ISO:9001-2008 Awareness Product Code: C108 Price: 199 USD www.globalmanagergroup.com
MESSAGE FROM ISO: 9000 • Message in 5 lines • Say what you do • Do what you say • Record what you do • Check the difference • Act on the difference Message in 1 line (1994) Do right thing, first time, every time to achieve consistent quality Message in 1 line (2000) Continual improvement is the way of life
HOW ARE ISO STANDARDS DEVELOPED? ISO standards are developed according to the following principles 1. ConsensusThe views of all interests are taken into account: manufacturers, vendors and users, consumer groups, testing laboratories, governments, engineering professions and research organizations. 2. Industry wideGlobal solutions to satisfy industries and customers worldwide. 3. VoluntaryInternational standardization is market driven and therefore based on voluntary involvement of all interests in the market-place.
PLANNED CHANGES TO ISO 9001:2008 • Forward: All reference to ‘Quality Assurance’ have now been removed • Introduction: Mention now made to ‘Business Environment’ and the ‘risks associated with that environment’. • Various: ‘Statutory and regulatory’ requirements now mentioned. • Out source process – controls are to be identified through Cl 7.4. Various new notes have been added. 5. Documentation: Clarification that a ‘Record’ is documentation. 6Management representative: Must be a member of the organization’s management team.
APPLICATION OF PDCA TO DEPARTMENT / SECTION HEADS CHECK • How is my department doing? • Are processes under control? • What are my employees telling me? • Are we meeting customer requirements? • Am i meeting my objectives? • What are the key problems in my area? • How can we improve? ACT • Systematic problem-solving (based on importance, risks involved etc) • Develop action plans • Concentrate on improvement (incremental or “breakthrough” improvements) • Review existing procedures, and need for new procedure
Quality manual Procedures Work instruction/SOP/process flow charts/other documents Quality records Marketing Purchasing Stores Production Q.A. Dispatch Servicing 4 TIER DOCUMENTATION STRUCTURE
RECORDS REQUIRED BY REVISED ISO 9001 • List of records • Document updating records • Control of quality records and master list of records • Management reviews • Record of training and skill and competency of personnel • Maintenance record • Process monitoring data and corrective action taken for process control • Record of product non conformities and products accepted on concession. • Data analysis and activities for continual improvement. • Result of internal audits and follow up action. • Data on customer feedback/satisfaction measurement and action taken on customer complaints. • Vendor evaluation and purchase orders and actions arising from the evaluations • Customer property that is lost, damaged or otherwise found to be unsuitable for use
WORKSHOP 2 ISO 9001: 2008 QUESTIONNAIRE • Analyze the statement provided and indicate in the box on the paper whether you consider the statements to be “True” or “False”. • If you consider the statements to be “True”, please indicate in the box the clause number from ISO 9001: 2008 which supports your decision
FOR EXISTING CERTIFIED CLIENTSSTEPS FOR UPDATION OF EXISTING ISO:9001-2000 SYSTEM TO REVISED ISO: 9001-2008 QUALITY MANAGEMENT SYSTEM( EXISTING CERTIFIED CLIENTS ) • Conduct awareness program for revision to ISO:9001-2008 • Review all documents to revised ISO:9001-2008 requirements and Identify changes. • Review quality policy and establish quality objectives • Revise quality manual and documents as per ISO:9001-2008. • Train internal auditors for requirements of revised ISO:9001 standard • Assess the system through internal audit as per revised ISO standard. • Take corrective actions for non-conformities. • Apply to revised existing certificate to ISO:9001-2008 to your existing certifying body. • Final audit( Either in surveillance audit or special audit by certifying body after release of ISO:9001-2008. Note: It can be seen from the list of changes, there are very few of any consequence and most organizations will have little problem adapting their system to satisfy these changes. Also all certified company needs to update the system within 1 year of release of standard.