A quality manual documents your organization’s quality management system (QMS). The quality manual demonstrates an organization’s commitment to determining and fulfilling customer requirements.
The quality manual also communicates the QMS, it's documentation hierarchy, the organizational reporting structure and other information flows.
Confidence in a business’s products or services can be communicated and acquired by prospective customers by using a quality manual.
The quality manual is usually one of the first, high-level documents of a multi-tiered structure that is created or revised when establishing or updating a quality management system and can be used as a mission-statement for your organization.
More specifically, a quality manual includes information about your organization’s strategic direction, its goals, its mission, and policies, and as a useful induction tool for new staff and as a road map for how the QMS operates. The manual also includes requirements needed for the organization to be compliant with the ISO 9001 standard.
Some organizations are faced with the question of whether or not it’s worth trying to develop such a seemingly complicated document for their business. This is because a quality manual is not a requirement of ISO 9001 and is therefore, not a mandatory document.
However, many mature organizations with existing ISO 9001 certification or those currently working towards certification often prefer to retain and update their existing quality systems.
The quality manual demonstrates management’s accountability for the QMS and for determining and fulfilling customer requirements, it communicates the structure of the QMS to employees, business partners, and stakeholders, as well as keeping the QMS in-line with ISO 9001 standards.
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 includes:
The manual is primarily used as a source of information regarding your quality management system and ISO certification. However, it also provides the following information:
No, it does not matter how long your quality manual is. However, you don’t want to overwhelm your readers with a too much detail and extraneous information but you also want to ensure that all of the applicable requirements are described and the clauses covered without confusion.
We've prepared 10-page quality manuals and other manuals with more than 150 pages that included all the documented procedures and forms. Each version of the quality manual was certified, along with QMS, because it met the requirements - not because they were a certain page length.
A well written quality manual acts as an interface between the standard, which is generic, and the requirements that are deployed by your business’s management system. It conveys how the quality management system works and what controls are in place to manage each process. Therefore, the size, context and complexity of your organization and extent of its individual processes will heavily influence the volume of content in the quality manual.
PRO TIP! You need to write the quality manual so that the intended audience will use it. The primary audience should never be the External Auditor. A good quality manual document is one that has a clear purpose (is it easy to follow?) and is one that has a targeted audience (is it useful for stakeholders?), and is then written and designed to meet contextual expectations.
Manage expectations — most organizations prepare a quality manual that covers the requirements of the international standard, includes or makes reference to the necessary operational procedures and outlines of the basic requirements as they relate to your business’s operations. 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 each quality requirement in 37 pages of text, while the quality procedures (supplied as separate documents) carry the burden of defining how compliance is achieved at an operational level.
The quality management system information could even be included in other business documents such as an Operations Manual, Company Guidance document, or a Business Systems Manual, just don't forget to reference the process maps, quality procedures, forms and work instructions in whatever you use as a ‘quality manual’.
The key is to decide who needs to read the quality manual and write the content for them. Most internal auditors, regulatory bodies, suppliers, employees and customers who are likely read your quality manual will know what they are looking for. To add value, you need to decide what is useful to your organization in meeting your unique needs and in your unique context.
We would recommend going for a quality manual that generally addresses each section of the standard, but if you think a 3-to-4-page summary document with links to the lower-level procedures and forms will fulfil your organization’s needs, then go for it! You should ideally include an appendix in the form of a matrix that shows how the sections of your quality manual align with the standard’s clauses.
PRO TIP! Ask your business partners, 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 colleagues (Boss / Top Management) — particularly those new to ISO 9001. It will help inform and manage their expectations, while providing a benchmark for your industry.
If your External Auditor has stated there is a requirement to number the quality manual’s headings to the ISO 9001 clause numbers, ask them to show you the requirement in the standard, it is not a requirement but simply a recommendation.
People often argue that you should create the quality manual based on your operations, not on the numbering system of the standard. While linking the quality manual to the clause numbers acts as a useful cross-reference in the early stages of implementing ISO 9001, doing so might create a bit more work when the standard itself is revised.
PRO TIP! Though this extra work helps you to look more closely at the clauses of the standard, making sure you did not miss anything, keeping such references can be helpful for an External Auditor and new employees but it might also be helpful for management too!
As such, the heading titles and numbering used in our quality manual template relate to the standard for ease of reference.
We recommend to clients they gather and review a number of relevant quality manuals before starting their documentation.
1. Ask your business partners, suppliers and customers for a PDF copy of their business quality manual.
2. Download a sample of our Quality Manual Example PDF.
3. Search online.
There are many quality manual examples available online - some good, some poor... so you need to be careful and use your best judgement. Here are some TIPS:
Although ISO 9001 business quality manuals and QMS documentation are unique to each organization, they all follow the same ISO requirements — thus a template is ideal. Some of the more common ISO templates include:
Many online QMS Templates and ISO 9001 Toolkits include other useful tools for ISO certification, such as Internal Audit tools, a Gap Analysis tool, Project Plan etc. these are invaluable for first time implementation of your QMS; they will help you write your documentation in a more structured way.
The ISO 9001 standard and requirements are very clear for QMS documentation. It is therefore easier for all involved (internal and external — such as business partners, suppliers, as well as ISO auditors) if the quality manual’s table of contents is similar to or mirrors the requirements. As such, we recommend:
The quality manual must consist of:
The quality manual contents will be the same, no matter what industry you're in. If you're a small one-man engineering business or a large manufacturing, ISO 9001's requirements are the same; the difference will be in your operating procedures.
Our Quality Manual Template is proven to work.
The introduction of the quality manual introduces you to both the ISO 9001 standard and the Scope of 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.
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.
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 8.3 Design and Development.
This section of the quality manual offers a glossary of terms that will be mentioned throughout the remainder of the manual.
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 systems documentation. This section also features strategies that can help overcome such issues.
Internal issues are problems found within the organization itself. Some internal problems can be related to the following:
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:
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 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 are responsible for overseeing and implementing your organization’s new QMS and control of documents. 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.
In the PDCA (plan-do-check-act) cycle, there are four different phases necessary for leaders to go through. These steps are:
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 should look at current trends as well as looking out for risks that the organization should plan to overcome. Most importantly they should continuously monitor the effectiveness of the QMS system in addition to any improvements or success it achieves.
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:
The risk evaluation cycle is one way for leaders to assess risks regularly. The cycle includes the following steps:
Following this cycle will help your organization actively recognize problems before they become problems and create proactive strategies to combat them.
Top Management 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.
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:
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 spending, more frequent customers; in addition to an increased chance of bringing in new customers. This will eventually result in higher profits.
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!
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.
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.
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:
Understanding and 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.
Keeping communication active between your organization and customers will help improve satisfaction and help reduce any concerns they may have. 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 many ways you can maintain communication with customers, including:
Of course, with emerging new technology and social media, it is important for organizations to keep up-to-date with how your customers would like to communicate with you. Make it easy for them using the channel they best prefer.
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 systems are working correctly — and which aren’t, so you can make improvements later.
There are various methods of developing and responding to performance evaluation, 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.
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.
Your rating should be monitored monthly, at the very least. Various analysis techniques can be applied to review the data. Feedback — Failure or Success should be followed-up with customer communication.
As mentioned before, customer satisfaction directly effects sales and profit — which should always be your goal for growing the business.
Last, but not least, in the quality manual — the last of the mandatory requirements, 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.
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.
There are many types of data inputs that could relate to the success of your QMS, including supplier performance, internal and external audit results, and evaluation of 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 continual 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.
Now that you have a better idea of what the business quality manual and QMS documentation looks like and what it generally includes, it is now up to you to customize it to fit your business.
In its original digital format, the quality manual should be classified as ‘controlled’ document that must be maintained accordingly. The quality manual will generally lose its ‘controlled’ status once it is printed.
In order to make sure your quality manual fits the requirements from your quality management system or ISO 9001, your quality manual should:
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.
When implementing ISO, you will need to document the procedures involved in your quality management system, including:
You also need to document your main operating procedures or processes for your QMS.
Some companies recommend documenting lots of operating procedures — some Quality Manual Templates include 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 or 18 procedures; these Templates are suitable for all business types, large and small.
ISO 9000:2015 (3.4.5) defines a procedure as a specified way to carry out an activity or a process. With this in mind, businesses often risk becoming overburdened with too many procedures that document each business activity. This cumbersome methodology detracts from the 'process approach' that is a central theme in ISO 9001:2015.
It is up to you how many procedures you document, there are no hard and fast rules for ISO 9001.
Some companies like to document all their operating procedures - we've seen documentation with more than 40 procedures — but beware, the more procedures you document the more work and internal audits you are creating for yourself and your company.
We recommend documenting the following procedures, which satisfies all the latest requirements:
No matter how large or small your organization, by documenting the mandatory QMS processes, our documented procedures provide what you need to generate the records needed to ensure the effective operation and control of your organization's QMS and its processes. Our templates fulfill all the requirements of ISO 9001:2015.
Free download - Calibrated Equipment Procedure (ISO 9001)
This free procedure will give you an idea of the current level of documentation required for ISO 9001.
Our Quality Manual Template includes either 10 or 18 procedures.
Some ISO consultants and professionals recommend documenting many, many processes and procedures, we see some Templates with over 40 procedures!
We do not agree with this. It is not necessary to document all your business processes to achieve ISO 9001.
Do not create too much documented information with too many procedures. You are going to be creating more work for yourself and everybody. It is going to take more time and it is going to cost more money.
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.
Free download - 4 example Process Maps
Ensure your documents are easy to read and understand, do not use jargon specific to your industry. Write in a professional, informative and concise manner. Use short, broken up sentences, with informative images and simply state what is actually done, in the present tense; to describe the process as it is meant to happen.
Finally, your manual should be presented in a professional manner. Use your branding for the design and layout (this is where Templates that use styles, such as ours, are ideal). Distribute in PDF format, always with the date and/or version number in the filename or metadata.
The content of our quality manual and procedure templates is clearly articulated by using future progressive tense phraseology to describe the sequence of steps, actions and outputs as they are meant to happen.
PRO TIP! Written in a clear and unambiguous, active voice style; the quality manual and procedures use the verbs 'will' and 'must', instead of 'shall' or 'should', which expresses an expectation of what has to happen in the present or future. It also implies the willingness of someone to undertake the task and conveys the typical behaviour of the things that must be done.
If you find that your organization is struggling to create a quality manual, consider these tips:
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 the documentation at first, it is quite straightforward to do with the right template in hand.
Our Quality Manual Template is proven to work.
Further ISO 9001 QMS Documentation
Updated: 10th December 2023
Author: 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