Quality management systems ISO 9001 2015 STANDARDS REQUIREMENTS

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

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

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

Structure of ISO 9001: 2015, from: www. p 4 p. uk. com/library-user-guide/datasheet-iso 90012015 -vs-iso 90012008/

CLAUSE 1 - SCOPE ISO 9001: 2015 specifies requirements for a QMS An organization implements the Standard in order to: 1. Demonstrate its ability to provide consistently products and services that meet customer and applicable statutory and regulatory requirements 2. Enhance customer satisfaction through the effective application of the system (improvement of the system, assurance of conformity) Requirements: generic and applicable to any organization

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

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

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

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

CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4. 1 Understanding the Organization and its Context v Requirements: - understanding the Organization & its context v Analysis/Actions: - determine the relevant external & internal issues - determine which issues affect its competence - monitor & review information

CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4. 1 Understanding the Organization and its Context v 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)

CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4. 2 Understanding the needs and expectations of interested parties v Requirements: - understanding needs & expectations of interested parties v 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

CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4. 2 Understanding the needs and expectations of interested parties v Documentation: - determination of interested parties & their requirements (customers, owners, providers, bankers, partners, regulators, universities, unions) - organization manual or context

CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4. 3 Determining the scope of the quality management system v Requirements: 1. determining the scope of the QMS 2. documentation v Analysis/Actions: - determine the boundaries & applicability of the QMS - consider external & internal issues, requirements of interested parties, products & services

CLAUSE 4 – CONTEXT OF THE ORGANIZATION 4. 3 Determining the scope of the quality management system v Documentation required: - scope of the QMS - products and services - justification for not applicable requirements & → not affect the Organization’s competence

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

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

CLAUSE 5 – LEADERSHIP 5. 1 Leadership and commitment v Requirement: 1. top management shall demonstrate leadership & commitment with respect to the QMS v 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

CLAUSE 5 – LEADERSHIP 5. 1 Leadership and commitment v Documentation: - quality policy & objectives, other policies, uploading - staff training, related resources - QMS efficiency determination, management review - corrective actions, continual improvement - internal communication, business plan v Performance indicators: - customer satisfaction, employee satisfaction level, percentage return on investment, gross margin, complaint escalation rate, personnel skills

CLAUSE 5 – LEADERSHIP 5. 1 Leadership and commitment v Requirement: 2. top management shall demonstrate leadership & commitment with respect to customer focus v 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

CLAUSE 5 – LEADERSHIP 5. 1 Leadership and commitment v Documentation: - specified customer requirements statutory & regulatory requirements, evaluation of customer requirements, customer satisfaction survey, customer complaints report, market survey reports v Performance indicators: - customer satisfaction, complaint escalation rate, percentage number of products or services delivered, track number of non-conformities, life cycle indicators

CLAUSE 5 – LEADERSHIP 5. 2 Policy v Requirement: 1. develop the quality policy v Analysis/Actions: - top management shall establish & review the quality policy: appropriate (purpose & context), framework for quality objectives, commitment to requirements, commitment to improvement v Documentation: - quality policy, other policies, management review

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

CLAUSE 5 – LEADERSHIP 5. 2 Policy v Requirement: 3. responsibilities & authorities for organizational roles shall be assigned, communicated & understood v 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 v Documentation: - organization charts, work analysis, management personnel, internal audit reports, management review

CLAUSE 6 – PLANNING 6. 1 Actions to address risks and opportunities v Requirement: 1. determine risks & opportunities v 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 v Documentation: - list of risks/opportunities, investment plan, strategic plan, changes v Performance indicators: - task completion rate, return on investment, non-conformities

CLAUSE 6 – PLANNING 6. 1. Actions to address risks and opportunities v Requirement: 2. evaluate actions to address risks & opportunities v 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 v Documentation: - list of risks/opportunities, FMEA analysis, strategic plan

CLAUSE 6 – PLANNING 6. 2 Quality objectives and planning to achieve them v Requirement: 1. establish quality objectives at functions, levels & processes + documentation v Analysis/Actions: - quality objectives: consistent with quality policy, measurable, concerning requirements, conformity of products & services, customer satisfaction, monitored, communicated, updated v Documentation required: - establishment of quality objectives & performance indicators v Performance indicators: - relevant to customers, product, suppliers

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

CLAUSE 6 – PLANNING 6. 3 Planning of changes v Requirement: - carry out determined changes in a planned manner v 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 v Documentation: - change management rules, plan of changes v Performance indicators: - percentage of successful changes, benefits of change

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

CLAUSE 7 – SUPPORT 7. 1 Resources v Requirement: 2. provide persons v Analysis/Actions: - determine & provide the persons necessary for: • effective implementation of the QMS • operation & control of processes v Documentation: - job responsibilities, qualification of available staff, staff allocation v Performance indicators: - HR metrics (recruitment, training, productivity, performance goals)

CLAUSE 7 – SUPPORT 7. 1 Resources v Requirement: 3. infrastructure v Analysis/Actions: - determine, provide & maintain the infrastructure necessary for: • operation of processes • conformity of products & services (buildings, equipment, transportation, information/communication) v Documentation: - investment plan, equipment list, plans of equipment maintenance, service records, certificates v Performance indicators: - maintenance costs, reliability of equipment

CLAUSE 7 – SUPPORT 7. 1 Resources v Requirement: 4. environment for the operation of resources v Analysis/Actions: - determine, provide & maintain the environment necessary for: • operation of processes • conformity of products & services (social, psychological & physical factors) v Documentation: - condition measuring records, cleaning programs & records, pest control, medical record v Performance indicators: - accident indicators, failure indicators

CLAUSE 7 – SUPPORT 7. 1 Resources v Requirement: 5. monitoring and measuring resources / a. general v Analysis/Actions: - determine & provide the resources for valid & reliable results (when monitoring/measuring is used to verify conformity) - ensure suitability & maintenance of resources - documentation v Documentation required: - calibration & verification records, certificates, corrective actions v Performance indicators: - equipment & measurement failure percentage, amount of maintenance rework

CLAUSE 7 – SUPPORT 7. 1 Resources v Requirement: 5. monitoring and measuring resources / b. traceability v 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 v Documentation: - standard evidence for calibration/verification, lab certificates

CLAUSE 7 – SUPPORT 7. 1 Resources v Requirement: 6. organizational knowledge (knowledge specific to the organization & gained by experience, based on internal or/and external sources) v 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 v Documentation: - legislation, literature references, training, product plan

CLAUSE 7 – SUPPORT 7. 2 Competence v Requirement: - competence of persons working for the Organization v 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

CLAUSE 7 – SUPPORT 7. 2 Competence v Documentation required: - list of staff & qualification - training programs & evidence - evaluation of training effectiveness - job roles & requirements v Performance indicators: - training completion percentage rate - training units per-year & per-employee - evaluation of training programs effectiveness - training cost analysis, employee satisfaction level

CLAUSE 7 – SUPPORT 7. 3 Awareness v Requirement: - awareness of persons working for the Organization v 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 v Documentation: - participation of personnel in QMS reviews, training on QMS v Performance indicators: - employee satisfaction level, evaluation of training effectiveness

CLAUSE 7 – SUPPORT 7. 4 Communication v Requirement: - internal and external communication v 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 v Documentation: - working directions, responsibilities, marketing, promotion v Performance indicators: - customer & employee satisfaction, market analysis

CLAUSE 7 – SUPPORT 7. 5 Documented information v Requirement: 1. the QMS shall include documented information v Analysis/Actions: - documented information required by the Standard - documented information determined by the Organization necessary for QMS effectiveness (size, scope, complexity, competence)

CLAUSE 7 – SUPPORT 7. 5 Documented information v 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

CLAUSE 7 – SUPPORT 7. 5 Documented information v Requirement: 2. creating and updating documented information v Analysis/Actions: - ensure appropriate identification & description - ensure appropriate format & media - ensure appropriate review & approval for suitability & adequacy v Documentation: - codification, format rules, responsibilities v Performance indicators: - customer & employee satisfaction, market analysis

CLAUSE 7 – SUPPORT 7. 5 Documented information v Requirement: 3. control of documented information v 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

CLAUSE 7 – SUPPORT 7. 5 Documented information v 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 v Performance indicators: - cost of information acquisition

CLAUSE 8 – OPERATION 8. 1 Operational planning and control v Requirement: - plan, implement & control the processes needed to meet the requirements for the provision of products & services v 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)

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 v Documentation required: - specification of raw materials & ingredients - specification of products & services - quality programs - evidence for acceptance by customers

CLAUSE 8 – OPERATION 8. 2 Requirements for products and services v Requirement: 1. customer communication v 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

CLAUSE 8 – OPERATION 8. 2 Requirements for products and services v Documentation: - list of products & specification - customer complaints & customer satisfaction survey - contingency plan - contract & statement of work v Performance indicators: - customer service - active issues - overall satisfaction

CLAUSE 8 – OPERATION 8. 2 Requirements for products and services v Requirement: 2. determining the requirements related to products & services v 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

CLAUSE 8 – OPERATION 8. 2 Requirements for products and services v Documentation: - statutory & regulatory requirements - list of products & specification - quality plan v Performance indicators: - product indicators (cost, profit, lifetime, technical characteristics) - statutory & regulatory requirements

CLAUSE 8 – OPERATION 8. 2 Requirements for products and services v Requirement: 3. review of requirements related to products & services v Analysis/Actions: - conduct a review before committing to supply products & services: • requirements specified by the customer (+delivery) • other requirements necessary for the specified/intended use • requirements specified by the Organization • statutory & regulatory requirements • other contract or order requirements - ensure that new contract or order requirements are resolved - confirm not-documented customer’s requirements before accept

CLAUSE 8 – OPERATION 8. 2 Requirements for products and services v Analysis/Actions: - retain documented information, as applicable: : • results of the review • new requirements for the products & services v Documentation: - orders, contracts, statements, agreements - order confirmation - communication in cases of changes

CLAUSE 8 – OPERATION 8. 2 Requirements for products and services v Requirement: 4. changes to requirements for products & services v Analysis/Actions: - ensure that relevant documented information is amended - ensure that relevant persons are made aware

CLAUSE 8 – OPERATION 8. 3 Design and development of products and services v Requirement: 1. establishment of a design & development process v Analysis/Actions: - establish, implement & maintain a design & development process appropriate to ensure the subsequent provision of products & services v Documentation: - design & development process - market analysis for the new products & services v Performance indicators: - internal cost/time management, new product development rate

CLAUSE 8 – OPERATION 8. 3 Design and development of products and services v Requirement: 2. design and development planning v Analysis/Actions: - determine stages & controls for design-development, considering: • nature, duration & complexity of activities • required process stages • verification & validation • responsibilities & authorities • internal & external resource needs • need to control interfaces between persons involved • need for involvement of customers & users • requirements for subsequent provision of products & services

CLAUSE 8 – OPERATION 8. 3 Design and development of products and services v Analysis/Actions: v Documentation required: (determine stages & controls for design-development, considering: ) • level of control expected by the interested parties • documentation - design & development plan (milestones, responsibilities/authorities test plans, verification plan, validation, changes) - communication to customers & interested parties - determination of customer requirements

CLAUSE 8 – OPERATION 8. 3 Design and development of products and services v Requirement: 3. design and development inputs v Analysis/Actions: - determine the essential requirements for the specific products & services to be designed & developed, considering: • functional & performance requirements • information derived from previous similar activities • statutory & regulatory requirements • standards or codes of practice committed to implement • potential consequences of failure (products/services nature) - inputs shall be adequate, complete & unambiguous v Documentation required: - design & development inputs, requirements, risk management

CLAUSE 8 – OPERATION 8. 3 Design and development of products and services v Requirement: 4. design and development controls v Analysis/Actions: - apply controls to the design & development process, to ensure that: • the results to be achieved are defined • reviews are conducted to evaluate results meet requirements • verification is conducted to ensure outputs meet the input requirements • validation is conducted to ensure resulted products-services meet the requirements for specified application/intended use • any necessary actions are taken on problems determined v Documentation required: - product/service specifications, control/verification methods/results

CLAUSE 8 – OPERATION 8. 3 Design and development of products and services v Requirement: 5. design and development outputs v Analysis/Actions: - ensure that design & development outputs: • meet the input requirements • are adequate for the subsequent processes for the provision of products & services • include monitoring/measuring requirements & acceptance criteria • specify the essential characteristics of products & services for their intended purpose & safe & proper provision v Documentation required: - product/service specifications, acceptance criteria, certificates

CLAUSE 8 – OPERATION 8. 3 Design and development of products and services v Requirement: 6. design and development changes v Analysis/Actions: - identify, review & control changes due to design & development, to ensure conformity of products/services to requirements - retain documented information on: • design & development changes • the results of reviews • the authorization of the changes • the actions taken to prevent adverse impacts

CLAUSE 8 – OPERATION 8. 3 Design and development of products and services v Documentation required: - evidence of design & development changes - requirements for changes - product/services specification review - record of changes, responsibilities v Performance indicators: - number of development changes - new product profitability - cost of verification & validation

CLAUSE 8 – OPERATION 8. 4 Control of externally provided processes, products and services v Requirement: 1. ensure conformity of externally provided processes, products and services v Analysis/Actions: - determine the controls to be applied when: • products & services from external providers are going to be incorporated into the Organization’s products/services • products & services are provided to customers on behalf of the Organization • a process is provided by an external provider as a result of an Organization’s decision

CLAUSE 8 – OPERATION 8. 4 Control of externally provided processes, products and services v Analysis/Actions: - determine & apply criteria for the evaluation, selection, monitoring of performance & re-evaluation of external providers. - documentation of control activities & subsequent actions v Documentation required: - specification of provided products & services - list of providers, contracts & statements with providers - provider performance evaluation, plan & results of provider audits v Performance indicators: - quantity order versus quantity received, delivery on-time - reject ratio, supplier chargebacks

CLAUSE 8 – OPERATION 8. 4 Control of externally provided processes, products and services v Requirement: 2. type and extent of control v Analysis/Actions: - ensure there is no adverse effect on the Organization’s activity to consistently deliver conforming products & services: • ensure QMS control on externally provided processes • define controls on external providers & resulting outputs • consider the potential impact on the Organization’s ability to consistently meet requirements v Documentation: • consider the effectiveness of external provider controls • determine the necessary verification or other activities - results of controls on delivered products & services

CLAUSE 8 – OPERATION 8. 4 Control of externally provided processes, products and services v Requirement: 3. information for external providers v Analysis/Actions: - ensure requirements adequacy before communication to external providers. Communicate Organization’s requirements for: • the processes, products & services to be provided • the approval of (a) products & services, (b) methods, processes & equipment and (c) the release of products & services • competence & qualification of relevant persons • the external providers’ interactions with Organization’s QMS • control & monitoring of external providers by the Organization • verification or validation by the Organization or its customers

CLAUSE 8 – OPERATION 8. 5 Production and service provision v Requirement: v Analysis/Actions: 1. control of production and service provision - implement production & service provision under controlled conditions: • availability of documented information that defines characteristics of products/services & the results to be achieved • availability & use of suitable monitoring-measuring resources • implement monitor-measuring activities → verify that criteria for control of processes/outputs & acceptance criteria have been met • suitable infrastructure & environment • appointment of competent & qualified persons • validation where monitoring/measuring inadequate to verify

CLAUSE 8 – OPERATION 8. 5 Production and service provision v Analysis/Actions: - implement production & service provision under controlled conditions: • implementation of actions to prevent human error • implementation of release, delivery & post-delivery activities v Documentation: - products & services specification - monitoring, measuring & verification methods & results - personnel qualification for processes & monitoring/measuring methods - list of relevant personnel, records of environmental conditions - reports of non-conformity, reports of product defects v Performance indicators: - production count, overall equipment effectiveness - percentage of non-conformity, percentage of product defects

CLAUSE 8 – OPERATION 8. 5 Production and service provision v Requirement: v Analysis/Actions: 2. identification and traceability - use suitable means to identify outputs when it is necessary for ensuring conformity of products & services - identify the status of outputs with respect to monitoring & measuring requirements throughout production & service provision - control the unique identification of the outputs - retain documentation necessary to enable traceability

CLAUSE 8 – OPERATION 8. 5 Production and service provision v Documentation required: - traceability process - product marking, non-conformity marking - definition of lot - documents of production process - disengagement of products - production plans v Performance indicators: - cost & rate of product recalls

CLAUSE 8 – OPERATION 8. 5 Production and service provision v Requirement: v Analysis/Actions: 3. property belonging to customers or external providers - exercise care with customers’ or external providers’ property while it is controlled or used by the Organization (material, components, tools, equipment, premises, intellectual property, personal data) - identify, verify, protect & safeguard external property provided for use or incorporation into products & services - report to the owner & retain documentation in cases of external property loss, damage or unsuitability for use

CLAUSE 8 – OPERATION 8. 5 Production and service provision v Documentation: - communication of damage/loss report - directions concerning handling of external property - list of external property, marking v Performance indicators: - cost due to quality loss of external property - cost percentage of safeguarding & maintenance of external - property

CLAUSE 8 – OPERATION 8. 5 Production and service provision v Requirement: v Analysis/Actions: 4. preservation of the outputs - preserve adequately the outputs during production & service provision → ensure conformity to requirements - preservation: identification, handling, contamination control, packaging, storage, transmission/transportation, protection v Documentation: - packaging, storage, preservation & transportation rules - list of material stock, spare parts & products, usage directions v Performance indicators: - complaint, cost of packaging, storage, maintenance & transportation

CLAUSE 8 – OPERATION 8. 5 Production and service provision v Requirement: v Analysis/Actions: 5. post-delivery activities - ensure conformity of post-delivery activities concerning products & services (warranty provision actions, maintenance, recycling, disposal) - determine the extent of activities required, considering: • statutory & regulatory requirements • potential undesired consequences concerning products/services • nature, use & intended lifetime of products & services • customer requirements • customer feedback v Documentation: - product warranty, certificates, usage directions v Performance indicators: - customer complaint indicators

CLAUSE 8 – OPERATION 8. 5 Production and service provision v Requirement: v Analysis/Actions: 6. control of changes - review & control changes for production or service provision → ensure continuing conformity with requirements - retain documented information: • results of the review of changes • the persons authorizing the change • any necessary actions arising from the review v Documentation required: - changes & subsequent monitoring actions, responsibilities v Performance indicators: - frequency of changes, verification/validation cost, profit

CLAUSE 8 – OPERATION 8. 6 Release of products and services v Requirement: - release of conforming products & services v Analysis/Actions: - implement planned inspections at appropriate stages → verify product & service conformity with requirements - do not release products & services until conformity is verified, unless release is approved by a relevant authority and/or by the customer - retain documented information: • evidence of conformity with the acceptance criteria • traceability to the persons authorizing the release

CLAUSE 8 – OPERATION 8. 6 Release of products and services v Documentation required: - acceptance criteria, control authorization - staff responsibilities - documents of product & service inspection - product certificates - list & competence of persons authorized for product/service release v Performance indicators: - percentage of released products, percentage of defectives - product delivery index - percentage of customer complaints

CLAUSE 8 – OPERATION 8. 7 Control of nonconforming outputs v Requirement: - identify & control nonconforming outputs v Analysis/Actions: - ensure that identified nonconforming outputs are controlled to prevent delivery or unintended use, taking the appropriate corrective actions: • correction • segregation, containment, return or suspension of provision • informing the customer • obtaining authorization for acceptance under concession - after correcting the nonconforming outputs, verify conformity

CLAUSE 8 – OPERATION 8. 7 Control of nonconforming outputs v Analysis/Actions: - retain documented information that: • describes the nonconformity • describes the actions taken • describes any concessions obtained • identifies the authority deciding the action in respect of the nonconformity v Documentation required: - reports of nonconformity & subsequent corrective actions - keeping of nonconforming products v Performance indicators: - percentage of product defects, percentage of defects in specific products, cost of defects

CLAUSE 9 – PERFORMANCE EVALUATION 9. 1 Monitoring, measurement, analysis and evaluation v Requirement: 1. determine & evaluate the QMS performance v Analysis/Actions: - determine: • what needs to be monitored & measured • methods for monitoring, measurement, analysis & evaluation → ensure valid results • timing of monitoring & measuring • timing of result analysis & evaluation - evaluate the QMS performance & effectiveness - retain documented information v Documentation required: - evaluation report of defined indicators

CLAUSE 9 – PERFORMANCE EVALUATION 9. 1 Monitoring, measurement, analysis and evaluation v Requirement: 2. customer satisfaction v Analysis/Actions: - monitor customers’ perception of the degree needs & expectations have been fulfilled - obtain & review information about customers’ perception - determine methods for obtaining & using this information v Documentation: - customer surveys, meetings with customers - customer feedback on delivered products & services, compliments - market-share analysis, warranty claims & dealer reports v Performance indicators: - customer value, satisfaction, loyalty & retention, equity, client list

CLAUSE 9 – PERFORMANCE EVALUATION 9. 1 Monitoring, measurement, analysis and evaluation v Requirement: 3. analysis and evaluation v Analysis/Actions: - analyse & evaluate data/information from monitoring & measurement - use the results of analysis (+ statistical techniques) to evaluate: • conformity of products & services • degree of customer satisfaction • performance & effectiveness of the QMS • if planning has been effectively implemented • effectiveness of actions taken to address risks & opportunities • performance of external providers • need for QMS improvements

CLAUSE 9 – PERFORMANCE EVALUATION 9. 1 Monitoring, measurement, analysis and evaluation v Documentation: - evaluation report of defined quality indicators - planning for improvement of QMS, products & services, customer satisfaction - statistical techniques of analysis v Performance indicators: - concerns all the indicators monitored

CLAUSE 9 – PERFORMANCE EVALUATION 9. 2 Internal audit v Requirement: 1. internal audit (general) v Analysis/Actions: - conduct internal audits at planned intervals to verify: v Documentation: • QMS conformity to the Organization’s requirements • QMS conformity to the Standard’s requirements • QMS is effectively implemented & maintained - internal audit process

CLAUSE 9 – PERFORMANCE EVALUATION 9. 2 Internal audit v Requirement: 2. internal audit implementation v Analysis/Actions: - plan, establish, implement & maintain an audit program: • including frequency, methods, responsibilities, planning requirements & reporting • considering importance of processes, changes & previous audit results - define the audit criteria & scope for each audit - select auditors & conduct audits → ensure objectivity & impartiality - ensure report of audit results to relevant management - take appropriate correction & corrective actions without delay - retain documented information

CLAUSE 9 – PERFORMANCE EVALUATION 9. 2 Internal audit v Documentation required: - strategic plan & program of internal audits - internal audit criteria - internal audit report, detection of nonconformities - plan of corrective actions - competence of internal auditors v Performance indicators: - percent of completed internal audits per year - number of repeat findings

CLAUSE 9 – PERFORMANCE EVALUATION 9. 3 Management review v Requirement: 1. management review (general) v Analysis/Actions: - top management shall review the QMS at planned intervals → ensure: • continuing suitability • adequacy • effectiveness • alignment with the strategic direction of the Organization

CLAUSE 9 – PERFORMANCE EVALUATION 9. 3 Management review v Requirement: 2. management review inputs v Analysis/Actions: - the status of actions from previous management reviews - changes in external & internal issues relevant to the QMS - information on QMS performance & effectiveness, including trends in: • customer satisfaction & feedback from interested parties • extent of quality objective fulfilment • process performance & conformity of products & services • nonconformities & corrective actions • monitoring & measuring results, audit results • the performance of external providers

CLAUSE 9 – PERFORMANCE EVALUATION 9. 3 Management review v Analysis/Actions: - the adequacy of resources - the effectiveness of actions taken to address risks & opportunities - opportunities for improvement v Documentation: - report of management review - business plans - requirements for resources - risk analysis - list of corrective actions - list of suppliers/external providers

CLAUSE 9 – PERFORMANCE EVALUATION 9. 3 Management review v Requirement: 3. management review outputs v Analysis/Actions: - outputs shall include decisions & actions related to: • opportunities for improvement • needs for changes to the QMS • resource needs - retain documented information v Documentation required: - report of management review - plan of improvement actions - quality objectives

CLAUSE 10 – IMPROVEMENT 10. 1 Improvement opportunities v Requirements: - determine & select opportunities for improvement - implement any necessary actions to meet customer requirements & enhance customer satisfaction v Analysis/Actions: - implementation of improvement opportunities shall include: • improving products & services while taking into account future needs & expectations • correcting, preventing or reducing undesired effects • improving QMS performance & effectiveness (improvement examples: correction, corrective action, continual improvement, breakthrough change, innovation & re-organization)

CLAUSE 10 – IMPROVEMENT 10. 1 Improvement opportunities v Documentation: - improvement of product & service design - management review - corrective actions - business plan - resources for training & innovation - continual improvement projects v Performance indicators: - on target percentage, satisfaction improvement - number of complaints received by product type or sales height - data compared to competitors, cost/defect/fault indicators

CLAUSE 10 – IMPROVEMENT 10. 2 Nonconformity and corrective action v Requirement: - determination of nonconformities and corrective actions v Analysis/Actions: - react to nonconformity or complaint and react, as applicable: • take action to control & correct it • deal with the consequences - evaluate the need for action to eliminate the cause of the nonconformity, in order not to recur or occur elsewhere: • review & analyse the nonconformity • determine the causes • determine if similar nonconformities exist or could occur - implement any action needed

CLAUSE 10 – IMPROVEMENT 10. 2 Nonconformity and corrective action v Analysis/Actions: - review the effectiveness of corrective actions taken - update risks & opportunities (if necessary) - make changes to the QMS (if necessary) - retain documented information (nonconformities, actions, results) v Documentation required: - nonconformities (complaints, satisfaction measurements, production faults, internal audits) & corrections/corrective actions - determination of causes of nonconformity - statistical analyses, management review v Performance indicators: - customer satisfaction, number of complaints - corrective action effectiveness

CLAUSE 10 – IMPROVEMENT 10. 3 Continual improvement v Requirement: - continual improvement of the QMS v Analysis/Actions: - continually improve the suitability, adequacy & effectiveness of the QMS - consider: analysis & evaluation results + management review outputs → determine if there are needs or opportunities to be addressed v Documentation: - results of QMS reviews, management reviews - alternative actions, business plan - internal communication v Performance indicators: - procedures effectiveness, on target percentage, comparing evaluation

References 1. ISO 9000: 2015, Quality management systems - Fundamentals and vocabulary 2. ISO 9001: 2015, Quality management systems – Requirements 3. www. bsigroup. com/Local. Files/es-ES/Documentos%20 tecnicos/ISO-9001 transition-guide. pdf 4. www. p 4 p. uk. com/library-user-guide/datasheet-iso-90012015 -vs-iso 90012008/ 5. www. sciqual. com. au/sites/default/files/iso 9001 process_approach_presentation. pdf 6. www. sciqual. com. au/sites/default/files/iso_9001 -2015_-_risk_based_thinking. pdf 7. www. tuvaustriahellas. gr/content/EN_iso 9001. pdf

Self-evaluation questions (1) Understanding the Organization and its Context requires to: A. determine the relevant external & internal issues B. determine which issues affect its competence C. monitor & review information D. all above (correct answer: D) (2) Top management shall demonstrate leadership & commitment with respect to the QMS and customer focus. A. Correct B. Not correct (correct answer: A)

Self-evaluation questions (3) Control of externally provided processes, products and services is required when: A. Products & services from external providers are going to be incorporated into the Organization’s products/services B. Products & services are provided to customers on behalf of the Organization C. A process is provided by an external provider as a result of an Organization’s decision D. All above (correct answer: D)

Author(s) information Evangelia is an Economist, Business Consultant and Quality Manager. Project Manager and Researcher/ Trainer in various National & EU Projects, in terms of entrepreneurship and industrial development. She is an evaluator within The “Competitiveness, Entrepreneurship and Innovation” (EPAn. EK) Operational Programme. Evangelia Daratsanou Veterinarian MSc in Food Science and Nutrition Ph. D student in Food Science and Technology-Dairy Research Quality Assurance and Food Safety consultant Lampros Sakkas