What is a Quality Manual and Do You Really Need One?

Mar 15, 2022 | Manufacturing

Maintaining ISO quality standards is critical for businesses looking to meet customer requirements and for competitive advantages with sales and quality. Many companies choose to implement a quality management system (QMS) in order to meet these standards. These organizations may create a quality manual to ensure they are compliant.

An effective quality manual can help your organization to improve its quality performance and meet or exceed ISO requirements.

What Is A Quality Manual?

A quality manual is a document that provides guidelines for an organization to uphold the quality system processes and requirements of their QMS.

QMS Meaning

A quality management system (QMS) is a set of processes and procedures that an organization uses to ensure that its products and services meet or exceed customer and regulatory requirements.

ISO Quality Manual

An ISO quality manual meets the requirements of an ISO standard, such as ISO 9001:2015 or AS9100 RevD. This document describes the specific policies and procedures, as well as other relevant information, that an organization adheres to in order to meet the ISO compliance requirement, improve performance, and satisfy customers.

When Is A Quality Manual Necessary?

This document is often necessary when an organization wants to establish, improve, or certify its quality management system.

In order to improve quality performance, many organizations create a quality manual. An effective manual and level II procedures can help your organization to improve its performance and efficiency, as well as meet or exceed customer expectations and regulatory requirements.

While it is not a requirement for all businesses to create a quality manual, creating this document can be a major asset in setting standards, understanding and addressing inefficiencies, identifying opportunities for improvement, and aligning company goals.

Benefits of Having a Quality Manual

A man in a suit traces an upward curving line transposed on an illustration of a graph indicating progress.

A quality manual is beneficial for organizations because it helps them to organize their QMS, adhere to quality standards, and improve their customer satisfaction.

Additional advantages and benefits for organizations that have a quality manual include:

  • Improved quality performance
  • Compliance with customer and regulatory requirements
  • Increased efficiency and effectiveness
  • Improved communication and collaboration
  • Reduced costs

With an effective manual to reference, businesses are more likely to meet quality standards and earn an ISO certification.

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.

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