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Before we get into the technical definitions and specific clause numbers that define, describe and require an organization to have a Quality Manual, let's first discuss in layman terms what the Quality Manual is and its purpose. In very basic terms, the Quality Manual is a document that states who the organization is and what they do at a very high "100,000 foot" level.
Now, for the more technical description we have to begin with ISO 9000:2005 Clause 3.7.4 which defines a Quality Manual as a "document specifying the Quality management system of an organization".
Your Hospital's Quality Manual is a requirement of the ISO9001 standard, Clause 4.2.2 to be exact. We will discuss Clause 4.2.2 exclusively in this newsletter's edition of Clause Chat (next article) and is a document that has to be controlled in accordance with the requirements of Clause 4.2.3.
Your Quality Manual is a document that clearly states your organization's intentions for operating the Quality Management System (QMS).
One fact to keep in mind is that the format and structure of the Quality Manual is an important decision for each hospital or healthcare organization. No guidelines exist regarding the format, structure or organization of the Manual. In fact, in the introduction of the standard under the "general" Clause 0.1 it is stated: "It's not the intent of this international standard to imply uniformity in the structure of the quality management systems or uniformity of documentation." These decisions are left up to your hospital or health organization to determine how exactly your Quality Manual will be structured to best support your hospital depending on its size, culture, and complexity. Some organizations may choose to include components other than the baseline requirements within the Quality Manual, and this is fine.
A clear distinction should be made between the contents of the Quality Manual and operating procedures.
With this said, there are a few content requirements your Quality Manual MAY include:
- Your hospital's quality policy stating its commitment to quality
- Policy statements indicating management's intention to comply with the standard's and must include all areas of the standard. These policies must include:
- How management expects operations to function
- Who is responsible (process owners) to implement these expectations
- Where and when the policies are applicable within the organization
- What inter-dependencies exist between functions and processes
NOTE: Your Quality Manual needs to be made available to customers and third party auditors such as your accreditation surveyors.
When it comes to creating and/or maintaining the Quality Manual within a healthcare setting, we are asked 5 questions on a regular basis:
1) How long does our Quality Manual have to be?
A "manual" in healthcare is not necessarily a "Quality Manual" in ISO9001, Many times the word manual invokes a thought of a 300-page work of dissertation. This is not necessarily the case within ISO9001. The typical Quality Manual could be anywhere from 3-10 pages. The organization however needs to ensure that all required components are included.
2) Do we have to identify the Management Representative within the Quality Manual?
There is not a requirement within ISO9001 4.2.2 for the Quality Management Representative (ISO9001 5.5.2) to be identified within the Quality Manual. The Standard requires that this position be "appointed".
3) Do we have to address all clauses within the ISO Standard within our Quality Manual?
The answer is no, because there is no requirement to restate the contents of the ISO standard within the Quality Manual.
4) Does our Quality Manual have to be approved? By who?
Yes, your Quality Manual needs to be approved and it is approved according to the document control process established by the ISO required policy stated in clause 4.2.3.
5) Where do we find the contents for our Quality Manual?
While the Quality Manual is a new document for your hospital, the contents for it are probably not. The content used to create you Quality Manual will come from previous and/or existing documents within your organization such as: Current quality/performance plans, high level strategic plans, etc.
The bottom-line, when it comes to your Quality Manual, is that it is a required document by the ISO standard that identifies who your organization is and what it does. The contents needed to create your Quality Manual probably already exist within your organization, and the overall structure of your Quality Manual is up to you. Overall, your Quality Manual serves as a guideline for your organization as it implements and maintains the Quality Management System.
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