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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 culture.

2. Evidence of conformity- provides evidence that what was planned and

what has actually been done.

3. Knowledge reservoir and sharing- to preserve and disseminate the

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 responsibilities

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 size,

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structure and complexity of your organization. Clause 4.2.2 specifies morerequirements for the contents of the quality manual.

This standard is not heavy on documented (written) procedures as was thecase with previous standards. Clause 4.2.1d requires you to have documents

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 below.

What criteria should an organization use to determine how much

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 educational requirements.

Regardless of how and to what extent you document your QMS, you mustdemonstrate the effective implementation of your QMS in terms of

conformity to ISO 9001, customer, regulatory and your own organizationalrequirements.

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, photograph, audio-

visual, etc.

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 additional

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 effective management

and control of your processes. These could include - process maps, processflow charts and/or process descriptions; organization charts; quality plan,material specifications; competence criteria, product specifications,

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 the

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; spreadsheets; etc.

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 information

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

manual.

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, if

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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 management system.

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

means."

Note that organizations may be able to demonstrate conformity without theneed for extensive documentation.

Objective evidence does not necessarily depend on the existence of

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.