Only the most important document of your Quality Management System!
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 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.
