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How to Document A Business Management System
What We Will Cover How to Document Your Business SystemIdentification of Required Procedures Developing Your Quality Policy Developing Your Quality Manual Developing Your Business Process Procedures Isocert Solutions © Rev C
Organizing for ISO 9000 ImplementationManagement 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 Isocert Solutions © Rev C
Steering Committee CharterTo 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 Isocert Solutions © Rev C
Where to Begin Assign a Team LeaderAssess 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 Isocert Solutions © Rev C
Documentation Needs AnalysisA 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 Isocert Solutions © Rev C
Documentation Needs AnalysisA 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 Isocert Solutions © Rev C
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 Isocert Solutions © Rev C
Example Overall process Flowchart Isocert Solutions © Rev C07/16/96 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 Isocert Solutions © Rev C
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 Isocert Solutions © Rev C
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! Isocert Solutions © Rev C
Beginning the Documentation ProcessFrom 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 Isocert Solutions © Rev C
Continuing the Documentation ProcessKeep 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 Isocert Solutions © Rev C
Reviewing the DocumentationWhen 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” Isocert Solutions © Rev C
What’s Next? Train Isocert Solutions © Rev C
Definition of the Needed ProceduresThe 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 Isocert Solutions © Rev C
Procedures Sales Design Planning Service/Product RealizationPurchasing and Supplier Management Administration Independent Activities Management Isocert Solutions © Rev C
Developing Your Quality PolicyWhat 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 Isocert Solutions © Rev C
Where to Start When Developing a Quality PolicyYour Vision statement What will your company look like in the future? Define it! Isocert Solutions © Rev C
The Next Step What is Your Mission StatementWhat the company will do to accomplish the Vision Statement This includes the objectives for meeting the Vision Statement Isocert Solutions © Rev C
Next Define your Strategic PlanThe goals you have put in place to accomplish the Mission Statement Isocert Solutions © Rev C
Finally Develop Your Tactical PlanWhat actions are necessary to take place that will cause the Strategic Goals to be met Isocert Solutions © Rev C
Completing the Quality PolicyOnce 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 Isocert Solutions © Rev C
Developing Your Quality ManualNow 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 Isocert Solutions © Rev C
Define Your OrganizationWhat are the Organizational interrelationships and responsibilities and authorities Establish a Management Representative Define the responsibilities of those responsible for Quality Establish your Management Review Isocert Solutions © Rev C
Define How You will Establish and Document Your Business SystemConsider 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 Isocert Solutions © Rev C
Describe How You Meet Each Section of the StandardUnderstand 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 Isocert Solutions © Rev C
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 Isocert Solutions © Rev C
Developing Level 2 Process ProceduresQuality System Documentation is composed of 2 different elements: Document Defines the system Record Verifies implementation of the quality system Isocert Solutions © Rev C
Quality System LinkageA 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 Isocert Solutions © Rev C
Procedure Development ProcessStandardized 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 Isocert Solutions © Rev C
Procedure Development ProcessFormat should follow this example: Title Purpose Scope Definitions Associated Documentation Responsibilities Procedure/Policy Flowchart (a picture is worth a thousand words) Revision History Isocert Solutions © Rev C
certificate of CompletionAWARDED TO [NAME] For Quality Management System Documentation Awarded this ___ day of __________, 20__ Presenter Name and Title Isocert Solutions © Rev C
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. Isocert Solutions © Rev C
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