has not only been added, but also appears in five additional areas of the standard. 8.1.4—“Counterfeit parts” likewise has been added and shows up in three additional areas of the standard. “Human factors” has been added to 10.2—“Nonconformity and corrective actions.” The other changes reflect movement of the clauses from the process model structure in AS9100 Rev. C to the plan-do-check-act (PDCA) structure of AS9100 Rev. D. (See Figure 2.)
When AS9100 Rev. D is compared
to AS9100 Rev. C, the changes in the additional aerospace requirements are not as significant as the changes in the base ISO 9001:2015 standard.
Changes in ISO 9001:2015 There are 18 changes in ISO 9001:2015 compared to ISO 9001:2008. Some of the significant changes include the High-Level Structure (HSL) change. Also, there is the addition of Context, Interested-party expectations, and risk- based thinking as three of the biggest changes in the standard. Omnex has provided a webinar on these changes through Quality Digest. For more on the ISO 9001 changes, see the “Planning for ISO 9001:2015 and ISO 14001:2015: What are your next steps?” webinar presented by Omnex.
Context, Interested-Party Expectations, and Objectives “Context” is a term that has been hot in business circles during the last few years. Context, or “contextual intelligence,” has been associated with setting company strategy. The argument has been that companies need to consider the context of the organization when they design their strategy, goals, and objectives. In a September 2014 article titled “Contextual Intelligence,” Tarun Khanna of the Harvard Business School had this to say: “Trying to apply management
practices uniformly across geographies is a fool’s errand, much as we’d like to think otherwise. To be sure, plenty of aspirations enjoy wide if not universal acceptance. Most entrepreneurs and
®
managers
agree,
for
example,
that
creating value and motivating talent are at the heart of what they do. But once you drill below the homilies, differences quickly emerge over what constitutes value and how to motivate people. That’s because conditions differ enormously from place to place, in ways that aren’t easy to codify—conditions not just of economic development but of institutional character, physical geography, educational norms, language, and culture.... “Context matters. This is not news to social scientists, or indeed to my colleagues who study leadership, but we have paid it insufficient attention in the field of management. There is nothing wrong with the analytic tools we have at our disposal, but their application requires careful thought. It requires contextual intelligence: the ability
to
understand the limits of our knowledge and to adapt that knowledge to an environment different from the one in which it was developed.”
Context, then, has entered into our lexicon from a business perspective. An organization’s context, both internal and external, will influence the policy, objectives, and processes of the quality management system (QMS). ISO 9001 says that an organization needs to identify the internal and external issues “relevant to the purpose and the strategic direction and that affect its ability to achieve the intended result(s).” In a note, ISO 9001:2015 suggests that both internal and external issues must be developed when determining the context of the organization. The external context needs to consider issues from legal,
technological,
market, cultural, social, and economic environments, whether
competitive, international,
national, regional, or local. Internal context needs to consider issues related to values, culture, knowledge, and performance. The organization then identifies not only customer expectations, but also interested-party expectations. ISO 9001:2015 scopes interested parties and their requirements to those that are relevant to the QMS.
Interested Party Expectations
Quality Policy
Risk & Opportunities Quality Objectives
Figure 3: A quality management system with context
Once the issues related to the context as well as interested-party expectations and requirements are identified, what’s next for the organization? The organization uses the context
and the strategic direction to formulate the quality policy and objectives (subclause 5.1.1 b). The organization also uses the context and the interested- party expectations to determine the risks and opportunities, and subsequently, the actions to address them (subclauses 6.1.1 and 6.1.2). Strategy is defined as planned activities to achieve an objective (subclause 3.35), and hence, strategic direction can be thought of as the mission and vision that define the quality policy and objectives. (See Figure 3.)
Risk-Based Thinking Many aerospace organizations thought that
subclause 7.1.2—“Product
realization risk” in AS9100 Rev. C would suffice for meeting the requirements of ISO 9001:2015. However, ISO 9001:2015’s risk-based thinking is more comprehensive; clause 6.1 is about planning risk or the risk and opportunities of not meeting “intended outcomes.”
November 2016 ❘ 19
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