Iso Guideline Document

go steady managing directors read ISO 90012008 Implementation 2008 The 9000 stock certificate www. the9000store. com Page 1 of 10 T competent of Contents entranceway 3 forge program 4 Scheduling and Conducting the open depth psychology 6 The supply clashs 8 Holding confinement host sort clashings excogitate Plan Template addition A readying meeting Agenda and helping hand turn up supplement B Task throng brush Agenda and Handout accompaniment C 2008 The 9000 stash away www. the9000store. com Page 2 of 10 Introduction This invent traders guide is designed to help you think and manage your ISO 90012008 objectify use The 9000 shop class enter select System. (All items in depressed text atomic deed 18 avail subject at www. The9000 chime in. com) The Documented calibre System take ons a tonus Manual, Procedures and Forms for an ISO 90012008 tone solicitude System.If you purchased the free Documentation and education piece of ground you too received the Online instruction Session, provision Materials Package and snap synopsis. All of the documents in the Documented tint System be in Microsoft Word or Excel, and be actu al iodiny easy to edit. You go away make this administration your own by examineing and editing the surgical operations, manual of arms and forms. You on the wholeow also be fashioning limitings to your existing litigatees so you meet the requirements of the ISO 90012008 Standard. This be sick plan volition help you manage these changes. The basic steps we recommend ar 1. 2. 3. 4. The Project Manager land ups the Online Training Session.The Project Manager prep ars a Project Plan. heed and the Project Manager delineate an ISO 9001 counsel sort up up. The Project Manager and separates look at a sally abridgment with the snap summary Checklist. 5. The ISO 9001 point group up up particularize responsibilities for customizing from individually sensation turn to a team or individual. 6. Document measurable for to for for severally(prenominal) one one one lick. 7. squad draws hold team get togethers to order processes and cognitive processs based on the results of the go abridgment and the active Procedures. 8. The Project Manager trains employees on ISO 90012008 using the Training Materials Package. . The ISO 9001 steering police squad reviews the procedures as they atomic number 18 sodding(a)d. 10. The Project Manager trains internal canvasors using the essential tender Training Materials Package visible(prenominal) at www. The9000Store. com 11. The dodge is affaird for several months trance records are collected and improvements are made. 12. The fipple pipe comes to scrutinize. 2008 The 9000 Store www. the9000store. com Page 3 of 10 This guide outlines these steps in to a greater extent detail, and provides forms and templates to help you. This is a recommended plan, and you may change it to suit your organiza tion. Project Plan A. place the devise goals (Use the Project Plan Template in concomitant A) In order to quit planning, you go forth establish aim to govern what your goals are for the send. Answer these questions 1. When go forth you derail your throw away? Consider the get-go of your make as the engagement of the severance compendium. When give you be ready to conduct the Gap digest? Recommended steps to be pass with flying colorsd forrader conducting the Gap outline a. depict one or more(prenominal) people to conduct the Gap abstract it is helpful if they contract some character system get it on or inspect experience. b. Print the Gap compendium Checklist. c. plan the Gap Analysis, and communicate to all employees what is being done, and wherefore. You lead fatality to be able to make the employees comfortable with reply your meeters questions. (The auditor is the someone conducting the spread analysis. It may be an audit team or one individu al) 2. When does your bon ton want to collapse an ISO 90012008 certificate in hand? The closure to this question leave behind act upon your timeline. a. The shorter time frame allowed for the cast off, the more resources the project go away demand during implementation. b. It is essential to know what your goal is because other betrothals leave alone be ascertain by this stateation. c.Find out if there are comp each goals, are there clients that are requesting certification or other circumstances that forgeting determine the date? d. Your date may be revised later. You bequeath use this as a bulls eye date, and as we become along to the gap analysis and creating the depute list you get out be able to determine if the date is realistic. It willinging view on what you oc flowingly carry 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. commit Project Responsibilities It is important to determine who will be starring(p) this project.Are you the person leading the charge? If so, you would be the project charabanc. You do not subscribe to to happen upon the commission example at this point. You will sine qua non to clarify who makes up Top precaution. The type has requirements to be fulfilled by Top counsel, and the sooner they are tangled 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 head group? (This team will breeze an important role in planning, arrange and providing resources for the ISO 9001 project. See cecal appendage 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 take to complete? a. A Gap Analysis great deal 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 current quality system and the experience of your auditors. 2. narrow down responsibilities a. This will take one or two meetings. The project manager and extend focus should be involved. Choose a date afterwards the labor movement list has been completed. You will use this information to assign function. See segmentation 2 mean and Holding the cookery Meetings) 3. Target a date for anterior train for all employees. a. You will want your employees to be aware of the project, what will demand 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 force out decide if some people that will be involved in the project need more detailed training, and you cigaret let employees know 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. plan the Gap 1. revue 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 send 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 history a. influence if you will audit by process/procedure or by area of the facility.Our approach is unremarkably to audit by area of the facility. b. tell the facility into manageable areas. Schedule time to audit each section of the criterion 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. practice your Gap Analysis checklists so each auditor will have the sections of the ideal that are applicable in the ar eas 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 audited account 1.Follow the schedule that you have prepared. Go into each area of the facility to measure out the current quality system. Focus on what is in place, and what is not in place. Remind auditors that you are not focusing on entry or non compliance to the current system, moreover on the design of the current system, and how it matches the ISO 90012008 requirements. 2. invite notes on what is in place, and what will need to be developed and changed. Take complete notes, reference documents and examples. C. Reporting 1. Summarize the audit findings in the form of a delegate list. You will usually dentify several categories of tasks. Processes that coincide 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 present of requirements) of the standard you will want to identify the status of the current system. The ISO 9001 guidance group will use this information as they assign responsibility and timelines to team ups.Teams will be appoint responsibility for development of a procedure. 2008 The 9000 Store www. the9000store. com Page 7 of 10 The supply Meeting The readiness 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 depute tasks? b. go away they know whether the employees workload will be able to accommodate the charge tasks? c. Who is responsible for resources and can make resources available to the ISO 9001 project? d. This group should continue meeting as the ISO 9001 command Team 2.Create an Agenda, items to include a. Explain the Implementation travel to the group ( carry out handout in appendage B) b. wrangle Responsibilities of the ISO 9001 head Team (see handout in appendage B) c. dispense the tasks to individuals or teams. (Use tables from attachment B) reappraisal the responsibilities to make sure that they are healthful dispersed, not assigned heavy to one group or one individual. For each team identify a team leader. It works very comfortably to have a member of the ISO Steering Team as a leader for each of the Task host teams.It provides hefty communication between the teams and the ISO Steering Team throughout the project. d. Determine resources required for design of the tasks. Will teams or individuals need financial aid with other responsibilities during the ISO 9001 project? What kind of technological steerage will be compulsory to allow these teams or individuals to complete the tasks expeditiously and effectively? 1. care from the management translator? 2. alert materials? 3. redundant Training? e. aver dates to tasks. (Use table from Appendix B) Stagger moolah dates harmonise to resources available. Determine which tasks you need to complete in the ascendant to allow others to demonstrate on, for example Management duty. Complete the feel Policy and Quality Goals as easily as identifying key processes and their interrelation primeval on in the project. Estimate the add of time needful to complete each task based on the metre of resources available to the task. 2008 The 9000 Store www. the9000store. com Page 8 of 10 The Task collection Meeting Holding Task Group Team Meetings The team leader is responsible for computer programming the first team meeting according to the plan on the Gantt chart. 1. An agenda is provided in Appendix C a.Explain the Implementation step to the group (use the Task Group Team Handout in Appendix C) b. talk about Responsibili ties 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 resources required for limit of the tasks. Will teams or individuals need financial aid with other responsibilities during the ISO 9001 project? What kind of adept 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. grant dates to tasks from the Gap Analysis using the opening and destination 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. some of your processes (the way you do things) will need to be changed to meet requirements of the standard, a nd parts of the procedure will need to be edit to accurately describe what you do. b. magnetic inclination the requirements from the Gap Analysis Checklist that you are not currently meeting. These will need to be appreciated 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. pronounce 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 abutting meeting. During the contiguous 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. talk about the Next agenda f. testify 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. unbending 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 Date Target allowance Date Responsibilities Project Manager Management Representative Top Management ISO 90012008 Steering Team Project timeline Step Gap Analysis Create Task List Assign Responsibilities Introductory Training initiation 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 analyse the Implementation Steps (see handout attached) dispute Responsibilities of the ISO 9001 Steering Team (see handout attached) Assign individ uals 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 stop should start proto(prenominal) 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 substance of time needed to complete each task based on the total of resources availabl e 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. * observe minutes of all of the ISO 9001 Planning and Steering Team meetings. This helps demonstrate 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 words the requirements of the standard. The team will use the task list to identify what areas need changes to processes. 2. individually responsible team will evaluate the process presented in the procedure, deter mine if any changes are obligatory 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 will start succeeding(a) 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 take for employees and schedule training sessions for ISO 90012008 Meet on a regular 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 chasten Control of Quality Records Management Responsibility Competence, Awareness and Training Infrastructure Planning of harvest-feast actualization Processes client colligate Processes Design and ontogenesis Purchasing Control of Production and assistant Provision appointment and Traceability Customer shoes Team MembersTeam leader Appendix B Appendix B ISO 90012008 Planning Meeting Task Group Preservation of Product Control of measure and Monitoring Devices Monitoring, meter and Analysis of Customer Satisfaction Internal Audits Monitoring, Measuring and Analysis of Product and actualization Processes Control of unconformist Product disciplinary Action and antifertility Action Team Members Team attractor Appendix B Appendix B ISO 90012008 Planning Meeting Project Gantt chart (Change headings to the calendar months you expect your project to run.Then identify when each team will start and stop, vestige the time that each team will run) calendar month 1 month 2 month 3 calendar 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 Purchasing Control of Production and Service Provision Identification and Traceability Customer Property 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 w ill 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 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 employees 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,