ISO 9001:2015. October 5 th, Brad Fischer.
|
|
- Ellen Cummings
- 6 years ago
- Views:
Transcription
1 ISO 9001:2015 October 5 th, 2017 Brad Fischer
2 Purpose of presentation Provide a summary of notable changes from ISO 9001:2008 to ISO 9001:2015
3 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
4 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
5 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
6 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
7 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.
8 The new ISO 9001:2015 The new ISO 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.
9 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.
10 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.
11 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.
12 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.
13 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.
14 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.
15 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.
16 Structure of the standard Perhaps the biggest difference between the old and the new standard is the structure. ISO had five main sections (4 to 8) and ISO 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.
17 ISO 9001:2015 to ISO 9001:2008 Correlation Matrix ISO 9001:2015 ISO 9001: 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 Quality manual 4 Quality management system 4.1 General requirements 5 Leadership 5 Management responsibility 5.1 Leadership and commitment 5.1 Management commitment General 5.1 Management commitment Customer focus 5.2 Customer focus 5.2 Policy 5.3 Quality policy Establishing the Quality Policy 5.3 Quality policy Communicating the Quality Policy 5.3 Quality policy 5.3 Organizational roles, responsibilities and authorities Responsibility and authority Management representative Quality management system planning 6 Planning Quality management system planning 6.1 Actions to address risks and opportunities Quality management system planning Preventive action 6.2 Quality objectives and planning to achieve them Quality objectives 6.3 Planning of changes Quality management system planning
18 ISO 9001:2015 to ISO 9001:2008 Correlation Matrix 7 Support 6 Resource management 7.1 Resources 6 Resource management General 6.1 Provision of resources People 6.1 Provision of resources Infrastructure 6.3 Infrastructure Environment for the operation of 6.4 Work environment processes Monitoring and measuring resources 7.6 Control of monitoring and measuring equipment General 7.6 Control of monitoring and measuring equipment Measurement traceability 7.6 Control of monitoring and measuring equipment Organizational knowledge No equivalent clause 7.2 Competence General Competence, training and awareness
19 ISO 9001:2015 to ISO 9001:2008 Correlation Matrix 7.3 Awareness Competence, training and awareness 7.4 Communication Internal communication 7.5 Documented information 4.2 Documentation requirements General General Creating and updating Control of documents Control of records Control of documented Information Control of documents Control of records
20 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 Customer communication Customer communication Determination of requirements for products and services Determination of requirements related to the product Review of the requirements for products and services Review of requirements related to the product Changes to requirements for products and services Review of requirements related to the product 8.3 Design and development of products and services 7.3Design and development General Design and development planning Design and development planning Design and development planning Design and development inputs Design and development inputs Design and development controls Design and development review Design and development verification Design and development validation Design and development outputs Design and development outputs Design and development changes Control of design and development changes
21 ISO 9001:2015 to ISO 9001:2008 Correlation Matrix 8.4 Control of externally provided processes, products and services Purchasing process General 4.1 General requirements Purchasing process Type and extent of control Purchasing process Verification of purchased product Information for external providers Purchasing information Verification of purchased product Release Production of products and service and provision services Verification Production and of purchased service provision product Control of production and service provision Control Monitoring of production and measurement and service of product provision 8.7 Control of nonconforming outputs Validation Control of of nonconforming processes for production and service provision Identification and traceability Identification and traceability Property belonging to customers or Customer property external providers Preservation Preservation of product Post-delivery activities Control of production and service provision Control of changes Control of Design and Development Changes
22 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 General 8.1 General Monitoring and Measurement Processes Customer satisfaction Customer satisfaction Analysis and evaluation 8.4 Analysis of data 9.2 Internal audit Internal audit 9.3 Management review 5.6 Management review General General Management review input Review input Management review output Review output 10 Improvement 8.5 Improvement 10.1 General Continual improvement 10.2 Nonconformity and corrective action 8.3 Control of nonconforming product Corrective action 10.3 Continual Improvement Continual improvement Preventive action
23 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
24 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.
25 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.
26 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 Before it was implicit; now it's explicit.
27 Documented information According to ISO's definition, the term documented information refers to information that must be controlled and maintained. So, whenever ISO 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".
28 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.
29 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.
30 Requirements and exclusions Section 4.3 of ISO 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 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.
31 Structure of ISO 9001: 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
32 Structure of ISO 9001: 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
33 Structure of ISO 9001: 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
34 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
35 The common structure and ISO 9001:2015 additions 8 Operation 8.1 Operational planning and control
36 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 People Infrastructure Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Monitoring and measuring resources Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
37 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
38 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
39 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)
40 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 People Infrastructure Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Monitoring and measuring resources Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
41 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities Clause 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 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
42 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
43 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
44 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 People Infrastructure Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Monitoring and measuring resources Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
45 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
46 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
47 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 Planning/implementing changes to the QMS Clause Organizational knowledge - for addressing changing needs and trends, with respect to knowledge Clause Controlling operational changes, planned and unintentional Clause Addressing changes affecting products & services
48 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 People Infrastructure Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Monitoring and measuring resources Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
49 7 Support 7.1 Resources People Infrastructure Environment for the operation of processes Monitoring and measuring resources 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
50 7 Support 7.1 Resources People 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 Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
51 7 Support 7.1 Resources People Infrastructure Environment for operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence 7.3 Awareness Clause 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 Enhanced requirement for the creation and updating of documented information, e.g. description, format & suitability Clause Control of documented information now explicitly includes confidentiality, integrity and access 7.4 Communication 7.5 Documented information
52 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 People Infrastructure Environment for operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Monitoring and measuring resources Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
53 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 General General Control of production and service provision 8.7 Control of nonconforming process outputs Customer communication Design and development planning Type and extent of control Identification and traceability Determination of requirements related to products and services Design and development Inputs Information for external providers Property belonging to customers or external providers Review of requirements related to products and services Design and development controls Preservation Changes to requirements for products and services Design and development outputs Post-delivery activities Design and development changes Control of changes
54 8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services Customer communication Determination of requirements related to products and services Review of requirements related to products and services Clause 8.1.b explicit requirement for establishing criteria for processes Clause explicit considerations are now linked to: customer communications; customer property, and contingency actions Clause Determination of requirements; this requires a process and is explicit with regard to substantiating claims for products and services being offered Changes to requirements for products and services
55 8 Operation 8.3 Design and development of products and services General Design and development planning Design and development inputs Design and development controls Design and development outputs Design and development changes Clause 8.3 This section on design and development of products and services has substantively changed and simplified: Clause 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 Design and development inputs explicit requirements for internal and external resource needs, potential consequences of failure, level of control expected by customers Clause Design and development controls new clause combining Reviews, Verification & Validation
56 8 Operation 8.4 Control of externally provided processes products and services General Type and extent of control 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 Conditions are applied when controls are required for externally provided processes, products and service Terminology has changed from supplier to external provider Clause Type and extent of control of external provision previous notes in 4.1 (ISO 9001:2008) now turned into requirements Clause Information for external providers are now more detailed and explicit
57 8 Operation 8.5 Production and service provision Control of production and service provision Identification and traceability Property belonging to customers or external providers Preservation Clause This clause specifically considers: monitoring and measurement activities will ensure the control of processes and output (clauses and 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 Post-delivery activities Control of changes
58 8 Operation 8.5 Production and service provision Control of production and service provision Identification and traceability Property belonging to customers or external providers Preservation Post-delivery activities Control of changes Clause The identification and traceability now focus on outputs rather than on product (includes intermediate products and services) rather than on product Clause Customer property has been expanded to include external providers property Clause Preservation of product has been changed to preservation of the output Clause Post-delivery activities is a new clause Clause A new requirement for the control of changes is addressed in the slide introducing the concept of change
59 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
60 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 People Infrastructure Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Monitoring and measuring resources Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
61 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation General Customer satisfaction Analysis and evaluation 9.2 Internal audit Clause 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 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
62 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 9.2 Internal audit 9.3 Management review General Management review input 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 Management reviews should be aligned to the strategic direction of the organization Clause Management review outputs have been enhanced to include many of the new areas of focus
63 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 People Infrastructure Environment for the operation of processes 8.1 Operational planning and control See next slide 9.1 Monitoring, measurement, analysis and evaluation Customer satisfaction Analysis and evaluation 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Monitoring and measuring resources Organizational knowledge 9.2 Internal audit 9.3 Management review 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
64 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 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 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
65 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
66 ISO 9001:2015 Certification Transition Timeline 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
67 Contact Information Brad Fischer SD Manufacturing & Technology Solutions
ISO 9001: 2015 Quality Management System Certification. Awareness Training
ISO 9001: 2015 Quality Management System Certification Awareness Training ISO 9001: 2015 STRUCTURE The new standard is modeled around the ISO Directive Annex SL, a high level structure (HSL) based on the
More informationSummary of ISO 9001:2015 New and Changed Requirements
This is a summary of the new and changed ISO 9001:2015 requirements compared to ISO 9001:2008. 4. Context of the Organization 4.1 Changes Understanding the Organization and its Context New requirement
More informationCorrelation matrices between ISO 9001:2008 and ISO 9001:2015
Correlation matrices between ISO 9001:2008 and ISO 9001:2015 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
More informationCorrelation Matrix & Change Summary
The correlation matrix compares the new requirements of ISO 9001:2015 to the requirements of ISO 9001:2008, and provides a summary of the changes. Correlation Matrix & Change Summary Introduction Correlation
More informationISO/DIS 9001: 2014 comparison with ISO 9001:2008. ISO 9001:2015 Updates. (Based on Draft International Standard, DIS) ISO/DIS 9001 ISO 9001:2008
ISO 9001:2015 Updates (Based ondraft International Standard, DIS) August 2014 Page 1 ISO 9001:2015 Updates (Based on Draft International Standard, DIS) ISO/DIS 9001: 2014 comparison with ISO 9001:2008
More informationISO 9001:2015 Readiness Review
ISO 9001:2015 Readiness Review Company Name Address Certification No. Contact Name Job Title Telephone Email BSI is committed to ensuring a smooth assessment for all clients wishing to certify to ISO 9001:2015,
More informationMoving from ISO/TS 16949:2009 to IATF 16949:2016. Transition Guide
Moving from ISO/TS 16949:2009 to IATF 16949:2016 Transition Guide IATF 16949:2016 - Automotive Quality Management System - Transition Guide An effective Quality Management System is vital for organizations
More informationClause Map IATF 16949:2016 to ISO/TS 16949:2009
Table of Contents Table of Contents Foreword Foreword + Foreword Automotive QMS Standard + History + Goal + 0.5 Goal of this Technical Specification + Remarks for Certification + Remarks for Certification
More informationSections of the Standard. Evidence / Comments. (Y) / Nonconforming (NC)
Date: Sections of the Standard 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
More informationWe are a global classification, certification, technical assurance and advisory company Ungraded
We are a global classification, certification, technical assurance and advisory company 1 Global reach local competence 150 300 100 15,000 years offices countries employees 2 DNV GL :: Focused on your
More informationMoving to the AS9100:2016 series. Transition Guide
Moving to the AS9100:2016 series Transition Guide AS9100-series - Quality Management Systems for Aviation, Space and Defense - Transition Guide Successful aviation, space and defense businesses understand
More informationISO 9001:2015 READINESS CHECKLIST YOU RE CLOSER THAN YOU THINK EXECUTIVE SUMMARY CLAUSE 4 - CONTEXT OF THE ORGANISATION CLAUSE 5 - LEADERSHIP
EXECUTIVE SUMMARY CLAUSE 4 - CONTEXT OF THE ORGANISATION CLAUSE 5 - LEADERSHIP CLAUSE 6 - PLANNING CLAUSE 7 - RESOURCES CLAUSE 8 - OPERATIONS CLAUSE 9 - PERFORMANCE EVALUATION CLAUSE 10 - IMPROVEMENTS
More informationDOCUMENTATION FOR QUALITY MANAGEMENT SYSTEM AS PER IS/ISO 9001 : 2015
DOCUMENTATION FOR QUALITY MANAGEMENT SYSTEM AS PER IS/ISO 9001 : 2015 01-12-2017 1 DEFINITION: INFORMATION SUPPORTED BY MEDIUM 01-12-2017 2 Some of the reasons are: Required by any Management System Standard
More informationCUSTOMER RELATIONSHIPS FURTHER EXCELLENCE GENERIC STANDARDS TRAINING SERVICES THE ROUTE TO ISO 9001:2015 AVOIDING THE PITFALLS
PROCESSES SUPPLY CHAIN SKILLED TALENT CUSTOMER RELATIONSHIPS FURTHER EXCELLENCE GENERIC STANDARDS INDUSTRY STANDARDS CUSTOMISED SOLUTIONS TRAINING SERVICES THE ROUTE TO ISO 9001:2015 FOREWORD The purpose
More informationQuality Manual. This manual complies with the requirements of the ISO 9001:2015 International Standard.
Quality Manual This manual complies with the requirements of the ISO 9001:2015 International Standard. Northeast Power Systems, Inc. 66 Carey Road Queensbury, New York 12804 Quality Manual Rev 0 Printed
More informationDocument: ISO/TC 176/SC 2/N 1147
ISO 2013 All rights reserved Document: ISO/TC 176/SC 2/N 1147 Secretariat of ISO/TC 176/SC 2 Date: 3 June 2013 To the Members of ISO/TC 176/SC 2 - Quality Management and Quality Assurance/ Quality Systems
More informationISO 14001:2015 Gap Analysis Check Sheet
? CONTEXT OF THE ORGANIZATION 4.1 Understanding the organization and its context The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability
More informationISO 9001:2015. Presented By: ASEAN Eng. DEXTER T. CHUA, PIE. Conference Room, University of Mindanao March 17, 2017
ISO 9001:2015 Presented By: ASEAN Eng. DEXTER T. CHUA, PIE Conference Room, University of Mindanao March 17, 2017 @CQL Business Systems Consulting (11-2015) ISO The International Organization for Standardization
More informationISO 9001:2015 Transition Presentation. Presented by Fredric Leung
ISO 9001:2015 Transition Presentation Presented by Fredric Leung 1 2 ISO Technical Committees TC 176 ISO = International Organization for Standardization Standards development work is done by Technical
More information25 D.L. Martin Drive Mercersburg, PA (717)
EMS MANUAL D. L. MARTIN CO. 25 D.L. Martin Drive Mercersburg, PA 17236 (717) 328-2141 Revision 13 January 2017 Kip Heefner Environmental Management Representative Daniel J. Fisher President & CEO D.L.
More informationTHE NEW ISO STANDARDS ON MANAGEMENT SYSTEMS & THE EFQM EXCELLENCE MODEL
THE NEW ISO STANDARDS ON MANAGEMENT SYSTEMS & THE EFQM EXCELLENCE MODEL 1. Introduction In the year 2015 two ISO standards were revised. ISO 9001:2015, released on October 1, and ISO 14001:2015, released
More informationQUALITY MANUAL. Number: M-001 Revision: C Page 1 of 18 THIS DOCUMENT IS CONSIDERED UNCONTROLLED UNLESS ISSUED IDENTIFIED AS CONTROLLED
Page 1 of 18 THIS DOCUMENT IS CONSIDERED UNCONTROLLED UNLESS ISSUED IDENTIFIED AS CONTROLLED Page 2 of 18 REVISION HISTORY DATE CHANGE DESCRIPTION 10/11/06 Original release 10/21/09 Revised to ISO9001:2008
More information9100 revision Changes presentation clause-by-clause. IAQG 9100 Team November 2016
Changes presentation clause-by-clause IAQG 9100 Team November 2016 INTRODUCTION In September 2016, a revision of the 9100 standard has been published by the IAQG (International Aerospace Quality Group)
More informationPre Audit Transition Gap Analysis QMS and EMS
Pre Audit Transition Gap Analysis QMS and EMS Company: Contact Name: Certification Number: Email: Contact Number: This document should be used in conjunction with the ISO 9001:2015 and ISO 14001:2015 standards
More informationPre Audit Transition Gap Analysis QMS (ISO 9001 Only)
Pre Audit Transition Gap Analysis QMS (ISO 9001 Only) Company: Contact Name: Certification Number: Email: Contact Number: This document should be used in conjunction with the ISO 9001:2015 standard and
More informationISO 9001: 2000 (December 13, 2000) QUALITY MANAGEMENT SYSTEM DOCUMENTATION OVERVIEW MATRIX
In completing your Documented Quality Management System Review, it is important that the following matrix be completed and returned to us as soon as possible. This will save time during the review and
More informationQUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURES
Your Company Name QUALITY MANAGEMENT SYSTEM POLICIES AND PROCEDURES Origination Date: XXXX Document Identifier: Date: Document Revision: QMS-00 QMS Policies and Procedures Latest Revision Date Abstract:
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 9001 Quality management systems Requirements Systèmes de management de la qualité Exigences Fourth edition 2008-11-15 Reference number ISO 9001:2008(E) ISO 2008 PDF disclaimer
More informationISO 9001:2015 How your ISO 9001 audit will be different. Whitepaper
ISO 9001:2015 How your ISO 9001 audit will be different Whitepaper Introduction The new ISO 9001 introduces some key changes to the way a quality management system (QMS) is incorporated into your organization
More informationISO 14001:2015 Transition Presentation. Presented by Fredric Leung
ISO 14001:2015 Transition Presentation Presented by Fredric Leung 1 2 ISO Technical Committees TC 207 ISO = International Organization for Standardization Standards development work is done by Technical
More informationISO 14001: 2015 Environmental Gap Analysis
Environmental Gap Analysis The revised ISO 14001 standard was published on 14 TH September 2015. How to use this document This document provides an overview of the changes between ISO 14001:2004 and ISO
More information25 D.L. Martin Drive Mercersburg, PA (717)
QUALITY MANUAL D. L. MARTIN CO. 25 D.L. Martin Drive Mercersburg, PA 17236 (717) 328-2141 Revision 14 August 2012 Michael A. White Manager, QA & Engineering D.L. Martin Co. Quality Manual UNCONTROLLED
More informationMoving from ISO 14001:2004 to ISO 14001:2015 Transition Guide
ISO Revisions Final Standard Moving from ISO 14001:2004 to ISO 14001:2015 Transition Guide ISO 14001 - Environmental Management System - Transition Guide Successful businesses understand that it is the
More informationINTEGRATING ISO 9000 METHODOLOGIES WITH PROJECT QUALITY MANAGEMENT
INTEGRATING ISO 9000 METHODOLOGIES WITH PROJECT QUALITY MANAGEMENT M a r ch 2015 OBJECTIVE ISO and Project Quality Management Process Are they different or the same? ISO 9000 QMS FAMILY ISO 9000:2005 Vocabulary
More information9100 Team July, IAQG is a trademark the International Aerospace Quality Group. Copyright 2014 IAQG. All rights reserved.
9100 Series 2016 Revision Overview 9100 Team July, 2014 1 9100 Revision The Plan 9100 Series Revision High Level Plan The 9100 is based on ISO 9001 and is thus affected by the ISO TC176 revision activity
More informationBusiness Management System Manual Conforms to ISO 9001:2015 Table of Contents
Table of Contents 1.0 Welcome to Crystalfontz... 3 2.0 About the Crystalfontz Business Systems Manual... 4 3.0 Terms and Conditions... 5 4.0 Context of the Organization... 6 4.1. Understanding the Organization
More informationThe following is an example systems manual from a low volume (TE, but not an automotive supplier) company.
The following is an example systems manual from a low volume (TE, but not an automotive supplier) company. You will note that this is essentially a copy of ISO 9001:2000. I take this path because long
More informationQuality Management System Guidance. ISO 9001:2015 Clause-by-clause Interpretation
Quality Management System Guidance ISO 9001:2015 Clause-by-clause Interpretation Table of Contents 1 INTRODUCTION... 4 1.1 IMPLEMENTATION & DEVELOPMENT... 5 1.2 MANAGING THE CHANGE... 5 1.3 TOP MANAGEMENT
More informationISO Environmental management systems Requirements with guidance for use
INTERNATIONAL STANDARD Environmental management systems Requirements with guidance for use ISO 14001 Third edition 2015-09-15 Systèmes de management environnemental Exigences et lignes directrices pour
More informationReliance Aerospace Solutions
Reliance Aerospace Solutions Quality Manual The information contained in this document is the property of Reliance Aerospace Solutions, a division of Reliance Steel & Aluminum Company This manual is a
More informationSpecification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry
Addendum 1 June 2010 Effective Date: December 1, 2010 Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry ANSI/API SPECIFICATION Q1 EIGHTH EDITION, DECEMBER 2007
More informationAnalysis of ISO 9001:2015 against the ICoCA Certification Assessment Framework
Analysis of ISO 9001:2015 against the ICoCA Certification Assessment Framework As detailed in the ICoCA Certification Procedure, the Board of Directors assesses and recognizes standards for potential recognition
More informationDocument Number: QM001 Page 1 of 19. Rev Date: 10/16/2009 Rev Num: 1. Quality Manual. Quality Manual. Controlled Copy
QM001 Page 1 of 19 Quality Manual QM001 Page 2 of 19 Table of Contents Page Company Profile 4 Approval 4 Revision History 4 Distribution List 4 1.0 Scope 5 Section 2: Normative Reference 6 2.0 Quality
More informationP. 1. Identify the Differences between ISO9001:2000 與 ISO9001:2008 ISO9001:2008 ISO9001:2000 版本的異同. 5 January 2009 ISO 9000 SERIES
Identify the Differences between ISO9001:2000 and ISO 9001:2008 審視 ISO9001:2000 與 ISO9001:2008 版本的異同 ISO 9000 SERIES ISO 19011 ISO9000 5 January 2009 ISO9001 ISO9004 2 ISO 9000 SERIES ISO 9001 ISO 9000
More informationISO 9001 REVISION INTRODUCTION TO ISO/FDIS 9001
ISO 9001 REVISION INTRODUCTION TO ISO/FDIS 9001 AGENDA Introduction Structure and Terminology Changes to ISO 9001 Future Development How SGS can support you 2 INTRODUCTION ISO/DIS 9001 Issued May 2014
More informationISO 9001:2015 Quality Management System. New/Revised Requirements
ISO 9001:2015 New/Revised The Quality System Checklist is intended to only identify the new/revised requirements. ISO 9001:2015 requires the adoption of the process approach which extends to internal quality
More informationISO /TS 29001:2010 SYSTEMKARAN ADVISER & INFORMATION CENTER SYSTEM KARAN ADVISER & INFORMATION CENTER
SYSTEM KARAN ADVISER & INFORMATION CENTER PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES -- SECTOR-SPECIFIC QUALITY MANAGEMENT SYSTEMS -- REQUIREMENTS FOR PRODUCT AND SERVICE SUPPLY ORGANIZATIONS
More informationISO 9001:2015. Quality Manual Template.
www.iso-9001-checklist.co.uk Insert your company s name or logo, and address. This quality manual is the property of Your Company. It must not be reproduced in whole or in part or otherwise disclosed without
More information20 September 2017 Document No. QM-ISO revision T ASTRONAUTICS CORPORATION OF AMERICA S. AS 9100 and FAA QUALITY MANUAL. Proprietary Notice
20 September 2017 Document No. QM-ISO revision T ASTRONAUTICS CORPORATION OF AMERICA S AS 9100 and FAA QUALITY MANUAL Proprietary Notice Information disclosed herein is the property of Astronautics Corporation
More informationISO 9001:2015 TRANSITION INFORMATION
ISO 9001:2015 TRANSITION INFORMATION ISO 9001:2015 Transition It Doesn t Need to be Difficult Whether your organization is transitioning from ISO 9001:2008 to the new ISO 9001:2015, or implementing an
More informationAB. OUR ISO CONFORMANCE AUDIT QUESTIONNAIRES 8. ASSESS HOW WELL YOU CONFORM TO ISO S REMEDIAL REQUIREMENTS
8.1 PLANNING REQUIREMENTS 1 Do you plan monitoring, measurement, and analytical processes? 2 Do you plan how monitoring will be used to ensure conformity and effectiveness? 3 Do you plan how it will be
More informationQMS Team: MR and all HODs (Internal Auditors) MR March 10. Quality policy Define quality policy The Steering committee Objectives and targets
QMS Roles, Responsibility and Authority Process Clause Activities Records Required Responsibility Authority Deadline Clause 4: Process Development 4.1 Develop processes and sequence, operation controls
More informationSubject: Quality Management System. Clause 8 - Operation
Subject: Quality Management System Clause 8 - Operation 31.3.2016. HOMEWORK? I cannot teach anybody anythink. I can only make them think. Socrates (Greek philosopher, 470/469 399 BC ) Contents ISO 9001:2015
More informationHACCPEUROPA PUBLICATIONS ISO 22000:2005 FOOD SAFETY QUALITY MANUAL. ISO 22000:2005 Quality Manual
HACCPEUROPA PUBLICATIONS ISO 22000:2005 FOOD SAFETY QUALITY MANUAL ISO 22000:2005 Quality Manual QUALITY MANUAL ISO 22000:2005 Food Safety Management HACCPEuropa Publications 2012 Table of Contents Introduction...
More informationWhat is ISO 30300? Who, when, where, why and how to implement
What is ISO 30300? Who, when, where, why and how to implement Barcelona, October 28th 2011 Carlota Bustelo Judith Ellis Index 1. What is ISO 30300: MSR? a) Background of MSR initiative b) What is a MSR?
More informationAAMI Quality Systems White Paper: Comparison of 21 CFR Part 820 to ISO 13485:2016 1
AAMI s White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 February 2017 AUTHORS Seb Clerkin, GMP Advisory Services Nicola Martin, Owner, Nicola Martin Consulting Jack Ward, Owner, Ward Sciences
More informationApril 2017 Latest update. ISO/DIS Understanding the new international standard for occupational health & safety
April 2017 Latest update ISO/DIS 45001.2 Understanding the new international standard for occupational health & safety ISO/DIS 45001.2 - Understanding the new international standard for occupational health
More information9 1.0 Step 1 Overview of what should be considered Step 2 ISO 9001:2015 Context of an organisation
INDEX Page Section Description 1 Index 2 0.0 Introduction and Summary 9 1.0 Step 1 Overview of what should be considered 11 2.0 Step 2 ISO 9001:2015 Context of an organisation 16 3.0 Annex SL (New ISO
More informationISO 22000:2005 SYSTEMKARAN ADVISER & INFORMATION CENTER SYSTEM KARAN ADVISER & INFORMATION CENTER FOOD SAFETY MANAGEMENT SYSTEM ISO 22000:2005
SYSTEM KARAN ADVISER & INFORMATION CENTER FOOD SAFETY MANAGEMENT SYSTEM ISO 22000:2005 WWW.SYSTEMKARAN.ORG 1 www.systemkaran.org Foreword... 6 Introduction... 7 Food safety management systems Requirements
More informationSADCAS POLICY ISO/IEC 17020:2012 TRANSITION
SADCAS POLICY ISO/IEC 17020:2012 TRANSITION Prepared by: SADCAS Approved by: SADCAS CEO Approval Date:2012 09 25 Effective Date: 2012 10 01 Page 1 of 11 Table of Contents Page 1. INTRODUCTION... 3 2. TRANSITION
More informationRisk Based Thinking & QMS Risk Management as per ISO
Risk Based Thinking & QMS Risk Management as per ISO 9001-2015 PMI, PMP, PMBOK and the PMI Registered Education Provider logo are registered marks of the Project Management Institute, Inc. At the end of
More informationPRODUCTS AND SERVICES:
COMPANY INFORMATION: Company Name: Newcastle Aviation Partners, LLC Address: 3201 West County Road 42, Unit 104 Burnsville, MN 55306 Phone: 952-223-0317 Facsimile: 952-223-4470 AOG phone number: 952-223-0317,
More informationQuality Manual ISSUED JANUARY Approved By: January 12, 2004 (President & Chief Executive Officer)
Quality Manual ISSUED JANUARY 2004 Approved By: January 12, 2004 (President & Chief Executive Officer) (Date) Quality Policy To be the industrial control industry's most preferred supplier of sensor integration
More informationQuality Manual ISO 9001:2015 Quality Management System
Quality management input comprises the standard requirements from ISO 9001:2015 which are deployed by our organization to achieve customer satisfaction through process control. Quality Manual ISO 9001:2015
More informationWhat is ISO 9001 QMS? Business Beam
1 What is ISO 9001 QMS? Business Beam Contents 2 What is Quality About Quality Management System About ISO 9001 ISO 9001 Certification Process 3 What is Quality? What is ISO 9001 QMS? What is Quality?
More informationISO 9001:2008 Quality Management System QMS Manual
2501 Kutztown Road Reading, PA, 19605 Tel. 610-929-3330 Fax 610-921-6861 ISO 9001:2008 Quality Management System QMS Manual The information contained in this document is Fidelity Technologies Corporation
More informationWHITE PAPER CQI. Chartered Quality Institute
WHITE PAPER CQI Chartered Quality Institute ISO 9001:2015 is set to be particularly significant as a result of fundamental changes to both its structure and its contents. Complying with the revised requirements
More informationMALAYSIAN STANDARD QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (FIRST REVISION) (ISO 9001:2008, IDT) (PUBLISHED BY STANDARDS MALAYSIA IN 2009)
MALAYSIAN STANDARD MS ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (FIRST REVISION) (ISO 9001:2008, IDT) (PUBLISHED BY STANDARDS MALAYSIA IN 2009) ICS: 03.120.10 Descriptors: quality management,
More informationRevision. Quality Manual. Multilayer Prototypes. Compliant to ISO / AS9100 Rev C
1 of 29 Quality Manual Multilayer Prototypes Compliant to ISO 9001-2008 / AS9100 Rev C This Quality Manual sets forth the quality system policies and Defines compliance with the ISO 9001-2008 SAE AS 9100
More informationThis document is a preview generated by EVS
TECHNICAL SPECIFICATION ISO/TS 22163 First edition 2017-05 Railway applications Quality management system Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements
More informationWhen Recognition Matters WHITEPAPER ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEMS - REQUIREMENTS.
When Recognition Matters WHITEPAPER ISO 14001:2015 ENVIRONMENTAL MANAGEMENT SYSTEMS - REQUIREMENTS www.pecb.com CONTENT 3 4 5 8 8 9 10 11 12 Introduction An overview of ISO 14001:2015 Key clauses of ISO
More informationAtlantic Technical Systems, Inc. 415 Headquarters Drive # 2 Millersville, MD USA Office: (410) Fax: (410)
ISO 9001 Page: 1 of 29 Quality Assurance Manual ISO 9001:2008 Atlantic Technical Systems, Inc. 415 Headquarters Drive # 2 Millersville, MD 21108 USA Office: (410) 507-2779 Fax: (410) 451-9609 APPROVALS
More informationAEROSPACE STANDARD. Quality Systems - Aerospace - Model for Quality Assurance in Design, Development, Production, Installation and Servicing
AEROSPACE STANDARD AS9100 Technically equivalent to AECMA pren 9100 Issued 1999-11 Revised 2001-08 Superseding AS9100 REV. A Quality Systems - Aerospace - Model for Quality Assurance in Design, Development,
More informationISO 14001:2015 How your ISO audit will be different. Whitepaper
ISO 14001:2015 How your ISO 14001 audit will be different Whitepaper Introduction The new revision of ISO 14001 introduces some key changes which could impact how your environmental management system (EMS)
More informationDocument ID: Revision: Date. Approved:
Document ID: Q&EMSM Standard: ISO 9001 / ISO 14001 Title: Quality and Environmental Management System Manual Approved By: Revision: ED170616 Date Approved: 6/26/17 Quality and Environmental Management
More informationINTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 19011 Second edition 2011-11-15 Guidelines for auditing management systems Lignes directrices pour l audit des systèmes de management Reference number ISO 19011:2011(E) ISO 2011
More informationExpert Commentary on BS EN ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes
Expert Commentary on BS EN ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes Author: Eamonn Hoxey, PhD, F.R.Pharm.S., Vice President, Medical Devices Quality
More informationISO 9001 QUALITY MANUAL
ISO 9001 QUALITY MANUAL Origination Date: 10/01/14 Document Identifier: AIF quality control manual Date: 10/01/14 Project: Customer review Document Status: Released Document Link: www.aeroindfast.com Abstract:
More information14620 Henry Road Houston, Texas PH: FX: WEB: QUALITY MANUAL
14620 Henry Road Houston, Texas 77060 PH: 281-447-3980 FX: 281-447-3988 WEB: www.texasinternational.com QUALITY MANUAL ISO 9001:2008 API Spec Q1, 9th Edition API Spec 8C 5 Th Edition MANUAL NUMBER: Electronic
More informationISO Revisions. ISO 9001 Whitepaper. The importance of risk in quality management. Approaching change
ISO Revisions ISO 9001 Whitepaper The importance of risk in quality management Approaching change Background and overview to the ISO 9001:2015 revision As an International Standard, ISO 9001 is subject
More informationQuality Assurance Manual, Revision F Page 1 of 20
Quality Assurance Manual, Revision F Page 1 of 20 AUTOMATION TECHNOLOGY QUALITY ASSURANCE MANUAL Prepared By: Joseph Pollard Date: 7/6/2015 Quality Assurance Manager Quality Management System Representative
More informationQuality Manual Revision: C Effective: 03/01/10
TABLE OF CONTENTS DESCRIPTION SECTION PAGE INTRODUCTION 1.0 1 APPROVAL SIGNATURE PAGE 1.1 1 AMENDMENT RECORD 1.2 2 SCOPE 2.0 3 EXCLUSIONS 2.1 3 CORPORATE POLICY 3.0 3 QUALITY MANAGEMENT SYSTEM 4.0 4 GENERAL
More informationAS/NZS ISO 9001:2016. Quality management systems Requirements AS/NZS ISO 9001:2016. Australian/New Zealand Standard. Superseding AS/NZS ISO 9001:2008
AS/NZS ISO 9001:2016 (ISO 9001:2015, IDT) Australian/New Zealand Standard Quality management systems Requirements Superseding AS/NZS ISO 9001:2008 AS/NZS ISO 9001:2016 AS/NZS ISO 9001:2016 This joint Australian/New
More informationClause-byclause. Interpretation. Transitioning to ISO 9001:2015
We re committed to helping you and your organization understand the updated requirements. This guidance document identifies the steps you should take to achieve compliance to ISO 9001:2015, and more importantly;
More informationEmployee Orientation to ISO 9001
Employee Orientation to ISO 9001 Sygnetics, Inc. is committed to quality. Quality is the ability to consistently produce a product or service that satisfies your customers needs. This presentation is designed
More informationLuminus Devices, Inc Quality Management Systems Manual ISO 9001:2008
Luminus Devices, Inc Quality Management Systems Manual ISO 9001:2008 This document belongs to Luminus Devices, Inc. It cannot be reproduced without authorized authority. Area: Quality System Document Page
More informationISO/IEC INTERNATIONAL STANDARD. Information technology Security techniques Guidelines for information security management systems auditing
INTERNATIONAL STANDARD ISO/IEC 27007 First edition 2011-11-15 Information technology Security techniques Guidelines for information security management systems auditing Technologies de l'information Techniques
More informationFitting ISO 9001:2000 into a 20 Element Quality System
Fitting ISO 9001:2000 into a 20 Element Quality System ASQ Washington DC Section 0509 Rockville Maryland Presented by Norman P. Moreau, P.E., CSQE, CQA President Theseus Professional Services 410-857-0023
More informationQuality Systems Manual
Quality Systems Manual This manual was developed to support ISO 9001 elements 1445 Oakland Drive, San Jose, CA 95112-2702 - Tel: (408) 294-9897 - Fax: (408) 297-1540 http://www.gorillacircuits.com Reference
More information2015 DEPARTMENT OF STANDARDS MALAYSIA
MALAYSIAN STANDARD MS ISO 9001:2015 Quality management systems - Requirements (Second revision) (ISO 9001:2015, IDT) ICS: 03.120.10 Descriptors: requirements, quality management systems Copyright 2015
More informationThis document is a preview generated by EVS
INTERNATIONAL STANDARD ISO 15378 Fourth edition 2017-09 Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing
More informationTL 9000 R6.0 REQUIREMENTS
Logo or heading here TL 9000 R6.0 REQUIREMENTS Nancy Patterson Nokia Tom Yohe - Consultant TL 9000 CONTAINS ALL OF THE AUDITABLE CLAUSES OF ISO 9001:2008 http://tl9000.org/alerts/alerts.html#10 QUEST FORUM
More informationList of Documented Information (Document & Records)
As per IATF 16949:2016 Clause Type Clause Reference 4.3 Determining the scope of the quality management system 5.1.1.1 Corporate responsibility The only permitted exclusion for this Automotive QMS Standard
More information9120 revision Key changes presentation. IAQG 9120 Team October 2016
Key changes presentation IAQG 9120 Team Table of contents Introduction (reason for revision, team and timeline) Quality Management Principles Key changes in ISO 9001 Key changes in 9120 additions Summary
More informationA S D T R A N S L A T E D I N T O P L A I N E N G L I S H 8. O P E R A T I O N S
8.1 DEVELOP, IMPLEMENT, AND CONTROL YOUR OPERATIOL PROCESSES 1 Plan the implementation and control of your operational processes. Black identifies ISO 9001 task. 2 Consider how you're going to implement
More informationISO 22000:2005 Standard INTERNATIONAL STANDARDS REGISTRATIONS
ISO 22000:2005 Standard Food Safety Management System INTERNATIONAL STANDARDS REGISTRATIONS 3.1 FOOD SAFETY concept that food will not cause harm to the consumer when it is prepared and/or eaten according
More informationStanley Industries, Inc. ISO 9001:2008 Quality Policy Manual
Stanley ISO 9001:2008 Table of Contents and STANLEY Document Reference Related STANLEY Section Page Procedure(s) 1. Introduction 1 None 2. Scope 1 None 3. Organizational Structure & 1 STANLEY Company History
More informationComparison ISO/TS (1999) to QS 9000, 3 rd edition (1998)
1 SCOPE QS 9000: new: Introduction, applicability In addition to the applicability for supplier sites for production and services and their subcontractors for: - parts or materials, or - services like
More informationISO 14001:2015 READINESS CHECKLIST YOU RE CLOSER THAN YOU THINK LEADERSHIP LIFECYCLE PERSPECTIVE DOCUMENTATION RISK TAKING PROTECTION
LEADERSHIP LIFECYCLE PERSPECTIVE DOCUMENTATION PROTECTION FURTHER EXCELLENCE RISK TAKING PERFORMANCE COMMUNICATION REPUTATION ISO 14001:2015 READINESS CHECKLIST YOU RE CLOSER THAN YOU THINK THE TRANSITION
More informationThe Relevance of Risk Based Thinking in ISO 9001:2015 and ISO 14001:2015. March 4, 2016 Our webinar will begin at 1:00 PM
The Relevance of Risk Based Thinking in ISO 9001:2015 and ISO 14001:2015 March 4, 2016 Our webinar will begin at 1:00 PM 1 The Relevance of Risk Based Thinking in ISO 9001:2015 and ISO 14001:2015 Carmine
More information