- A Quality Manual – what is it and what should it contain?
- ISO 9001 Quality Manual
- Quality Manual
- Is a Quality Manual Required for ISO 9001?
- Find out about our course ranges
- Related Articles
- 4.2.2 The Quality Manual in ISO 9001:2015
- ISO 9001 Quality Manual ~~ Everything You Need to Know
- ISO 9001 Knowledge base
- Is a Quality Manual Useful?
- How to write a short, concise Quality Manual
- Sections of a quality manual
A Quality Manual – what is it and what should it contain?
ISO checklist. Help Contact Us. 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 However, the key to overcoming this is to first understand what the ISO 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. The manual also includes requirements needed for the organization to be compliant with ISO standards.
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 requirements and mandatory documents.
ISO 9001 Quality Manual
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 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 standard and what is expected of your quality management system. Some of the other benefits the manual offers organizations include:.
The manual is primarily used as a source of information regarding quality management systems and ISO certification. However, it also provides the following information:.
We use the same numbering sequence as ISO 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 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 page quality manuals and others with more than 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? 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. It might be useful to go through these with your colleuges - particuarly those new to ISO Although ISO quality manuals are unique to each organization, they all follow a general template.
Some of the more common ISO templates include the following:. 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 requirements are the same, the difference will be in the documented operating procedures. The introduction of the quality manual introduces you to both the ISO standard and the manual itself. The quality management principles section will cover the core principles that drive ISO operations, in addition to your quality management system.
Is a Quality Manual Required for ISO 9001?
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 management system.
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.
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.
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Leadership is one of the biggest principles expressed by the ISO 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.
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 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. This next chapter in the quality manual is focused on management system planning. 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. 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.
This group is responsible for ensuring that a risk-based style of thinking is implemented within your organization. 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.
4.2.2 The Quality Manual in ISO 9001:2015
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:. 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.
ISO 9001 Quality Manual ~~ Everything You Need to Know
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.
ISO 9001 Knowledge base
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.
Is a Quality Manual Useful?
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.
How to write a short, concise Quality Manual
While your organization plans operations, certain operation details will need to be reviewed, including:. Meeting customer requirements is crucial.
Customer complaints should be documented and fed into the continuous improvement process or control of nonconforming process. 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:.
Of course, with the age of modern technology and social media, there are many more ways for organizations to communicate with their customers. Owners are always anxious to see performance evaluations. 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 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. 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.
Sections of a quality manual
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.
The success that stems from these corrective actions will be assessed through the management review process.