A quality management system manual (QMSM) is an essential document for any organization. The QMSM should present formally, concisely and systematically, the general principles which guide the management and operation of the organization in order to guarantee the quality and integrity of a product or service.
Although not an exhaustive list, this important document should include at minimum:
- A quality policy
- Objectives of the manual
- Normative references
- Scope of the manual (i.e. what products or services are covered by the manual)
- General organizational hierarchy including organizational charts
- Descriptions of the responsibilities of personnel working within the quality system, and the processes that comprise the organization, as well as how they interact
- A brief outline of how the regulatory references are met
- A description of the organization’s facilities
- Identification of or reference to the controlled documents that make up or support the quality system
- Justification for exclusions in the scope of the system (applicable for certain ISO-regulated organizations)
- Strategies and tools for continuous quality improvement
- Protocol for revisions to the manual outlining when and why the manual may be updated
Internally, the QMSM should be read and understood by all employees encompassed within the quality system with documented approvals secured and maintained in the employees’ training file. In addition, these employees should be very familiar with the quality policy.
The intent of the QMSM is to familiarize external audiences like clients and regulatory bodies with the quality system. Depending on the standard used, some manuals may have very specific requirements, where a laundry list of concerns is heavily scrutinized by auditing agencies. As far as messaging is concerned, it should be brief enough to not lose the reader, but detailed enough so that an understanding of the organization’s commitment to quality is gained.
Because the quality manual may be the first impression of an organization, it may also be viewed as a marketing tool. Potential customers may think twice about using a company that has a poorly written, disorganized manual. With that said, it is very important to have the drafted manual reviewed and edited by a technical writer prior to its release so that the end product is well-written and professional sounding.
Although a QMSM is one of the most important documents of an organization, it is just that—a document. The next step in the process is to ensure that the stated quality system is effectively implemented. Coming up in the August Quality Corner: how the process approach can be used as an implementation tool for a solid and successful quality system.
Have quality questions that you’d like Tricia to answer? Email: firstname.lastname@example.org
Tricia Wood has more than 20 years of experience working in quality-related positions for several regulated industries, including pharmaceutical development and manufacture, medical device manufacture, and analytical services.