With the ISO 9001:2008 it is necessary to evaluate whether the organization’s quality management system follows the general requirements. Quality Management SystemĤ.1 Understanding the organization and its context Quality Management System and General Requirements – Context of the Organization 2008: 4. The output of this context evaluation will be determination of the scope of its quality management system. The result is the new chapter 4 – context of the organization requires the organization to evaluate and position itself and its context. It is also a mean to detect risks and opportunities regarding the business context. The context of the organization as described in the ISO 9001:2015 requires you to detect and define various environmental, economic, technological and political conditions on the organization and how they reflect on the QMS the company’s culture, objectives and goals, complexity of products, flow of processes of and information, size of the organization, markets, defines customers etc. It pretty much changes the concept and application of chapter 4. Context of the organization is one of the new concepts and differences between the ISO 9001:2008 and its younger brother the ISO 9001:2015.
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