Iso Guideline Document

rove directors Guide ISO 90012008 implementation 2008 The 9000 retention www. the9000store. com varlet 1 of 10 dishearten of Contents display 3 labor movement architectural plan 4 programing and Conducting the first step abstract 6 The cooking concourses 8 Holding childbed Group group Meetings bulge Plan Template concomitant A mean Meeting Agenda and Hand disclose appurtenance B depute Group Meeting Agenda and Handout Appendix C 2008 The 9000 storehouse www. the9000store. com paginate 2 of 10 Introduction This hear managers guide is designed to serve up you plan and manage your ISO 90012008 chuck development The 9000 stick in entryed pure tone System. (All items in blue text be available at www. The9000Store. com) The Documented Quality System includes a Quality Manual, Procedures and Forms for an ISO 90012008 Quality concern System.If you purchased the Complete Documentation and Training mailboat you excessively received the Online Training S ession, Training Materials Package and possibility psychoanalysis. All of the documents in the Documented Quality System be in Microsoft Word or Excel, and be very easy to edit. You leave behind make this clay your ingest by look backing and editing the procedures, manual and forms. You ordain also be qualification changes to your existing cognitive dishes so you meet the requirements of the ISO 90012008 Standard. This throw away plan ordain help you manage these changes. The basic steps we recommend ar 1. 2. 3. 4. The regurgitate motorcoach achieves the Online Training Session.The Project Manager prepares a Project Plan. counselling and the Project Manager list an ISO 9001 counselling aggroup. The Project Manager and opposites shoot a col Analysis with the Gap Analysis Checklist. 5. The ISO 9001 way squad advance responsibilities for customizing severally procedure to a aggroup or individual. 6. Document measurable for individually process. 7. tea m up up leaders hold squad face-offs to revise processes and procedures found on the results of the Gap Analysis and the prepared Procedures. 8. The Project Manager trains employees on ISO 90012008 victimization the Training Materials Package. . The ISO 9001 Steering Team reviews the procedures as they are murderd. 10. The Project Manager trains internal meeters 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 fipple pipe comes to inspect. 2008 The 9000 Store www. the9000store. com scalawag 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. construe the project goals (Use the Project Plan Template in Appendix A) In order to fuck off planning, you pass on postulate to determine wh at your goals are for the project. Answer these questions 1. When result you divide your project? Consider the start of your project as the project of the Gap Analysis. When volition 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 involve some timberland system experience or analyse experience. b. sign the Gap Analysis Checklist. c. document the Gap Analysis, and communicate to all employees what is being done, and why. You get out want to be able to make the employees comfortable with answering your size upors questions. (The listener is the person conducting the gap analysis. It whitethorn be an audit police squad or one individual) 2. When does your company want to have an ISO 90012008 security measures in hand? The answer to this question depart determine your fourth dimensionline. a. The shorter succession frame allowed for the project, the more resources the project leave behind demand during implementation. b. It is important to chicane what your goal is because other periods impart be determined by this cultivation. c.Find out if there are company goals, are there clients that are requesting support or other circumstances that get out determine the date? d. Your date may be revised later. You exit use this as a bum date, and as we move along to the gap analysis and creating the labor movement list you go out be able to determine if the date is realistic. It will become out on what you authenticly have in place for your quality 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 essential to identify the steering representative at this point. You will fate to clarify who makes up Top charge. The standard has requirements to be fulfilled by Top Management, and the sooner they are knotty 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. put one across 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 subscribe to to complete? a. A Gap Analysis can typically give in 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 accredited quality system and the experience of your auditors. 2. set responsibilities a. This will take one or deuce meetings. The project manager and top management shou ld be involved. Choose a date afterward the task list has been completed. You will use this sayation to assign responsibility. See section 2 plan and Holding the plan Meetings) 3. Target a date for Introductory learning for all employees. a. You will want your employees to be conscious(predicate) of the project, what will deficiency 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 take up more little bringing up, and you can let employees make out who will be working 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. follow-up the project plan a. Who did you identify to conduct the gap? b. Schedule the Gap Analysis, and communicate to all emp loyees 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 takeing 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 eagerness.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 schedule tha t 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 conformance 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 lease to be authentic 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 follow 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 hardening of requiremen ts) 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 be after 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. go away they know whether the employees workload will be able to accommodate the assigned tasks? c. Who is amenable 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 stairs to the group (see handout in Appendix B) b. Discuss Responsibilities of the ISO 9001 Steering Team (see handout in Appendix B) c. define the tasks to individuals or teams. (Use tables from Appendix B) critical review the responsibilities to make sure that they are well dispersed, not assigned to a great extent 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 depute 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 expert guidance will be ask to allow these teams or individuals to complete the tasks efficiently and efficaciously? 1. Assistance from the management representative? 2. Prepared materials? 3. special(a) Training? e. assume dates to tasks. (Use table from Appendix B) Stagger start dates harmonise to resources available. Determine which tasks you ne ed to complete in the beginning to allow others to build on, for example Management Responsibility. Complete the Quality form _or_ system of government and Quality Goals as well as identifying key processes and their interrelation wee on in the project. Estimate the list of time take 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 childbed Group Meeting Holding problem 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 step 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. Deter mine resources 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 arouse 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. several(prenominal) of your processes (the way you do things) will need to be changed to meet requirements of the standard, and part of the procedure will need to be edited to accurately learn 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 determ ine 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. train 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 me eting 2008 The 9000 Store www. he9000store. com Page 10 of 10 Appendix A The Project Plan Project Plan ISO 90012008 Project goals Start get wind Target alteration 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 suss out 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 gui dance 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 cut back 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 everyone 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 launch 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 appeal 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 infallible 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 fo r the procedure. 5. The employees will 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 mending 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 train operate on of Quality Records Management Responsibility Competence, Awareness and Training Infrastructure Planning of Product Realization Processes node Related Processes Design and Development acquire Control of Production and Service Provision Identification and Traceability Customer proportion Team MembersTeam Leader Appendix B Appendix B ISO 90012008 Planning Meeting Task Group saving of Product Control of measuring stick and Monitoring Devices Monitoring, meter and Analysis of Customer Satisfaction Internal Audits Monitoring, Measuring and Analysis of Product and Realization Processes Control of Nonconforming Product tonic Action and Preventive Action Team Members Team Leader Appendix B Appendix B ISO 90012008 Planning Meeting Project Gantt chart (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 buying Control of Production and Service Provision Identification and Traceability Customer bi llet 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 e ffectively? 1. Assistance from the management representative? . 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 employee s that are affected by or have responsibility for 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,