To make it easier for organizations to understand the unique requirements of IATF 16949 from ISO 9001, all supplementary requirements for the Automotive Industry (IATF 16949) will be in italics.
Section 6 Planning
Section 6.1: Actions to Address Risks and Opportunities
Section 6.1 comes from ISO 9001, this section was updated in 2015, and emphasizes planning as a key dictate in achieving and maintaining registration.
Planning now embraces the risk and opportunity management concept, because of the need to include the influence of the wider elements of the organization. This is to be implemented as a key activity in order to achieve quality goals on a continual basis, which includes the evaluation of the risk management process and a priority of when, how and where and to what level it should be applied.
18.104.22.168 Risk Analysis
The organization must include in its risk analysis, at a minimum, lessons learned from product recalls, audits, returns and repairs, complaints, scrap and rework. Organizations are required to retain documented information of risk analysis.
22.214.171.124 Preventive Action
The organization is required to determine and implement any action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventative actions must be suitable to the potential issues.
Section 6.2: Quality Objectives and Planning to Achieve Them
This subsection builds upon an accurate definition and plan to achieve specific quality objectives including:
The ISO 9001 standard requires taking the general concepts of planning into operations by defining the needs associated with service or product provision, creating supportive processes, and understanding customer acceptance criteria and the needed assets to ensure compliance with quality standards.
126.96.36.199 Quality objectives and planning to achieve them-supplemental
Top management is required to ensure that quality objectives meet customer requirements as defined, established and maintained for relevant functions, processes and levels throughout the organization. When the organization establishes its annual quality objectives and performance targets they must consider the results of the organization’s review regarding interested parties and their relevant requirements.
Section 6.3: Planning of Changes
When changes to the organization’s QMS are necessary, they must be carried out in strategic manner. Common changes of a QMS include making improvements to your existing QMS. Risks, resources needed, re-assignment of employee responsibility and the integrity of the QMS all need to be considered with developing plans for implementing changes.
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