We think you have liked this presentation. If you wish to download it, please recommend it to your friends in any social system. Share buttons are a little bit lower. Thank you!
Presentation is loading. Please wait.
Published byRosamund Lamb
Modified about 1 year ago
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 10019 for audits O ISO 9000-3 for software O ISO 10012-1 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
Prepared by Long Island Quality Associates, Inc. ISO 9001:2000 Documentation Requirements Based on ISO/TC 176/SC 2 March 2001.
ISO 9001:2000 ISO 9001:2000 Documentation Requirements Based on ISO/TC 176/SC 2 March 2001.
ISO 9001:2008 An Overview of the International Quality Management Standard Isocert Solutions.com To insert your company logo on this slide From the Insert.
1 The ISO 9002 Quality Assurance Management System For SCHOOLS.
Visit us at E mail: Tele:
Submitted By: Tanveer Khan M.Tech(CSE) IVth sem. The ISO 9000 standards are a collection of formal International Standards, Technical Specifications,
Training. Corrective Action Training How to Implement, Process and Administer the Corrective Action Process.
Fundamentals of ISO. Quality Quality is Conformance with requirements Quality is fitness for purpose Quality is fitness for use Quality is user dependent.
1 Introduction to ISO 9001: Outline ISO 9000 is the most successful standard in ISO history and is accepted world-wide 4Over 500,000 registrations.
Version 10.0 The High Performance Organisation Ltd ISO9001:2000 Foundation Workshop 1 ISO9001:2000 Foundation Workshop Welcome.
Examine Quality Assurance/Quality Control Documentation All projects involve the production and control of documentation. There will be many types of documentation.
ISO 9000 Certification ISO 9001 and ISO ISO 9000 There are 5 Standards in the basic ISO 9000 series: conformance models or guides. A conformance.
Employee Orientation to ISO Sygnetics, Inc. is committed to quality. ‘Quality’ is the ability to consistently produce a product or service that.
Q-Policy statement Q-manual Instructions and forms Procedures (SOPS) Documentation system.
1 Quality Management Z SUZSANNA E SZTER T ÓTH R ITA D ÉNES Department of Management and Corporate Economics 1 March 2016.
Effectively applying ISO9001:2000 clauses 5 and 8 ISO9001:2000 Clause 5 and 8 workshop Version JP.10.1-UK Oct 03 The High Performance Organisation Ltd.
It was found in 1946 in Geneva, Switzerland. its main purpose is to promote the development of international standards to facilitate the exchange of goods.
DOCUMENTATION ISO/IEC 17025:2005 Documentation.
ISO 9001:2015 refers to documented information and retained documented information. Other documentation may be required by an organization in order to.
Copyrights I Global Manager Group | Revision 0.1 Feb 2009 | 1 GMG DEMO OF ISO: ENERGY MANAGEMENT SYSTEM AUDITOR TRAINING PRESENTATION KIT.
Enterprise Architecture 1. What is an Enterprise An “enterprise” is any collection of organizations that has a common set of goals. For example, an enterprise.
Radiopharmaceutical Production Quality Manual STOP.
IE673Session 10 - ISO Quality Management System ISO 9000.
THE PRINCIPLES OF QUALITY MANAGEMENT. DEFINING QUALITY Good Appearance? High Price? The Best? Particular Specification? Not necessarily, but always: Fitness.
Company LOGO. Company LOGO PE, PMP, PgMP, PME, MCT, PRINCE2 Practitioner.
1 WHAT IS ISO ISO is a ‘nickname’ to “International Organization for Standardization”. An international standard more than 100 countries ISO is.
Hadjicostas, E: ISO 9000: 2000 Quality Management System © Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance.
AET0012PPT by Dr. Anwar El-Tawil Dr. Anwar El-Tawil Director ISO Programme for Developing Countries QUALITY MANAGEMENT SYSTEM ACCORDING TO.
Transition from Q1- 8 th to Q1- 9 th edition. Changes to Q1– 9 th Edition Additional Requirements Section 1: Scope Section 2: Normative References.
1 EMS Fundamentals An Introduction to the EMS Process Roadmap AASHTO EMS Workshop.
Project quality management. Introduction Project quality management includes the process required to ensure that the project satisfies the needs for which.
1. Describe an overall framework for project integration management ◦ RelatIion to the other project management knowledge areas and the project life.
Process Auditing Why do people think that this is something new? Presented by Kevin Gilson, Orion Registrar, Inc. For the ASQ ISO Users Group October 8,
Paul Hardiman and Rob Brown SMMT IF Planning and organising an audit.
1 Quality Management Standards. 2 THE ISO 9000 FAMILY ISO 9000: 2005 Identifies the fundamentals and vocabulary for Quality Management Systems (QMS) ISO.
ISO EPSON STAMPING. AIM OF TRAINING awareness and understanding To promote awareness and understanding of ISO 9000 standards and its requirements.
TEC 5133 Team Presentation. Quality Management System Definition: A Quality Management System is a collection of policies, procedures, plans, resources,
1 ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS REQUIREMENTS 1.0 SCOPE ISO 9001:2000 – Clause 1.1 “General” This clause includes also the requirement.
Software Engineering Process - II 7.1 Unit 7: Quality Management Software Engineering Process - II.
Lecture #9 Project Quality Management Quality Processes- Quality Assurance and Quality Control Ghazala Amin.
1 ISO 9000:2000 Quality system standards adopted in 1987 by International Organization for Standardization; revised in 1994 and 2000 Technical specifications.
Overview of ISO Requirements Lynn Penniman Penniman LLC.
ISO 9001 : Objective Introduce the concept of ISO 9001 Standard Highlight important areas of ISO 9001 Standard Briefly introduce the system requirements.
Accelerated EMS Session 4 – 28 January Agenda - WIP Review –Policy – complete –Aspects and Impacts – complete –Legal and Other Drivers – complete.
Preventive Action Training How to Implement, Process and Administer the Preventive Action Process.
Alex Ezrakhovich Process Approach for an Integrated Management System Change driven.
WORKSHOP ON ACCREDITATION OF BODIES CERTIFYING MEDICAL DEVICES INT MARKET TOPIC 6 CH 5 ISO MANAGEMENT RESPONSIBILITY Philippe Bauwin Medical.
Review homework Chapter 8, 9 Final Exam requirments ISO 9000 Baldridge Six sigma Assignment Problem 14-4 Read Ch 10, 11, 12 Week 13 Agenda.
© 2017 SlidePlayer.com Inc. All rights reserved.