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Iso 9001 systems

Iso 9001 systems

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  • 1. Iso 9001 systemsKeys for SuccessImplementing a new Quality System takes time and resources. Your new ISO 9001Quality Manual and Quality System will become your road map to success. There aremany resources that can help keep an implementation on the right track. The InternationalOrganization for Standards has a wealth of information at your disposal. ISO has some ofthe most valuable resources available in the form of guidance documents. Some of theseresources are listed below: • Guidance on ISO 9001:2008 • Guidance on the documentation requirements of ISO 9001:2008 • Guide to the Terminology used in ISO 9001 and ISO 9004 • Guidance on the concept and use of the process approach for management systems • Guidance on "Outsourced processes" • Implementation guidance for ISO 9001:2008The following keys for success will help you keep on track to accomplish a successfulimplementation.1. Management CommitmentImplementing a new quality system takes time, effort and resources. If you are launchinga project to implement ISO 9001, make sure you have the full support form yourManagement Team. Commitment from the Management Team will not only help achieveyour implementation schedule but will help sustain the cross functional ownership of thesystem once it is implemented. A single person cannot be responsible for implementation.Engage the Management Team early by defining a mission statement and quality policy.Discuss the following benefits of ISO 9001 with the Management Team • Improved Customer Satisfaction • Improved Internal Communication • Measurable Objectives • Reduced Non-Conformances and Scrap • System to correct and prevent problems • World recognized standard for Quality • Continuous Improvement objectives2. Create a Project Team
  • 2. The success of any project requires effective Project Management. Project Managementwill establish project priorities, time lines and resource allocation. The ISO 9001 ProjectManager should be a member of the Management Team who is supported by theManagement Team. The Project Manager should have the responsibility and authority tokeep the team on track. • Assign a cross functional team to the project to win buy in • Assign members from each functional area in the company even though their contributions may be limited.3. Launch the ProjectThe Project Manager should launch the project by announcing it to the company so thateveryone in the organization is aware of the new Quality System requirements thecompany is implementing. Announce the team and set incentives like a company lunch,team certificates, etc. The monetary value is not as important as the recognition andsatisfaction personnel will feel if they are involved along the way • Try to set up a training webinar or internal training session on ISO 9001 so that the team and/or company can get acquainted with the concepts. • Post signs with updates on progress • Have periodic meetings with employees to get their feedback4. Conducting an ISO 9001 Gap AnalysisConducting a Gap Analysis of a quality system is a formal way for a company to evaluatewhere they are and where they need to be. The goal is to understand how to improve thecurrent quality system to meet the regulatory requirements of the ISO 9001 Standard. AGap Analysis Checklist can be written or purchased to accomplish this task. Each sectionof the standard is checked to determine if the current system meets the requirements ofthe standard. Upon completion of the Gap Analysis, the scope of the project can beunderstood. ISO 9001 requires specific documented procedures and records to complywith the standard.5. Team MeetingsTeam Meetings should be planned around each quality system requirements as it relatesto each functional area in the company. For instance, Supplier Controls and Purchasingrequirements should be discussed with the Purchasing Team. Non-Conforming MaterialControl could involve manufacturing as well as receiving inspection. The system whichwill be implemented needs to work in both departments. The meetings should be shortand to the point reviewing progress, time lines, and accomplishments. Ensure the timelines are realistic. Keep everyone informed with bulletins, or progress reports so theproject does not loss its momentum.6. Create the Quality System Documentation
  • 3. The first document that should be written is the Quality Manual. The ISO 9001 QualityManual is the overriding policy statement and the document which will identify thequality system requirements that your company will implement. The Quality Manual alsodocuments exclusions and justification for not complying to a requirement. Somerequirements are not relevant to your companys business. The Quality Manual will beused moving forward as the upper level policy document which should be consistent witheach Standard Operating Procedure written. Remember, ISO 9001 is a process approach.Using the Gap Analysis, the project plan can be updated to include all the StandardOperating Procedures which need to be created or modified to comply with the standard.As the procedures are written, a central repository should be created to save thedocuments electronically. Each document will require review and approval to determineif the requirements have been met. As the project progresses, each procedures createdwill fill a gap identified during the gap analysis.There are five sections in the standard that specify activities that need to be consideredwhen you implement your system: • Overall requirements for the quality management system and documentation • Management responsibility, focus, policy, planning and objectives • Resource management and allocation • Product realization and process management, and • Measurement, monitoring, analysis and improvement.When creating a quality system from the ground up, Standard Operating ProcedureTemplates can be very useful and save a lot of time. There are various debates regardingif using a template is an effective way to implement a Quality System. Each companyneeds to evaluate the pros and cons. Using a good template can save thousands of dollars,establish a consistent format and give the company a solid foundation to build on.Remember, templates are to be modified to meet the companys core competencies andorganization structure.7. Implement the System and Train StaffA lot of work has been done to get to the point of implementation. The ISO 9001 QualitySystem will be successful once the company understands the new requirements,documentation and their new roles in complying with the standard. Training all personnelis the key to success. Although this process is cumbersome, if effective training is notaccomplished the system will not be effective. It takes commitment from the companyand the Management Team to make it a successful launch.8. Verify the Effectiveness of the Quality SystemNow that your system is in place and the company is using the system, it is time to verifythe effectiveness of the system. The best way to verify effectiveness is to audit the newprocesses. This can be accomplished by using an external third party auditor or your own
  • 4. Internal Audit Team. Using your Internal Audit Team provides many benefits. Itreinforces the understanding of the requirements and keep the employees workingtogether on compliance. Creating an Internal Audit Checklist can be very helpful sincethe Internal Audit Team will have difficulty recalling all the requirements that need to beverified during an audit. The audit results should be discussed at Management Review todetermine is corrective actions need to be taken to address any issues that may have beenidentified.9. Manage the Quality SystemManaging a new Quality System is challenging after a launch. The focus on customersatisfaction is critical as well as the core requirements of the ISO 9001 Quality System. • Monitor and measure the progress of your Quality Management System • Strive for continual improvement • Consider implementing goals and objectives in the company operation10. Find a RegistrarThere are many companies that can certify organizations to the ISO 9001 Standard.Interview several registrars to determine which company is right for you. Consider theirlocation, travel costs and other administrative fees. There are a lot of resources available,talk to other companies and ask for referrals.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards