Comparing the new IATF 16949 and the ISO 9001:2015 Standard with the old ISO/TS 16949:2009 Standard
4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.
4.2 Understanding the needs and expectations of interested parties
Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
2.a) the interested parties that are relevant to the quality management system;
2.b) the requirements of these interested parties that are relevant to the quality
The organization shall monitor and review information about these interested parties and their relevant requirements.
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. These further lead to shorter 3 to 5 year business development plans, which are supported by annual goals and objectives. 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.
The issues can relate to:
Legal (FDA, FAA, DOT, EPA, OHSA)
Market & competition Technology development Cultural & social directions Economic development International Trade
For automotive specifically legal issues could relate to
1. Passenger restraints
2. Engine air emissions
3. Braking systems
4. Exterior light illumination and others depending on the types of products and position in the supply chain
Organization’s interested parties include:
Owner(s) – individuals, investment
companies, corporate ownership, stockholders
Employees Regulators Customers Competitors
State and local business community Owners
For automotive specifically, interested parties could include AIAG, SAE, DOT and EPA, ISO/TS certification body
For Tier 2 and below, interested parties include the OEMs that their customers supply to.
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