Documentation Requirements

 
The Importance of ISO 9001 Documentation
There are two important parts to the ISO 9001:2008 quality management system (QMS):
(1) your company has to document the entire ISO 9001 QMS according to requirements; and
(2) your company has to actually do everything that is written in your company's ISO 9001
documentation.
 
Because your company not only needs to have a nice set of ISO 9001 documents but also
needs to actually conduct its business according to these ISO 9001 documents, it is crucial
that the ISO 9001 documentation not only meets ISO 9001:2008 requirements but that the
ISO 9001 documentation is efficient and doesn't increase bureaucracy at your company.  This
is a very important consideration as we have seen far too many companies that unnecessarily
spend many employee hours and much money just to maintain an overly complicated and
bureaucratic ISO 9001 QMS.  We, therefore, urge you to keep your documentation as
simple and efficient as possible.  If you use templates, choose wisely! 
 
  

What Documents are required?

ISO 9001:2008 specifically requires the following documents:

 Quality Manual
The ISO 9001 quality manual defines how each requirement of the rather vague ISO
9001:2008 standard is applied at the company. In a sense, the ISO 9001 quality
manual is a company specific version of the ISO 9001:2008 standard.
The requirements for the content of the ISO 9001 quality manual are defined in ISO
9001:2008 section 4.2.2.
 
 Quality Procedures
The ISO 9001 quality procedures are the essence of the ISO 9001 documentation.  The ISO
9001 quality procedures explicitly describe how certain processes within the company must be
performed, and who is responsible for them.  Ideally, the quality procedures and the quality
manual are combined in a single user-friendly document.
ISO 9001:2008 sets the requirements on the ISO 9001 quality procedures and their content in
sections 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, and 8.5.3.
 
 Quality Policy
The ISO 9001 quality policy is the company's policy defining its stance towards quality and
customer satisfaction. As such, the quality policy is the overall guiding principle.
The content of the ISO 9001 quality policy must meet the requirements of ISO 9001:2008
section 5.3.
 
 Quality Objectives
The ISO 9001 quality objectives define measurable goals relative to the company's quality
management system. Requirements on the quality objectives are in ISO 9001:2008
section 5.4.1.
 
 Process Flowchart
The ISO 9001 process flowchart is a description of how the processes of the ISO 9001 QMS
interact with each other.  The ISO 9001 process flowchart is required in ISO 9001:2008
 section 4.2.2.
 
 Work Instructions
Work instructions are the most detailed and most company-specific of all ISO 9001
documents.  Work instructions describe in detail how particular tasks must be performed. 
Work instructions are typically written up by the people who perform the actual work.  ISO
9001:2008 requires work instructions only where they add real value to the company; it is a
common misconception that every task in the company needs to be documented.
Work instructions are required by ISO 9001:2008 section 7.5.1.
 
 Records
Records are different from the above documentation which provides directions on how to
conduct business.  Records, on the other hand, are evidence of things done.  ISO 9001:2008
contains numerous explicit requirements on records plus requirements for many more
undefined records.

Forms are optional

ISO 9001:2008 does not contain requirements on using forms.  In fact, it would not be a violation of
ISO 9001:2008 requirements not to have any forms at all.  However, good forms provide many benefits
to any business, ranging from time savings to consistency.  Using forms can be a tremendous help
creating the various records that ISO 9001:2008 requires.  The best forms even act as instructions as
they guide the user through a work process.
 
 
Format and Content
There are many requirements in ISO 9001:2008 regarding the content of the above
mentioned documents.  On the other hand, there are many things that ISO 9001:2008 does
not require, for example:
- ISO 9001:2008 does not require any particular format or layout;
- referencing every document and form to each other is not required;
- there are no requirements regarding introductory paragraphs to procedures;
- and there are certainly no requirements in ISO 9001:2008 saying that the documentation
needs to be hard to read.
 
Remember that the ISO 9001 documentation is supposed to provide instructions on how to
operate your company's ISO 9001 quality management system.  The best documentation is
easy to understand and user-friendly; the easier it is to follow the instructions, the better.
 
We have seen many companies making the mistake of creating various different documents
and then referencing in each document all the other pertinent documents.  Such an approach
not only causes redundancies, but it is also simply burdensome and not user-friendly. 
Creating the ISO 9001 documentation in this way is usually the beginning of a cumbersome
and bureaucratic ISO 9001 quality system.
 
Create user-friendly ISO 9001 documentation by combining the different documentation
requirements (i.e., quality manual, procedures, corporate policy and objectives) as much as
possible into one comprehensive manual. This reduces repetition and bureaucracy, and it
saves time implementing the ISO 9001 quality system.
 
Good ISO 9001 documentation always keeps the user of the document in mind. Some prefer
instructions in form of pictures, others like flowcharts. Not many like long and convoluted text.
 
A word of caution...
In case you chose templates for your ISO 9001 documentation, take a look at samples.  If
they seem complicated and hard to understand, they will not be useful to your company and
its employees.  If an ISO 9000 consultant insists on writing ISO 9001 documentation that you
don't understand, chances are that this documentation will be useless at best or a burden to
your company's performance at worst.
 

 ISO 9001 Templates

 
Because we have received so many inquiries about the pros and cons of using templates for
ISO 9001 quality manuals and forms, we decided to give this topic its own section.  We even
reviewed several ISO 9001 templates and share our opinion in the Reviews section.

Using Templates for the ISO 9001 Documentation

Using good templates for ISO 9001 quality manuals, quality procedures, forms, as well as the
quality policy, quality objectives, flowchart etc can have huge benefits for any organization
implementing the ISO 9001:2008 quality management system.  Be aware, however, that bad
templates may achieve the opposite. 
 
Good ISO 9001 documentation templates are similar to proven examples for ISO 9001
documents with crucial additional features:
- Designed to be Templates
  Good ISO 9001 templates are specifically designed to be customized so it is easy to edit
them and make them fit your
  organization.  They are designed to be used for your organization.  That's a crucial
difference to just using another
  company's ISO 9001 documentation.
- Customization Instructions
  Included with good templates are step-by-step customization instructions that explain in
detail where and how to make
  changes to each section of the templates.  The customization instructions are the guide to
creating your company's own
  ISO 9001 documentation based on the templates.
- Easy Implementation
  One of the main reasons for using ISO 9001 templates is to make it easier to implement a
good ISO 9001 QMS.  All good
  ISO 9001 templates are designed from scratch with "ease of use" in mind.
- Most Important:  Business-Friendly
  If you use ISO 9001 templates, these templates will form your ISO 9001 documentation and,
thus, the entire foundation of
  your company's ISO 9001 quality management system.  A good ISO 9001 quality
management system will make your
  company be more efficient; a bad ISO 9001 quality system may become a burden.  It is,
therefore, crucial that you use
  the most business-oriented templates that to ensure a business-friendly ISO 9001 system. 
 
A word of caution...
There are numerous companies that sell ISO 9001 quality manuals that you can use as
templates to create your own quality manual.  We urge you to carefully evaluate them before
making a purchase decision as we found so many of these templates convoluted,
bureaucratic and cumbersome. See our Reviews section for suggestions and reviews.
 
 
Benefits of Templates for Quality Manuals, Procedures and Forms
 

Using templates for your ISO 9001 quality documents and forms can provide the following
benefits:
 Completeness
The ISO 9001 standard is written in a very generic way so that it can be applied to any
company of any industry. The disadvantage is that it is much less of a specific guidance for
your particular circumstances, and it is often very difficult to find out what is actually required.
Good ISO templates could help ensure that all requirements are addressed.
  Jumpstart
Writing quality manuals, quality procedures and useful forms is at the beginning of any ISO
9001 implementation. It is usually a big hurdle to take, especially due to the "I don't even
know where to start" factor. Using ISO 9001 templates gets you over this hurdle, and hence
you can get a huge jumpstart on your ISO 9001 implementation. Similarly, templates for forms
and checklists will move you ahead with your ISO 9001 implementation.

 Savings
By using ISO 9001 templates, you can implement an ISO 9000 quality management system
(QMS) in very short time and without the use of expensive ISO 9000 consultants. You spend
much less time on researching the ISO 9001:2008 standard and its requirements, much less
time on writing, and much less time on correcting your mistakes. ISO 9001 templates are
typically a huge money and time saver.

 Quick Certification
The reduced time to implement ISO 9001 can allow you achieve ISO 9001:2008 certification
very quickly. Once certified, you will be able to reap the marketing rewards that come with
certification. Together with the improvements to your company, this could lead to significant
savings and increased business.

 Quality
Good ISO templates lead to good ISO 9001 quality management systems. Using good
templates to model your new ISO 9001 system on allows you to start with an excellent ISO
9001 system from the beginning; or you can improve an existing ISO 9001 system when
using good templates as guide for improvement.

 Simplicity and User-Friendliness

The more user-friendly your ISO 9001 system, the better! If you can use templates to set up a
simple, user-friendly ISO 9001 quality management system, you are already half the way to a
system that makes business sense.

 Benefit from Others' Mistakes

If you use proven, successful templates, you benefit from others' mistakes. There are usually
many mistakes made until a real good ISO 9001 system evolves. With quality materials that
are proven successful you don’t have to make the same mistakes that others have already
made.

 Guidance through Forms

Good forms have two purposes: (1) to collect and record information, and (2) to guide the
user through the process of collecting the information. Truly good forms not only collect all the
necessary information, they also do it in a very efficient manner. Often, forms can replace
work instructions by guiding the user through an entire process that could extend beyond the
mere collection of data.

 Better Compliance through Forms

Good business forms can make it easy for employees to meet the ISO 9001:2008
requirements. Instead of having to look at work instructions, forms can in a subtle way guide
employees and ensure that they follow ISO 9001 requirements.
It is interesting to note that all these benefits of ISO 9001 templates will translate into real,
monetary benefits.
 
 
Disadvantages of Templates for Quality Manuals, Procedures and Forms
 

The disadvantages of using templates can be summarized in two categories:

 Bad Templates
There is a significant danger in using bad ISO 9001 templates. Not only could you lose many
of the above listed benefits, the result of bad ISO 9001 templates could even be the opposite
of those benefits.  We recommend that you carefully chose your ISO 9001 templates. Please
see our Reviews section for reviews of numerous ISO 9001 templates on the market.
  Bad Usage
No matter how good the ISO 9001 templates, they will always require customization.
Template that are blindly adopted as one's own quality manual, procedures or forms
could be a liability as they may not fit the company. In addition, the customization
process of templates provides valuable benefits as it allows the user to focus on
improving their own company's processes. Skipping the focus on customization is a
missed opportunity for improvement.
 
The Bottom Line

ISO 9001 templates can add tremendous value if you...

 

Select Carefully
In order for a company to reap benefits from the use of ISO 9001 templates, the company has
to carefully select its ISO templates; please see our Reviews section for expert reviews of
ISO 9001 templates; in addition, you may want to visit a good ISO 9001 discussion forum
(see our Reviews section).
 
Customize to Fit your Company
Secondly, we urge you to not blindly adopt templates but to invest time and efforts in the
customization phase. Consider good ISO 9001 documentation templates as something that
worked well for other companies. There may be many good ideas in those templates which
could lead to process improvements at your company.  But there may also be processes
described that just don't make sense for your company.  In this case, come up with your own
process that works for you. Remember, there are countless ways to meet the ISO 9001:2008
requirements - find the ones that are best for your company.
 
 

How to Select Good ISO 9001 Templates

Since it is crucial to select good ISO 9001 templates for your ISO 9001 implementation, we
urge you to take your time and choose well. 

Expert Reviews
We reviewed some of the more popular ISO 9001 templates and we are happy to share our
reviews with you.  Our Reviews section contains detailed reviews and editor rating of
templates for quality manuals and procedures, of templates for ISO 9001 forms and
checklists, as well as ISO 9001 implementation packages that contain templates and guides.

Review by Yourself

We realize that there are several providers of ISO 9001 templates that we haven't
reviewed yet due to a lack of resources or because their publishers have tried to
prevent us from publishing a review of their products.  If you conduct your own
reviews, please be aware that there are far too many bad ISO 9001 templates on the
market.  Please watch out.  If you conduct your own reviews, we suggest that you
consider the following warning signals:

 "ISO 9001:2000" in the Product Description 

Check product descriptions carefully for a reference to ISO 9001:2000.  Providers that are still
selling ISO 9001:2000 based materials are not only selling an outdated product but they are
also showing a tendency not to keep their materials current.  The current version of the ISO
9000 families of standards is 2008.
  Completely Obsolete - but Hidden
Even so many years after the major revision of the ISO 9000 standards in the year 2000, there
are still numerous products that are based on the completely obsolete ISO 9001:1994 or that
are mainly slightly revised to give the impression of being up-to-date. We recommend that
you consider the following as warning signals:

  -  there are exactly 20 quality procedures templates

     (the completely obsolete 1994 version of ISO 9000 required 20 quality
procedures);
  -  the first edition of the templates was published in the year 2000 or earlier
     (the major 2000 revision was published in December 2000).

 ISO 9000 Consultants 

Please beware of "black sheep" that lure buyers with ISO templates only to sell them
expensive ISO 9000 consulting services later on.  We are not saying that ISO 9000 consultants
are bad "per se" but they tend to become very costly.  The purpose of templates is inexpensive
in-house ISO 9001 implementation so you should not later find out that you need the
consulting services of the publisher.  We, therefore, consider the following as warning
signals:

  -  the publisher also sells ISO 9000 consulting services;

  -  the publisher also sells ISO training classes.

 Confusing
We recommend that you review a sample page to see if the ISO 9001 template is easy-to-
understand and user-friendly. An ISO 9001 quality manual that nobody understands will have
no value - and it won't lead to certification either!  Very clear warning signals are:

  -  check sample pages:  are there many references to other ISO 9001 documents?
     (who wants to jump from one document to the next to find needed information?);

  -  check sample pages:  is the text full of words that you don't understand?
     (anybody should be able to understand good ISO 9001 documents).

 Bureaucratic
"Unnecessary bureaucracy" is probably the most frequent complaint about ISO 9001 systems.
There are many reasons for bureaucratic ISO 9001 systems, ranging from incompetence of the
author to the deliberate complexity in order to appear more valuable.  The result is always the
same: it will make your business less efficient and less profitable!  Watch out for these
warning signals:

  -  check samples for unnecessary formalities, including definitions, abbreviations,

and complicated numbering
     systems (these are often be found in the beginning of procedures)

  -  check sample pages for lack of content:  how much meaningful content is there
compared to unnecessary
     formalities.

  -  check if the templates include or reference a "Master-List of Documents" (keeping

such a huge list current takes
     much resources, adds little value, and is not required by ISO 9001:2008).
 Store versus Publisher
There are many ISO 9000 stores that are merely reselling ISO 9001 templates.  Even
though those ISO 9000 stores may offer customer service, the customer service reps
may not be sufficiently knowledgeable in ISO 9001:2008 and in all the intricacies of
the ISO 9001 templates to provide real help during your ISO 9001 implementation.  If
you are not completely sure, we suggest you choose the original publisher over the
ISO 9000 store