Planning - 6.1 in IATF 16949

Posted in IATF 16949

Planning 6.0: Comparing the new IATF 16949 and the ISO 9001:2015 Standard with the old ISO/TS 16949:2009 Standard

IATF 16949

ISO/TS 16949:2009

ISO 9001:2015

6.1    Actions    to    address    risks    and opportunities

6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

a) give assurance that the quality management system can achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects;

d) achieve improvement.
6.1.2    The organization shall plan:

a) actions    to    address    these    risks    and opportunities;

b) how to:

1) integrate and implement the actions into its quality management system processes (see 4.4);

2) evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new clients, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’  needs

5.4.2 Quality management system planning

Top management shall ensure that

4.2.a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1,  as well as the quality objectives, and

4.2.b) the integrity of the quality management system is maintained when changes to the quality management  system are planned and implemented.

There is not a comparable clause in 2008 version; only the very general that planning of the QMS should meet the process approach requirements and quality objectives

This revision expects that the QMS addresses identified risks arising from the consideration of the context of the organization and the requirements of interested parties

The context of the organization might lead to risks such as:

Product risks – FDA, DOT, EPA (examples gas mileage requirements on vehicles; product shipping risks-hazardous materials; vehicle lighting requirements; food and drug risks)

The requirements of interested parties may lead to risks identified during contract review such as short delivery times or difficult product requirements or suppliers ability to provide raw materials or components

Most of our clients will identify risks during contract review and take actions such as negotiating delivery dates or taking exception to product requirements or evaluating risks during design activities (especially design reviews, verification and validation) or identifying risks when selecting and evaluating suppliers

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