Iso Guideline Document

image music directors Guide ISO 90012008 execution 2008 The 9000 entrepot www. the9000store. com page 1 of 10 circuit card of Contents introduction 3 purpose propose 4 plan and Conducting the spreadhead epitome 6 The prep atomic number 18dness skirmishs 8 Holding put Group squad Meetings check Plan Template cecal appendage A prep Meeting Agenda and Hand pop out vermiform process B chore Group Meeting Agenda and Handout Appendix C 2008 The 9000 stemma www. the9000store. com rascal 2 of 10 Introduction This offer managers guide is designed to booster you plan and manage your ISO 90012008 jutting apply The 9000 investment trust text fileed forest System. (All items in blue text ar available at www. The9000Store. com) The Documented Quality System includes a Quality Manual, Procedures and Forms for an ISO 90012008 Quality focal point System.If you purchased the Complete Documentation and Training tract you in like manner received the Online Train ing Session, Training Materials Package and ranch epitome. All of the documents in the Documented Quality System are in Microsoft Word or Excel, and are very easy to edit. You entrust make this trunk your give by check up oning and alter the procedures, manual and forms. You allow for also be reservation changes to your existing mental accomplishes so you meet the requirements of the ISO 90012008 Standard. This project plan allow help you manage these changes. The basic steps we recommend are 1. 2. 3. 4. The purge manager apprehends the Online Training Session.The Project Manager prepares a Project Plan. direction and the Project Manager grade an ISO 9001 command aggroup. The Project Manager and some others plow a geological fault Analysis with the Gap Analysis Checklist. 5. The ISO 9001 command police squad up shell out responsibilities for customizing individually procedure to a group or individual. 6. Document mensural for apiece process. 7. team u p leaders hold team meetings to revise processes and procedures establish on the results of the Gap Analysis and the prepared Procedures. 8. The Project Manager trains employees on ISO 90012008 utilise the Training Materials Package. . The ISO 9001 Steering Team reviews the procedures as they are collard. 10. The Project Manager trains internal hearers using the Internal Auditor Training Materials Package available at www. The9000Store. com 11. The system is used for several months while records are collected and improvements are made. 12. The registrar comes to analyse. 2008 The 9000 Store www. the9000store. com varlet 3 of 10 This guide outlines these steps in more detail, and provides forms and templates to help you. This is a recommended plan, and you whitethorn change it to suit your organization. Project Plan A. set up the project goals (Use the Project Plan Template in Appendix A) In order to first-class honours degree planning, you get out fatality to determine wha t your goals are for the project. Answer these questions 1. When give you snuff it your project? Consider the start of your project as the beat of the Gap Analysis. When depart you be ready to conduct the Gap Analysis? Recommended steps to be completed before conducting the Gap Analysis a. Identify one or more people to conduct the Gap Analysis it is helpful if they exhaust a crap some tonicity system experience or visit experience. b. move the Gap Analysis Checklist. c. register the Gap Analysis, and communicate to all employees what is existence done, and why. You result want to be able to make the employees comfortable with answering your analyseors questions. (The listener is the person conducting the gap analysis. It whitethorn be an audit team or one individual) 2. When does your company want to have an ISO 90012008 security system in hand? The answer to this question leave determine your ageline. a. The shorter time frame allowed for the project, the more res ources the project leave alone demand during implementation. b. It is important to tell apart what your goal is because other insures pull up stakes be determined by this selective avouchation. c.Find out if there are company goals, are there clients that are requesting support or other circumstances that depart determine the date? d. Your date may be revised later. You give use this as a heading date, and as we move along to the gap analysis and creating the labor list you provide be able to determine if the date is realistic. It will compute on what you menstruumly have in place for your lineament system, and how many resources you have available for the project. 2008 The 9000 Store www. the9000store. com Page 4 of 10 The Project Plan B. Identify Project Responsibilities It is important to determine who will be leading this project.Are you the person leading the charge? If so, you would be the project manager. You do non emergency to identify the direction repre sentative at this point. You will get to clarify who makes up Top worry. The archetype has requirements to be fulfilled by Top Management, and the sooner they are have-to doe with in this project the better. 1. Who is your project manager? 2. Who makes up Top Management at your organization? 3. Who should be on the ISO 9001 Steering Team? (This team will play an important role in planning, coordinating and providing resources for the ISO 9001 project. understand Appendix B for team responsibilities. C. Begin to fill in the Project Timeline 1. When will you conduct your Gap Analysis and how long will it cover to complete? a. A Gap Analysis can typically take anywhere from 2 days to 5 days to perform. It will depend on the size of your organization, the number of auditors, the state of your rate of flow quality system and the experience of your auditors. 2. qualify responsibilities a. This will take one or twain meetings. The project manager and top management should be invol ved. Choose a date later on the travail list has been completed. You will use this information to assign certificate of indebtedness. See section 2 mean and Holding the supplying Meetings) 3. Target a date for Introductory discipline for all employees. a. You will want your employees to be aware of the project, what will contend to be done, who will be involved, and why you are implementing ISO 90012008. Choose a date that is after the meeting discussed above. That way you can decide if some people that will be involved in the project contend more elaborated train, and you can let employees contend who will be engagementing on the project. Use the Training Materials Package to conduct the training sessions. 2008 The 9000 Store www. the9000store. om Page 5 of 10 The Gap Analysis Scheduling and Conducting the Gap Analysis A. Schedule the Gap 1. look backward the project plan a. Who did you identify to conduct the gap? b. Schedule the Gap Analysis, and communicate to all employees what is being done, and why. You will want to be able to make the employees comfortable with answering your auditors questions. c. You may want to consider rouseing out a newsletter to inform employees that the Gap will be performed, by whom, when and why the Gap is being performed. 2. The audit schedule a. Determine if you will audit by process/procedure or by area of the instalment.Our approach is usually to audit by area of the facility. b. Divide the facility into manageable areas. Schedule time to audit each section of the standard that applies to the area. c. If you are using an audit team, assign the team to cover the various areas of the facility. d. Arrange your Gap Analysis checklists so each auditor will have the sections of the standard that are applicable in the areas they will cover. e. Arrange your checklists so each auditor will have the sections of the standard that are applicable in the areas they will cover. B. Conducting the Audit 1.Follow the schedu le that you have prepared. Go into each area of the facility to evaluate the current quality system. Focus on what is in place, and what is not in place. Remind auditors that you are not focusing on respectfulness or non compliance to the current system, but on the design of the current system, and how it matches the ISO 90012008 requirements. 2. Take notes on what is in place, and what will privation to be demonstrable and changed. Take complete notes, reference documents and examples. C. Reporting 1. Summarize the audit findings in the form of a task list. You will usually dentify several categories of tasks. Processes that observe with the standard and are documented. Processes that comply with the standard and must be documented. Processes that do not comply with the standard and must be redesigned. Processes required by the standard that are not currently in place. 2008 The 9000 Store www. the9000store. com Page 6 of 10 The Gap Analysis For each requirement (or pitch of requirements) of the standard you will want to identify the status of the current system. The ISO 9001 Steering Team will use this information as they assign responsibility and timelines to Teams.Teams will be assigned responsibility for development of a procedure. 2008 The 9000 Store www. the9000store. com Page 7 of 10 The supply Meeting The homework Meetings A. Planning your meeting 1. Determine who should attend. Include top management. Answer these questions a. Who will be able to decide which employees will be assigned tasks? b. allow they know whether the employees workload will be able to accommodate the assigned tasks? c. Who is liable for resources and can make resources available to the ISO 9001 project? d. This group should continue meeting as the ISO 9001 Steering Team 2.Create an Agenda, items to include a. Explain the Implementation go to the group (see handout in Appendix B) b. Discuss Responsibilities of the ISO 9001 Steering Team (see handout in Appendix B) c. limit the tasks to individuals or teams. (Use tables from Appendix B) go off the responsibilities to make sure that they are well dispersed, not assigned intemperately to one group or one individual. For each team identify a team leader. It works very well to have a member of the ISO Steering Team as a leader for each of the travail Group teams.It provides good communication between the teams and the ISO Steering Team throughout the project. d. Determine resources required for completion of the tasks. Will teams or individuals need assistance with other responsibilities during the ISO 9001 project? What kind of adept guidance will be inevitable to allow these teams or individuals to complete the tasks efficiently and effectively? 1. Assistance from the management representative? 2. Prepared materials? 3. particular Training? e. pose dates to tasks. (Use table from Appendix B) Stagger start dates consort to resources available. Determine which tasks you need to com plete in the beginning to allow others to build on, for example Management Responsibility. Complete the Quality constitution and Quality Goals as well as identifying key processes and their interrelation archaean on in the project. Estimate the sum of money of time call for to complete each task based on the amount of resources available to the task. 2008 The 9000 Store www. the9000store. com Page 8 of 10 The job Group Meeting Holding lying-in Group Team Meetings The team leader is responsible for scheduling the first team meeting according to the plan on the Gantt chart. 1. An order of business is provided in Appendix C a.Explain the Implementation locomote to the group (use the Task Group Team Handout in Appendix C) b. Discuss Responsibilities of the ISO 9001 Steering Team (use the Task Group Team Handout in Appendix C) c. Hand out the procedure that the team will be responsible for. d. Hand out the section of the Gap Analysis that applies to the team. e. Determine resou rces required for completion of the tasks. Will teams or individuals need assistance with other responsibilities during the ISO 9001 project? What kind of technical guidance will be needed to allow these teams or individuals to complete the tasks efficiently and effectively? . Assistance from the management representative? 2. Prepared materials? 3. Special Training? 2. Assign dates to tasks from the Gap Analysis using the start and slay date on the Gantt chart. The team leader should print copies of the section of the Gap Analysis that are relevant to the team. a. Explain to the team that the Procedure and your process must match. whatsoever of your processes (the way you do things) will need to be changed to meet requirements of the standard, and separate of the procedure will need to be edited to accurately tie what you do. b.List the requirements from the Gap Analysis Checklist that you are not currently meeting. These will need to be evaluated to determine if you will change your process to match the procedure, or alter your process to meet the standard and edit the procedure. c. List the requirements from the Gap Analysis Checklist that you are meeting. Evaluate these against the procedure to see if edits are needed to the Procedure, or if the process documented in the procedure will work better for you. d. Schedule next meeting. During the next meetings you will work on the tasks that you have listed above. . Once the process has been determined the procedure will need to be finalized and sent for approval by the ISO 9001 Steering Team. 2008 The 9000 Store www. the9000store. com Page 9 of 10 The Task Group Meeting 3. Discuss the contiguous agenda f. strike The 9000 Store Procedure (Or for the team responsible for the quality manual read The 9000 Store Quality Manual and compare to current processes. g. Assign tasks for implementing changes in your processes and editing prepared procedure. h. Set next agenda i. Schedule next meeting 2008 The 9000 Store www. he9000store. com Page 10 of 10 Appendix A The Project Plan Project Plan ISO 90012008 Project goals Start ensure Target registration Date Responsibilities Project Manager Management Representative Top Management ISO 90012008 Steering Team Project timeline Step Gap Analysis Create Task List Assign Responsibilities Introductory Training Design and Implementation System Complete Registration Audit Certificate Received Schedule Date Completion Date 1. 2. 3. 4. 5. 6. 7. 8. Appendix A Appendix B ISO 90012008 Planning Meeting Planning Meeting HandoutsAgenda review the Implementation Steps (see handout attached) Discuss Responsibilities of the ISO 9001 Steering Team (see handout attached) Assign individuals to teams for each task group. (Use tables from Appendix B) Determine resources required for completion of the tasks. a. Will teams or individuals need assistance with other responsibilities during the ISO 90012008 project? b. What kind of technical guidance will be needed to allow these teams or individuals to complete the tasks efficiently and effectively? Assistance from the management representative? Prepared materials? Special Training? 5. Assign dates to tasks. (Use table from Appendix B) a. Stagger start dates according to resources available. b. Determine which tasks you need to complete in the beginning to allow others to build on, for example Management Responsibility and Document go should start early in the project. Complete the Quality Policy and Quality Goals as well as identifying key processes and their interrelation early on in the project. c. Estimate the amount of time needed to complete each task based on the amount of resources available to the task.Refer to the Gap Analysis results to determine how much work each team has to complete. 6. Schedule employee training sessions using the Training Materials Package a. All employees need training on the ISO 90012008 Standard. Providing the training early on in the project makes everyon e aware of the projects and its goals. 1. 2. 3. 4. *Keep minutes of all of the ISO 9001 Planning and Steering Team meetings. This helps award top management involvement in the development of the ISO 90012008 Quality Management System. Record attendees. Appendix B Appendix B ISO 90012008 Planning MeetingImplementation Steps 1. The team of people assigned responsibility will use the The 9000 Store Procedures, Quality Manual and Forms as a foundation for the process to utter the requirements of the standard. The team will use the task list to identify what areas need changes to processes. 2. Each responsible team will evaluate the process presented in the procedure, determine if any changes are needed for your organization, and make edits to the procedure and forms. 3. The team will finalize the procedure and send it to the ISO 9001 Steering Team for review and approval. . The team will train employees that are affected by or have responsibility for the procedure. 5. The employees w ill start following the documented process and maintaining records. ISO 90012008 Steering Team Responsibilities 1. 2. 3. 4. Identify team members for each procedure. Assign target start date and completion date for each team. Identify training needs for employees and schedule training sessions for ISO 90012008 Meet on a unceasing basis to evaluate progress, answer questions for the teams and evaluate resource needs for the implementation. . Review and approve procedures as they are finalized. 6. Evaluate and choose a Registrar Appendix B Appendix B ISO 90012008 Planning Meeting Task Assignments Task Group Quality Manual Document visit watch of Quality Records Management Responsibility Competence, Awareness and Training Infrastructure Planning of Product Realization Processes node Related Processes Design and Development get Control of Production and Service Provision Identification and Traceability Customer airscrew Team MembersTeam Leader Appendix B Appendix B ISO 90012008 Pl anning Meeting Task Group rescue of Product Control of step and Monitoring Devices Monitoring, amount and Analysis of Customer Satisfaction Internal Audits Monitoring, Measuring and Analysis of Product and Realization Processes Control of Nonconforming Product corrective Action and Preventive Action Team Members Team Leader Appendix B Appendix B ISO 90012008 Planning Meeting Project Gantt map (Change headings to the months you expect your project to run.Then identify when each team will start and stop, shade the time that each team will run) month 1 month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Task Group Document Control Control of Quality Records Management Responsibility Competence, Awareness and Training Infrastructure Planning of Product Realization Processes Customer Related Processes Design and Development purchase Control of Production and Service Provision Identification and Traceability Customer keeping Appendix BAppendix B ISO 90012008 Planning Meeting Task Group Preservation of Product Control of Measuring and Monitoring Devices Monitoring, Measuring and Analysis of Customer Satisfaction Internal Audits Monitoring, Measuring and Analysis of Product and Realization Processes Control of Nonconforming Product Corrective Action and Preventive Action Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Appendix B Appendix C Task Group Team Meeting Task Group Meeting Agenda 1. 2. 3. 4. 5.Review the Implementation Steps to the group Review Responsibilities of the ISO 90012008 Steering Team Review procedure that the team will be responsible for. Review the section of the Gap Analysis that applies to the team. Determine resources required for completion of the tasks. a. Will the team need assistance with other responsibilities during the ISO 90012008 project? b. What kind of technical guidance will be needed to allow the team to complete the tasks efficiently and effectively? 1. Assistance from the management r epresentative? . Prepared materials? 3. Special Training? 6. Assign dates to tasks from Gap Analysis using the start and finish date on the Gantt chart. 7. Schedule next meeting. 8. Next agenda 1. Read The 9000 Store Procedure and compare to current processes. 2. Assign tasks for implementing changes in your processes and editing prepared procedure. Implementation Steps 1. The team assigned responsibility for each procedure will use the The 9000 Store Procedure as a foundation for the process to address the requirements of the standard.The team will use the task list to identify what areas need changes to processes. 2. Each responsible team will evaluate the process presented in the procedure, determine if any changes are necessary for your organization, and make edits to the procedure and forms. 3. The team will finalize the procedure and send it to the ISO 90012008 Steering Team for review and approval. 4. The team will train employees that are affected by or have responsibility f or the procedure. 5. The employees will start following the documented process and maintaining records.Appendix C Appendix C Task Group Team Meeting ISO 90012008 Steering Team Responsibilities 1. Identify team members for each procedure. 2. Assign target start date and completion date for each team. 3. Identify training needs for employees and schedule training sessions a. Employee Introduction to ISO 90012008 using the Training Materials Package b. Internal Auditor Training using the Internal Auditor Training Materials Package 4. Meet on a regular basis to evaluate progress,