Auditors will need evidence of monitoring and reviewsĭetermine the boundaries and applicability of the quality management system to establish its scope.Ī) external and internal issues (see 4.1) ī) requirements of relevant interested parties (see 4.2) Ĭ) products and services of organization.Īpply the requirements of ISO 9001 if they are applicable within the determined scope.
The relevant requirements may also change.The relevant interested parties may change.Interested parties may be customers, owners, employees, providers, bankers, regulators, unions, partners, community, news media, competitors, law enforcement, emergency responders.This is a new requirement on interested parties (a person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity).Monitor and review information about these interested parties and their relevant requirements. Auditors will look for evidence of issue monitoring and reviewsĭue to their effect, or potential effect, on your ability to consistently provide products and services that meet customer and applicable legal requirements, determine:Ī) interested parties that are relevant to the quality management system ī) relevant requirements of these interested parties.Your organization may already monitor and review these issues.The Notes provide examples of types of external and internal issues.Links quality system and business system.This is a new requirement on the context of the organization.Note 3: Consider internal issues related to organizational values, culture, knowledge, and performance. Note 2: Consider external issues arising from legal, technological, competitive, market, cultural, social, and economic environments (local, regional, national, or international). Note 1: Issues can include positive and negative factors or conditions for consideration. Monitor and review information about these external and internal issues. and affect its ability to achieve the intended results of its quality management system.are relevant to the organization’s purpose and strategic direction.This article summarizes the ISO 9001:2015 requirements in Clause 4, Context of the Organization, and identifies the changes from ISO 9001:2008.Ĥ.1 Understanding the Organization and its ContextĤ.2 Understanding the Needs and Expectations of Interested PartiesĤ.3 Determining the Scope of the Quality Management SystemĤ.4 Quality Management System and its Processesĭetermine the external and internal issues that: