FINAL IMS PPT - Read-Only - Compatibility Mode.pdf
- 1. INTERNAL AUDIT COURSE ISO 9001 2015, ISO 14001 2015, ISO 45001 2018 IMS/ QEHS What has Changed? • new concepts are considered - more risk based thinking • the customer remains the primary focus • a new common ISO format has been developed for use across all Management System Standards • a significant re-ordering of the key clauses. • a significant re-ordering of the key clauses • International Focus on managing Occupational Health and Safety • First International Standard • Supported by ISO and Industry for the prevention of work-related injury and ill-health What has changed? • new concepts are considered - more risk based thinking • a new common ISO format has been developed for use across all Management System Standards • a significant re-ordering of the key clauses. What else? • Strategic Environmental Management ▫ increased emphasis on strategic planning ▫ new requirement to understand the organisation’s context ▫ aim to identify and leverage opportunities for the benefit of both the organisation and the environment ▫ issues or changing circumstances related to the needs and expectations of interested parties and local, regional or global environmental conditions that can affect, or be affected by, the organisation ▫ if identified as a priority, actions to mitigate adverse risk or exploit beneficial opportunities are integrated in the operational planning of EMS. 2015 – Annex A
- 2. And more……. • Leadership ▫ a new clause that assigns specific responsibilities for those in leadership roles to promote environmental management • Protecting the environment ▫ expectation on organisations has been expanded to commit to proactive initiatives to protect the environment from harm and degradation, consistent with the context of the organisation ▫ ‘protect the environment’ is not defined but it notes that it can include prevention of pollution, sustainable resource use, climate change mitigation and adaptation, protection of biodiversity and ecosystems, etc... 2015 – Annex A And more………. • Environmental performance ▫ emphasis with regard to continual improvement now improving environmental performance ▫ Note - consistent with the organisation’s policy commitments • Life-cycle thinking ▫ need to extend control and influence to the environmental impacts associated with product use and end-of-life treatment or disposal ▫ Note - does not imply a requirement to do a life cycle assessment. 2015 – Annex A And more! • Communication ▫ must develop communications strategy with equal emphasis on external and internal communication ▫ requirement to communicate consistent and reliable information ▫ establish mechanisms for persons working under the organisation's control to make suggestions on improving the EMS ▫ Note - the organisation decides whether to communicate externally but it must consider regulatory requirements and expectations of interested parties • Documentation ▫ term ‘documented information’ instead of ‘documents’ and ‘records’ ▫ flexibility to determine when ‘procedures’ are needed. 2015 – Annex A Key Changes • increased emphasis on Achieving Value for the organisation and its customers • increased emphasis on understanding and control of Risk to the organisation • reduced emphasis on Documentation • no stated requirement for Documented Procedures • no reference to a Quality Manual.
- 3. And……… • no requirement for a Management Representative • no formal requirement for Preventive Action • outsourcing is now External Provision • enhanced Leadership Requirements • Organisational Context – responsiveness to changing Business Environment • No exclusions, only Not Applicable clauses! High Level Structure • the new standard adopts the high-level structure and terminology of Annex SL (used for the development of all new ISO standards) • High Level Structure - identical core text and common terms and core definitions for use in all Management System Standards: ▫ purpose - enhance the consistency and alignment of different management system standards ▫ organisations that integrate multiple standards (eg QMS, EMS, OHS) will see the most benefit ▫ uses simplified language and writing styles to aid understanding and consistent interpretations of requirements. Common structure for MSS Introduction 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement.
- 4. Clause structure (4-6) 4. Context of the organization Understanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of the XXX management system XXX management system 5. Leadership Leadership and commitment Policy Organizational roles, responsibilities and authorities 6. Planning Actions to address risks and opportunities Objectives and plans to achieve them. Clause structure (7-10) 7. Support Resources Competence Awareness Communication Documented information 8. Operation Operational planning and control 9. Performance evaluation Monitoring, measurement, analysis and evaluation Internal audit Management review 10. Improvement Nonconformity and corrective action Continual improvement. Control Outsourcing and purchasing External provision Documents and records Documented information Management representative Assigned responsibility and authority Quality Manual a) how scope is determined b) QMS scope types of products and services c) Details and justification for any exclusions details and justification for any n/a reqt d) Documented procedures e) Description of the interaction between QMS processes required inputs and expected outputs. Top management requirements 5.1 Leadership and commitment Top management shall demonstrate leadership and commitment by: Ensuring (ie someone else can do it) • the Quality Policy and quality objectives are established for the QMS and are compatible with the context and strategic direction of the organisation • the integration of QMS requirements into the organisation’s business processes • the resources needed for the QMS are available • the QMS achieves its intended results Doing (ie they must do it themselves) • take accountability for the effectiveness of the QMS • promote the use of the process approach and risk-based thinking • communicate the importance of effective quality management and of conforming to QMS requirements • engage, direct and support persons to contribute to the effectiveness of the QMS • promote improvement • support other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
- 5. Risk-based approach • organisations are required to understand its context (Clause 4.1) and determine the risks and opportunities that need to be addressed (Clause 6.1) • one of the key purposes of a QMS is to act as a preventive tool • there is no separate clause or sub-clause titled “preventive action” • the concept of preventive action is expressed through a risk-based approach to formulating QMS requirements. 2015 – Annex A Applicability • no specific reference to “exclusions” when determining applicability of requirements to the organisation’s QMS • an organisation will need to review the applicability of requirements due to the size of the organisation, the management model it adopts, the range of activities and the nature of the risks and opportunities it encounters. 2015 – Annex A Documented information • a common clause of “Documented Information” has been adopted • the terms “documented procedure” and “record” have both been replaced throughout the requirements by “documented information” • documented procedures (eg to define, control or support a process) are now expressed as a requirement to maintain documented information • records are now expressed as a requirement to retain documented information. 2015 – Annex A Organisational knowledge • organisational knowledge (Clause 7.1.6) addresses the need to determine and maintain the knowledge obtained by the organisation and its personnel, to ensure that it can achieve conformity of products and services • the process for considering and controlling knowledge needs to take account the organisation’s context, its size and complexity, the risks and opportunities it needs to address and the need for accessibility of knowledge • the balance between knowledge held by competent people and knowledge made available by other means is at the discretion of the organisation. 2015 – Annex A
- 6. Control of externally provided processes, products and services • control of externally provided products and services (Clause 8.4) addresses all forms of external provision, whether by: ▫ purchasing from a supplier ▫ an arrangement with an associate company ▫ the outsourcing of processes and functions of the organisation, or by any other means • now required to take a risk-based approach to determine the type and extent of controls appropriate to external providers and externally provided products and services. 2015 – Annex A ISO 9001:2015 Quality Management Systems – requirements. Introduction 0.1 General 0.2 Quality management principles 0.3 Process approach 0.4 Relationship with other MSS • introduces the rationale for the Standard • more formally structured. 0.1 General • identifies potential benefits • it is not the intent of the standard to imply: ─ uniformity in the structure of different quality management systems ─ uniformity of documentation to align to the clauses of the Standard ─ impose specific terminology to be used.
- 7. 0.2 Quality management principles • ISO 9001:2008 was based on eight quality management principles whereas the revised version refers to just seven • the principle of “a systems approach to management” has been dropped • the last principle is now called “Relationship management” instead of “Mutually beneficial supplier relationships”. New Quality Management Principles 1. Customer Focus 2. Leadership 3. Engagement of People 4. Process Approach 5. Improvement 6. Evidence-based Decision Making 7. Relationship Management. 0.3 Process Approach • understand and manage interrelated processes as a system • enables consistent and predictable results • PDCA cycle is fundamental • introduces risk based thinking (always been an implied requirement). Plan-Do-Check-Act Leadership & Worker (5) Support and Operation (7, 8) Performance (9) Improvement (10) Planning (6) 28 Needs and Expectations of relevant interested parties Intended outcomes Context of the organisation
- 8. 0.4 Relationship with other Management System Standarad • now a framework to improve alignment among all International Standards for management systems • better facilitates immigration. Section 1 - Scope • consistently provide products and services to meet requirements and enhance customer satisfaction – no change • all requirements are intended to be applicable to all organisations, regardless of type, size and product provided – no change • removal of exclusions. Section 2 – Normative references • ISO 9000:2015, Quality management systems – Fundamentals and vocabulary ▫ also describes quality management principles in detail. Section 3 – Terms and Definitions • no terms and definitions • reference to ISO 9000 – no change • maintains clause numbering for consistency.
- 9. Some Terms (docs) • document – information and the medium on which it is contained • documented information - information required to be controlled and maintained by an organisation and the medium on which it is contained • procedure – specified way to carry out an activity or a process (can be documented or not) • record – document stating results achieved or providing evidence of activities performed. More Terms (improvement) • improvement – activity to enhance performance • objective – result to be achieved • nonconformity – non-fulfilment of a requirement • correction – action to eliminate a detected nonconformity • corrective action – action to eliminate the cause of a nonconformity and prevent recurrence • preventive action – action to eliminate the cause of a potential nonconformity or other undesirable situation • verification – confirmation that specified requirements have been fulfilled • validation – confirmation that requirements for a specified intended use or application have been fulfilled. More Terms (product) • product – output of an organisation that can be produced without any transaction taking place between the organisation and the customer • service – output of an organisation with at least one activity necessarily performed between the organisation and the customer • performance - measurable results • risk - effect (positive or negative) of uncertainty • outsource - to make an arrangement where an external organisation performs part of an organisation’s function or process - Note: An external organisation is outside the scope of the management system although the outsourced function or process is within the scope. More Terms (people) • top management – person or group of people who directs and controls an organisation at the highest level • QMS consultant – advisor on QMS realisation – can assist in realising parts of a QMS • interested party – person or organisation that can have an affect, be affected by, or perceive itself to be affected by a decision or activity • competence – ability to apply knowledge and skills to achieve intended results • infrastructure – facilities, equipment & services • work environment - conditions under which work is performed.
- 10. Section 3 – Terms and Definitions 2004 – clause 3 • environmental aspect – element of an organisation’s activities, products or services that interacts or can interact with the environment – the activity • environmental impact – change to the environment (adverse or beneficial), wholly or partly resulting from the organisation’s environmental aspects – potential change or harm. Some more terms • environmental performance – performance related to the management of environmental aspects • life cycle – consecutive and interlinked stages of a product (or service) system, from raw material acquisition or generation from natural resources to final disposal. 2004 – clause 3 Terms and Definitions Organisation “persons of group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives” Interested party “person or organisation that can affected, be affected by, or perceive itself to be affected by a decision or activity” Contractor “external organisation providing services to the organisation at a workplace in accordance with agreed specifications, terms and conditions” 39 Terms and definitions Worker “person performing work or work related activities under the control of the organisation Note1: persons perform work or work related activities under various arrangements- paid/unpaid Note2: workers include top management, managerial and non-managerial Note 3: work or work related activities performed by workers employed by another organisation – insourced activities 40
- 11. Continued .. Participation “involvement of workers in decision-making” Consultation “seeking the views making a decision” Workplace “place under the control of the organisation where a person needs to be or go by reason of work” Note 1: the organisation responsibilities depends on the degree of control 41 Continued .. Risk “effect of uncertainty” OH&S Risk “combination of the likelihood of occurrence of a work related hazardous event and exposure(s) and severity of injury and ill-health that can be caused by the event or exposure(s) Injury and ill-health “adverse effect on the physical, mental or cognitive condition of a person” Note 1 – adverse effects includes occupational disease, illness and death 42 What Does Hazard Mean • A hazard is any object, situation, or behavior that has the potential to cause injury, ill health, or damage to property or the environment. • Health and safety hazards exist in every workplace. Some are easily identified and corrected, while others are necessary risks of the job and must be managed in other ways (for instance, by using protective equipment). • Most occupational hazards are inactive or have a low potential of actually occurring; however, employers must be prepared to deal with them since a hazard becoming active can generate an emergency situation Hazards can be classified as: • Physical Hazards: These are the most common hazards and they include extremes of temperature, ionizing or non-ionizing radiation, excessive noise, electrical exposure, working from heights, and unguarded machinery. • Mechanical Hazards: These are usually created by machinery, often with protruding and moving parts. • Chemical Hazards: These appear when a worker is exposed to chemicals in the workplace. Some are safer than others, but for workers who are more sensitive to chemicals, even common solutions can cause illness, skin irritation, or breathing problems. • Biological Hazards: These include the viruses, bacteria, fungus, parasites, and any living organism that can infect or transmit diseases to human beings. • Ergonomic Hazards: Including considerations of the total physiological demands of the job upon the worker, even beyond productivity, health, and safety. • Psychosocial Hazards: These may arise from a variety of psychosocial factors that workers may find to be unsatisfactory, frustrating, or demoralizing.
- 12. Examples of Hazards and Their Effects Workplace Hazard Example of Hazard Example of Harm Caused Thing Knife Cut Substance Benzene Leukemia Material Mycobacterium tuberculosis Tuberculosis Source of Energy Electricity Shock, electrocution Condition Wet floor Slips, falls Process Welding Metal fume fever Practice Hard rock mining Silicosis Behaviour Bullying Anxiety, fear, depression Verbal Words • “shall” indicates a requirement • “should” indicates a recommendation • “may” indicates a permission • “can” indicates a possibility or capability • “Note” is guidance/clarification on requirements • “Note to entry” additional information that supplements the terminology 47 Section 4 – Context of the Organisation
- 13. Section 4 – Context of the Organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes • this is a new clause and provides a key insight into the organisation What constitutes the organisation’s quality management system. Section 4 – Context of the organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes • determine external and internal issues relevant to the QMS/EMS/OH&S • must monitor these issues. • External context – cultural, social, political, key trends in industry • Internal context- governance, policies, objectives, culture, trends Section 4 – Context of the organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes • determine interested parties relevant to the QMS/EMS/OH&S • determine their needs and expectations • must monitor information about interested parties’ requirements. • which ones are compliance obligations • Needs and expectations of managerial and non-managerial workers • Other interested parties – legal and regulatory authorities, includes workers, customers and clients • Applicable legal requirements Section 4 – Context of the organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes • establish scope by determining boundaries and applicability of the QMS/EMS/OH&S to consider external/internal issues, requirements of interested parties and the organisation’s products and services • scope must be documented and available, justify any clauses of QMS/EMS/OH&S that is not applicable • any N/A clauses must not effect conformity of products/services and customer satisfaction.
- 14. Section 4 – Context of the organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes • must establish, implement, maintain and continually improve the QMS/EMS/OH&S • interaction of processes required (but not documented!) • assign roles, responsibilities and authorities for processes • retain documented information to ensure in the processes Documented procedures are not necessarily required…. except where they are needed! Section 5 - Leadership Section 5 – Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities • top management to now have a greater involvement in the QMS/EMS/OH&S What is required by top management. Section 5 - Leadership 5.1 Leadership and commitment 5.1.1 General 5.5.1 Customer focus 5.2 Policy 5.3 Organisational roles, responsibilities and authorises • must take accountability for the QMS/EMS/OH&S effectiveness • ensure QMS/EMS/OH&S Policy and objectives are established • ensure QMS/EMS/OH&S is integrated into business processes • ensure resources are available;
- 15. Section 5 - Leadership 5.1 Leadership and commitment 5.1.1 General…cont 5.5.1 Customer focus 5.2 Policy 5.3 Organisational roles, responsibilities and authorises • communicate importance of effective QMS/EMS/OH&S and conformance • ensure QMS/EMS/OH&S achieves intended results • promote continual improvement • support other management to demonstrate leadership. • Developing, leading and promoting a culture supporting OH&S • Consider need to establish H&S committees • Ensuring active participation of workers, worker representation using consultation Section 5 - Leadership 5.1 Leadership and commitment 5.1.1 General 5.5.1 Customer focus 5.2 Policy 5.3 Organisational roles, responsibilities and authorises • top management must ensure: • customer and regulatory requirements are met • risks and opportunities are determined and addressed • focused on enhancing customer satisfaction. Section 5 – Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities • must be documented • must be available internally and to interested parties. • OH&S policy set of principles and overall sense of direction • H&S policy on consultation with workers at all levels and communicated • Commitment to provide safe and healthy working conditions • Prevention of injury and ill-health • Policy appropriate to size and context of organization • Specific nature of it OH&S risk and OH&S opportunities • Communication of policy Section 5 – Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities 5.4 Consultation and participation • ensures responsibilities and authorities for relevant roles are assigned, communicated and understood • no formal requirement for specific management representative • specific mention of changes to QMS. • no requirement for a specific management representative • however those duties must be assigned. • Establish, implement, maintain process(es) for consultation and participation in developing, planning, evaluation and actions for improvement in OH&S • Provide mechanisms, time, training and resources necessary for participation • Provide timely access to clear, understandable and relevant information on OH&S
- 16. Section 6 – Planning Section 6 – Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes • introduces risk based approach to planning • addresses risks, opportunities and quality objectives How quality planning is achieved. Section 6 – Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes • when planning, must consider external/internal issues and interested parties • determine risks to ensure QMS/EMS/OH&S achieves results, enhance desirable effect and achieve improvement • determine the risks related to environmental aspects, compliance obligations and other issues • Hazard identification and assessment of risks and opportunities • Determination of applicable legal requirements and other requirements • must evaluate effectiveness of actions • must be risk based. • 6.1 Actions to address risks and opportunities 6.1.2 Environmental aspects 6.1.3 Compliance obligations 6.1.4 Planning action 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes • requires criteria for significant environmental aspects to be established • environmental aspects must be communicated within the organisation • environmental aspects and associated environmental impacts must be documented.
- 17. 6.1 Actions to address risks and opportunities 6.1.2 Environmental aspects 6.1.3 Compliance obligations 6.1.4 Planning action 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes • “compliance obligations” in lieu of legal and other requirements • compliance obligations must be documented. • organisations must plan to take action to address significant environmental aspects, compliance obligations and risks/opportunities • must also plan to implement actions into the EMS and evaluate effectiveness of the actions. 6.1 Actions to address risks and opportunities 6.1.2 Environmental aspects 6.1.3 Compliance obligations 6.1.4 Planning action 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 6.1.2 Hazard identification and assessment of risk and opportunities 6.1.2 Hazard identification and assessment of risks and opportunities 6.1.2.1 hazard identification 6.1.2.2 assessment of OH&S risk and other risks to OH&S management system 6.1.2.3 assessment of OH&S opportunities and other opportunities 67 6.1.2 Hazard Identification and assessment of risk and opportunities 6.1.2.1 Hazard identification • Ongoing proactive identification of hazards • Past incidents, emerging trends • Routine & non-routine activities and situations • Emergency situations • Human factors • Other issues – design, situations in the vicinity of workplace, situations not controlled by organisations • Changes or proposed changes • Change in knowledge • How work is organised, social factors, workload, work hours, leadership and culture 68
- 18. 6.1.2 Hazard Identification and assessment of OH&S risks 6.1.2.2 Assessment of OH&S risks and other risk to the OH&S management system • Assess OH&S risks from hazards identified • Take account of issues from context 4.1 & needs and expectations of interested parties 4.2 • Define methodology and criteria • Methodologies and criteria be maintained and retained as documented information 69 6.1.2 Hazard Identification and assessment of OH&S risks 6.1.2.3 Identification of OH&S opportunities and other opportunities • New! • Opportunities to enhance OH&S performance taking into account: ▫ Planned changes ▫ Opportunities to eliminate or reduce risk ▫ Opportunities to adapt work, work organisation and work environment to workers • Opportunities for improving OH&S management system 70 6.1.3 Determination of applicable legal requirements and other requirements 6.1.3 Determination of applicable legal requirements and other requirements • Process replaces procedure • Determine and have access to up to date legal requirements • Determine how these apply and will be communicated • Take into account when establishing, implementing • Maintain and retain documented information 71 6.1.4 Planning action 6.1.4 Planning action • Address risk and opportunities (6.1.2.2 & 6.1.2.3) • Address applicable legal requirements (6.1.3) • Emergency preparedness emergency situation (8.2) • Integrate actions to other business process(s) – Business Continuity, Financial or HR • Eliminating hazards and reducing OH&S risk (HoC) (8.1.2) • Best practice 72
- 19. 6.2 OH&S objectives 6.2 OH&S objectives • Maintain and improve OH&S management system and OH&S performance • Take into account results of assessment of OH&S risk and opportunities and other risks and opportunities • Take into account outputs of consultation with workers and workers representative • Be measurable or capable of evaluation • Clearly communicated 73 6.2.2. Planning to achieve OH&S objectives 6.2.2. Planning to achieve OH&S objectives • What will be done • What resources • Who will be responsible • When completed • How measured through indicators if practicable, monitored and frequency • How actions will be integrated into overall business processes • Maintain and retain documented information 74 Section 6 – Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes • quality objectives need to be established at relevant functions, levels and processes • these objectives should be: ─ consistent with the Quality Policy, measurable and take into account applicable requirements ─ relevant to conformity of products and services, and the enhancement of customer satisfaction ─ monitored, communicated and updated as appropriate • must determine what, how, who, when, etc • quality objectives must be documented. Section 6 – Planning • 6.1 Actions to address risks and opportunities • 6.2 Environmental objectives and planning to achieve them • 6.2.1 Environmental objectives • 6.2.2 Planning actions to achieve environmental objectives • only really requires objectives for significant environmental aspects and associated compliance obligations • environment objectives must be updated • they must be documented.
- 20. Section 6 – Planning • 6.1 Actions to address risks and opportunities • 6.2 Environmental objectives and planning to achieve them • 6.2.1 Environmental objectives • 6.2.2 Planning actions to achieve environmental objectives • requires planning to determine what, how, who, when, how the objectives will be monitored and how the results will be evaluated • must consider how environmental objectives can be integrated into the organisations processes. 6.2 OH&S objectives 6.2 OH&S objectives • Maintain and improve OH&S management system and OH&S performance • Take into account results of assessment of OH&S risk and opportunities and other risks and opportunities • Take into account outputs of consultation with workers and workers representative • Be measurable or capable of evaluation • Clearly communicated 78 6.2.2. Planning to achieve OH&S objectives 6.2.2. Planning to achieve OH&S objectives • What will be done • What resources • Who will be responsible • When completed • How measured through indicators if practicable, monitored and frequency • How actions will be integrated into overall business processes • Maintain and retain documented information 79 Section 6 – Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes • where change is needed, it needs to be carried out in a planned and systemic manner • must ensure integrity of QMS.
- 21. 8.1.3 Management of Change 8.1.3 Management of Change • Establish a process for the implementation and control of planned changes • Changes include: ▫ Work processes ▫ Legalisation ▫ Knowledge and information about hazards and related OH&S risk ▫ Developments in knowledge and technology • Control changes to mitigate against adverse impact on OH&S 81 Section 7 - Support Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information The support required to meet the organisation’s goals. Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • must provide resources for the implementation and maintenance of the QMS • must consider constraints of existing resources and what may be provided from external providers.
- 22. 7.1 Resources 7.1 Resources • Determine resources and provide resources needed for OH&S • Resources can include HR, natural resources, infrastructure and technology • Human resources includes - diversity, skills and knowledge 85 Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • must determine and provide people necessary for effective information of QMS and operations/control of processes. Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable, a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport, communication or information systems). Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge Work environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. A suitable environment can be a combination of human and physical factors, such as: a) social (e.g. non-discriminatory, calm, non confrontational); b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise). These factors can differ substantially depending on the products and services provided
- 23. Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • determine resources needed to ensure valid and reliable monitoring and measuring results resources must be suitable for the activity and maintained as fit for purpose evidence of fit for purpose must be retained other requirements for measuring equipment unchanged. Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • clause required to determine, maintain and make available the knowledge necessary for the operation of its processes and to achieve conformity of products and services • particular care required for changing need and trends. 7.1.6 Organisational Knowledge Note: • organisational knowledge can include information such as intellectual property and lessons learned • may consider: ─ internal sources (eg learning from failures and successful projects, capturing undocumented knowledge and expert experience) ─ external sources (eg standards, training, conferences, knowledge from customers or providers). Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experienceremoval of providing ‘training’ to ‘competence’ Criteria for each role f) must now evaluate the effectiveness of action taken to address competence g) Workers evaluated periodically to ensure continued competence for their roles documented information (record) must be obtained, retain of competence.
- 24. Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information • specific clause for awareness • Aspect Impact • must be aware of Policy, objectives, contribution to effective QMS/EMS/OH&S and implication of not conforming with QMS/EMS/OH&S. • Implication of not conforming with OH&S requirements • Information and outcomes of investigations of relevant incidents • OH&S hazards and risk relevant for them Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information • much expanded clause for communication • must now determine what will be communicated internally and externally about the QMS/EMS/OH&S, when, to whom, how and by whom. • Environmental parameter 7.4 Communication 7.4 Communication • Determine the need for internal or external information and communication relevant to QMS/EMS/OH&S What , when, who and when it will inform and communicate • Who – internally, externally with interested parties, contractors or visitors to the workplace • how it will received, maintain documented information and respond to relevant communications 95 Section 7 - Support 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information • QMS/EMS/OH&S needs documented information required by the Standard and as determined by the organisation Note: the extent of documented information can differ from one organisation to another due to its size, activities, processes, products and services, complexity of processes and their interactions, and the competence of people.
- 25. Section 7 - Support 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information • documented information requires: ▫ identification and description ▫ format and media ▫ review and approval. 7.5 Documented information 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information • Replaces documented “documentation”, “documented procedure” and “records” • Extent and nature of documented information dependant on complexity of organisation • Access by workers of documented information • Confidentiality of personal information of workers 98 Documented information • Clause where reference to documented information • 4.3, 5.2, 5.3, 6.1.1, 6.1.2.2,6.1.3, 6.2.2, 7.2, 7.4, 7.5.1. 7.5.3, 8.1.1., 8.2, 9.1.1, 9.1.2, 9.2.2, 9.3, 10.1 & 10.2 99 Section 8 - Operation
- 26. Section 8 - Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs • covers many of the Product Realisation requirements contained in Clause 7 of the 2008 version The heart of the management system (the business). Section 8 - Operation 8.1 Operational planning and control • must plan, implement and control processes needed to meet requirements for the provision of products and services • must control planned changes and review unintended changes • any outsourced processes must be controlled. • similar intent but also includes controlling changes • also addresses outsourcing processes are controlled • introduces lifecycle perspective to ensure organisation controls environmental requirements for the lifecycle of products and services • must communicate these requirements • consider transport, delivery, use and final disposal • documented information is to be maintained as considered necessary by the organisation. 8.1 Operational planning and control 8.1.1 General • Implement controls in Clause 6 • Establishing criteria for process(s) • Implementing control defined in criteria • Keeping documented information • Absence of documented information could lead to deviations • Adapting work to workers including induction of new workers (A 8.1.1) 103 8.1 Operational planning and control 8.1.2 Eliminating hazards and reducing OH&S risks • Establish a process and determine controls for achieving reduction in OH&S risks using Hierarchy of Controls; ▫ Eliminate ▫ Substitute ▫ Engineering controls ▫ Administrative controls ▫ Provide and ensure safe use of PPE ▫ Note provision of PPE at not extra cost to workers 104
- 27. Section 8 - Operation 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of requirements for products and services 8.2.4 Changes to requirements for products and services The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints. d) includes communicating with customers about handling and controlling their property, establishing contingency requirements, when relevant. Section 8 - Operation 8.2 Determination of requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of requirements for products and services 8.2.4 Changes to requirements for products and services The organization shall determine a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by the organization.plus the organisation must meet the claims of products or services it offers. 8.2 Determination of requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of requirements for products and services 8.2.4 Changes to requirements for products and services a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by the organization. e) documented information required on results of the review and any new requirements. 1.) product requirements are defined, 2) contract or order requirements differing from those previously expressed are resolved, and 3) the organization has the ability to meet the defined requirements. Section 8 - Operation Section 8 - Operation • 8.1 Operational planning and control • 8.2 Emergency preparedness and response • The organisation shall establish and maintain procedures to identify potential emergency situations and potential accidents that can have an impact on the environment and how it will respond to them. It shall respond to actual emergencies and accidents and prevent or mitigate associated adverse environmental aspects The organisation shall periodically review and, were necessary, revise its emergency preparedness and response procedures, in particular, after the occurrence of accidents or emergency situation documented information is to be maintained as considered necessary by the organisation.
- 28. 8.2 Emergency Preparedness and Response 8.2 Emergency Preparedness and Response • Identify potential emergency situations • Assess OH&S risks associated with these • Preventative controls • Planned response to emergency situations including provision of first aid • Periodic testing and exercise of emergency response capabilities • Evaluate and revise plans • Communicate information relevant to their duties • Training • Needs and capabilities of interested parties • Maintain and retain documented information 109 Section 8 - Operation 8.3 Design and development of products and services • where the detailed requirements of the organisation’s products and services are not already established or not defined by the customer or by other interested parties, such that they are adequate for subsequent production or service provision, the organisation shall establish, implement and maintain a design and development process; 8.3 Design and development of products and services…cont • changes are mainly terminology and simplified wording • there is, however, a significantly increased focus on the role the customer has in all stages of the design process • the need for documented information to confirm appropriateness of all stages is also clearly stated • any changes made to design inputs and design outputs during the design and development must be clearly identified. Section 8 - Operation 8.4 Control of externally provided processes, products and services 8.4.1 General 8.4.2 Type and extent of control 8.4.3 Information for external providers • changes are mainly terminology and revised wording (ie suppliers become ‘external providers!’) • much as before, each stage of the purchasing process, including evaluation, selection, performance monitoring and re-evaluation remains a key requirement • there is a significant increase in the steps needed to control external provision. Section 8 - Operation
- 29. Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • the most significant change is the move of monitoring and measuring equipment to Section 7 • reference to ‘changes and post delivery activities’ have been strengthened. Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes 8.5.1 Control of production and service provision The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable, a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, as necessary, c) the use of suitable equipment, d) the availability and use of monitoring and measuring equipment, e) the implementation of monitoring and measurement, and f) the implementation of product release, delivery and post-delivery activities. The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable, a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records and e) revalidation. Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records
- 30. Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. • . Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • The organization shall meet requirements for post-delivery activities associated with the products and services. In determining the extent of post-delivery activities that are required, the organization shall consider: a) statutory and regulatory requirements; b) the potential undesired consequences associated with its products and services; c) the nature, use and intended lifetime of its products and services; d) customer requirements; e) customer feedback. Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • specific clause for control of changes to ensure continuing conformity • documented information must be retained describing the review of changes and any action arising.
- 31. 8.1.3 Management of Change 8.1.3 Management of Change • Establish a process for the implementation and control of planned changes • Changes include: ▫ Work processes ▫ Legalisation ▫ Knowledge and information about hazards and related OH&S risk ▫ Developments in knowledge and technology • Control changes to mitigate against adverse impact on OH&S 121 Section 8 - Operation 8.6 Release of products and services • must verify that product and service requirements have been meet and evidence of conformity retained • release to customer does not proceed until the planned verification of conformity has been satisfactorily completed, unless otherwise approved by a relevant authority and by the customer • documented information to provide traceability to the person(s) authorising release for delivery to the customer. Section 8 - Operation 8.7 Control of nonconforming outputs The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.Where applicable, the organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application; d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.documented information required describing nonconformity, actions taken, any concessions and authority for taking action. Section 9 – Performance Evaluation
- 32. Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review Determining what is to be monitored, measured, analysed and evaluated will enable the organisation to determine ‘if the management system suitable, adequate and effective ?’ How performance of the QMS is evaluated. Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation • must determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results • additionally, when the monitoring and measuring is to be performed and when the results from monitoring and measurement is to be analysed and evaluated • retain appropriate documented information as evidence of the results. Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation • performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. Section 9 – Performance Evaluation • 9.1 Monitoring, measurement, analysis and evaluation • 9.1.1 General • 9.1.2 Evaluation of compliance • frequency of compliance evaluation must be determined • must understand compliance status • evidence of compliance evaluation is to be documented.
- 33. 9.1 Performance monitoring, measurement, analysis and evaluation 9.1.2 Evaluation of compliance • Determine frequency • Evaluate compliance • Take action (10.1) • Maintain knowledge and understanding of its status of compliance • Retain documented information of results 129 Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation • information resulting from monitoring and measuring appropriate data should be analysed and evaluated • the results of analysis is to be used to evaluate seven specific criteria described. Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review • split into two sub-clauses • still at planned intervals • evidence of internal audits and results must be documented. • A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. • Competent auditors • Relevant findings reported to relevant workers • Take appropriate action to addresses non-conformities and continually improve its OH&S performance Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review • still at planned intervals • clearer agenda items (inputs) • evidence of management review results must be documented.
- 34. 9.3 Management Review 9.3 Management Review • Additional requirements • OH&S performance including trends in: ▫ Incidents ▫ Worker participation and outputs of consultations ▫ OH&S risks, risks and OH&S opportunities • Relevant communication with interested parties • Adequacy of resources for maintaining effective OH&S • Actions needed when objectives not achieved 133 Section 10 - Improvement Section 10 - Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement • QMS must continually improve • nonconformities must be identified and reacted to • corrective action must be considered Continual improvement remains a core focus of the QMS. Section 10 – Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement • opportunities for improvement must be determined • action must be taken to meet customer requirements and enhance customer satisfaction: ▫ improve products and service ▫ correcting, preventing or reducing undesired effects ▫ improve performance and effectiveness of the QMS.
- 35. Section 10 - Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement • nonconformities (including complaints) must be reacted to and applicable action taken • root cause analysis must be considered based on its significance • effectiveness of corrective action must be reviewed • change QMS if required • evidence of action taken from nonconformities must be documented • evidence of results of corrective action must be documented. Section 10 – Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement • organisations must continually improve the suitability, adequacy and effectiveness of the QMS • must consider results of analysis and evaluation, and outputs from management review. Section 10 – Improvement • 10.1 General • 10.2 Nonconformity and corrective action • 10.3 Continual improvement • nonconformities must be reacted to, applicable action taken and deal with any mitigation • root cause analysis must be considered based on its significance • effectiveness of corrective action must be reviewed • change EMS if required • evidence of action taken from nonconformities must be documented • evidence of results of corrective action must be documented. Section 10 – Improvement • 10.1 General • 10.2 Nonconformity and corrective action • 10.3 Continual improvement • organisations must continually improve the suitability, adequacy and effectiveness of the EMS to enhance environmental performance.
- 36. 10.2 Incident, nonconformity and corrective action 10.2 Incident, non- conformity and corrective action • React to incidents in timely manner • Take direct action to control and correct • Evaluate the root cause • Determine action based on HoC and MoC • Review of assessment of OH&S risks prior to taking action (6.1) • Communicate documented information to relevant workers • Note: reporting of incidents without delay can assist in removal of hazard 141 10.3 Continual improvement 10.3 Continual improvement • Enhance OH&S performance • Promote a positive OH&S culture • Promoting the participation of workers in implementing actions • Communicate results • Retain documented information 142 Annex A – Clarification • information on new structure, terminology and concepts. Annex B – Other (informative) • other international standards on quality management and quality management systems developed by ISO/TC 176.
- 37. Summary of Changes • better format and ease for integration • increased emphasis of achieving value • enhanced leadership requirements • risk based thinking • documentation requirements • interested parties. Any Questions?