How to Create a Quality Manual for Your Laboratory the Smart Way (and Impress the Auditor!)

In this article, we will share tips on how to write a quality manual the smart way, as well as how to maintain and improve it over time.

Have you ever wondered how to write a quality manual, what makes a good one, or why you even need one? This article will answer all these questions and more. 

For far too long, organisations have treated quality manuals like the bible of their Quality Management System, comprehensively describing every single process they have. Or worse, regurgitating the standard almost word by word, replacing the ‘shall’ with ‘will’ without explaining how the requirements are met.

It doesn’t have to be that way. 

A quality manual is essentially a document that describes your quality management system.

Historically, a quality manual was a requirement for ISO certification until the revision of ISO 9001: 2015, where the provision of a quality manual was removed. 

Nevertheless, it is still essential as it gives an overview of your quality management processes and acts as a road map or framework for meeting quality system requirements. You can also use it to train new staff or create new systems in your laboratory. 

Moreover, whilst not a compulsory audit requirement, a quality manual is helpful for internal and external auditing. 

For external auditors, it demonstrates your laboratory’s commitment to quality; for internal auditors, it gives structure to your quality monitoring processes and helps identify and fill any gaps in your quality management systems.

Identify Relevant Standards and Requirements

The structure and the content of a quality manual can vary depending on the size of your organisation, the complexity of your operations and the standard you are following.

For laboratories, ISO 9001 and ISO/IEC 17025 is a common starting point. ISO 9001 is a general quality management system standard, and ISO/IEC 17025 is specific for testing and calibration laboratories. 

Depending on the nature of your lab (medical, environmental, food testing, etc.), there might be other industry-specific standards to which you must also adhere. Research these based on your lab’s focus.

How to find the relevant standards

  • Review the ISO website for information on various standards.
  • Research other similar organisations and the standards they are certified to/ accredited for. You can find many examples of laboratories on the NATA website
  • Consult experts specialising in laboratory compliance and ISO implementation.


Understanding the Components of a Quality Manual

Following are some critical components of a quality manual document:

Document Control Properties

This includes the document title, versioning and approval information, and table of contents.

Purpose & Scope.

This section defines the why and the what of a document, respectively. 

The Purpose establishes the intention of the quality manual document, while the scope outlines the boundaries of the quality manual, specifying what aspects of the laboratory’s operations the manual covers. 

Does it encompass the entire department, a specific process, or a particular laboratory’s activities? 

Scope ensures clarity, preventing any misinterpretations or assumptions.

Terms/Definitions

This section defines words, acronyms, and phrases used throughout the manual. Having a clear set of definitions ensures consistency in understanding and eliminates potential ambiguities.  It also helps create language alignment with other laboratory documentation.

References.

This section lists other documents, standards, regulations, and resources on which the quality manual is based. 

Organisational Context and Leadership

This is where you can describe the organisation’s context, governance structure and who has the overall responsibility and authority for the laboratory.

You should also include any affiliation, partnership, and relationship that influences your operations (i.e., academic affiliation, steering community, etc).

Organisational Structure

Describe the hierarchy, roles, and responsibilities within the laboratory. 

Quality policy and Quality objectives.

A Quality Policy is a brief statement that explains how your organisation aligns Quality Management with its overall purpose, mission, and strategic direction. 

It summarises the essence of Quality Management in the context and focus of your laboratory so that key stakeholders understand their role’s impact and the times are measurable goals related to your Quality Policy. 

They help you identify resources and responsibilities and define a way to measure the results of your Quality Management System.  You can include quality policy and objectives as part of Quality or refer to them if you want them to exist as standalone documents. 

Process Control and Management System

This is the core of the manual, where you outline all your quality processes to show how you meet the standard’s requirements. 

For various reasons, I prefer to provide a more high-level outline or a summary statement and refer to the relevant documents (i.e., SOPs, Policies, or Registers) whenever possible. This protects the manual from unnecessary updates and ensures the information stays ‘evergreen’.


Planning and Organising your Quality Manual 

Once you have identified the sections needed for your quality manual, you can start 

planning how you will gather the required information and how you want to organise it. 

Some people write their quality manual before they finish documenting all their procedures. I find this method quite risky as process changes may occur as you write your procedures, necessitating updates to the manual and additional training, etc. 

I recommend writing the quality manual after most, if not all, procedures have been finalised. This will reduce the risk that information (i.e., document name, location, etc.) may change and speed up the Manual writing process. 

Again, I prefer referring to relevant documents instead of copying information into the quality manual. Duplication of content can result in inconsistencies as documents change over time.

Pro tip: Organise the content of your quality manual following the Standard clauses

This will help you tremendously when writing the manual as you can just follow the flow of the standard in your manual. 

You will always know where to find the information for the specific requirement as your manual section aligns with the standard clause. Now, you are ready to write your quality manual.


Quality Manual Writing: 7 Tips to Transform Your Write-Up 

Now that you have planned and structured your manual smartly, it is time to begin the writing process. A blank screen can be overwhelming, but we are here to help.  

Here are some tips on how to write your quality manual smartly and impress the auditor!

Structure according to the standard selectively.

As mentioned earlier, aligning the sections of your document with the standard clauses will make it easier for you to write the manual. However, understand that you don’t have to follow it strictly. For example, you don’t have to have sections down to the sub-sub-sub-clauses or use the same clause title for the section heading. It’s your document, and it has to work for your laboratory. Customise it to suit your needs.

Incorporate visual aids when it makes sense to do so.

Diagrams and flowcharts can explain complex processes and connections quickly and efficiently. They simplify intricate workflows and provide an at-a-glance snapshot of the entire process. For instance, you can use diagrams to describe the organisation’s relationship with its parent company or other inter-process relationships.

Cross-reference throughout.

Use internal links or references to connect related sections or procedures. This can help readers understand the interconnectedness of procedures and standards. List all sections and subsections in a table of contents to support lookups and ease of browsing. 

Reframe rather than copy the standard verbatim.

Instead, explain how the specified requirements will be fulfilled  (e.g., by doing steps a and b as outlined in SOP x ).

Simplify the content so people can understand it.

Adopt the KISS method to keep your manual clear and easy to read. Avoid jargon when possible and ensure the language is accessible to all staff and potential customers, not just those with technical expertise. 

Integrate interactive modules.

If your quality manual is digital, consider integrating interactive modules or videos to explain intricate procedures.

Utilise bullet points and lists.

Use bullet points, numbered lists, and tables to break down complex information and make it easily digestible.

 A well-structured and well-written quality manual showcases your commitment to quality and will impress any auditors or potential clients who read it.

Review and Approval Process 

Now that the document is drafted.  A thorough review ensures that your quality manual:

  • Accurately reflects every nuance and intricacy of your laboratory quality management systems.
  • Communicates its points clearly.
  • Ensures that the manual aligns with all parties’ expectations and requirements, from lab floor technicians to top management.

Ideally, the management, laboratory and other relevant personnel should review the quality manual.


Training and Implementation 

If you follow our writing tips and keep your quality manual as clear and concise as possible, you can go through training and implementation quickly.

The first step is to get everyone to read the document and then, if needed, schedule a follow-up group training session to answer any questions or provide additional information to support your team’s understanding of the document.

Once everyone is trained, ensure quality manual review and training forms part of new employee induction.


A final word on preparing your quality manual

A good quality manual requires thorough planning, research, and concise writing. 

A great quality manual has enough information to be effective but not too much that it drowns the reader with excessive information, repetition of the standard clauses and pages of words and jargon that are tedious and painful to read.

Writing your first quality manual will always be a little challenging. Still, hopefully, by following these tips, you will be able to have an easier time and publish not only a good quality manual but one that will impress whoever reads it, be it an auditor, your top management, or your potential client.
Need a guiding hand in your quality journey? We’re here to simplify Quality Management for you. After all, teamwork and a little guidance can go a long way. Get in touch if you’d like some support.

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