What’s the Difference Between a Quality Manual and Quality Plans?

If you’re responsible for introducing a quality management system into your company or department, you must understand the differences between a quality manual and a quality plan. Though these documents go hand in hand with an organization’s quality management, they entail different things.

Quality Manuals

Quality management system manuals are documents that define and explain a company’s quality management system. They provide a framework for meeting quality requirements and show the company’s commitment to maintaining this system.

QMS manuals comprise all the following records:

Quality policy statement: This document details the level of commitment an organization exhibits in maintaining quality.

Quality policies: The quality policy outlines a company’s plans in great detail and includes extensive documentation.

Standard operating procedures: These procedures identify the parties responsible for carrying out each activity and their allotted time frames.

Work instructions: Work instructions highlight the activities and procedures set to occur.

Quality Plans

Quality plans are documents that outline the quality standards, resources, specifications, practices, and processes for a specific project, product, or service. Their goal is to identify all the requirements needed to deliver the product or service as intended.

Quality plans outline all procedures that fall under the following activity types:

Quality assurance: These activities include all proactive preproduction efforts, such as developing quality standards and creating process checklists, and striving to improve process accuracy

Quality control: Quality control procedures refer to reactive post-production efforts focused on identifying any defective goods or services. Examples include product monitoring and inspections.

In short, a quality manual defines a business’s quality management system, while a quality plan explains how a company will meet quality requirements for a specific product or service.

Content:  What to Include in Your Quality Manual

For ISO 9001:2015 users, the contents of your quality manual are entirely up to you and should be based on your processes. ISO requires you to provide evidence of your QMS’s intentions, actions, and results. When creating your quality manual, focus on making sure the policies you include accurately reflect your actual practices.

Here are some common topics included in quality manuals.

• Quality policy
• Explanation of the company’s documentation structure
• Organizational chart
• Policy statements for each applicable ISO requirement
• Reference to operating procedures

These are not required by ISO – your quality manual may not cover each of these topics, or it may include much more. The key is to strike a balance between what could be included and what truly needs to be, focusing on the essential elements that will make your manual effective.

At Core Business Solutions, we recommend six steps to help you break down the task, creating a manageable and approachable process.

1. List policies to be written i.e. a Quality Policy (note any ISO requirements that do not apply).
2. Draft policies based on applicable ISO requirements.
3. List operating procedures or refer to them as appropriate.
   • • Including the operating procedure for each process included in your QMS.
4. Determine the format and structure of the manual and make the first draft.
   • • The format of your quality manual is dependent on your specific needs and company. Remember to aim for simplicity and focus – it doesn’t have to be long, it just needs to be applicable and effective.
5. Circulate the draft manual for input from all departments and address inadequacies identified.
   • • Lean on the experts within each process to ensure that this “how to” document is as accurate as possible. This could include review by process handlers in addition to management and leadership.
6. Attain a formal approval and release.
   • • “Release” is the complete and thorough communication of the manual to your full team. Your company will need to be intentional with regard to training and communication so that the manual truly serves a purpose (as opposed to just being something you “have”).

The quality manual is a controlled document that must be carefully handled, requiring stringent communication protocols throughout its creation, as well as regular reviews to update and maintain the accuracy of the manual.

XX Management Review

XX.1 Requirement: Top management conducts planned reviews of the QMS to ensure its suitability, adequacy, effectiveness, and alignment with the strategic direction considering:

• the status of actions from previous management reviews;
• changes in external and internal issues that are relevant to the QMS;
• information on the performance and effectiveness of the quality management system, including trends in:
• customer satisfaction and feedback from relevant interested parties;
  • the extent to which quality objectives have been met;
  • process performance and conformity of products and services;
  • nonconformities and corrective actions;
  • monitoring and measurement results;
  • audit results;
  • the performance of external providers;
  • the adequacy of resources;
  • the effectiveness of actions taken to address risks and opportunities;
  • opportunities for improvement.

The outputs of management review are to include decisions and actions related to:

• opportunities for improvement;
• any need for changes to the quality management system;
• resource needs.

Retain documented information as evidence of the results of management reviews.

NOTE how this section directly addresses the REQUIREMENTS of what is EXPECTED of each management review meeting. It OUTLINES what is to be executed during each session.

XX.2 Policy: Our management reviews are planned and occur on a [interval] basis. At a minimum, these reviews are attended by:

• President
• VP, Business Development
• VP, Operations
• Quality Manager

The Management Reviews are scheduled and a meeting agenda consisting of all required inputs is prepared.

Outputs from Management Reviews include the actions and decisions relating to any opportunities for improvement, needed changes to the QMS and resource needs.

This is short and to the point, stating the expectation of this specific section of the manual and the requirements related SPECIFICALLY to Management Review Meetings.

XX.3 Records: The meeting minutes and outputs are retained on the [record name].

Once more – simple and to the point, this section simply states where one can access the records of the management review meetings.  You may follow this same format as your work through the additional applicable requirements for your system and business.

As you work toward certification, it’s crucial to be constantly vigilant to purpose, benefit, and balance as you create the required or supporting documentation. Careful considerations of how policies, procedures, and records are reflected can help organizations ensure they are completing tasks and living up to the standards they have set for themselves.

Implement an ISO-Compliant QMS Today

You can ensure your company meets ISO 9001 requirements by implementing a compliant QMS with the help of Core Business Solutions. Our family-owned company is dedicated to helping American small businesses get ISO certified.

Contact us to learn more about our services today!