ISO 9001 2015 DIS 4.0 Organization Context Slides 01-25-15
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The document discusses changes to ISO 9001:2015 regarding understanding organizational context and interested parties. It introduces two new requirements - determining internal/external issues relevant to organizational purpose and strategy, and identifying interested parties and their requirements. It also more explicitly requires determining quality management system scope based on products/services and issues/party requirements. The changes aim to make requirements previously implied in ISO 9001:2008 more clear and explicit, with a focus on process-based management systems.
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ISO 9001 2015 DIS 4.0 Organization Context Slides 01-25-15
- 1. ISO 9001:2015 4.0 Context of the Organization © 2014 Cavendish Scott, Inc. www.CavendishScott.com 1
- 2. Overall Purpose • Two new requirements introduced in ISO 9001:2015 DIS Section 4 – Sections 4.1 Understanding the organization and its context – Section 4.2 Understanding the needs and expectations of interested parties (new definition added) • Requirements that were implicated in 2008 are now more explicit in DIS 2015. • What has not changed: This section is still about planning the quality management system for the organization. © 2014 Cavendish Scott, Inc. www.CavendishScott.com 2
- 3. 2015 DIS v. 2008 Comparison ISO 9001:2015 DIS ISO 9001:2008 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 4 Quality management system 4.1 General requirements Significant Differences • Determine internal and external issues that are relevant to its purpose • Determine interested parties that are relevant • Boundaries and applicability of requirements (available and maintained as documented information) • Determine process inputs, outputs, sequence and interaction
- 4. 4.1 Understanding the organization and its context • New Requirement – Organizations shall determine and monitor external and internal issues that are relevant to its strategic direction and purpose, and that have the ability to affect the achievement of the intended results of the quality management system. – The strategic direction of the organization is in line with the quality policy and objectives to continue to drive improvement. © 2014 Cavendish Scott, Inc. www.CavendishScott.com 4
- 5. 4.2 Understanding the needs and expectations of interested parties • New Requirement – The organization shall determine • the interested parties that are relevant to the quality management system • the requirements of the interested parties that are relevant to the quality management system – The organization shall monitor and review the information about these interested parties and their relevant requirements. © 2014 Cavendish Scott, Inc. www.CavendishScott.com 5
- 6. 4.3 Determining the scope of the quality management system • Not New, but more explicit – Continues with the topics in sections 4.1 and 4.2 for consideration of external and internal issues, as well as requirements of relevant interested parties when determining the scope of the management system. – More explicit with consideration to products and services offered – If a requirement within the determined scope can be applied, then it shall be applied by the organization © 2014 Cavendish Scott, Inc. www.CavendishScott.com 6
- 7. 4.4 Quality Management system and its processes • Not completely new, but more explicit – Explicit emphasis on the process approach – Adds focus on risks and opportunities – Less documentation requirements - i.e., “documented information to the extent necessary to support the operation of processes” – No Quality Manual Required © 2014 Cavendish Scott, Inc. www.CavendishScott.com 7
- 8. What do you need to do? • Formalize process measures that support strategic direction of organization • Identify interested parties / relevance • Determine external and internal issues (aka, risk management) and a plan to address • Ensure scope statement is clearly defined • Ensure management system is process-based with clear inputs and outputs identified • Identify Risks and Opportunities © 2014 Cavendish Scott, Inc. www.CavendishScott.com 8
- 9. We are here to help! For more information please contact us! • Colin Gray – colin@cavendishscott.com 303 668 2500 • Emily Myers – emily@cavendishscott.com 720 226 5968 • Dave Moskal – dave@cavendishscott.com 303 386 6788 • Diana Lough – diana@cavendishscott.com 720 212 7300 Or visit our Website for current status: www.cavendishscott.com © 2014 Cavendish Scott, Inc. www.CavendishScott.com 9
Editor's Notes
- Organizations have always done this to an extent just as part of maintaining and growing the business, but it will require more demonstrable evidence to prove it is being done. It will also drive organizations to be more proactive in planning for continuing, growing and expanding to other markets, versus reactive in regards to external issues (i.e. technological, cultural, competitive, economic environments, whether they are international, national, regional or local). This is now part of management review requirements in section 9.3.
- Interested party is a new term to the 2015 DIS… ‘a person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or activity’. Examples of this are customers, owners, employees, suppliers, and even competitors. All of these parties may have an impact on the organization’s ability to consistently provide products and services that meet customer and applicable legal requirements. Again, organizations that run a good business already, are doing this, but evidence will now need to be provided to demonstrate it is being monitored and reviewed, and it is part of the new requirement in management review, section 9.3.
- In ISO 9001:2008 section 1.2 applicability allowed organizations to exclude requirements that were not applicable to their type of operation as long as it did not affect products and services offered to meet customer requirements and that it came out of section 7, the product realization section. The applicability section has been moved to section 4.3 in the 2015 DIS requiring the organization to state in their scope statement the justification for any instance where a requirement of the standard cannot be applied. The scope statement also has to state the products and services that are covered by the quality management system. The biggest difference is that it makes it clear if a requirement within the determined scope can be applied, then it shall be applied by the organization.
- . ISO 9001:2008 had most of these requirements ‘scattered’ throughout the standard in the ‘general’ clauses (i.e. 4.1 general requirements of the quality management system, 5.4.2 planning to meet requirements and objectives, and to maintain the integrity of the management system, 6.1 planning resources needed to maintain and improve the management system and meet customer requirements, 7.1 planning product realization, 8.1 planning where monitoring, measurement, analysis, and improvement is to needed). There is explicit emphasis on the process approach, which was always intended from ISO 9001:2008, but not explicitly required for organizations to implement, and now it is. There is also focus on risks and opportunities to be determined and actions planned and implemented to address them. The documentation requirements are less, as it does not require a documented quality manual, just “documented information to the extent necessary to support the operation of processes”.