More Leadership Involvement
The new version ( 5.1.1) requires top management to become more accountable
than before for the quality or environmental management system’s effectiveness. Its objective is the decentralization of the system and sharing of the responsibilities throughout the company, Jenrich and Lutz said.
No longer will management be able to remain uninvolved in the standards, leaving all of the tasks and accountability to one person or small group, Jenrich said.
The greater emphasis on leadership involvement is intended to ensure that
the management systems are embedded at the strategic level, and that they
are consistent with the organization’s strategic direction and processes.
The new version details the responsibilities, roles, and authorities within
the QMS and EMS.
Risk Planning Replaces Preventive ( 6.1)
The new ISO standards no longer require preventive action; now they expect
companies to establish a risk planning process. This process identifies and addresses the risks and opportunities that could influence the performance of
their management systems, disrupt their operations, or impede their ability to
provide compliant and satisfactory products. It then expects them to define actions to address these risks and opportunities—and determine how they’re going to make these actions part of their management system processes.
“Risk-based thinking has always been implicit,” states the standard, driving
training, planning, validation, auditing, monitoring, measuring, and controlling—all intended to prevent mistakes and reduce risk. “Now it is explicit,” Jenrich said.
How to Achieve Objectives ( 6. 2)
ISO pushes companies a little further in this planning clause in that it not only
requires companies to plan objectives, as was required in the 2004 and 2008
revisions, they must also describe how they will achieve those objectives.
Bye-bye Records, Documents; Hello Documented Information. The new ISO
has eliminated the long-standing distinction between documents and records
( 7. 5. 2). Now they are both referred to as “documented information,” which re-
fers to information that must be maintained and retained. The standards ask
manufacturers to maintain information—what used to be referred to as docu-
mented procedures—and retain that information—what used to be referred
to as records. “So while the definition of the term ‘documented information’
abandons the distinction between documents and records, essentially it is
still required that companies document and record information,” Jenrich said.
“Companies don’t need to keep records they can later get sued for, but they
have to show their process methodology.”
The new version emphasizes documenting the treatment of customer prop-
erty ( 8. 2) as well as monitoring and controlling external providers ( 8. 4. 3). This
is especially significant for environmental management. Operational schedul-
ing and controlling should pay closer attention to upstream and downstream
processes—in particular, outsourced processes—including their environmen-
tal impacts, Lutz said.
Leading certification bodies have announced that they will stop certification on
the 2008 revision in September 2016. Companies certified against the 2008 revision must transition by September 2018. The 14001 environmental standards
have been unchanged since 2004. “That’s unprecedented,” Jenrich said.
Companies can certify the 2015 revision right now, though Jenrich and Lutz
advise companies to jump in with only one foot for now.
They advise manufacturers seeking ISO 9001:2015 and 14001:2015 certification to begin with a gap analysis—a comparison of where the company is now
against what it needs to do to satisfy certification requirements. They should
identify necessary changes in their organization. Is training required? Does the
company need to make adjustments to its documentation or existing management system? “Then that plan becomes part of your new management system,” Jenrich said.
“Immediately intensify consideration of the environmental impacts of the
value chain of your products, processes, and services regarding raw materials, suppliers, customer use, and waste management,” Lutz advises for those
seeking ISO 14001.
Manufacturers need to stay up-to-date on the public debate regarding the
standard and interpretation of its requirements, she added.
Fortunately, ISO plans to maintain the 2015 standards for 10 years, so certifying manufacturers can be assured that they won’t need to make changes
again for about a decade.
Contributing Editor Kate Bachman can be reached at email@example.com.
Source: Chuck Jenrich, “ISO 2015: Are you ready for the transition?” presented at The Business &
Professional Institute of Rock Valley College, October 13, 2015.
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