New ISO Standards Transition Workshop (Auditors)

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.

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.

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 Scope Normative references Terms and definitions Context of the organization Leadership Planning Support Operation Performance evaluation Improvement.

Clause structure (4-6) 4. Context of the organization 5. Leadership 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 8. Operation 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.

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

Document 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

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. 2008 – Introduction

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. 2008 – Clause 0.1

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”. 2008 – Clause 0.2

New Principles Customer Focus Customer Focus Leadership Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships Customer Focus Leadership Engagement of People Process Approach Improvement Evidence-based Decision Making Relationship Management. 2008 – Clause 0.2

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). 2008 – Clause 0.3

0.4 Relationship with other MSS now a framework to improve alignment among all International Standards for management systems better facilitates immigration. 2008 – Clause 0.4

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. 2008 – Clauses 1.1 & 1.2

Section 2 – Normative references ISO 9000:2015, Quality management systems – Fundamentals and vocabulary also describes quality management principles in detail. 2008 – Clause 2

Section 3 – Terms and Definitions no terms and definitions reference to ISO 9000 – no change maintains clause numbering for consistency. 2008 – Clause 3

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. 2008 – Clause 3

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. 2008 – Clause 3

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. 2008 – Clause 3

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. 2008 – Clause 3

Section 4 – Context of the Organisation 2008 – No direct equivalent

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. 2008 – No direct equivalent

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 must monitor these issues. 2008 – No direct equivalent

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 determine their needs and expectations must monitor information about interested parties’ requirements. 2008 – No direct equivalent

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 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 ISO 9001 that is not applicable any N/A clauses must not effect conformity of products/services and customer satisfaction. 2008 – Clauses 1.2 & 4.2.2

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 interaction of processes required (but not documented!) assign responsibilities and authorities for processes retain documented information to ensure in the processes Documented procedures are not necessarily required…. except where they are needed! 2008 – Clause 4.1

Section 5 - Leadership 2008 – Clause 5

What is required by top management. 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 What is required by top management. 2008 – No direct equivalent

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 new clause must take accountability for the QMS’ effectiveness ensure Quality Policy and quality objectives are established ensure QMS is integrated into business processes ensure resources are available; 2008 – Clause 5

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 and conformance ensure QMS achieves intended results promote improvement support other management to demonstrate leadership. 2008 – Clause 5

Section 5 - Leadership customer and regulatory requirements are met 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. 2008 – Clause 5

Section 5 – Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities now split into two sub-clauses to save the confusion in the previous version of what must be in the policy and what must be done with the policy must be documented must be available internally and to interested parties. 2008 – Clause 5.3

Section 5 – Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities 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. 2008 – Clause 5.5

Section 6 – Planning 2008 – Clause 5.4.2

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 introduces risk based approach to planning addresses risks, opportunities and quality objectives How quality planning is achieved. 2008 – Clause 5.4.2

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 achieves results, enhance desirable effect and achieve improvement must evaluate effectiveness of actions must be risk based. 2008 – Clauses 5.4.2 & 8.5.3 3

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. 2008 – Clause 5.4.1

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. 2008 – Clause 5.4.2

Section 7 - Support 2008 – Clause 6

The support required to meet the organisation’s goals. Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information newly constructed clause much of what was in 2008 Version Clauses 4,5 & 6 The support required to meet the organisation’s goals. 2008 – Clause 6

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. 2008 – Clause 6.1

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 new clause must determine and provide people necessary for effective information of QMS and operations/control of processes. 2008 – Clause 6.1

Section 7 - Support same as for previous Clause 6.3. 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 same as for previous Clause 6.3. 2008 – Clause 6.3

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 same as for previous Clause 6.4 note definition of work environment. 2008 –Clause 6.4

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 previous Clause 7.6 split into two clauses 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. 2008 –Clause 7.6

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 new 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. 2008 – No equivalent clause

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). 2008 – No equivalent clause

Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information very similar to previous Clause 6.2.2 removal of providing ‘training’ to ‘competence’ documented information (record) must be obtained of competence. 2008 – Clause 6.2.2

Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information specific clause for awareness must be aware of Quality Policy, quality objectives, contribution to effective QMS and implication of not conforming with QMS. 2008 – Clause 6.2.2

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, when, to whom, how and by whom. 2008 – Clause 5.5.3

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 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. 2008 – Clause 4.2.1

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. 2008 – Clause 4.2.3

Section 7 - Support 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information combines previous Clauses 4.2.3 (documentation) and 4.2.4 (records). 2008 – Clauses 4.2.3 & 4.2.4

Section 8 - Operation 2008 – Clause 7

The heart of the management system (the business). 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). 2008 – Clause 7

Section 8 - Operation 8.1 Operational planning and control similar to previous Clause 7.1 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. 2008 – Clause 7.1

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 same as previous Clause 7.2.3 includes communicating with customers about handling and controlling their property, establishing contingency requirements, when relevant. 2008 – Clause 7.2.3

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 same as previous Clause 7.2.1 plus the organisation must meet the claims of products or services it offers. 2008 – Clause 7.2.1

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 combines previous Clauses 7.2.1 and 7.2.2 documented information required on results of the review and any new requirements. 2008 – Clause 7.2.2

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; 2008 – Clauses 7.3

Section 8 - Operation 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. 2008 – Clause 7.3

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. 2008 – Clauses 7.4

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 changes are mainly terminology and revised wording 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. 2008 – Clauses 7.5

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 previous Clauses 7.5.1 and 7.5.2 combined. 2008 – Clauses 7.5.1 & 7.5.2

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 no change. 2008 – Clause 7.5.3

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 no change. 2008 – Clauses 7.5.4

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 no change. 2008 – Clauses 7.5.5

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 new clause for post-delivery activities a number of considerations are required. 2008 – Clauses 7.5.1

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. 2008 – Clauses 7.3.7

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. 2008 – Clause 8.2.4

Section 8 - Operation 8.7 Control of nonconforming outputs similar to previous Clause 8.3 documented information required describing nonconformity, actions taken, any concessions and authority for taking action. 2008 – Clause 8.3

Section 9 – Performance Evaluation 2008 – Clause 8

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. 2008 – Clause 8

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. 2008 – Clause 8.2.3

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 same as previous Clause 8.2.1. 2008 – Clause 8.2.1

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. 2008 – Clause 8.4

Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review same as previous Clause 8.2.2 split into two sub-clauses still at planned intervals evidence of internal audits and results must be documented. 2008 – Clause 8.2.2

Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review similar to previous Clause 5.6 still at planned intervals clearer agenda items (inputs) evidence of management review results must be documented. 2008 – Clause 5.6

Section 10 - Improvement 2008 – Clause 8.5

Continual improvement remains a core focus of the QMS. Section 10 - 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. 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 2008 – Clause 8.5

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. 2008 – Clause 8.5.1

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. 2008 – Clauses 8.3 & 8.5.2

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. 2008 – Clause 8.5.1

Annex A – Clarification information on new structure, terminology and concepts. 2008 – No equivalent clause

Annex B – Other (informative) other international standards on quality management and quality management systems developed by ISO/TC 176. 2008 – No equivalent clause

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? Thanks