The organization shall monitor and review No equivalent clause Organizations interested parties include: Owner(s) individuals, investment companies, corporate ownership, stockholders Employees Regulators Customers Competitors Trade Associations State and local business community Owners Suppliers
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Organizations ability to consistently provideĪ) the interested parties that are relevant to the quality management system ī) the requirements of these interested parties that are relevant to the quality The issues can relate to: Legal (FDA, FAA, DOT, EPA, OHSA) Market & competition Technology development Cultural & social directions Economic development International TradeĤ.2 Understanding the needs and expectations of interested partiesĭue to their effect or potential effect on the For small to medium size organizations, these may be unstated and undocumented and be in the mind of the owner or may not exist at all.
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These further lead to shorter 3 to 5 year business development plans, which are supported by annual goals and objectives. No equivalent clause Generally organizations address this by developing a vision statement and a mission statement these are developed into a long term strategic direction and a strategic plan. To values, culture, knowledge and performance NOTE 3 Understanding the internal contextĬan be facilitated by considering issues related Whether international, national, regional or local. Legal, technological, competitive, market,Ĭultural, social and economic environments, NOTE 2 Understanding the external context canīe facilitated by considering issues arising from NOTE 1 Issues can include positive and negative factors or conditions for consideration. The organization shall monitor and review information about these external and internal issues. Result(s) of its quality management system. Purpose and its strategic direction and thatĪffect its ability to achieve the intended
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The organization shall determine externalĪnd internal issues that are relevant to its ISO 9001:2015 clause ISO 9001:2008 clause CommentsĤ.1 Understanding the organization and its context