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Tips on ISO 9001 Quality Management System Documentation
What is a document?Lets begin with some definitions. Adocument
is information that is writtenor recorded on some medium such as
paper or computer. A document may
specify requirements (e.g. a drawing or technical
specification); providedirection (e.g. quality plan); or show
results or evidence of activitiesperformed (e.g. records).
What is a procedure?
A procedure is a specific way to perform an activity or process
(methods orpractice used by an organization) and it may or may not
be written. If it iswritten, it is called a documented procedure.
The same reasoning applies towork instructions (which are ways to
perform a discrete task) which may or
not be documented.
What purpose does QMS documentation serve?QMS documentation
provide the following benefits and objectives:
1. Communication of Information- needed by the organization to
plan,operate and control its processes. The type and extent of the
documentationwill depend on the criteria listed above, as well as
the degree of formality ofcommunication systems and the level of
communication skills within theorganization, and the organizational
2. Evidence of conformity- provides evidence that what was
what has actually been done.
3. Knowledge reservoir and sharing- to preserve and disseminate
organizations experiences; business and technical know-how. A
typicalexample would be a technical specification, which can be
used as a base for
design and development of a new product.
4. Training tool- to train personnel in performing their
5. Consistency of performance- by having all personnel perform
to the same
method, practice or procedure
6. Promote best practice - document the best way of performing
activityusing internal and external knowledge
What are the ISO 9001 requirements for QMS documentation?Clause
4.2.1 specifies all the different types of documentation needed
foryour QMS. You must have documented statements of your
qualitypolicy and objectives. Specific requirements for these
documents arestated elsewhere in clause 5 of the standard.
You must have a documented Quality Manual. There are many ways
todocument your Quality Manual;and this would be determined by the
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structure and complexity of your organization. Clause 4.2.2
specifies morerequirements for the contents of the quality
This standard is not heavy on documented (written) procedures as
was thecase with previous standards. Clause 4.2.1d requires you to
needed to ensure the effective planning, operation and control
for QMSprocesses. The nature and extent of such documentation will
vary fromorganization to organization, based on factors listed
What criteria should an organization use to determine how
QMS documentation it should have?The need to have additional
documentation beyond those specified in thisstandard may depend
upon - customer, regulatory and your ownorganizational
requirements. Other factors to consider may include -
complexity of products and processes; effect on quality; risk of
customerdissatisfaction; economic risk; effectiveness and
efficiency; competence ofpersonnel; workforce stability and past
quality problems andnonconformities.
For example, the complex your products or processes are, the
greater therisk of problems occurring. The use of documentation and
other controlsserve to prevent or reduce these risks.
If you have a highly educated and stable workforce, then the
amount ofdocumentation needed may be significantly less than an
organization thathas a high workforce turnover and lower
Regardless of how and to what extent you document your QMS, you
mustdemonstrate the effective implementation of your QMS in terms
conformity to ISO 9001, customer, regulatory and your own
In what medium should QMS documents be communicated?Any
combination ofmedia is acceptable for documents and records
providedthey conform to requirements specified in clause 4.2.3
control of documentsand clause 4.2.4 control of records. These may
include, but not limited to:
paper, magnetic. electronic or optical computer disc,
What are the mandatory documented procedures required by
ISO9001:2000?Under ISO 9001, you must have documented procedures
for - clause 4.2.3- Control of documents; clause 4.2.4 - Control of
records; clause 8.2.2 -Internal audit; clause 8.3 - control of
nonconforming product; clause 8.5.2 -Corrective action and clause
8.5.3 - Preventive action.
These documented procedures have to be controlled in accordance
with therequirements of clause 4.2.3
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You may choose to include your procedures and lower level
documentation inyour quality manual or organize them in some other
fashion. The practicalityof this would depend on the size of your
organization, complexity of productsand processes; competency of
personnel, media used for documentation(hard copy versus
computerized); ease of use and understanding by
personnel; maintainability; etc.
Depending on these same criteria, you may decide to have
procedures (beyond the mandatory six) or carry over some or all
theprocedures you had under previous QMS systems.
Some of the mandatory procedures can be combined, e.g.,
correction andpreventive action may be combined as long as you
address the specificrequirements of each clause 8.5.2 and 8.5.3.
You could also have more than
one procedure for any of the mandatory clauses listed above.
Note there are several ways to write procedures, other than the
conventionalnarrative form. In fact, narrative documentation has
been found to be theleast effective way to promote user
comprehension and ease of use.
Procedures may be documented graphically (e.g. flowchart; video;
series ofpictures or photographs, etc.).
Can you provide examples of documents, other than policies,
qualitymanual and procedures, that an organization may need for its
QMS?In addition to the documents specifically called out in ISO
9001, clause4.2.1d calls for documents deemed necessary for
and control of your processes. These could include - process
maps, processflow charts and/or process descriptions; organization
charts; quality plan,material specifications; competence criteria,
packaging specifications, manufacturing specifications, work and
testinstructions; forms; schedules; set-up specifications, etc.
ISO 9001 calls for many records to provide evidence of effective
planning,operation and control of processes. Examples include -
management reviewrecords; calibration records, internal audit
records; corrective action records,etc. Again, your processes may
call for additional records beyond those
expected by ISO 9001.
Many clauses do not specifically call for documents and records,
but there isa strong implication in the wording of the need to have
them. This is whereyou must be guided by clauses 4.2.1d and 7.1b
for documents and 4.2.1e;4.2.4 and 7.1d for records. Use these
clauses to determine what documentsand records are needed to
provide evidence of effective planning, operationand control.
Remember to use the requirements of clause 4.2.3 to control all
documentsyou choose to include in your QMS; and the requirements of
clause 4.2.4 tocontrol all QMS records.
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What should be documented in my Quality Manual?The quality
manual (QM) is a special type of document that describes yourQMS.
Your QMS is comprised of a number of business processes needed
tosatisfy customer and other stakeholder requirements. For your QMS
manualto be meaningful, provide a brief description of each of
these processes and
the key ISO 9001 control requirements that apply to them.
Do not follow the common practice of writing back the clauses of
standard. This serves no useful purpose to anyone.
Your quality manual must also include a description of the
interaction of yourQMS processes. This can be done in any number of
ways including - processmaps; flowcharts; process diagrams;
You QM must define the scope of your QMS. Your QMS scope should
include- facilities (manufacturing and support locations),
products, processes, yourpolicies for Quality Management and other
standards, etc. Customers willwant to know the extent of your
product, QMS and manufacturing capabilitiesand the Certification
Body (Registrar) will want to determine the time and
effort needed to audit your organization.
Provide details of any clause exclusions from your scope, e.g.
7.3 ProductDesign and Development, and yourjustification for it.
You must justify allexclusions and remember, exclusions can only be
made from clause 7.
Besides describing your QMS, your quality manual could provide
on organizational background and capabilities. It may be used by
customers,regulatory bodies, suppliers and company personnel for a
variety ofpurposes. There are many other acceptable ways to
document your quality
You have flexibility in whether or not to include your
procedures and lowerlevel documentation with your quality manual or
organize them in someother fashion. You may include all or some of
your procedures in yourQuality Manual or reference them to your
Quality Manual. Keep a listing orindex at the front or back of your
Manual showing the complete list of your
procedures whether included or referenced.
The practicality of all this would depend, of course, on the
size of yourorganization; complexity of products and processes;
competency ofpersonnel; media used for documentation (hard copy
versus computerized);ease of use and understanding by personnel;
etc. So go ahead and organizeyour documentation to facilitate ease
of use; understandability, availabilityand maintainability.
As a part of your QMS (see 4.2.1) documentation, the quality
manual issubject to all of the controls in clause 4.2.3.
How does an organization demonstrate conformance to ISO 9001,
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it has minimal documentation?In order to claim conformity with
ISO 9001:2000, the organization mustbe able to provide objective
evidence of the effectiveness of its processesand its quality
Clause 3.8.1 of ISO 9000:2000 defines "objective evidence" as
"datasupporting the existence or verity of something" and notes
that "objectiveevidence may be obtained through observation,
measurement, test, or other
Note that organizations may be able to demonstrate conformity
without theneed for extensive documentation.
Objective evidence does not necessarily depend on the existence
documented procedures, records or other documents, except
wherespecifically mentioned in ISO 9001:2000. In some cases, (for
example, inclause 7.1(d) Planning of product realization, and
clause 8.2.4 Monitoringand measurement of product), it is up to the
organization to determine whatrecords are necessary in order to
provide this objective evidence.
Where the organization has no specific internal procedure for a
particularactivity, and this is not required by the standard, (for
example, clause 5.6Management Review), it is acceptable for this
activity to be conducted usingas a basis the requirements of clause
5.6 and it can also be used for bothinternal and external
conformity audit purposes.