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Ms. Evangelia Daratsanou Agricultural University of Athens edaratsanou@gmail

Quality management systems (ISO 9001:2015). STANDARD’S REQUIREMENTS – ANALYSIS/ACTIONS – DOCUMENTATION EXAMPLES/EVIDENCING - EXAMPLES OF MEASUREMENT AND PERFORMANCE INDICATORS. Ms. Evangelia Daratsanou Agricultural University of Athens edaratsanou@gmail.com. Mr. Lampros Sakkas

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Ms. Evangelia Daratsanou Agricultural University of Athens edaratsanou@gmail

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  1. Quality management systems (ISO 9001:2015) STANDARD’S REQUIREMENTS – ANALYSIS/ACTIONS – DOCUMENTATION EXAMPLES/EVIDENCING - EXAMPLES OF MEASUREMENT AND PERFORMANCE INDICATORS Ms. Evangelia Daratsanou Agricultural University of Athens edaratsanou@gmail.com Mr. Lampros Sakkas Agricultural University of Athens lasakkas@hotmail.com

  2. Outline • Structure of ISO 9001:2015 • Clause 0-3 – Introduction and scope of the standard • Clause 4 – Context of the organization • Clause 5 –Leadership • Clause 6 – Planning • Clause 7 – Support • Clause 8 – Operation • Clause 9 - Performance evaluation • Clause 10 – Improvement

  3. Learning outcomes The trainee/student will: - understand the typical structure of ISO 9001:2015 - understand the ten clauses of ISO 9001:2015

  4. Structure of ISO 9001:2015, from: www.p4p.uk.com/library-user-guide/datasheet-iso-90012015-vs-iso90012008/

  5. CLAUSE 1 - SCOPE • ISO 9001:2015 specifies requirements for a QMS • An organization implements the Standard in order to: • Demonstrate its ability to provide consistently products and services that meet customer and applicable statutory and regulatory requirements • Enhance customer satisfaction through the effective application of the system (improvement of the system, assurance of conformity) • Requirements: generic and applicable to any organization

  6. CLAUSES 2 & 3 • CLAUSE 2 - NORMATIVE REFERENCES • ISO 9000:2015 • CLAUSE 3 - TERMS AND DEFINITIONS • Shall • Should • May • Can

  7. CLAUSES 2 & 3 • CLAUSE 3 - TERMS AND DEFINITIONS • Organization • Customer • Products & Services • Interested parties • Quality management system • Process & Procedure • Continual improvement

  8. CLAUSES 2 & 3 • CLAUSE 3 - TERMS AND DEFINITIONS • Competence • Design & Development • Policies & Objectives • Verification • Traceability • Risk • Efficiency & Effectiveness

  9. CLAUSES 2 & 3 • CLAUSE 3 - TERMS AND DEFINITIONS • Information & Document • Feedback • Customer satisfaction & Complaints • Measurement process & Measuring equipment • Validation • Preventive & Corrective action • Audit

  10. CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4.1 Understanding the Organization and its Context • Requirements: - understanding the Organization & its context • Analysis/Actions: - determine the relevant external & internal issues - determine which issues affect its competence - monitor & review information

  11. CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4.1 Understanding the Organization and its Context • Documentation: - factors (political, economical, social, technological) - external issues (statutory & regulatory requirements, technological advances, market analysis) - internal issues (organization management, culture) - organization manual or context (profile, chart, scope, context, interested parties, business model)

  12. CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4.2 Understanding the needs and expectations of interested parties • Requirements: - understanding needs & expectations of interested parties • Analysis/Actions: - determine the relevant interested parties - determine the relevant requirements of interested parties - monitor & review information - effect or potential effect on competence → determination of the Organization competence

  13. CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4.2 Understanding the needs and expectations of interested parties • Documentation: - determination of interested parties & their requirements (customers, owners, providers, bankers, partners, regulators, universities, unions) - organization manual or context

  14. CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4.3 Determining the scope of the quality management system • Requirements: 1. determining the scope of the QMS 2. documentation • Analysis/Actions: - determine the boundaries & applicability of the QMS - consider external & internal issues, requirements of interested parties, products & services

  15. CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4.3 Determining the scope of the quality management system • Documentation required: - scope of the QMS - products and services - justification for not applicable requirements & → not affect the Organization’s competence

  16. CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4.4 Quality Management System and its processes • Requirements: 1. establish, implement, maintain & continually improve: QMS + processes + interactions 2. documentation • Analysis/Actions: - determine the processions needed & their application - inputs & outputs, sequence & interaction, criteria & methods, resources, responsibilities & authorities, risks & opportunities, evaluation & changes

  17. CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4.4 Quality Management System and its processes • Documentation required: - operation of processes - processes carried out as planned (process approach, process holders & roles, resources availability, evidence of process application) • Performance indicators: - customer satisfaction, process efficiency, success rate, cost performance index, resource index

  18. CLAUSE 5 – LEADERSHIP 5.1 Leadership and commitment • Requirement: 1. top management shall demonstrate leadership & commitment with respect to the QMS • Analysis/Actions: - take accountability for : QMS effectiveness, compatible quality policy & objectives, integration of requirements into business processes, process approach & risk-based thinking, available resources, quality policy communication, competence, supporting persons, promoting improvement, supporting leadership demonstration

  19. CLAUSE 5 – LEADERSHIP 5.1 Leadership and commitment • Documentation: - quality policy & objectives, other policies, uploading - staff training, related resources - QMS efficiency determination, management review - corrective actions, continual improvement - internal communication, business plan • Performance indicators: - customer satisfaction, employee satisfaction level, percentage return on investment, gross margin, complaint escalation rate, personnel skills

  20. CLAUSE 5 – LEADERSHIP 5.1 Leadership and commitment • Requirement:2. top management shall demonstrate leadership & commitment with respect to customer focus • Analysis/Actions: - ensure determination, understanding & fulfilment of customer & statutory/regulatory requirements - ensure determination of risk & opportunities → conformity of products & services + customer satisfaction - ensure focus on enhancing customer satisfaction

  21. CLAUSE 5 – LEADERSHIP 5.1 Leadership and commitment • Documentation:- specified customer requirements statutory & regulatory requirements, evaluation of customer requirements, customer satisfaction survey, customer complaints report, market survey reports • Performance indicators: - customer satisfaction, complaint escalation rate, percentage number of products or services delivered, track number of non-conformities, life cycle indicators

  22. CLAUSE 5 – LEADERSHIP 5.2 Policy • Requirement:1. develop the quality policy • Analysis/Actions: - top management shall establish & review the quality policy: appropriate (purpose & context), framework for quality objectives, commitment to requirements, commitment to improvement • Documentation: - quality policy, other policies, management review

  23. CLAUSE 5 – LEADERSHIP 5.2 Policy • Requirement:2. communicate the quality policy • Analysis/Actions: - documentation of the quality policy - communication within the Organization → quality policy understood & applied - available to interested parties • Documentation: - quality policy, other policies, staff training, uploading hard copies for interested parties

  24. CLAUSE 5 – LEADERSHIP 5.2 Policy • Requirement:3. responsibilities & authorities for organizational roles shall be assigned, communicated & understood • Analysis/Actions:top management shall assign responsibilities & authorities for - ensuring: conformity of QMS, intended outputs of processes, promotion of customer focus, maintenance of QMS integration - reporting: performance of QMS & opportunities for improvement • Documentation: - organization charts, work analysis, management personnel, internal audit reports, management review

  25. CLAUSE 6 – PLANNING 6.1 Actions to address risks and opportunities • Requirement:1. determine risks & opportunities • Analysis/Actions: - planning for the QMS shall consider issues & requirements and determine risk & opportunities to be addressed to: achieve QMS intended results, enhance desirable effects, prevent/reduce undesired effects, achieve improvement • Documentation: - list of risks/opportunities, investment plan, strategic plan, changes • Performance indicators: - task completion rate, return on investment, non-conformities

  26. CLAUSE 6 – PLANNING 6.1.Actions to address risks and opportunities • Requirement:2. evaluate actions to address risks & opportunities • Analysis/Actions: - plan actions to address risks & opportunities (a. avoiding risk, taking risk to pursue an opportunity, risk source, changing likelihood/consequences, sharing risk, retaining risk b. new practices, products, clients, markets, technology, partnerships) - plan how to integrate & implement these actions - plan how to evaluate their effectiveness • Documentation: - list of risks/opportunities, FMEA analysis, strategic plan

  27. CLAUSE 6 – PLANNING 6.2 Quality objectives and planning to achieve them • Requirement:1. establish quality objectives at functions, levels & processes + documentation • Analysis/Actions: - quality objectives: consistent with quality policy, measurable, concerning requirements, conformity of products & services, customer satisfaction, monitored, communicated, updated • Documentation required: - establishment of quality objectives & performance indicators • Performance indicators: - relevant to customers, product, suppliers

  28. CLAUSE 6 – PLANNING 6.2 Quality objectives and planning to achieve them • Requirement:2. planning to achieve quality objectives • Analysis/Actions: - determine: • actions • resources • responsibilities • time frame • results • Documentation: - action plans for target achievements, evaluation results of quality objectives, management review

  29. CLAUSE 6 – PLANNING 6.3 Planning of changes • Requirement:- carry out determined changes in a planned manner • Analysis/Actions: - planning shall consider: a. the purpose of the changes & potential consequences b. the integrity of the QMS c. the availability of resources d. the allocation of responsibilities & authorities • Documentation: - change management rules, plan of changes • Performance indicators: - percentage of successful changes, benefits of change

  30. CLAUSE 7 – SUPPORT 7.1 Resources • Requirement:1. determine & provide resources • Analysis/Actions: - determine & provide the resources needed for: • establishment • implementation • maintenance • continual improvement of the QMS - consider internal resources & needs from external providers • Documentation: - job responsibilities, staff/structure/equipment availability, needs

  31. CLAUSE 7 – SUPPORT 7.1 Resources • Requirement:2. provide persons • Analysis/Actions: - determine & provide the persons necessary for: • effective implementation of the QMS • operation & control of processes • Documentation: - job responsibilities, qualification of available staff, staff allocation • Performance indicators: - HR metrics (recruitment, training, productivity, performance goals)

  32. CLAUSE 7 – SUPPORT 7.1 Resources • Requirement:3. infrastructure • Analysis/Actions: - determine, provide & maintain the infrastructure necessary for: • operation of processes • conformity of products & services (buildings, equipment, transportation, information/communication) • Documentation: - investment plan, equipment list, plans of equipment maintenance, service records, certificates • Performance indicators: - maintenance costs, reliability of equipment

  33. CLAUSE 7 – SUPPORT 7.1 Resources • Requirement:4. environment for the operation of resources • Analysis/Actions: - determine, provide & maintain the environment necessary for: • operation of processes • conformity of products & services (social, psychological & physical factors) • Documentation: - condition measuring records, cleaning programs & records, pest control, medical record • Performance indicators: - accident indicators, failure indicators

  34. CLAUSE 7 – SUPPORT 7.1 Resources • Requirement:5. monitoring and measuring resources / a. general • Analysis/Actions: - determine & provide the resources for valid & reliable results (when monitoring/measuring is used to verify conformity) - ensure suitability & maintenance of resources - documentation • Documentation required: - calibration & verification records, certificates, corrective actions • Performance indicators: - equipment & measurement failure percentage, amount of maintenance rework

  35. CLAUSE 7 – SUPPORT 7.1 Resources • Requirement:5. monitoring and measuring resources / b. traceability • Analysis/Actions:(when measurement traceability is a requirement or considered essential for the validity of measurement results) - calibrate/verify measuring equipment against traceable standards - identify measuring equipment → determine status - safeguard equipment from adjustments, damage or deterioration - unfit → determine validity of previous results + corrective actions • Documentation: - standard evidence for calibration/verification, lab certificates

  36. CLAUSE 7 – SUPPORT 7.1 Resources • Requirement:6. organizational knowledge (knowledge specific to the organization & gained by experience, based on internal or/and external sources) • Analysis/Actions: - determine the knowledge necessary for: • operation of processes • conformity of products & services - maintain knowledge & ensure necessary availability - in the case of new needs & trends → consider current knowledge & determine how to acquire/access additional knowledge/updates • Documentation: - legislation, literature references, training, product plan

  37. CLAUSE 7 – SUPPORT 7.2 Competence • Requirement: - competence of persons working for the Organization • Analysis/Actions: - determine the necessary competence of persons doing work under the Organization’s control (affecting the QMS) - ensure competence regarding education/training/experience - take actions to acquire competence & evaluate effectiveness (training/reassignment of employees, hiring competent persons) - documentation

  38. CLAUSE 7 – SUPPORT 7.2 Competence • Documentation required: - list of staff & qualification - training programs & evidence - evaluation of training effectiveness - job roles & requirements • Performance indicators: - training completion percentage rate - training units per-year & per-employee - evaluation of training programs effectiveness - training cost analysis, employee satisfaction level

  39. CLAUSE 7 – SUPPORT 7.3 Awareness • Requirement: - awareness of persons working for the Organization • Analysis/Actions: - ensure that persons doing work under the Organization’s control are aware of: • the quality policy • relevant quality objectives • contribution to QMS effectiveness & improved performance • the implications of not conforming with QMS requirements • Documentation: - participation of personnel in QMS reviews, training on QMS • Performance indicators: - employee satisfaction level, evaluation of training effectiveness

  40. CLAUSE 7 – SUPPORT 7.4 Communication • Requirement: - internal and external communication • Analysis/Actions: - determine the communications relevant to the QMS, including: • on what it well communicate • when to communicate • with whom to communicate • how to communicate • who communicates • Documentation: - working directions, responsibilities, marketing, promotion • Performance indicators: - customer & employee satisfaction, market analysis

  41. CLAUSE 7 – SUPPORT 7.5 Documented information • Requirement:1. the QMS shall include documented information • Analysis/Actions: - documented information required by the Standard - documented information determined by the Organization necessary for QMS effectiveness (size, scope, complexity, competence)

  42. CLAUSE 7 – SUPPORT 7.5 Documented information • Documentation required:- 4.3 QMS scope, 4.4 QMS processes - 5.2 quality policy, 6.2 quality objectives - 7.1.5 calibration/verification, 7.2 competence, 7.5 document rules - 8.1 conformity, 8.2.3 customer requirements review, 8.3.2 design & development planning & 8.3.6 changes, 8.4.1 monitoring of performance & re-evaluation of the QMS, 8.5.1 characteristics of products, services & activities, 8.5.2 identification-traceability,8.5.6 changes in products/services 8.6 release of products/services, 8.7 non-conforming outputs, - 9.1.1 monitoring & measurement of products & services, 9.2.2 internal audits, 9.3.3 management review outputs

  43. CLAUSE 7 – SUPPORT 7.5 Documented information • Requirement:2. creating and updating documented information • Analysis/Actions: - ensure appropriate identification & description - ensure appropriate format & media - ensure appropriate review & approval for suitability & adequacy • Documentation: - codification, format rules, responsibilities • Performance indicators: - customer & employee satisfaction, market analysis

  44. CLAUSE 7 – SUPPORT 7.5 Documented information • Requirement:3. control of documented information • Analysis/Actions: - control the required documented information to ensure: • availability & suitability for use, where & when it is needed • adequate protection (confidentiality, proper use, integrity) - shall address the following activities, as applicable: • distribution, access, retrieval & use • storage & preservation (including legibility) • control of changes • retention & disposition

  45. CLAUSE 7 – SUPPORT 7.5 Documented information • Documentation: - list of approved documents, list of external documents - distribution lists, document review lists - document changing processes - information security - control & identification of external documents - customer specification & plans - requirements/specifications of contracts • Performance indicators: - cost of information acquisition

  46. CLAUSE 8 – OPERATION 8.1 Operational planning and control • Requirement: - plan, implement & control the processes needed to meet the requirements for the provision of products & services • Analysis/Actions: - determine the requirements for products & services - establish criteria for processes & acceptance of products-services - determine the resources needed to achieve conformity - implement control of the processes in accordance with the criteria - determine & keep documented information (confidence processes carried out as planned & demonstrate conformity)

  47. CLAUSE 8 – OPERATION 8.1 Operational planning and control → output shall be suitable for the Organization’s operations → control planned changes & review consequences of unintended → control outsourced processes • Documentation required: - specification of raw materials & ingredients - specification of products & services - quality programs - evidence for acceptance by customers

  48. CLAUSE 8 – OPERATION 8.2 Requirements for products and services • Requirement:1. customer communication • Analysis/Actions: - provide information relating to products & services - handle enquiries, contracts or orders (+ changes) - obtain customer feedback on products & services (+ complaints) - handle/control customer property - establish specific requirements for contingency actions

  49. CLAUSE 8 – OPERATION 8.2 Requirements for products and services • Documentation: - list of products & specification - customer complaints & customer satisfaction survey - contingency plan - contract & statement of work • Performance indicators: - customer service - active issues - overall satisfaction

  50. CLAUSE 8 – OPERATION 8.2 Requirements for products and services • Requirement:2. determining the requirements related to products & services • Analysis/Actions: - establish, implement & maintain a process to determine the requirements for the products & services - ensure that the requirements are defined, including: • any applicable statutory & regulatory requirements • those considered necessary by the Organization - ensure that the Organization can meet the claims for the products & services it offers

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