ISO 9001 Quality Manual ~~ Everything You Need to Know

What is the ISO 9001 Quality Manual? The quality manual documents an organization’s quality management system (QMS). The Quality Manual demonstrates the commitment to meeting customer expectations delivering quality products or services.

Creating a quality manual for your organization seem intimidating, especially for businesses new to ISO 9001:2015. However, the key to overcoming this is to first understand what the ISO 9001 quality manual is, what it contains, and how a quality manual can help your organization.

The quality manual is often the first form of documentation created during the process of establishing a quality management system (QMS) of ISO standards. It is often used as a template for organizations to follow when implementing and improving their QMS.

More specifically, a quality manual “states the company’s intentions for operating the processes within the quality management system.” In other words, the manual includes information about the organization’s goals, expectations, policies, and more in relation to their QMS. The manual also includes requirements needed for the organization to be compliant with ISO 9001 standards.

quality management folder

Is a Quality Manual Required for ISO 9001?

Many organizations are faced with the question of whether or not it’s worth trying to develop such a seemingly complicated document for their business ISO implementation projects. This is because the quality manual is not always required by an organization’s QMS — or as a general ISO 9001 requirement.

ISO standards dictate that a Quality Manual is not required — it is not one of the mandatory documents or requirements of ISO (unlike some documentation and records).

Learn more about the ISO 9001 requirements and mandatory documents.

However, many businesses opt to include it anyway as a way to keep them accountable as it is useful for implementing ISO and in line with ISO 9001 standards.

Is a Quality Manual Useful?

The quality manual can be used in a number of ways, including:

  • Communicating management’s expectations to employees
  • Demonstrate the organization’s plan to conform to the latest ISO 9001 standard
  • Demonstrate ISO 9001’s Clause 5.3 in that all organizational roles, responsibilities, and authorities have been assigned, communicated, and understood
  • Provide company context for internal, customer, and ISO certification body auditors new to the organization

Benefits of the Manual

The quality manual provides a wide range of benefits for organizations. Not only is it organized and easy to follow, but it also covers almost everything you and your employees will need to know about the ISO 9001 standard and what is expected of your quality management system. Some of the other benefits the manual offers organizations include:

  • Improved quality management systems
  • Easier transition to ISO 9001 operations
  • Easier adjustment to updated ISO 9001 standards
  • Guidance in increasing efficiency and improving processes

How is the Quality Manual Used?

The manual is primarily used as a source of information regarding quality management systems and ISO certification . However, it also provides the following information:

  • Description of ISO 9001:2015 Clause 5.3, which outlines organizational roles, authorities, as well as responsibilities for assignment
  • Guidance on having clear and concise communication throughout the organization’s documents and between departments
  • Set expectations from both management and employees
  • Provided steps on implementing the new QMS
  • Serves as a form of evidence for auditors - those doing certification audits, the lead auditor and internal auditor(s)

How should I assign document numbers and their sequence?

We use the same numbering sequence as ISO 9001 in our quality manuals. You are free to replace these with a system that works best for your staff and for the business - as long as the system is logical, documented and communicated, it should be more than adequate.

We find it easier for external auditors during certification audits if it is the same as ISO standards. The lead auditor and other internal auditors often comment it is easier for documentation and records to have the same number and sequence as the requirements of ISO 9001.

Does it matter how big the Quality Manual is?

No.

The size and complexity of your organisation and its individual processes will determine the volume of information required to successfully convey how the system works and what controls are in place to manage each process.

We've prepared 10-page quality manuals and others with more than 150 pages. Each manual was certified because it met the requirements not because they were a certain page length.

My boss wants a 4 page Quality Manual - what should I do?
Managements expectations - organisations often address the requirements of the standard by preparing a quality manual that ‘covers the requirements of the international standard and includes or makes reference to the quality system procedures and outlines the structure of the documentation used in the quality system’. It would be difficult address all the requirements in 3 or 4 pages.

Most quality manuals are typically 30 or 40 pages in length. Our quality manual template addresses these requirements in 20 pages of text, while the procedures carry the burden of defining how compliance to a requirement is acheived at an operational level.

Ask your Suppliers and Customers for a PDF copy of their quality manual if they are ISO 9001 certified. It might be useful to go through these with your colleuges - particuarly those new to ISO 9001.

ISO 9001 building blocks

Quality Manual Template

Although ISO 9001 quality manuals are unique to each organization, they all follow a general template. Some of the more common ISO templates include the following:

  • Quality Manual
  • Policy statement
  • Objectives
  • Operating procedures

Many online Quality Manual templates include other useful tools for ISO certification, such as Internal Audit tools, a Gap Analysis tool, reports & forms, training material, six sigma processes etc.

Of course, there are many other topics your organization’s quality manual may include. The next few sections will follow the general outline/template of the quality manual found across businesses:

What Should be Included in a Quality Manual?

The quality manual’s table of contents includes a list of multiple chapters the manual will cover, including:

  • Introduction
  • Quality Management Principles
  • References and Definitions
  • Context of the Organization
  • Leadership
  • Management System Planning
  • Support
  • Operation
  • Performance Evaluation
  • Improvement
  • Appendices

The quality manual contents will be the same, no matter what industry you're in. If you're a small one-man business or a large manufacturing or pharmaceutical, the ISO 9001 requirements are the same, the difference will be in the documented operating procedures.

Introduction & Quality Management Principles

The introduction of the quality manual introduces you to both the ISO 9001 standard and the manual itself. The quality management principles section will cover the core principles that drive ISO 9001 operations, in addition to your quality management system.

References and Definitions

This section of the quality manual offers a glossary of terms that will be mentioned throughout the remainder of the manual.

Context of the Organization

The context of the organization section has a lot of information discussing various types of issues that may arise while implementing or updating the quality management system. This section also features strategies that can help overcome such issues.  

Internal Issues

Internal issues are problems found within the organization itself. Some internal problems can be related to the following:

  • Products
  • Services
  • Planning
  • Leadership
  • Workforce size

A SWOT analysis (Strengths, Weaknesses, Opportunities, and Threat Analysis) can be performed by an organization in order to get a baseline of where they stand in comparison to where they want to be after implementing the new QMS.
The results from a SWOT analysis also helps provide insight into what an organization’s current internal values are, which can include:

  • Performance
  • Knowledge
  • Culture
  • Competence
  • Strategy
  • Values

External Issues

External issues are problems that exist outside of your organization and can be much more challenging to overcome. External problems are usually associated with requirements that need to be met within your industry, in technology, globalization, and more.

Similar to how SWOT is used for internal issues, a PESTLE analysis (Political, Economic, Social, Technological, Legal and Environmental Analysis), is used to assess external forces that can affect your organization. The PESTLE analysis can also help businesses understand their target market and improve growth.

Your adopted quality management system should use both the SWAT and PESTLE analysis to continue monitoring potential internal or external conflicts.

Leadership

Leadership is one of the biggest principles expressed by the ISO 9001 standard. This is who is responsible for making sure that the development and implementation of the policies regarding your quality management system are going according to plan.

Top management and management responsivities will be involved a lot when it comes to overseeing and implementing your organization’s new QMS and documents control. Some of their responsibilities will include directing strategies and providing communication in processes and performance.

They will also need to make sure that resources for ISO implementation are allocated to areas that need more focus on improvement and responsibilities are distributed to the right people or departments.

For example, leadership may need to ensure that the quality manager has all of the necessary resources—such as finances or technology—to initiate processes and complete them successfully.

quality management folder

Leadership in the PDCA (Plan-Do-Check-Act) Cycle

In the PDCA (plan-do-check-act) cycle, there are four different phases necessary for leaders to go through. These steps are:

  1. Plan - This is when strategies are developed to implement or improve the quality management system. Leaders must make sure that these strategies are followed through.
  2. Do - Leaders must ensure that each step of the developed strategy is performed correctly. It is in this phase where they must check resources and the distribution of tasks to ensure it aligns with QMS needs. They may also monitor improvement, assess risks or problems, or review the outcome of recent QMS changes.
  3. Check - This is essentially a review of everything that was done during the “Do” step. This will include checking the system’s performance, making sure that it is working properly, and changes that have been put in effect. Policies and other documentation will also be under review. 
  4. Act - The final part of the cycle is acting. This phase involves making sure that all changes made for improvement have been put into place, as well as removing any processes or changes that previously provided negative results.

Governance

The governance structure of an organization is also a large part of the quality manual’s leadership chapter. This section of the manual should discuss what the company defines as “proper support” in order to make sure processes are able to complete objectives under the ISO 9001 standards of quality.

The governing leaders of the organization will also be responsible for verifying the system itself, usually through the form of internal audits and reviewing data. Leaders with this responsibility may also look at current trends and overall QMS performance.

It is important for governing leaders to continuously monitor the effectiveness of the QMS system in addition to any improvements or success it achieves. It is equally important to continue looking out for risks that the organization should plan to overcome.

Management System Planning

This next chapter in the quality manual is focused on management system planning. In order to have success in this area, there are a number of features to assess, including internal and external connections, risks/issues, successes, and opportunities that may arise.

The best QMS will consider maintaining a balance between the number of risks versus opportunities available from certain processes. This balance must be managed internally in order to achieve effectiveness.

Risks and opportunities will need to be reviewed in the following contexts:

  • Internal context
  • Stakeholders
  • External context
  • QEHS management system

Risk Evaluation Cycle

The risk evaluation cycle is one way for leaders to assess risks regularly. The cycle includes the following steps:

  • Plan
  • Identify
  • Assess
  • Respond
  • Review
  • Report
  • Monitor
  • Repeat

Following this cycle will help your organization actively recognize problems before they become problems and create proactive strategies to combat them.

Top Management

This group is responsible for ensuring that a risk-based style of thinking is implemented within your organization. They are in charge of establishing procedures and planning around risk management and make sure that your organization’s principles are included in your quality management system.

Top management will also be expected to provide the resources necessary to cover any processes within their departments, as well as planning and assigning responsibilities for ISO certification.

Support

The next chapter that is covered in the quality manual is support. Support can come in many forms, including customer support, financial support, and even human resources. The goal of support is to ensure improvements are made in some of the following areas:

  • Customer satisfaction
  • Employee satisfaction
  • Human resources
  • Financial resources
  • Working area

The biggest area of focus in this section is customer satisfaction, which is critical to any company’s success. Without customer satisfaction, your business risks profit losses in addition to a reduced customer base and market. On the positive side, having good customer satisfaction leads to higher frequent customers, in addition to an increased chance of bringing in new customers. This will eventually result in higher profits.

General

General support includes resources such as human resources and financial resources, as well as the working environment. Making sure your employees are satisfied with their work environment is important. With comfort, efficiency, and productivity in the workplace, your employees will produce more quality products and services. Your customers will thank you later!

People

Job descriptions are designed to include all of the qualifications and experience your organization requires from ideal candidates for a specific position. Descriptions also include a general list of responsibilities that come with the role. Creating an accurate job description will help you filter out candidates much more effectively, saving time and effort both for applicants and hiring managers.
One reason why human resources is required in the hiring process is that they often hold records for employee qualifications. They also have documentation surrounding training materials new employees will need in order to perform their roles effectively and efficiently. Having human resources involved makes the hiring process go more smoothly.

Infrastructure

Organizations need building blocks and blueprints to be successful, and that is exactly what the infrastructure section of the quality manual does a great job of covering.

Providing necessary resources to departments and maintaining them are important for a successful working environment, whether it be physical workspaces or software. Quality managers and facility managers will often be the brains behind this process, responsible for making sure operations are completed successfully.

Operation

Managing operations is one of the hardest parts of implementing a new quality management system, as it requires a lot of time and energy to ensure its success. While your organization plans operations, certain operation details will need to be reviewed, including:

  • Objectives and requirements for the product or service
  • Verification, validation, monitoring, inspection, and test requirements
  • Documented information to demonstrate conformity
  • Related life risks and opportunities
  • Documented information to demonstrate conformity and control of nonconforming products
  • Necessary resources or outsourced processes and their controls
  • Criteria for process performance and product/service acceptance
  • Potential consequences and mitigation to change affecting input requirements
  • Resources necessary to support the ongoing operation and maintenance of the product

Customer Requirements

Meeting customer requirements is crucial. As mentioned earlier, making sure that customers are satisfied with what they receive from your business—whether it be a product or service — is important to a company’s success.

Customer complaints should be documented and fed into the continuous improvement process or control of nonconforming process.

In fact, the ISO recommends that your customers’ expectations should be exceeded to ensure continual growth and success.

Communication

Keeping communication active between your organization and customers will help improve satisfaction and help reduce any concerns they may have as well. The customer service team and the sales and marketing department are both responsible for ensuring a line of communication always exists between you and the customer. There are a few ways companies can maintain communication with customers, including:

  • Emails
  • Inquiries
  • Letters
  • Surveys
  • Notes
  • Customer care center
  • Data sheets

Of course, with the age of modern technology and social media, there are many more ways for organizations to communicate with their customers.

Performance Evaluation

Owners are always anxious to see performance evaluations. However, it is important to review your business’s performance rate routinely, so you know which facets of your quality management system are working correctly—and which aren’t, so you can make improvements later.

There are, in total, seven types of methods of developing and responding to performance reviews, including looking trends that occur in non-conformities, creating and implementing corrective actions and reviewing requirements set out by both the QMS and ISO 9001.

Customer Satisfaction

We’ve talked about customer satisfaction quite a bit already, but this is next up on the list for the requirements of ISO and should be part of your documentation and records.

The rate of success in this department should be monitored monthly, at the very least. Success can be followed by various analysis techniques to review the data.

As mentioned before, customer satisfaction will generally result in having an increase in profit, which is always a goal for growing businesses.

Improvement

Last, but not least, in the quality manual - the last of the mandatory documents, we have improvement. The quality manager is one of the more important roles involved in this section, responsible for using evaluation tools to assess the QMS and develop recommendations for improvements.

Your organization should also make sure that the data that is analyzed is relevant to your QMS and relates to both short-term and long-term improvement.

There are 11 types of data inputs that could relate to the success of your QMS, including supplier performance, internal and external audit results, and evaluate risks and opportunities. The quality manager often checks these data inputs as they become available.

If there are changes required to ensure that there is more improvement in your organization’s processes, the quality manager may recommend a series of corrective actions that will need to be performed before your next audit or performance evaluation. The success that stems from these corrective actions will be assessed through the management review process.

ISO 9001 building blocks

Non-Conformity & Corrective Action

The ISO 9001 quality manual ends on the note of non-conformities and discussing corrective actions that can address them. Any non-conformities found are brought to the attention of the quality manager. The records from these findings are then logged alongside recommendations for corrective actions to resolve them.

Creating a Quality Manual & Document Management

Now that you have a better idea of what the quality manual looks like and what it generally includes, it is now up to you to customize it to fit your business. In order to make sure your quality manual fits the possible requirements from your quality management system or ISO 9001, your quality manual should:

  • Demonstrate proper roles are assigned for processes
  • Provide clear, concise information throughout
  • Be detailed, but not too long
  • Break up segments frequently

Scope of the Quality Management System

You should include the boundaries of the new quality management system in your quality manual. Mention the types of products or services your organization offers, in addition to the industry you work in.

Learn more about how to write your scope

Also, make sure you mention exclusions for your business, rather than omitting them entirely. Some ISO 9001:2015 requirements, for example, may not apply to your specific organization, such as Clause 7.3 Design and Development. The ISO 9001:2015 guide provides more information regarding how to mention exclusions to your quality manual.

Documented Procedures

When implementing ISO, in your quality manual, you will need to mention the documented procedures involved in your quality management system, including:

  • Preventive actions
  • Corrective actions
  • Control of non-conforming products
  • Control of documents
  • Control of records
  • Internal audit

You will also need to include information about written procedures or policies for your QMS.

Some companies sell Quality Manual Templates with lots of procedures - some more than 40 procedures! Our advice is to NOT make life so complicated for yourself, there is no need to document all these procedures, keep it simple and document fewer. Our ISO 9001 Quality Manual Template for example, comes with 10 procedures; this Template is suitable for all business types, large and small.

Process Maps - Description of Interaction of Processes

Represented by a flow chart, this description helps showcase each and every process within your company and how each one is connected to the other. This really is quite beneficial, as it does a great job of tying everything up and providing clarity if there is still any confusion left.

The description also makes the processes clear and concise to employees as well, which is important in ensuring they understand how to perform their tasks efficiently.

Get 4 FREE process maps here

Length

Length is always tricky for a quality manual. You don’t want to overwhelm readers with a ton of information, but you also want to ensure that all of the most important areas of your manual are covered, so there is no confusion left by the end.

It is recommended to try to keep your quality manual on the shorter side, as it will do a better job of keeping attention spans longer. Also, you may add certain features to help provide understanding or information about your organization, such as a mission statement.

USEFUL TIP! Ask your customers and suppliers for a PDF of their quality manual. You will find these invaluable and will they will help Top Management envisage the work to do. Ensure your quality manual is compatible with your most trusted suppliers, if possible.

How you frame your manual will be critical to its success, so you will want to make sure that it is written in the most informative, concise manner, so it offers the best of both worlds.

At the end of the day, you will also want your manual to be easy to read. Small, broken up sentences, with informing, large pictures are a great way to start.

Finally, your manual should be presented in a professional manner. Think about how articles are set up to be appealing and use inspiration from that to help with your quality manual’s design and format.

helpful tips

Final Tips for Creating Your Manual

If you find that your organization is still having trouble creating a foolproof quality manual, consider these tips:

  • To pass a certification body audit, a Quality Management System must be an auditable entity.
  • Just writing about it is not enough – the QMS must also be implemented.
  • Aim for minimal documentation (especially if you're a small business). Don't document 40+ procedures - you're creating too much work for everyone.
  • Start with the assumption that you're currently doing all (or most) of what ISO 9001 asks.
  • Use separate documents for each procedure.
  • Use the same numbering as the standard.
  • USEFUL TIP! Ask your Suppliers and Customers for a PDF copy of their Quality Manual.
  • Use a Quality Manual Template - start your documentation out on the right track.
  • Create a list of policies that your organization needs. Think about what requirements you need to meet ISO 9001 standards in addition to what helps fulfill your quality management system’s needs.
  • Draft policies based on ISO requirements. These will be the most important, so make sure that you continuously review and revise them as needed until they are compliant.
  • Make sure that any terms specific to your company or industry are defined in a glossary or appendix within the manual; never assume that everyone will understand those business-specific terms.
  • Determine a general format for your quality manual and create a few first drafts to review and tweak as needed. Allow management from all departments to review the manual to ensure that the final draft is accurate to their areas. Doing this will also help you identify any inadequacies in various sections.
  • Once your team has finished reviewing and have agreed on any revisions, obtain a formal approval for the final draft before releasing.
  • Revision Control is important - particuarly if many people are involved with contributing to different documents. Always document the revision date.
  • Make sure your official quality manual stays a controlled document as per ISO 9001 requirements. Update the document as your business needs change, and keep the language simple and easy for anyone who has access to it to understand.
  • Finally, ensure your quality manual is relevant to your organization; one of the benefits of creating a quality manual is that it can be unique to your business and your business alone.

Whether your business is looking to better satisfy ISO 9001 requirements or simply needs a way to ease the transition to a new quality management system, a quality manual can help. Although it seems complicated to create, it is quite simple to do with the right template in hand. From there, customizing your quality manual to fit your organization becomes easy.

 

ISO 9001 Documentation

 

Updated: 19th September 2019
Author: Richard Keen

Richard Keen

Richard Keen

Richard is our Compliance Director, responsible for content & product development.
But most importantly he is ISO's biggest fanboy and a true evangelist of the standards.
Learn more about Richard

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