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Editor's Notes

• #2: Context is one of the most important requirements in the standard. It provides the environment for the planning of the whole system.
• #3: Colin has been working in the industry for many years and focuses on value added solution and the precise interpretation of the standard.
• #5: Context starts with organizational purpose and strategic direction. These should be discussed and documented before considering the context. It is possible to consider purpose, strategy and context from a much broader business perspective. However, the standard requires it only address quality and this is a good place to start. If an organization feels comfortable extending their focus later then that is fine – later. Note that the process here goes beyond identifying the context. Organizations are required to monitor issues which means the data must be maintained. Typically there are two elements to this. The issues should be reviewed “periodically” (often annually) in case something happened that would change things but was not noticed. Also, whenever there is a known planned (or unplanned) change then consideration should be given to whether issues are impacted. These elements must be formally included in the process.
• #6: Like all “requirements” there needs to be a formal process to address this section. And like all processes there should be a procedure (or equivalent) and appropriate controls and tools to ensure it is followed. The process must be designed to provide a valuable benefit to the organization, BUT it should also generate records so that it can be used (e.g. action items) but also such that the process and its effectiveness can be demonstrated to an external auditor. Note the potential complexity here. Change management – needs to interact with Issues. Interested parties change, could affect issues (and vice versa). Processes change – could affect issues. Issues change, risks and opportunities change. There is substantial interaction throughout the organization.
• #7: A quick review of SWOT for this presentation
• #8: A quick review of SWOT for this presentation
• #9: The previous quick SWOT was not effective beach we did not determine a clear perspective. From whose perspective were we doing this. The presenter? The attendees? The Conference organizers? The answers will be different. Definitions of SWOT were not formally established and so confusion could exist over what is a strength and what is not, for instance No clear understanding of the level of detail – we could discuss threats that really don’t manifest if we go to too much detail.
• #10: Internal (SW) and External (OT) Positive (SO) and Negative (WT) Developed as a tool for business. In practice we are limiting it to quality, but the approach is valid. Google it.
• #11: Discuss and agree categories or factors to break down SWOT elements. Note that this will help shape research Conduct research in advance so the SWOT “meeting” is more productive. Define and Document the Scope. What are we going to cover. What time line? If we have a growth strategy, how much growth and when will it be over? What then? We are discussing organizational strategy. We need top management Clarify the purpose of the organization and the strategic direction – make sure they are documented.
• #12: In practice this is a “meeting” or brainstorming session. It can be multiple sessions and could be conducted without an actual meeting e.g. reports, comments, blogs, telephone discussions, Ensure the process is clearly defined and all tools available to make it happen. No confusion. Initial discussions and possibly internal/external interviews need to be conducted beforehand to enable the process to be defined and direction established. Flexibility must exist to allow change of direction, additional research, more interviews etc. if that is the outcome. It may not always be possible to predict everything that comes out of the meeting in advance and prepare. SWOT can be applied forward or backwards TOWS. Some people advocate a reverse approach to change bias. We break the organization into categories or elements that help us consider issues that are important. These categories or factors may lead us to further research and then may identify an issue that can be considered a strength, weakness, opportunity or threat. There are many different options: Functional departments. Sales, Design, Production, etc. and they we ask what are the strengths for that department. We can also use processes (so Document Control and Records Management will be factors to consider) For external issues consider breaking into these categories/factors: PESTLEE Political, economic, social, technological, legal, environmental, ethical STEEPLE Social, technological, economic, environmental, political, legal, ethical These tend to be more applicable for the external issues – Opportunities and Threats. ISO defined some categories/factors in the notes to 4.1. External issues: legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Internal Issues context: values, culture, knowledge and performance of t Also look to your own mission, vision and values. e.g. Integrity, Ethical Behavior, Innovation, Productivity, etc. While these can be used at categories and factors, they should also be considered to help identify relevant answers (strengtyhs/weaknesses) because they shape the organization. Brainstorm issues Agree additional research Agree actions. Actions are important. Plan what you are going to do with this information – does it feed to risk management, are there opportunities.
• #13: Cavendish Scott has been working with ISO 9001:2015 since the DIS was released in the middle of 2014 We remain on the cutting edge of meaningful management systems while not overlooking the need for conformance to standards to achieve certification. Cavendish Scott offers gap analysis audits to ISO 9001:2015, Project and Document planning solution for ISO 9001:2015, IRCA approved and public and customized Transition and Auditor training, and standardized and open consulting projects for ISO 9001:2015 – as well as AS9100, ISO 13485:2016 and ISO 14001:2015.