Does ISO 9001 require a quality manual?

A quality manual is no longer an obligatory document that is required to achieve compliance, according to the ISO 9001:2015 standard. Yet, many organisations choose to create a quality manual due to its many benefits. In this article, we will explore what a quality manual is, how it differs from quality plans, its uses, content and associated benefits.

What is a quality manual?

A quality manual can be described as a document that summarises the organisation’s intention for executing and operating the processes related to its Quality Management System (QMS). The document can include policies for all areas within your business, that have the ability to affect the quality of your products/services, your customer requirements and the recommendations of the ISO 9001 standard. The policies included in the quality manual define how department managers will implement the determined procedures within the specified boundaries of the QMS.

What is the purpose of the quality manual?

The purpose of the quality manual is to serve as a reference guide for all the operational processes of your company. As the document contains details of policies that can affect the quality of your products, ability to meet your customer demands, and satisfy ISO requirements, it will be utilised by department managers to implement procedures, define boundaries and adhere to specifications.

Overall, the quality manual is an important instrument for businesses to ensure continued efficiency within their quality management system, as it outlines the intentions of your daily operations. Additionally, the quality manual is also important, as it sets the expectations for the calibre of your deliverables and your team’s performance. However, as we mentioned, the quality manual is not among the requirements of ISO 9001.

Uses of a quality manual

• In addition to serving as a guide to managers, the quality manual has several other important purposes:
• It serves as a communication channel, helping to communicate the expectations of the management to the employees.
• It serves as a compliance tool, helping the organisation demonstrate their conformity to the requirements of the ISO 9001:2015 standard.
• It is used to demonstrate the fulfilment of clause 5.3, which requires organisations to define their roles, responsibilities and authorities related to the quality management system, so that these entities can be appropriately assigned, communicated and understood.
• To provide a place to begin the audit for auditors, either internal, external, customer-affiliated or associated with the ISO certification body.

What is the difference between a quality manual and a quality plan?

It is vital to understand the difference between a quality manual and a quality plan when introducing the quality management system into your company. Although these documents are complementary to each other, they entail different components.

Quality manual features

A quality manual contains a set of documents that clearly define and communicate a business’s quality management system, including its policies and procedures. The resources in the quality manual serve as a framework for meeting quality system requirements and conveying an organisation’s commitment to the system. A quality manual will comprise the following records:

• Quality policy statement: The quality policy statement details the level of commitment of an organisation in maintaining the quality of its products or services.
• Quality policy: The quality policy outlines an organisation’s plans in detail regarding the actual steps that are needed, to enhance the quality of their services/products.
• Standard operating procedures: These procedures identify the resources responsible for carrying out each task within the QMS, in addition to their allotted time frame.
• Work instructions: Work instructions highlight the set of procedures that need to take place to implement the policies.

Quality plan features

A quality plan, on the other hand, comprises a collection of documents that specify the quality standards, resources, practises, specifications and all activity sequences relevant to a specific component of the QMS. Their purpose is to identify all requirements that are needed to produce services or products as intended.

Quality plans categorise procedures as either quality assurance or quality control. Quality assurance includes all the pre-production efforts that are proactive, such as developing quality standards, creating process checklists and striving to improve process accuracy. Quality control includes all procedures that are reactive to the post-production efforts, and focuses on identifying any defects within the products or services. Examples of quality control procedures include monitoring and inspection.

To summarise, a quality manual defines an organisation’s QMS, whereas a quality plan explains how the business will meet its quality requirements for a specific product or service.

What are the benefits of a quality manual?

There are many benefits of a quality manual in creating an efficient QMS, including:

• Helping in designing quality management processes.
• Enabling organisations to build an effective QMS.
• Providing a concise and clear overview of the system.
• Facilitating continuous improvement within an organisation.
• Outlining a more efficient method of running the business.
• Helping in removing obstacles in registration.
• Enhancing cost saving.

Conclusion

When creating the quality manual, organisations need to include the quality policy, an explanation of their document structure, an organisational chart, policy statements and references to operating procedures. Understanding these crucial inclusions will help enhance the effectiveness of your manual.