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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 Isocert Solutions © Rev C2
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 Isocert Solutions © Rev C3
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 Isocert Solutions © Rev C4
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 Isocert Solutions © Rev C5
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 Isocert Solutions © Rev C6
Documentation Needs Analysis A structured way to documentation needs as well as training needs 6. 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 Isocert Solutions © Rev C7
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 Isocert Solutions © Rev C8
9 Example Overall process Flowchart Isocert Solutions © Rev C
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 Isocert Solutions © Rev C10
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! Isocert Solutions © Rev C11
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 for audits O ISO for software O ISO and 2 for calibration Isocert Solutions © Rev C12
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 Isocert Solutions © Rev C13
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” Isocert Solutions © Rev C14
What’s Next? O Train Isocert Solutions © Rev C15
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 Isocert Solutions © Rev C16
Procedures O Sales O Design O Planning O Service/Product Realization O Purchasing and Supplier Management O Administration O Independent Activities O Management Isocert Solutions © Rev C17
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 Isocert Solutions © Rev C18
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! Isocert Solutions © Rev C19
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 Isocert Solutions © Rev C20
Next O Define your Strategic Plan O The goals you have put in place to accomplish the Mission Statement Isocert Solutions © Rev C21
Finally O Develop Your Tactical Plan O What actions are necessary to take place that will cause the Strategic Goals to be met Isocert Solutions © Rev C22
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 Isocert Solutions © Rev C23
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 Isocert Solutions © Rev C24
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 Isocert Solutions © Rev C25
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 Isocert Solutions © Rev C26
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 Isocert Solutions © Rev C27
What Should the Quality Manual Contain? O Title Page O Manual Index O Manual Control O Introduction O Something about the company O Scope - What do you do? O References O Definitions, as applicable O Quality Policy O Processes and their interactions O Responsibility and Authority O Business System Element requirements O Quality Manual Revision History Isocert Solutions © Rev C28
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 Isocert Solutions © Rev C29
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 Isocert Solutions © Rev C30
Procedure Development Process O Standardized Formats O Employees become accustomed to the format O Training can be more effective O Document Control is easier O It is easier to assign employees to new activities O Quality of procedures is improved Isocert Solutions © Rev C31
Procedure Development Process O Format should follow this example: O Title O Purpose O Scope O Definitions O Associated Documentation O Responsibilities O Procedure/Policy O Flowchart (a picture is worth a thousand words) O Revision History Isocert Solutions © Rev C32
Isocert Solutions © Rev C33 CERTIFICATE OF COMPLETION AWARDED TO [NAME] For Quality Management System Documentation Awarded this ___ day of __________, 20__ Presenter Name and Title
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. Isocert Solutions © Rev C34
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