Context of the organization training
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The document discusses the new requirements in ISO 9001:2015 for organizations to consider the internal and external context that can impact objectives and quality management systems. It provides guidance on evaluating internal factors like culture, objectives, and processes as well as external factors like regulations, market conditions, and competition. The key steps are to define the quality management system scope, identify processes and interactions, conduct a SWOT analysis, determine interested parties, and document it all in a new Context of the Organization document. Understanding the organization's full context through tools like a COTO Log, FMEA, and PEST analysis can help identify risks, opportunities, and improvements.
Context of the organization training
- 1. Identifying the Context of the Organization ISO 9001:2015
- 2. Context of the organization – Context of the organization is a new requirement in ISO 9001, stating an organization must consider both the internal and external issues that can impact its strategic objectives and the planning of the QMS. t pretty much changes the concept and application of clause 4, and requirements regarding the context of the organization do sound a little bit vague, so what does this clause actually require? – Clause 4 of ISO 9001:2015 Context of the organization requires the organization to evaluate itself and its context. This means that you need to define influences of various elements on the organization and how they reflect on the QMS, the company’s culture, objectives and goals, complexity of products, flow of processes and information, size of the organization, markets, customers, etc. It is also a means to detect risks and opportunities regarding the business context.
- 4. Context of the organization – Although the standard doesn’t prescribe the method for determining the context of the organization, there are some logical steps and milestones. If you are implementing the standard from scratch, then you need to determine the scope of your QMS and identify the processes and their interactions.
- 5. Defining The Scope of the QMS – Once the scope of the QMS is defined, together with exclusions, and processes and their relations are identified, the following steps need to be taken
- 7. Internal Context – An organization’s internal context is the environment in which it aims to achieve its objectives. Internal context can include its approach to governance, its contractual relationships with customers, and its interested parties. Things that need to be considered are related to the culture, beliefs, values, or principles inside the organization, as well as complexity of processes and organizational structure.
- 8. External Context – To determine external context, you should consider issues arising from its social, technological, environmental, ethical, political, legal, and economic environment. Examples of external context may include: – government regulations and changes in the law – economic shifts in the organization’s market – the organization’s competition – events that may affect corporate image – changes in technology – Basically, all this information is in the heads of the CEO and other members of management, but it was never put on paper; the best way to gather it is by organizing some brainstorming. Systematization of all this information can be very valuable and demonstrate where you stand as an organization.
- 9. – This requirement of clause 4 can seem too general, and there is a risk of going too wide when defining the internal and external issues. In fulfilling this clause, you should focus only on issues that can affect customer satisfaction and delivery of quality product and/or service.
- 10. S.W.O.T. ANALYSIS- Good 1st Step
- 12. Should we care about other people’s opinions? In simple terms, the requirement for identifying relevant interested parties means that you need to decide whose opinion about your company you should care about. Interested parties include direct customers, end users, suppliers and partners, regulators, and others. Others could include people in the organization, owners/shareholders, and even society. These parties add value to the organization or are impacted by the activities within the organization. Identifying and meeting their needs is important to implementing an efficient and effective quality management system. Their feedback can really help you to determine what can be improved in your organization, and how.
- 13. Let’s put it on paper – Once all this information is gathered, it should be documented; the standard is pretty explicit about it. But where it should be documented? The first choice is to create a new document, and this document will be something that the certification body will require instead of a Quality Manual prior to the audit.
- 14. Putting it all together Once the SWOT Analysis is completed and the interested parties are determined, you can begin to construct your organizations full context along with its risks and opportunities as seen by your interested parties and your identified processes. Some Great tools that can help build a strong road map that will help bring out the full extent of the context include: COTO Log (Context of the Organization) FMEA-Failures Modes Effects Analysis “PEST” (political, economic, social, technological) ”
- 15. COTO Log Defines all of the Requirements of Context Interested Parties Issues and Requirements Risks Opportunities
- 16. FMEA Defines the Risks
- 17. PEST
- 18. The context of the organization seems like one of the “document and forget about it” requirements, but it shouldn’t be. Information gathered through defining context can be very useful for identifying room for improvement, and it shouldn’t be taken for granted. Knowing the context of your organization and opinions of your interested parties can help you improve your organization and make it even better.