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Intro To ISO 9001:2008


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Intro To ISO 9001:2008

  1. 1. ISO 9001:2008 Quality Management System Angela O'Sullivan, Arwen Consulting Arwen
  2. 2. Why Adopt ISO 9001:2008? <ul><li>Benefits to internal operations: </li></ul><ul><li>Helps you to streamline and align your processes & helps to focus efforts on key processes </li></ul><ul><li>Helps to ensure that your processes are efficient and effective </li></ul><ul><li>Why having ISO is attractive to customers / prospective customers </li></ul><ul><li>Provides them with a level of assurance that your product or service meets their requirements </li></ul><ul><li>Reduces the requirement for customer audits </li></ul><ul><li>Meets their requirements for supplier approval or development in regulated sectors such as medical, food and automotive </li></ul>Arwen
  3. 3. Reasons for adopting ISO where the customer has not made the request <ul><li>Since 2008 the ISO standard places increased focus on control of outsourced services & subcontractors - possibility of increased scrutiny by existing customers </li></ul><ul><li>Move up the food chain </li></ul><ul><li>Attract new customers </li></ul><ul><li>Enter new markets </li></ul>Arwen
  4. 4. The Process of ISO registration (Step One)– Develop the Quality Management System QMS <ul><li>Assign a management representative with responsibility for quality </li></ul><ul><li>Develop a project plan (timing and milestones) </li></ul><ul><li>Obtain a copy of the ISO 9001:2008 standard </li></ul><ul><li>Identify the main processes & support processes within the organisation </li></ul><ul><li>Develop the quality policy, quality manual, quality procedures & other support documents such as work instructions & forms (this is the QMS) </li></ul><ul><li>Check that all elements of ISO are included in your QMS </li></ul><ul><li>Start using the QMS, metrics, internal audits etc. </li></ul>Arwen
  5. 5. The Process of ISO registration (Step Two)– Engage with Registrar <ul><li>Select a registrar </li></ul><ul><li>Agree dates for pre-assessment & registration audit </li></ul><ul><li>Carry out pre-assessment audit (or Gap Audit) </li></ul><ul><li>Registrar will issue a list of corrective actions which need to be carried out prior to registration audit </li></ul><ul><li>Registration Audit, after which further corrective actions will be identified </li></ul><ul><li>Once a corrective action plan is submitted & accepted by the registrar, the ISO certification will be issued. </li></ul>Arwen
  6. 6. Maintenance of ISO quality management system <ul><li>Follow the QMS – some typical activities </li></ul><ul><li>Keep proper records of activities as outlined in the procedures </li></ul><ul><li>Measure your key processes and take actions on same </li></ul><ul><li>Hold regular management meetings to review elements of the quality management system </li></ul><ul><li>Carry out internal audits according to your internal audit program </li></ul><ul><li>Maintain a corrective/preventive action program </li></ul><ul><li>Maintain control over your suppliers/subcontractors </li></ul>Arwen
  7. 7. Thank you Please contact me if you need any advice on the benefits/costs to your organisation if you are considering ISO registration [email_address] 0876895785 Arwen