How to Document A
Business Management
System
What We Will Cover
O How to Document Your Business System
O Identification of Required Procedures
O Developing Your Quality Policy
O Developing Your Quality Manual
O Developing Your Business Process
Procedures
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Organizing for ISO 9000
Implementation
O Management
MUST first agree to the
project
O Establish a Steering Committee
O The key is to have the decision makers for
each function represented on the
committee
O Committee meets as required to drive the
implementation efforts
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Steering Committee
Charter
O To monitor and manage the
implementation and maintenance of the
Business Management System and
Quality Improvement Efforts in a way that:
O provides consistent understanding of quality
responsibilities
O identifies and prioritizes opportunities for
improvement
O defines and coordinates needed corrective
actions
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Where to Begin
O Assign a Team Leader
O Assess what documentation you already have
O Assess its compliance to the ISO 9001
standard
O Establish a Matrix of business processes in
your company and map them to the standard
(see example)
O Cross-reference them to the applicable
section of the standard
O At this time you are only concerned with level
1 (Quality Manual) and 2 (procedures)
documents
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Documentation Needs
Analysis
O A structured way to documentation needs, as well
as training needs
O 9 Steps
1. Define the process to be modeled and place it in the
main activity block
2. Identify the inputs ( things, information)needed to
perform the process
3. Identify the outputs ( information, data) required to
perform the process
4. Identify the first tier controlling documents, 8 principal
processes and system requirements
5. Break down the process into the first level of detailed
activities
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Documentation Needs
Analysis
A structured way to documentation needs as
well as training needs
Link input/output arrows to show the interrelationships
between the activity blocks
7. Identify lower tier controlling documents
8. Identify specific skills, knowledge etc. needed to
perform the activity
9. Breakdown each activity ( parent blocks) into three to
five more action blocks
6.
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The Next Step
O Flowchart the interactions of each department
as you have identified them in your matrix
O Review the flow charts to the standard for
compliance
O Create a master document development list
breaking down the sections of the standard
into interlinking modules
O Maintain the revision status of each document
using this list
O Review your findings with the team
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Sales
Cont ract
Review
Accept
Cont ract
Cont inuous
Im provem ent
Marketing
end
Creat e
Proposal
no
Cust om er
Int erface
Cust om er
St at isfact ion
Advert ising
Product Tech
Support
CDRl
Product
Design
Q.A.
Concept
Design
Proposal
Input
Proposal
Input
CDRL
Qualit y Plan
Proposal
Input
CDRL
Process
Design
Rev C
Managem ent
review
yes
Proposal
Input
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Approve
Proposal &
Negot iat e
Manufacture
R&D
(Toyon)
Overall process
Flowchart
President
Example
Cust om er
Training
Supplier
Managem ent
Mat erial
Procurem ent
Engineering
Docum ent
COnt rol
Nonconform ing
Mat erial Cont rol
Receive
Product
Final
Assem bly
Docum ent
Cont rol
Environm ent al
& Final Test
Calibrat ion
Int ernal
Audit s
CSI
Produce
product
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The Next Step
O Create an Index of Procedures, cross
referencing them to a section of the standard
(required by the standard)
O Remember, the standard tells you what to
document, but never how!
O Select a style of document
O written, flowchart or combination
O Written can be descriptive, narrative, scripted
O You decide your style, but it must describe the
activity and show compliance to the standard
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Of Special Note
O To alleviate fears of the system,
emphasize that it is simply documenting
how you do business
O Emphasize: Document what you do; Do
what you say you do!
O Only change if you have to change!
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Beginning the
Documentation Process
O From your flow charts, begin to put words
to the applicable sections and steps
O Danger Note:
O This is an interactive process; do not work in a
vacuum!
O Review the sections that may have reference
standards for guidelines, e.g.
O ISO 10019 for audits
O ISO 9000-3 for software
O ISO 10012-1 and 2 for calibration
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Continuing the
Documentation Process
O Keep checking with departments you are
working with.
O The Steering Committee needs to meet
and take action regularly
O What needs to be documented are your
business processes as well as your
manufacturing or service processes
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Reviewing the
Documentation
O When Complete with a document, review
with the appropriate personnel/groups that
have worked with you on the document
O This will assist in getting the necessary
department approvals
O After the review and updating of the
documents for any changes, obtain the
necessary signatures for final release.
O Place a copy of the document in
Document Control marked “ Master,
Controlled Document”
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What’s Next?
OTrain
OTrain
OTrain
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Definition of the Needed
Procedures
O The standard has been broken into 8
logical procedures for ease of developing
the system
O Remember, the standard is based upon
common sense and the way you conduct
business
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Procedures
O Sales
O Design
O Planning
O Service/Product Realization
O Purchasing and Supplier Management
O Administration
O Independent Activities
O Management
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Developing Your Quality
Policy
O What is your idea of what your companies
commitment to quality really is.
O The standard tells you the minimum of
what you must have as a quality policy
O Must include your commitment to your
customers
O The Quality Policy should be a part of
your Business Plan
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Where to Start When
Developing a Quality Policy
O Your Vision statement
O What will your company look like in the future?
O Define it!
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The Next Step
O What is Your Mission Statement
O What the company will do to accomplish the
Vision Statement
O This includes the objectives for meeting the
Vision Statement
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Next
O Define your Strategic Plan
O The goals you have put in place to accomplish
the Mission Statement
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Finally
O Develop Your Tactical Plan
O What actions are necessary to take place that
will cause the Strategic Goals to be met
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Completing the Quality
Policy
O Once you have all of these you can now
define your policy as it relates to Quality!
O Will need to include a commitment to
comply with regulatory and statutory
requirements
O Focus on customer satisfaction and
continuous improvement
O Is understood and involves everyone in the
company
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Developing Your Quality
Manual
O Now that you have defined the following, you
can begin to build your Quality Manual
O Business Process Matrix
O Responsibilities and Authorities Matrix
O Quality Policy
O Defined your process, flowcharted them and their
interactions
O Begin to layout the format for your Quality
Manual and incorporate the requirements into
the appropriate sections
O See examples
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Define Your Organization
O What are the Organizational
interrelationships and responsibilities and
authorities
O Establish a Management Representative
O Define the responsibilities of those
responsible for Quality
O Establish your Management Review
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Define
How You will Establish and Document
Your Business System
O Consider
O Quality Plans
O Identification of controls necessary to achieve
quality
O Updating of quality techniques to meet the
business system needs
O Clarification of the standards of acceptability
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Describe
How You Meet Each Section of the
Standard
O Understand how your process fits for each
section in accordance with ISO 9001
O Describe it in general terms
O Make a reference to each appropriate
procedure supporting the section
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What
Should the Quality Manual Contain?
O
O
O
O
O
O
O
O
O
O
O
O
Title Page
Manual Index
Manual Control
Introduction
O Something about the company
Scope - What do you do?
References
Definitions, as applicable
Quality Policy
Processes and their interactions
Responsibility and Authority
Business System Element requirements
Quality Manual Revision History
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Developing Level 2
Process Procedures
O Quality System Documentation is
composed of 2 different elements:
O Document
O Defines the system
O Record
O Verifies implementation of the quality
system
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Quality System Linkage
O A tiered approach to the system is
necessary
O Level 1, 2 and 3 documentation
O Linked together to support the system
O Reference to each level contained in each
document
O Level 1 references level 2 and level 2
references level 3
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Procedure Development
Process
O Standardized Formats
O Employees become accustomed to the
O
O
O
O
format
Training can be more effective
Document Control is easier
It is easier to assign employees to new
activities
Quality of procedures is improved
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Procedure Development
Process
O Format should follow this
example:
O
O
O
O
O
O
O
O
O
Title
Purpose
Scope
Definitions
Associated Documentation
Responsibilities
Procedure/Policy
Flowchart (a picture is worth a thousand words)
Revision History
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CERTIFICATE OF COMPLETION
AWARDED TO
[NAME]
For Quality Management System Documentation
Awarded this ___ day of __________, 20__
Presenter Name and Title
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O For more information visit our website
Isocertsolutions.com
O We are a full service provider of products
and services to support Quality Assurance in
any industry.
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