2017 was a year of revisions for those involved in the ISO standards community. ISO 9001, ISO/TS 16949 and AS9100 series all underwent structure revisions. While it is vitally important for you to understand the requirements that now need to be met, it is also extremely important to understand why the requirements positively impact your organization. This article will briefly breakdown and explain the revisions to each ISO standard.
ISO 9001: 2015, previously known as ISO 9001:2008, welcomed a 10-clause structure in its latest revisions. Due to this revision, users now have two new themes to pitch into, including context of the organization and leadership.
ISO 9001: 2015 standard has pinpointed organizational context as the revision’s centerpiece. The latest version now considers both internal and external issue reviews. The updated clause allows organizations to have elbow room when adapting their business to meet the new ISO 9001: 2015 standard. Due to this revision, diversity between organizational contexts is expected to grow. Another benefit that can be reaped by this clause, is the ability to create an efficient mechanism for fitting these reviews into risk-based thinking demands.
With the latest revision, top management involvement has expanded. Compared to ISO 9001: 2008, the new stand now has requirements for customer focus and communications. The revisions to top management involvement are not subtle; therefore, it is important to have more than a discuss with those involved. Individuals with leadership roles should understand that the new standard requires them to hold responsibility for the quality management system and its effectiveness.
Another theme within the ISO 9001: 2015 standard that should be noted is risk-based thinking. Although this theme is present within many business models, since the release of ISO 9001: 2015 risk-based thinking has been frequently discussed. The latest revision now includes risk and opportunity based thinking, or in other words, positives and negatives. Potential impact of the positives and negatives should always be weighed and equal to ensure that neither side is overly managed.
Intended to be an additional automotive requirement on top of ISO 9001:2016, ISO/TS 16949:2016, soon to be known as IATF 16949: 2016, has also undergone some extensive revisions. Expanded requirements include:
These requirements have been expanded to support the revisions underlying theme of defined competencies for internal and second party auditors. In the past, an organization was required to send their employees to a lengthy training session in order to learn the required competencies. Now, ISO/TS 16949: 2016 provides a list of competencies that are required and must be achieved. The expectation of expanding requirements and adding these competencies into the standards revision is that organizations will achieve the requirements needed during their transition into ISO/TS 16949: 2016.
The AS9100- series was forced to follow a revision after ISO 9001:2015 due to the series framework built around ISO 9001. Two major themes that have been revised within the series include, configuration management and human factors. The configuration management revision is of extreme importance because it will impact the activities the organization uses to control the functionality of its products. The human factor theme was revised to consider the social, psychological and physical factors used during the design process. The human factor revisions will be mostly implemented during the analysis of nonconformities.
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