoroughly addresses your operations and meets certification standards.