What is enterprise quality? Simply put, it is a system where there is one quality manual, and a core of common processes, work instructions, and forms and checklists for a multisite environment. Why is this a good idea? Because it saves money.

Figure 1 illustrates how enterprise quality takes many isolated management systems and transforms them into a common one.

Figure 1: Enterprise quality for a multisite environment

Due to the aggressive time frames for implementing standards, which in many industries is 12 to 18 months, organizations in a multisite environment are shying away from an integrated management system. Instead, they are using enterprise quality as a first step toward an integrated system. There are enough savings in a companywide implementation to justify the expenditure for enterprise quality management systems. In fact, these systems are not possible without a web-based or cloud based implementation.

Enterprise quality with enterprise quality software

Enterprise quality enables global processes for:

In 2014, the International Automotive Task Force (IATF) reported that the automotive industry wouldn’t upgrade the ISO/TS 16949 standard to ISO 9001:2015, much to the dismay of Tier One suppliers. In a survey that same year, Tier One suppliers related their desire to update their management systems to ISO 9001. Additionally, they weren’t happy with the industry’s onerous customer-specific requirements.

It’s interesting to note that many years ago, QS-9000, the predecessor to ISO/TS 16949, was written to reduce the proliferation of standards in the automotive industry. The number of new requirements coming from both the OEMs and Tier Ones in the last few years definitely looks like a return to the pre-QS-9000 days.

The IATF took two steps based on this feedback from Tier One suppliers. First, they would update ISO/TS 16949 to ISO 9001:2015, and that they were going to create a task force to do so. Second, they would try to understand customer needs before embarking on the change.

When evaluating a new draft standard against the current ISO/TS 16949, the following forces come into play (figure 1):

ISO 9001:2015, ISO 14001:2015, and ISO 45001:2015 establish clear expectations for top management. Not only are executives accountable for the effectiveness of these respective systems, they also have specific tasks ranging from establishing objectives to supporting relevant managers in their roles.

All of these standards require that managers integrate requirements into the organization’s business process, thereby creating the need for an integrated management system (IMS). These managers will need to focus on the planning process to ensure that these systems meet the intended outcomes, as well as to establish performance objectives.

For those implementing an environmental management system (EMS), ISO 14001 expects the organization not only to include the prevention of pollution, but also protection of the environment. This requires top management to learn and understand what the standard means when it says “protect the environment.” Topics such as sustainability, climate change mitigation, and protection of biodiversity and ecosystems are suggested by the standard in a note.

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Risk is not a straightforward concept. Definitions of risk vary, even within documents published by the International Organizations for Standardization (ISO). One ISO definition indicates that risk is the “effect of uncertainty on an expected result.” Risk is now addressed by ISO 9001:2015, “Quality management systems—Requirements,” the international standard for quality management systems (QMS), scheduled for publication next month. In it, organizations are asked to “address risks and opportunities.”

New language in the final draft international standard (FDIS) of ISO 9001 focuses on “risk-based thinking,” although it stops short of actual “risk management.” As a result, the international community is wrestling with how best to audit risk. What are the concerns of auditors? What does ISO 9001:2015 ask for?