1. How to Document A Business Management System

2. What We Will Cover How to Document Your Business System
Identification of Required Procedures
Developing Your Quality Policy
Developing Your Quality Manual
Developing Your Business Process Procedures
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3. Organizing for ISO 9000 Implementation
Management MUST first agree to the project
Establish a Steering Committee
The key is to have the decision makers for each function represented on the committee
Committee meets as required to drive the implementation efforts
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4. Steering Committee Charter
To monitor and manage the implementation and maintenance of the Business Management System and Quality Improvement Efforts in a way that:
provides consistent understanding of quality responsibilities
identifies and prioritizes opportunities for improvement
defines and coordinates needed corrective actions
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5. Where to Begin Assign a Team Leader
Assess what documentation you already have
Assess its compliance to the ISO 9001 standard
Establish a Matrix of business processes in your company and map them to the standard (see example)
Cross-reference them to the applicable section of the standard
At this time you are only concerned with level 1 (Quality Manual) and 2 (procedures) documents
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6. Documentation Needs Analysis
A structured way to documentation needs, as well as training needs
9 Steps
Define the process to be modeled and place it in the main activity block
Identify the inputs ( things, information)needed to perform the process
Identify the outputs ( information, data) required to perform the process
Identify the first tier controlling documents, 8 principal processes and system requirements
Break down the process into the first level of detailed activities
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7. 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
Identify lower tier controlling documents
Identify specific skills, knowledge etc. needed to perform the activity
Breakdown each activity ( parent blocks) into three to five more action blocks
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8. The Next Step
Flowchart the interactions of each department as you have identified them in your matrix
Review the flow charts to the standard for compliance
Create a master document development list breaking down the sections of the standard into interlinking modules
Maintain the revision status of each document using this list
Review your findings with the team
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9. Example Overall process Flowchart Isocert Solutions © Rev C
07/16/96
Example
Overall process
Flowchart
You will notice all the departments listed along the left margin
The individual tasks are in the colored boxes ses and the lines connecting each step within an overall process move from department to department
This is a classic representation of an overall process flow depicting interactions
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10. The Next Step
Create an Index of Procedures, cross referencing them to a section of the standard (required by the standard)
Remember, the standard tells you what to document, but never how!
Select a style of document
written, flowchart or combination
Written can be descriptive, narrative, scripted
You decide your style, but it must describe the activity and show compliance to the standard
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11. Of Special Note
To alleviate fears of the system, emphasize that it is simply documenting how you do business
Emphasize: Document what you do; Do what you say you do!
Only change if you have to change!
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12. Beginning the Documentation Process
From your flow charts, begin to put words to the applicable sections and steps
Danger Note:
This is an interactive process; do not work in a vacuum!
Review the sections that may have reference standards for guidelines, e.g.
ISO for audits
ISO for software
ISO and 2 for calibration
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13. Continuing the Documentation Process
Keep checking with departments you are working with.
The Steering Committee needs to meet and take action regularly
What needs to be documented are your business processes as well as your manufacturing or service processes
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14. Reviewing the Documentation
When Complete with a document, review with the appropriate personnel/groups that have worked with you on the document
This will assist in getting the necessary department approvals
After the review and updating of the documents for any changes, obtain the necessary signatures for final release.
Place a copy of the document in Document Control marked “ Master, Controlled Document”
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15. What’s Next?
Train
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16. Definition of the Needed Procedures
The standard has been broken into 8 logical procedures for ease of developing the system
Remember, the standard is based upon common sense and the way you conduct business
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17. Procedures Sales Design Planning Service/Product Realization
Purchasing and Supplier Management
Administration
Independent Activities
Management
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18. Developing Your Quality Policy
What is your idea of what your companies commitment to quality really is.
The standard tells you the minimum of what you must have as a quality policy
Must include your commitment to your customers
The Quality Policy should be a part of your Business Plan
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19. Where to Start When Developing a Quality Policy
Your Vision statement
What will your company look like in the future?
Define it!
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20. The Next Step What is Your Mission Statement
What the company will do to accomplish the Vision Statement
This includes the objectives for meeting the Vision Statement
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21. Next Define your Strategic Plan
The goals you have put in place to accomplish the Mission Statement
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22. Finally Develop Your Tactical Plan
What actions are necessary to take place that will cause the Strategic Goals to be met
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23. Completing the Quality Policy
Once you have all of these you can now define your policy as it relates to Quality!
Will need to include a commitment to comply with regulatory and statutory requirements
Focus on customer satisfaction and continuous improvement
Is understood and involves everyone in the company
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24. Developing Your Quality Manual
Now that you have defined the following, you can begin to build your Quality Manual
Business Process Matrix
Responsibilities and Authorities Matrix
Quality Policy
Defined your process, flowcharted them and their interactions
Begin to layout the format for your Quality Manual and incorporate the requirements into the appropriate sections
See examples
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25. Define Your Organization
What are the Organizational interrelationships and responsibilities and authorities
Establish a Management Representative
Define the responsibilities of those responsible for Quality
Establish your Management Review
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26. Define How You will Establish and Document Your Business System
Consider
Quality Plans
Identification of controls necessary to achieve quality
Updating of quality techniques to meet the business system needs
Clarification of the standards of acceptability
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27. Describe How You Meet Each Section of the Standard
Understand how your process fits for each section in accordance with ISO 9001
Describe it in general terms
Make a reference to each appropriate procedure supporting the section
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28. What Should the Quality Manual Contain?
Title Page
Manual Index
Manual Control
Introduction
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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29. Developing Level 2 Process Procedures
Quality System Documentation is composed of 2 different elements:
Document
Defines the system
Record
Verifies implementation of the quality system
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30. Quality System Linkage
A tiered approach to the system is necessary
Level 1, 2 and 3 documentation
Linked together to support the system
Reference to each level contained in each document
Level 1 references level 2 and level 2 references level 3
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31. Procedure Development Process
Standardized Formats
Employees become accustomed to the 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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32. Procedure Development Process
Format should follow this example:
Title
Purpose
Scope
Definitions
Associated Documentation
Responsibilities
Procedure/Policy
Flowchart (a picture is worth a thousand words)
Revision History
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33. certificate of Completion
AWARDED TO
[NAME]
For Quality Management System Documentation
Awarded this ___ day of __________, 20__
Presenter Name and Title
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34. For more information visit our website Isocertsolutions.com
We are a full service provider of products and services to support Quality Assurance in any industry.
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