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ISO 9001:2015 Quality Management System Requirements Analysis

This training module provides a comprehensive analysis of the ISO 9001:2015 standard's requirements with examples and documentation. From understanding the structure to the ten clauses, participants gain insights into implementing an effective quality management system. The course covers key aspects such as organization context, leadership, planning, support, operation, performance evaluation, and improvement. Learning outcomes focus on grasping the standard's structure and clauses for practical application in any organization.

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ISO 9001:2015 Quality Management System Requirements Analysis

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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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