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  • Writer's pictureArmin Honarasa

How to write a Quality Manual (QMS) for ISO 9001? With Examples (complete guide)



To obtain ISO 9001 certification, it is essential to have a comprehensive Quality Manual encompassing all information and procedures. This document serves to substantiate the organisation's commitment to ISO 9001 standard.

man writing QMS
Creating a quality manual can be a complex task.


A well-structured and easily understandable representation of your business operations is important and creating a quality manual can be a complex undertaking, posing challenges for certain businesses. Fortunately, we have developed a detailed, step-by-step guide to assist you in successfully navigating the ISO certification process, alleviating any concerns you may have.


Prior to proceeding, it is important to familiarise yourself with the concept of PDCA, which stands for Plan, Do, Check, and Act. This framework should serve as your guiding approach when formulating your Quality Manual. First, let's look at the clauses in ISO 9001 standard:


• Clauses 0 to 3: Introduction, Scope, References, Terms and Definitions

• Clause 4: Context of the organisation

• Clause 5: Leadership and commitment

• Clause 6: Planning for the QMS

• Clause 7: Support & resource management

• Clause 8: Operational planning and control

• Clause 9: Performance evaluation

• Clause 10: Improvement actions



Now, with the understanding of the above items, we are going to prepare a quality manual document that get you certified for ISO 9001:2015.



 

Clauses 4, 5, 6 & 7 are under the "plan" phase. To address Section 4 of the ISO 9001 standard, it is essential to commence your document by providing a comprehensive overview of your organisation. This should include a description of your organisation, its activities, the scope of work undertaken, identification of stakeholders, details about your customer base, and any additional pertinent information pertaining to the operation and management of your business.


Some of the headings here could include:

• Company overview & Context

• Scopes and Exclusions

• Office & Site locations

• Interested parties


In Clause 5 of the quality manual is where we should identify leadership, their roles and responsibilities as well as commitment to quality.


Effective leaders must adopt a customer-centric approach and ensure the provision of adequate resources to all staff members involved in the relevant area or project. It is crucial to maintain an appropriate staffing level to prevent anyone from being overlooked or left behind. This encompasses various aspects, ranging from the personal involvement of management to meticulous tasks such as monthly progress measurement against set goals.


The Managing Director is committed to the development and implementation of the quality management system and continually improving its effectiveness by:


• Communicating to the organisation the importance of meeting customer as well as statutory and regulatory requirements,

• Ensuring the quality policy is current and relevant,

• Ensuring the KPIs are established and relevant,

• Conducting the Management Review annually, and

• Ensuring the availably of resources detrimental to the company.


This sections should also mention the roles and responsibilities, authority and decision making, policies, frameworks and compliance requirements established by management. Management should also indicate how information, decisions and news are communicated with staff and interested parties.


Incorporating actions to address risks and opportunities is essential when addressing Clause 6 of ISO 9001:2015 within your quality manual. A recommended approach to prioritise internal and external risks is the utilization of a risk matrix or chart.

Risks, which arise from uncertainties, necessitate the adoption of a "Risk-based approach/thinking" within your business.

To cover this section first identify all the internal and external issues (risks), and develop plans and actions to address them.


Then set SMART objectives to address, control and mitigate these risks under this section.


Recommended headings for this sections are:

  • - Risk Matrix

  • - Actions to address risks and opportunities

  • - Objectives and Planning



 

The next part of your quality manual is about Support which covers Clause 7 of ISO 9001:2015. Hereunder this section, you must provide information about how to provide resources, how to ensure they are competent, how to communicate with stakeholders and how to document all the required information.



Resources include qualified people, infrastructure (IT, equipment) and all other physical & intellectual resources. Your resources must demonstrate being fit for purpose, valid and reliable and traceable.


Your business resources must show they are competent and have all required qualifications and experiences. They must be identified, recorded, and monitored which must be mentioned under this section of your Quality manual.


It also needs to include a plan to ensure staff, visitors and subcontractors are aware of the quality policy which can be achieved by an induction course for example.


These are the headings you can have under this section:

• Resources including Monitoring & Measuring Devices

• Competence

• Awareness

• Communication

• Documented information



You should also include information about documents of resources such as:

• Technical Data Sheets (TDS)

• Material Safety Data Sheets (MSDS)

• Product Specifications

• Certificates of Analysis

• General/Technical documentation on products.



Download our free IMS template today to help you get started.

 

Under clause 8 of your quality manual which is the "Do" part of PDCA, you must discuss the operation method of your business on a day to day basis. This is a chunky part of your Quality manual with lots of links to other processes and procedures to validate their point.

You should start by explaining your organisations work in brief, steps taken to receive, process and deliver the job, and methods to guarantee meeting customer’s needs.



This section starts as the extension of section 4.4 and 6 of ISO 9001:2015 standard which is "Quality Management System And Its Processes" and "Risk assessment schedule".


You must clearly mention under this section what happens if changes are required, for any reason, such as customer requests or legislations etc.



In Clause 8 of ISO 9001, it is essential to explicitly outline the steps taken to communicate with customers, comprehend their requirements, conduct reviews, and ensure their safety. Additionally, if your organisation is entrusted with the safekeeping of customer properties, it is crucial to establish a method for safeguarding them. Here's an example of how to address these aspects in your quality manual:


Communication with Customers: Describe the established channels and methods for effective communication with customers. This can include regular meetings, phone calls, emails, or other forms of direct communication. Emphasize the importance of actively listening to customer feedback, addressing their inquiries and concerns, and promptly providing them with relevant information.


Understanding Customer Requirements: Outline the procedures for gathering and comprehending customer requirements. This involves conducting thorough discussions, utilizing questionnaires or surveys, and engaging in active dialogue to gain a clear understanding of their expectations, preferences, and specific needs.


Review of Customer Requirements: Detail the process for reviewing customer requirements within your organisation. This can include internal reviews with relevant stakeholders, cross-functional discussions, and verification of requirements against the organisation's capabilities and resources. Emphasize the importance of ensuring that customer requirements are feasible, realistic, and aligned with the organisation's objectives.


Ensuring Customer Safety: Clearly establish the measures taken to ensure the safety and well-being of customers. Describe the specific protocols, procedures, or safety standards implemented to mitigate risks and hazards associated with the use of your products or services. Highlight the organisation's commitment to providing safe and reliable solutions.


Protection of Customer Properties: If your organisation is entrusted with customer properties, outline the method used to protect these assets. This may include specifying secure storage facilities, access control measures, insurance coverage, or any other relevant safeguards. Emphasize the organisation's commitment to maintaining the integrity, confidentiality, and protection of customer properties throughout the entire engagement.


Complete product/service provision must be written under this section which describes all the steps from order to delivery and customer care.

These are other sub-clauses you must address:


• Products and services are not to be released until planned arrangements are completed

• Nonconforming outputs are to be identified and controlled

• Identification and Traceability

• Objects, Outputs, Products and Services


As mentioned above, this section can be quite heavy and deep, but as an operating business you have most of this information already and you only need to sort them out and prepare some procedures for each. In order to get your ISO 9001, you must develop procedures and policies for your business activities such as


• Supplier selection

• Control of production and service provision

• Identification and traceability

• Purchasing process

• Customer communication

• Determination of requirements related to the product

• Review of requirements related to the products

• Customer property


 

Clause 9 of ISO 9001 is "Performance evaluation". This section must show how you measure and analyse the performance of your business. Don't forget the main purpose of this standard is to have continual improvement, meaning you should do and perform better than before on a regular basis.


What are your KPIs? How do you measure customer satisfaction? How often do you check/monitor these performance indicators? Who is responsible for this etc.



This section must include the Internal Audit schedule and its purpose. It also needs the Management review section. You must mention what will be covered in your management review meetings. Here are some examples of the Management review agenda:

• Actions from prior management reviews

• Review the external and internal issues from the Context

• Customer satisfaction and feedback

• Review quality objectives have been met

• Review process performance and conformity of products and services

• Check nonconformities and corrective actions

• Review audit results

• Review suppliers

• Check you have enough resources

• Review risk (and opportunities) register

• Review improvements



The headings for this part of your Quality manual could include:

• Monitoring & measurements

• Customer satisfaction

• Monitoring and measurement of processes

• Monitoring and measurement of product(s)

• Internal Audit

• Management Review


 

The last section of your Quality Manual is the "Improvement" (clause 10) which is Check part of PDCA. Here you must demonstrate how you are going to drive improvement and implement actions, find out the root cause of problems and execute the continual improvement.



Here you must write about your commitment to continuous improvement and achieving your quality objectives. You must also demonstrate your plan for taking corrective actions and improving your organisation day after day.



The headings for this section are:

• General

• Non-conformity and corrective actions (Root cause analysis)

• Continual improvement




This document is your promise to customers that you care about quality. It is a live document which can be updated and referred to as a guide. Preparing this Quality manual helps you run your business more smoothly and have a system to communicate with all staff and other parties, as well as prepare you to get ISO 9001:2015 certification. This manual should be linked to all other related documents such as policies and procedures to make it easier to track them when needed.



Completing Quality Manual can be difficult and time-consuming. We at #APIC have a specialised team and years of experience to help you design and develop a Quality manual that gets your ISO 9001 certified with minimum hassle.


If you need a copy of the Quality Manual template to

start your process Contact us

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