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6. Resource Mgmt

ISO 9001:2008 Requirements. 4. Quality Management System (QMS). 5. Management Responsibility. 7. Product Realisation Processes. 6. Resource Mgmt. 8. Measurement, Analysis & Improvement. ISO 9001:2008 Requirements. 4 Quality Mgmt System (QMS) Requirements Key processes documented

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6. Resource Mgmt

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  1. ISO 9001:2008 Requirements 4. Quality Management System (QMS) 5. Management Responsibility 7. Product Realisation Processes 6. Resource Mgmt 8. Measurement, Analysis & Improvement

  2. ISO 9001:2008 Requirements • 4 Quality Mgmt System (QMS) Requirements • Key processes documented • 4.2.3 Control of Document • 4.2.4 Control of Records • 8.2 Internal Audit • 8.3 Control of Non-conforming Products • 8.5.2 Corrective Actions • 8.5.3 Preventive Actions • Key business processes / activities • Document control in place • Records properly maintained & retrievable

  3. ISO 9001:2008 Requirements • 5 Management Responsibility • Commitment to development, implementation and improvement of QMS • Customer-focus • Establish quality policy / mission for organisation • Quality objectives & planning • Ensure responsibility & authorities are defined • Appoint mgmt representative (member of orgn mgmt *) for the implementation and improvement of the QMS • Ensure QMS requirements are communicated • Mgmt review of QMS deficiencies & possible improvements

  4. ISO 9001:2008 Requirements • 6 Resource Mgmt • Provide adequate manpower resources • Staff or personnel* are competent & properly trained for assigned duties • Adequate supporting infrastructure & facilities • Work environment does not affect performance • Lighting, noise, temperature, humidity, weather*

  5. ISO 9001:2008 Requirements • 7 Product Realisation Processes • Product realisation planning (mainly for projects) • Determine product/customer requirements • Post-delivery activities include 1) Actions under warranty provisions, 2) Contractual obligations such as maintenance activities and 3) Supplementary services such as recycling or final disposal* • Channels for customer communication • Design and development processes • Planning, inputs, outputs, review, verification, validation*, changes • Purchasing • Production and service operations • Include handling of customer property (include intellectual properties& personal data*) • Control of measuring and monitoring devices

  6. ISO 9001:2008 Requirements • 8 Measurement, Analysis & Improvement • Measurement and Analysis Planning • Measures on customer satisfactions*, internal audits and other process/product measures* • Control of non-conformity • Analysis of data (determine characteristics or trends) • QMS Improvements, corrective and preventive actions • Verify effectiveness*

  7. ISO 9001:2008 Requirements • 4 QMS Requirements (Document Key Processes) • 4.1 General QMS Requirements • Document sequence/interaction of key processes • Document criteria & methods to ensure effective operation • The type & extend of controls to be applied for outsourced processes shall be defined within the Quality Mgmt System* • 4.2.1 QMS documentation • Quality policy & objectives, Quality Manual • Control documents such as checklists & work instructions • Required procedures and records • Levels of details depends on competence of staff, size of organisation & complexity of processes • 4.2.2 Quality Manual • Scope of QMS, including details of and justifications for any exclusions

  8. ISO 9001:2008 Requirements • 4.2.3 Control of Documents • Review & approve document before issue • Changes & current revision status identified • Relevant versions are available at point of use • Documents are legible & Identifiable • Documents of external origins are identified and distribution controlled

  9. ISO 9001:2008 Requirements • 4.2.4 Control of Records • Are records legible, readily identifiable & retrievable • E.g. mgmt review records, training records, purchase evaluation records, audit records, customer complaints and other process related records

  10. ISO 9001:2008 Requirements • 5.1 Management Commitment • Development, implementation & improvement of QMS • Establish quality policy • Ensure quality objectives are met • Conduct mgmt review of QMS deficiencies / improvements • Ensure availability of resources for QMS implementation and improvements

  11. ISO 9001:2008 Requirements • 5.2 Customer Focus • Top mgmt ensure customer requirements are determined and fulfilled • Customer satisfaction is also achieved / enhanced

  12. ISO 9001:2008 Requirements • 5.3 Quality Policy • Appropriate to purpose of organisation (e.g. mission) • Include commitment to meet customer and regulatory requirements • Include commitment for continual improvement & meeting quality objectives • Is communicated to all staff • Is reviewed for continuing suitability

  13. ISO 9001:2008 Requirements • 5.4 Quality Objectives / QMS Planning • Quality objectives set at relevant functions & levels • Quality objectives measurable and consistent with quality policy • QMS Planning: • Ensure QMS requirements & quality objectives are met • Ensure integrity of QMS is maintained when changes are implemented

  14. ISO 9001:2008 Requirements • 5.5 Responsibility, Authority & Communication • Responsibility and authorities for various staff defined • Mgmt Representative (shall be a member from within organisation’s management*) appointed to: • Ensure QMS is established, implemented & maintained • Report to top mgmt on the performance of the QMS and any need for improvement • Promote awareness of customer requirements throughout the organisation • Effectiveness of QMS communicated through established channels

  15. ISO 9001:2008 Requirements • 5.6 Mgmt Review • Conducted at planned intervals to ensure continuing suitability, adequacy and effectiveness of the QMS • Review inputs include: • Audit results, customer complaint, customer satisfaction, process performance & product conformity, follow-up actions, changes / improvement to QMS • Review Outputs: • Improvement of the effective of the QMS & its processes • Improvement of products • Resource needs

  16. ISO 9001:2008 Requirements • 6 Resource Mgmt • 6.1 Provision of Resources • Determine & provide resources to implement, maintain, improve the QMS & enhance customer satisfaction • 6.2 Human Resources • Ensure staff or other personnel* are adequately competent & trained for assigned roles • Maintain training records • 6.3 Infrastructure: • Determine, provide & maintain infrastructure (include bldg, workspace, equipment and supporting services) needed to achieve conformity to product requirements • 6.4 Work Environment • Determine & manage the work environment (include factors such as noise, lighting, temperature, humidity and weather*) needed to achieve conformity to product requirements

  17. ISO 9001:2008 Requirements • 7.1 Planning of Product Realisation • Plan & develop the product realisation processes • Determine quality objectives & requirements for product • Establish product-specific processes, documents, resources • Document required verification, validation and criteria for product acceptance

  18. ISO 9001:2008 Requirements • 7.2 Customer Related Processes • Determine product requirements • Post-delivery activities include 1) Actions under warranty provisions, 2) Contractual obligations such as maintenance activities and 3) Supplementary services such as recycling or final disposal* • Review product requirements • Requirements are defined • Requirements differing from what customer wants are resolved • Organisation has ability to fulfilled defined requirements • Customer Communication • Communication channels available to provide product information, answer queries, taking orders and amendments, customer feedback

  19. ISO 9001:2008 Requirements • 7.3 Design and Development • Design and development planning • Update plan as design and development progresses • Design and Development Review, Verification, Validation have distinct purposes* • They can be conducted and recorded separately or in any combination, as suitable for the product and the organization* • Design and development inputs • Functional, performance and regulatory requirements to be documented and reviewed • Design and development outputs • In form suitable for verification against for design & dev. Inputs* • Include details for preservation of products* • Design and development review, verification, validation and changes • Procedures to be defined

  20. ISO 9001:2008 Requirements • 7.4 Purchasing • Evaluate and select suppliers based on their ability to meet purchase requirements • Purchasing information to contain level of adequate purchasing requirements • Verification of purchased products • Key Records: • Purchase specifications • Supplier evaluation records • Evidence of satisfaction receipt

  21. ISO 9001:2008 Requirements • 7.5 Production & Service Provision • 7.5.1 Control of Production & Service Provision • Plan and carry out production and service provision under controlled conditions - repeatable processes • Ensure availability of work instructions, as necessary • 7.5.2 Validation of processes for production and service provision • Required when resulting output cannot be verified or tested (e.g. packing of parachutes) • Processes, equipment, personnel needs to be qualified

  22. ISO 9001:2008 Requirements • 7.5 Production & Service Provision • 7.5.3 Identification & Traceability • Identify product by suitable means throughout the product realisation • Also know as configuration mgmt for some industry sector • 7.5.4 Customer property • Exercise care of customer property (include intellectual propertyand personal data*) • Identify, verify, protect and safeguard customer property • If lost, damaged or otherwise found unsuitable for use, this shall be reported to the customer & records maintained

  23. ISO 9001:2008 Requirements • 7.5 Production & Service Provision • 7.5.5 Preservation of product • Preserve conformity of product during internal processing and delivery to intended destination • Include identification, handling, packaging, storage & protection

  24. ISO 9001:2008 Requirements • 7.6 Monitoring and Measuring Devices • Measuring devices to be calibrated at specific intervals • Calibration records to be maintained • Equipment ID • Calibration date • Calibration accuracy • Next calibration date • Calibration to be safeguarded from adjustments • E.g. seal for taxi meter

  25. ISO 9001:2008 Requirements • 8 Measurement, Analysis & Improvement • 8.1 Monitoring and Measurement Planning • Required to demonstrate product conformity, conformity to QMS and continually improve the QMS • 8.2 Monitoring and Measurements • 8.2.1 Methods for obtaining measures on customer satisfaction shall be determined which may be derived from • Customer satisfaction survey • Customer data • User opinion • Lost business analysis • Compliments • Warranty claims • Dealer reports*

  26. ISO 9001:2008 Requirements • 8 Measurement, Analysis & Improvement • 8.2.2 Internal audit • Conducted at planned interval to determine if QMS requirements have been implemented • Audit programme to be planned • Audit criteria, scope and methods shall be defined • Auditors shall not audit their own work • Audit results & follow-up actions to be recorded

  27. ISO 9001:2008 Requirements • 8 Measurement, Analysis & Improvement • 8.2.3 Monitoring & measurement of processes • To monitor QMS processes, to verify conformity to product requirements & the effectiveness of the quality mgmt systems* • 8.2.4 Monitoring & measurement of product • To monitor characteristics of product to verify if the product requirements have been met • 8.3 Control of non-conforming product • Ensure that product which does not conforms to product requirements is identified and prevented from unintended use or delivery • E.g. segregation of non-conforming products

  28. ISO 9001:2008 Requirements • 8 Measurement, Analysis & Improvement • 8.4 Analysis of Data • Determine, collect and analyse appropriate data to demonstrate suitability and effectiveness of the QMS • Evaluate where continual improvement can be made through trend analysis • 8.5.1 Continual Improvement • Continually improve the QMS through quality policy, objectives, audit results, analysis of data, corrective / preventive actions and mgmt review

  29. ISO 9001:2008 Requirements • 8 Measurement, Analysis & Improvement • 8.5.2 Corrective Action • Determine root cause of non-conformities in order to prevent recurrence • Effort should be proportionate to the effects of the non-conformities • Corrective actions taken to be recorded & their effectiveness*verified • 8.5.3 Preventive Action • Determine root cause of potential non-conformities to prevent their occurrence • Effort should be proportionate to the effects of the potential non-conformities • Preventive actions taken to be recorded & their effectiveness*verified

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