Newbury ~ 01635 595123
Warrington ~ 01925 206123

The Quality Manual

Quality Manual – guidance for all levels of the organisation

The top-level document in your Quality System is the Quality Manual. This essential document pulls together all the other documents in your Quality Management System (QMS). A QMS is a set of values and processes put in place by an organisation to ensure it meets high enough standards to satisfy customer requirements, expectations and specifications. As a result, the Quality Manual sets out the commitment of your organisation to meet, and even exceed, customer expectations. It is your baseline statement of intent to deliver quality products or services. Hence, the Quality Manual represents the heart of the ISO Standard addressed by the QMS.

The Quality Manual is the first, and most important, document in your QMS. It is the document that sums up the organisation’s aspirations for, and current state of, the QMS.

Scope of the Quality Manual

The Quality Manual has a number of important jobs. In general, these provide:

  • Reasons for developing a QMS framework in your organisation.
  • The statement of the role of Quality within your organization.
  • A demonstration of commitment to Quality principles and continuous improvement.
  • The requirements of the QMS standard your organisation is using.
  • A summary of your QMS as you have it in place now.
  • Detailed statement of what you are going to do to implement the QMS.
  • The scope of the QMS, including a justification for any exclusions, references to specific documented procedures and a description of the processes of the QMS and their interactions (diagrams).
  • A definition of organisational structure by assigning the appropriate roles, responsibilities, and authorities.

While the Quality Manual provides for a wide scope, it is especially important. This is because it is the top level document that pulls the all the others into a coherent system.

Hierarchy

As the top document in your QMS, the Quality Manual references all the other documents in the system. For example, the role of Quality within your organization requires at least a specific umbrella statement. Then, under that statement, the Manual requires a full reference to policy, “Quality Policy and Quality Objectives” in a further section.

In fact, a clear hierarchy provides the preferred model for organising a Quality Document System. For example, it could be laid out like this…

  1. Quality Manual.
  2. Policies.
  3. Procedures
  4. Work Instructions.
  5. Check Lists.
  6. Forms.
  7. Supplementary and external documents.
  8. Work specifications.

Set out like the above heirarchy, the organisation of your documents becomes easy to understand. Most important, the Quality Manual sits as the over-riding document. In effec, it enables you to introduce the QMS. Furthermore, it will act as the top reference point to all the detail in the sections below.

(See also in the ISO online store: ISO 10013:2021 :: QUALITY MANAGEMENT SYSTEMS — GUIDANCE FOR DOCUMENTED INFORMATION )

Creating and using the Quality Manual

The Quality Manual is usually the first document created for the QMS. It includes information about the goals, expectations, policies, and plans of your organisation. So, pulling all the detail and policies together is a good way of starting off the document hierarchy. Subsequently, once Management agree the policy documents, the rest of the documentation follows. Each new document builds upon the principles and policies in the Quality Manual. Consequently, this gives the organisation an overview. Thus, the manual acts as a guide to help your QMS work better, as further detail gets added..

Principles and policies – for everyone

Some people think the Quality Manual is irrelevant to the staff. Nothing could be farther from the truth. In fact, the Quality Manual is useful at all levels of the organisation. Here are some ways it helps. For example, the Quality Manual will…

  • Communicate the expectations of the management to employees.
  • Set out the plan to conform to the chosen management standard.
  • Demonstrate ISO 9001’s Clause 5.3 (The assignment, communication and understanding of all organizational roles, responsibilities, and authorities).
  • Provide company context for internal, customer, and ISO certification body auditors new to the organization.
  • Create a primary training tool for staff induction, instruction and development.
  • Help the entire staff understand the context and place of the organisation in the community.

The characteristics of a good Quality Manual include simple, clear writing. Of course, maintaining clear documentation means all levels of staff will find it easy to read and understand. It is worth making sure that clarity is achieved because it also makes it easy to follow the details and get feedback. Feedback, especially, leads to improvements. So, make it a priority to ensure your documentation is clear and understanable.

The benefits of a Quality Manual

An effective Quality Manual should stand alone as the central repository of “How we do things here”. It should cover everything that people need to know about the Quality Management Standard set within your organisation. The Quality Manual should also make clear the the expectations and goals of the QMS. Then, the staff will be able to see the effectiveness of the system overall. So, with training, everyone will also recognise the benefits and improvements as they come along. So, the Quality Manual is undoubtedly the best guide to the the document system overall.

Let’s talk about benefits and improvements. Firstly, the Quality Manual sets out the principles for the various QMS procedures. Secondly, the Quality Manual links to the details of those procedures. Also, the Quality Manual refers to the detailed work instructions that staff follow while working. So, from the top down, the Quality Manual refers employees to actions that can directly help them in their work. Furthermore, it can also provide an organised way for employees to find better ways of doing things. Thus, the benefit of having a set of procedures and work instructions set out is to find ways to improve those very procedures and instructions. Significantly, a good QMS will be easy work with. So, improvements will be easy to find, to document and to put into place.

Other benefits

There are other benefits to developing the Quality Manual and the documents in the hierarchy under it. These benefits go beyond improved quality management systems. Examples include…

  • Easier transition to Quality Management Standard operations.
  • Smoother adjustment to future updates in the Quality Standards your organisation meets.
  • Guidance for staff and management in increasing efficiency and improving processes.
  • Improved and consistent training standards you can apply through the organisation.
  • Easy reference guide for all aspects of organisational operations.

What goes into your Quality Manual?

Under the top-level of the Quality manual are a whole range of other documents. Altogether these make up the QMS. So, what are these other documents?

The documentation covers all aspects of the quality system. For example, these might include…

Top level documents
  • Quality Mission Statement for the organisation to explain your aspirations.
  • Introduction to your Quality System and the Standard(s) it will meet.
  • The Quality Management Principles:
    • The Quality Policy.
    • Detailed Quality Objectives.
  • Quality References to the relevant standards and requirements you will meet.
  • An organisational glossary to explain Quality Terms you will use.
  • The internal and external Context of the Organisation and its QMS:
    • Strategic direction;
    • External factors affecting the organisation;
    • Internal factors the QMS must encompass and improve.
Management of the QMS
  • Leadership:
    • Management overview;
    • Management responsibilities;
    • Directing strategic developments;
    • Planning Quality improvements;
    • Implementing Quality improvements;
    • Ensuring customer satisfaction (inclusive of meeting customer requirements).
  • Quality Management System Planning – The strategic direction of the QMS.
  • Support – providing resources and appropriately qualified personnel:
    • Employee fulfilment (happy staff are effective staff);
    • Human resources;
    • Financial resources;
    • Healthy, safe and pleasant working and rest areas;
    • Supply of appropriate non-financial resources.
The Operational Documents
  • Operational planning, detail and review:
    • Operational strengths, weaknesses, opportunities and threats;
    • Objectives and requirements for the product or service operation;
    • Operational verification, validation, monitoring, inspection, and test requirements;
    • Documented information to show conformity to the QMS and to specifications.
    • Documentation and evidence to show:
      • conformity and control of nonconforming products or services
      • effective operational record keeping for evidence
    • Planning, implementation, control and management of resources or outsourced processes;
    • Criteria for successful operational performance and product or service acceptance
    • Potential consequences and mitigation to change affecting input requirements
    • Resources to ensure the ongoing operation and maintenance of the product or service
  • The Quality Management of Documents.
  • Quality Management of Audit, Inspection and Review.
  • The Quality Management of Continuous Improvement.
  • Performance Evaluation.
Additional documents and references
  • Appendices to the Quality Manual.
  • Quality References (to internal and external documentation and sources).
  • Additional documents related to the QMS but not necessarily Quality Documents:
    • Specifications, contracts, service requirements etc.
    • Specific reference books, manuals, websites etc.
    • Details of licence verification, distribution control, validation, monitoring, inspection, and test requirements for management of software.
  • Index to the Quality Manual (and therefore the QMS).

It’s pretty easy!

That list looks like it might take a lot of work. However, most organisations find that much of the material needed to put together the Quality Manual already exists. So, each department, or operational unit, will quickly be able to put their hands-on existing guidance and documentation. Basically, that is your starting point for putting together your Quality Manual. Furthermore, it structures the hierarchy of documents underneath.  There is obviously some research needed to do this work. So, the documents in your Manual may not all immediately fall into place. Nevertheless, step by step, you will move toward meeting the requirements of the Quality Management Standard. As a result, your QMS will help you to improve the standards of your business overall.

At CHARTER4 we have many years experience of helping business organisations implement standards projects of all types. Central to all of them is a Quality Manual for the Standard they are pursuing. Basically, we think it is important that you gain your certification. However, we also subscribe to one other principal. That principle is to, significantly, ensure you get a real business return for your investment in ISO Standards. We therefore focus our attention on ensuring your QMS will, “Improve your business, rather than just comply”.

We have some established methods, and effective techniques to help you. In particular, we want you to achieve your ISO Standards goal with maximum business improvement while your ISO project is underway. If you would like to know more about our unique approach, simply press one of the buttons below.

Your Quality Manual acts as the top-level document for all your other QMS documents.
If you can’t explain it simply, you don’t understand it well enough.

~ Albert Einstein

Certification with Charter 4 – the Business Benefits
  • Improve, rather than just comply.
  • Full service and ongoing support to compliment your resources.
  • Build on your Processes & Systems (no standard templates).
  • Help defining your Best Practice.
  • Certification by independent UKAS accredited Assessors.
  • 100% Success & guaranteed support until Certification.
  • Help to get Government Grant (when available).
  • Flexible support to complement your resources.
CHARTER4 – Partners you with the experience and insight to help you grow using management Standards. We will help you improve your business, rather than just comply with the Standards.