ISO 9001:2015 October 5 th, 2017 Brad Fischer www.sdmanufacturing.com
Purpose of presentation Provide a summary of notable changes from ISO 9001:2008 to ISO 9001:2015
Key perspectives ISO 9001 needs to change, to: adapt to a changing world reflect the increasingly complex environments in which organizations operate provide a consistent foundation for the future ensure the new standard reflects the needs of all relevant interested parties ensure alignment with other management system standards
Key benefits of the common clause structure A new common format has been developed All ISO management systems standards will look the same with the same structure (some deviations) More efficient to address multiple management system requirements Provides the option of integrating management systems Standardized core definitions
Beneficial changes to ISO 9001 Enhanced leadership involvement in the management system Risk-based thinking Simplified language, common structure and terms Aligning QMS policy and objectives with the strategy of the organization
Potential benefits to the user Focus on achieving planned results Flexibility for documented information Improved risk control Better process control leading to improved results Improved customer satisfaction Customer retention and loyalty Improved image and reputation Greater credibility
Use ISO 9001:2015 if: You need to be able to show that your organization is consistently capable of providing products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements. You need to be able to demonstrate that your organization can enhance customer satisfaction because it is consistently capable of continually improving both its products and services and its practices and processes. You need to be able to assess your organization's ability to consistently provide products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements.
The new ISO 9001:2015 The new ISO 9001 2015 standard is based on seven quality management principles. These principles were chosen because they can be used to enhance corporate performance and to achieve sustained success. They form the conceptual foundation for the ISO portfolio of quality management standards and were used to guide the development of this new standard.
Focus on customers and interested parties In order to enhance corporate performance and achieve sustained success, organizations must focus on both their customers and their interested parties. Organizations can establish this focus by trying to understand the current and future requirements and expectations of both their customers and their interested parties and by constantly trying to meet these requirements and exceed these expectations.
Provide leadership for your organization In order to enhance corporate performance and achieve sustained success, organizations must ensure that suitable leadership is provided at all levels. Suitable leadership is provided whenever leaders at all levels establish a unity of purpose and whenever they create an environment that encourages people to pursue a common direction and achieve a common set of objectives. By establishing a common purpose, leaders can ensure that all strategies, policies, processes, and resources are aligned and being used to pursue a common direction and to achieve a common set of objectives.
Engage and involve your people In order to enhance corporate performance and achieve sustained success, organizations must be able to create and deliver value. In order to do so they must have people who are competent, they must enhance their knowledge and skills, and they must manage them effectively by empowering them, by encouraging their involvement and engagement at all levels, and by recognizing their achievements.
Use a process approach In order to enhance corporate performance and achieve sustained success, organizations must use a process approach to manage their activities. The process approach is a management strategy. When managers use this approach, it means that they manage and control their processes, the interactions between these processes, and the inputs and outputs that tie these processes together. It also means that they manage these interactions as a system. When this approach is applied to quality management, it means that they manage their processes and their process interactions as a coherent quality management system.
Encourage improvement In order to enhance corporate performance and achieve sustained success, organizations must encourage and support improvement. If they wish to maintain current levels of performance, if they wish to respond to changing conditions, and if they wish to identify, create, and exploit new opportunities, organizations must establish and sustain an ongoing focus on improvement.
Use evidence to make decisions In order to enhance corporate performance and achieve sustained success, organizations must establish an evidencebased decision making process. Decision making is evidencebased whenever multiple types of input are gathered from multiple sources, whenever facts are identified, whenever data is analyzed objectively, whenever cause and effect relationships are examined, whenever potential unintended consequences are considered, and whenever all of this is used to make corporate decisions.
Manage your corporate relationships In order to enhance corporate performance and achieve sustained success, organizations must manage their relationship with suppliers, partners, and other interested parties. Relationships must be carefully managed because suppliers, partners, and other interested parties can influence corporate performance and undermine corporate success.
Structure of the standard Perhaps the biggest difference between the old and the new standard is the structure. ISO 9001 2008 had five main sections (4 to 8) and ISO 9001 2015 now has seven (4 to 10). This is because the new edition uses the new Annex SL template. According to ISO, all future management system standards (MSSs) will use this new layout and share the same basic requirements.
ISO 9001:2015 to ISO 9001:2008 Correlation Matrix ISO 9001:2015 ISO 9001:2008 1 Scope 1 Scope 1.1 General 4 Context of the organization 4 Quality management system 4.1 Understanding the organization and its 4 Quality management system context 5.6 Management review 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 4 Quality management system 5.6 Management review 1.2 Application 4.2.2 Quality manual 4 Quality management system 4.1 General requirements 5 Leadership 5 Management responsibility 5.1 Leadership and commitment 5.1 Management commitment 5.1.1 General 5.1 Management commitment 5.1.2 Customer focus 5.2 Customer focus 5.2 Policy 5.3 Quality policy 5.2.1 Establishing the Quality Policy 5.3 Quality policy 5.2.2 Communicating the Quality Policy 5.3 Quality policy 5.3 Organizational roles, responsibilities and authorities 5.5.1 Responsibility and authority 5.5.2 Management representative 5.4.2 Quality management system planning 6 Planning 5.4.2 Quality management system planning 6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning 8.5.3 Preventive action 6.2 Quality objectives and planning to achieve them 5.4.1 Quality objectives 6.3 Planning of changes 5.4.2 Quality management system planning
ISO 9001:2015 to ISO 9001:2008 Correlation Matrix 7 Support 6 Resource management 7.1 Resources 6 Resource management 7.1.1 General 6.1 Provision of resources 7.1.2 People 6.1 Provision of resources 7.1.3 Infrastructure 6.3 Infrastructure 7.1.4 Environment for the operation of 6.4 Work environment processes 7.1.5 Monitoring and measuring resources 7.6 Control of monitoring and measuring equipment 7.1.5.1 General 7.6 Control of monitoring and measuring equipment 7.1.5.2 Measurement traceability 7.6 Control of monitoring and measuring equipment 7.1.6 Organizational knowledge No equivalent clause 7.2 Competence 6.2.1 General 6.2.2 Competence, training and awareness
ISO 9001:2015 to ISO 9001:2008 Correlation Matrix 7.3 Awareness 6.2.2 Competence, training and awareness 7.4 Communication 5.5.3 Internal communication 7.5 Documented information 4.2 Documentation requirements 7.5.1 General 4.2.1 General 7.5.2 Creating and updating 4.2.3 Control of documents 4.2.4 Control of records 7.5.3 Control of documented Information 4.2.3 Control of documents 4.2.4 Control of records
ISO 9001:2015 to ISO 9001:2008 Correlation Matrix 8 Operation 7 Product realization 8.1 Operational planning and control 7.1 Planning of product realization 8.2 Requirements for products and services 7.2 Customer-related processes 8.2.1 Customer communication 7.2.3 Customer communication 8.2.2 Determination of requirements for products and services 7.2.1 Determination of requirements related to the product 8.2.3 Review of the requirements for products and services 7.2.2 Review of requirements related to the product 8.2.4 Changes to requirements for products and services 7.2.2 Review of requirements related to the product 8.3 Design and development of products and services 7.3Design and development 8.3.1 General 7.3.1 Design and development planning 8.3.2 Design and development planning 7.3.1 Design and development planning 8.3.3 Design and development inputs 7.3.2 Design and development inputs 8.3.4 Design and development controls 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 8.3.5 Design and development outputs 7.3.3 Design and development outputs 8.3.6 Design and development changes 7.3.7 Control of design and development changes
ISO 9001:2015 to ISO 9001:2008 Correlation Matrix 8.4 Control of externally provided processes, products and services 7.4.1 Purchasing process 8.4.1 General 4.1 General requirements 7.4.1 Purchasing process 8.4.2 Type and extent of control 7.4.1 Purchasing process 7.4.3 Verification of purchased product 8.4.3 Information for external providers 7.4.2 Purchasing information 7.4.3 Verification of purchased product 8.6 8.5 Release Production of products and service and provision services 7.5 7.4.3 Verification Production and of purchased service provision product 8.5.1 Control of production and service provision 7.5.1 8.2.4 Control Monitoring of production and measurement and service of product provision 8.7 Control of nonconforming outputs 7.5.2 8.3 Validation Control of of nonconforming processes for production and service provision 8.5.2 Identification and traceability 7.5.3 Identification and traceability 8.5.3 Property belonging to customers or 7.5.4 Customer property external providers 8.5.4 Preservation 7.5.5 Preservation of product 8.5.5 Post-delivery activities 7.5.1 Control of production and service provision 8.5.6 Control of changes 7.3.7 Control of Design and Development Changes
ISO 9001:2015 to ISO 9001:2008 Correlation Matrix 9 Performance evaluation 8 Measurement, analysis and improvement 9.1 Monitoring, measurement, analysis and evaluation 8 Measurement, analysis and improvement 9.1.1 General 8.1 General 8.2.3 Monitoring and Measurement Processes 9.1.2 Customer satisfaction 8.2.1 Customer satisfaction 9.1.3 Analysis and evaluation 8.4 Analysis of data 9.2 Internal audit 8.2.2 Internal audit 9.3 Management review 5.6 Management review 9.3.1 General 5.6.1 General 9.3.2 Management review input 5.6.2 Review input 9.3.3 Management review output 5.6.3 Review output 10 Improvement 8.5 Improvement 10.1 General 8.5.1 Continual improvement 10.2 Nonconformity and corrective action 8.3 Control of nonconforming product 8.5.2 Corrective action 10.3 Continual Improvement 8.5.1 Continual improvement 8.5.3 Preventive action
Key feature changes 10-clause structure and core text for all Management System Standards (MSS) More compatible with services and non-manufacturing users Clearer understanding of the organization s context is required one size doesn t fit all Process approach strengthened/more explicit Concept of preventive action now addressed throughout the standard by risk identification and mitigation The term documented information replaces the terms document and record Control of externally provided products and services replaces purchasing/outsourcing Increased emphasis on seeking opportunities for improvement
Context of the organization Unlike the old standard, the new one expects you to understand your organization's context before you establish its QMS. This means that you need to understand your organization's external environment, its culture, its values, its performance, and its interested parties before you develop its QMS. Why? Because your QMS will need to be able to manage all of these influences.
Use a process approach In order to enhance corporate performance and achieve sustained success, organizations must use a process approach to manage their activities. When this approach is applied to quality management, it means that they manage their processes and their process interactions as a coherent quality management system.
Risk-based thinking ISO 9001 has always been about anticipating and preventing mistakes, which is what risk-based thinking is all about. That's why we train people, why we plan our work, why we assign roles and responsibilities, why we validate and verify results, why we audit and review activities, and why we monitor, measure, and control processes. We do these things because we want to prevent mistakes. We do them because we're trying to manage risk. So, if we think of risk-based thinking in this way, it's always been an inherent part of ISO 9001. Before it was implicit; now it's explicit.
Documented information According to ISO's definition, the term documented information refers to information that must be controlled and maintained. So, whenever ISO 9001 2015 uses the term documented information it implicitly expects you to control and maintain that information and its supporting medium. An annex to the new standard (A.6) further says that "Where ISO 9001:2008 would have referred to documented procedures... this is now expressed as a requirement to maintain documented information, and "Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information".
Documented information So, whenever the new standard refers to documented information and it asks you to maintain this information, it's talking about what used to be referred to as procedures, and whenever it asks you to retain this information, it's talking about what used to be called records. So sometimes it must be maintained and sometimes it must be retained.
Encourage improvement In order to enhance corporate performance and achieve sustained success, organizations must encourage and support improvement. If they wish to maintain current levels of performance, if they wish to respond to changing conditions, and if they wish to identify, create, and exploit new opportunities, organizations must establish and sustain an ongoing focus on improvement.
Requirements and exclusions Section 4.3 of ISO 9001 2015 says The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system. However, while the new ISO 9001 2015 standard says that every requirement must be applied, section 4.3 and Annex A5 also says that any requirement may be excluded if it cannot be applied, if you can justify and explain why it can t be applied, and if excluding it does not undermine your ability or responsibility to ensure that products and services are in compliance.
Structure of ISO 9001:2015 1 Scope 2 Normative references 3 Terms and definitions 4 Context of the organization 4.1 Understanding the organization 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 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes
Structure of ISO 9001:2015 7 Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 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
Structure of ISO 9001:2015 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement
The common structure and ISO 9001:2015 additions 4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance Evaluation 10 Improvement 4.1 Understanding context 5.1 Leadership and commitment 6.1 Risks and opportunities 7.1 Resources 8.1 Operational planning and control 9.1 Monitoring, measurement, analysis and evaluation 10.1 General 4.2 Interested parties 5.2 Policy 6.2 Planning 7.2 Competence 9.2 Internal audit 10.2 Nonconformity and corrective action 4.3 Scope 4.4 QMS 5.3 Organizational roles, responsibilities and authorities 7.3 Awareness 7.4 Communication 7.5 Documented information 9.3 Management review 10.3 Continual improvement
The common structure and ISO 9001:2015 additions 8 Operation 8.1 Operational planning and control
Plan Do Check Act 4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning 6.3 Planning of changes 7.1 Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
4 Context of organization 4.1 Understanding context Clause 4.1 Determine what the relevant external and internal issues are for your organization, and that are relevant to its strategic direction 4.2 Interested parties 4.3 Scope 4.4 QMS
4 Context of organization 4.1 Understanding context Clause 4.2 Identify the relevant interested parties and their relevant requirements 4.2 Interested parties 4.3 Scope 4.4 QMS
4 Context of organization 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS Clause 4.3 and 4.4 The requirement for the scope is now better defined, must be documented and consider: external and internal issues requirements of relevant interested parties the products and services covered (must also be stated in scope) allowing applicability of specific requirements justification for any case where a requirement cannot be applied (exclusion)
4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Objectives and planning 6.3 Planning of changes 7.1 Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Clause 5.1.1 Leadership is required to ensure: take accountability for the effectiveness of the quality management system ensure the quality policy and quality objectives are compatible with the context and strategic direction of the organization ensure the integration of the QMS requirements into the organization s business processes promote the use of the process approach and risk-based thinking ensure that the QMS achieves its intended results engage, direct and support persons to contribute to the effectiveness of the QMS supporting relevant management roles promotion of improvement Clause 5.1.2 Top management needs to ensure customer satisfaction through: customer and applicable statutory and regulatory requirements being determined and met risk and opportunities are being addressed the focus on products and services meeting customers and other requirements
5 Leadership Clause 5.2 Explicit requirement to apply the policy 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities
5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Clause 5.2 Explicit requirement to apply the policy Clause 5.3 Explicit requirement for relevant roles to be assigned, communicated and understood No requirement for a specific management representative and the responsibility now resides with top management to assign and manage Requirement for defining responsibility and authority for ensuring processes are delivering their intended outputs
4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning 6.3 Planning of changes 7.1 Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
6 Planning 6.1 Actions to address risks and opportunities 6.2 Objectives and planning Clause 6.1 Considering the issues raised and relevant interested parties requirements identified (4.1 and 4.2), this clause requires the determination of risks and opportunities which need to be addressed, actions to be taken and evaluation of the effectiveness of these actions 6.3 Planning of changes
6 Planning 6.1 Actions to address risks and opportunities 6.2 Objectives and planning 6.3 Planning of changes Clause 6.2 Objectives should be: established for processes relevant to the QMS in line with customer requirements in line with products and services conformity monitored, communicated & updated
6 Planning 6.1 Actions to address risk and opportunity 6.2 Objectives and planning 6.3 Planning of changes Clause 6.3 Changes to the QMS should be carried out in a planned manner The standard has evolved to enable organizations to adapt to changing environments or circumstances Note: It is important to know that change is addressed in the following clauses: Clause 6.3 - Planning/implementing changes to the QMS Clause 7.1.6 - Organizational knowledge - for addressing changing needs and trends, with respect to knowledge Clause 8.1 - Controlling operational changes, planned and unintentional Clause 8.5.6 - Addressing changes affecting products & services
4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Objectives and planning 6.3 Planning of changes 7.1 Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
7 Support 7.1 Resources 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 Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication Clause 7.1 There should be adequate resources to ensure effectiveness of the QMS. Resource considerations now include: internal resources external providers people monitoring and measuring resources organizational knowledge required to ensure the processes provide conforming products and services external communication. 7.5 Documented information
7 Support 7.1 Resources 7.1.2 People 7.1.3 Infrastructure Clause 7.3 and 7.4 Relevant persons doing work under the organization s control need to have awareness and communication (internal and external) of the QMS and benefits of improving performance 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
7 Support 7.1 Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 7.2 Competence 7.3 Awareness Clause 7.5.1 Requirements that used to be required for a quality manual have been enhanced and made more flexible to allow for the use of documented information needed for the quality management system Clause 7.5.2 Enhanced requirement for the creation and updating of documented information, e.g. description, format & suitability Clause 7.5.3 Control of documented information now explicitly includes confidentiality, integrity and access 7.4 Communication 7.5 Documented information
4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Objectives and planning 6.3 Planning of changes 7.1 Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and Evaluation 10 Improvement 8.1 Operational planning and control 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 8.2 Requirements for products and services 8.3.1 General 8.4.1 General 8.5.1 Control of production and service provision 8.7 Control of nonconforming process outputs 8.2.1 Customer communication 8.3.2 Design and development planning 8.4.2 Type and extent of control 8.5.2 Identification and traceability 8.2.2 Determination of requirements related to products and services 8.3.3 Design and development Inputs 8.4.3 Information for external providers 8.5.3 Property belonging to customers or external providers 8.2.3 Review of requirements related to products and services 8.3.4 Design and development controls 8.5.4 Preservation 8.2.4 Changes to requirements for products and services 8.3.5 Design and development outputs 8.5.5 Post-delivery activities 8.3.6 Design and development changes 8.5.6 Control of changes
8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determination of requirements related to products and services 8.2.3 Review of requirements related to products and services Clause 8.1.b explicit requirement for establishing criteria for processes Clause 8.2.1 explicit considerations are now linked to: customer communications; customer property, and contingency actions Clause 8.2.2 Determination of requirements; this requires a process and is explicit with regard to substantiating claims for products and services being offered 8.2.4 Changes to requirements for products and services
8 Operation 8.3 Design and development of products and services 8.3.1 General 8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls 8.3.5 Design and development outputs 8.3.6 Design and development changes Clause 8.3 This section on design and development of products and services has substantively changed and simplified: Clause 8.3.2 Design and development has been restructured to allow for a more process orientated approach Involvement of customers and users as part of design planning to be considered Clause 8.3.3 Design and development inputs explicit requirements for internal and external resource needs, potential consequences of failure, level of control expected by customers Clause 8.3.4 Design and development controls new clause combining Reviews, Verification & Validation
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 Clause 8.4 The terms which previously referred to purchasing and outsourcing is now Control of externally provided processes, products and services Clause 8.4.1 Conditions are applied when controls are required for externally provided processes, products and service Terminology has changed from supplier to external provider Clause 8.4.2 Type and extent of control of external provision previous notes in 4.1 (ISO 9001:2008) now turned into requirements Clause 8.4.3 Information for external providers are now more detailed and explicit
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 Clause 8.5.1 This clause specifically considers: monitoring and measurement activities will ensure the control of processes and output (clauses 8.2.3 and 8.2.4 of ISO 9001:2008 have been moved to 8.5.1) acceptance criteria for products and services are met the use, and control of suitable infrastructure and process environment suitable monitoring and measuring resources Requires competent persons 8.5.5 Post-delivery activities 8.5.6 Control of changes
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 Clause 8.5.2 The identification and traceability now focus on outputs rather than on product (includes intermediate products and services) rather than on product Clause 8.5.3 Customer property has been expanded to include external providers property Clause 8.5.4 Preservation of product has been changed to preservation of the output Clause 8.5.5 Post-delivery activities is a new clause Clause 8.5.6 A new requirement for the control of changes is addressed in the slide introducing the concept of change
8 Operation 8.6 Release of products and services 8.7 Control of nonconforming outputs Clause 8.6 The release of products and services is now part of the operational requirements Clause 8.7 The control of nonconforming output is more explicit; it now considers the options to apply correction and corrective action Nonconforming product changed to nonconforming output
4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning 6.3 Planning of changes 7.1 Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
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 9.2 Internal audit Clause 9.1.1 In 8.1 ISO 9001:2008 (clause 8.1) there was a requirement for planning. This is replaced with identifying what needs monitoring and measuring, and the methods to be used Clause 9.1.3 There are specific requirements for analysis and evaluation when using results as inputs to management review Effective implementation of planning and actions to address risks and opportunities are new requirements in this clause 9.3 Management review
9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 9.2 Internal audit 9.3 Management review 9.3.1 General 9.3.2 Management review input 9.3.3 Management review output Clause 9.2 Internal audit program now has explicit considerations for: quality objectives, customer feedback and changes impacting the organization; management responsibility for action is now implicit whereas previously this was explicit An auditor is now required to be impartial versus in the previous version they could not audit their own work Clause 9.3 There are now additional requirements for management review. These include: changes in external and internal issues (such as strategic direction) performance concerning external providers adequacy of resources for effective QMS and effectiveness of actions taken addressing risks & opportunities Clause 9.3.1 Management reviews should be aligned to the strategic direction of the organization Clause 9.3.3 Management review outputs have been enhanced to include many of the new areas of focus
4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance Evaluation 10 Improvement 4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Objectives and planning 6.3 Planning of changes 7.1 Resources 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 7.1.5 Monitoring and measuring resources 7.1.6 Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Clause 10.1 This clause is new, it addresses more comprehensive opportunities for improvement; not only continual improvement Addresses improvement of products and services and future needs and expectations Emphasis is now on improving processes to prevent nonconformities and improving products and services Clause 10.2 The nonconformity referred to in this clause concerns the entire QMS and not specifically the products or services which are addressed under clause 8.7 Clause 10.2.1 New emphasis is placed on nonconformity and corrective action Consequences are now included thus actions taken now recognize the potential occurrence of a similar nonconformity elsewhere Risks and opportunities now need to be updated when required following a nonconformity Clause 10.2.2 Documented information is now required on the nature of the nonconformity and subsequent actions taken Clause 10.3 Opportunities shall be addressed as part of continual improvement
Summary Determining the organizational context enables a more effective implementation of the quality management system Greater emphasis on processes being managed to achieve planned results Alignment with strategic direction Integration of the QMS into organization s business processes Determining risks and opportunities increase the effectiveness of the organization s QMS Change management has been expanded to add emphasis that the QMS should be carried out in a planned manner The concept of organizational knowledge introduced to ensure the organization acquires and maintains the necessary knowledge Communication expanded to include external
ISO 9001:2015 Certification Transition Timeline 2015 2016 2017 2018 September 2015 Published International Standard September 2015 start of 3 years transition period to September 2018 Certifications to ISO 9001:2008 will no longer be valid after September 2018
Contact Information Brad Fischer SD Manufacturing & Technology Solutions 605-202-9118 brad.a.fischer@usd.edu www.sdmanufacturing.com