By Kate Bachman, Contributing Editor
Fabricators, metal formers, and other manu- facturers can now begin International Stan- dards Organization (ISO) 2015 certifications.
In September 2015, the universally recognized
global standards body released its 9001:2015 standards for quality management systems (QMS) and
14001:2015 for environmental management systems (EMS). Fabricators can continue to use the
2008 and 2004 standards until September 2018,
but they won’t find validating agencies certifying
the 2008 revision after September 2016.
Key changes to both the ISO 9001 and ISO 14001
standards are that they are structured to align with
other standards; are less prescriptive; require greater upper management involvement; and require less
documentation but more emphasis on defining processes and risks and opportunities planning. They
also require that the manufacturer determine its
context both internally and externally.
A Lot in Common
Fabricators and metal formers familiar with previous ISO versions and other standards, such
as the AS9000 Aerospace Basic Quality System
Standard, and those issued by other organizations, such as the American Society for Quality (ASQ), will recognize that the ISO structure has
been reorganized to integrate with other standards via a common structure and 10 clauses:
2. Normative references
3. Terms and definitions
4. Context of organization
9. Performance evaluation
A common structure is possible because basic
concepts such as management, customer require-
ments, policy, procedure planning, performance,
objective, control, monitoring, measurement, au-
diting, decision-making, corrective action, and non-
conformity are common to all management system
standards, according to Chuck Jenrich, an ISO cer-
tification specialist. “A common structure should
make it easier for organizations to implement mul-
tiple standards because they will all share the same
basic language and the same basic requirements,”
“This will enable better integration into an organi-
Context of the Organization ( 4.0)
zation’s overall strategy, rather than management of
a series of ‘bolt-on’ systems,” said Karen Lutz, senior
program manager, EHS compliance and sustainabil-
ity for TRC, in her article “Update: Environmental
Management Systems Standard ISO 14001-2015.”
The new standard is less prescriptive, Jenrich
said, doing away with the requirement for a qual-
ity manual and management representative and in-
stead leaving it up to the company to devise strate-
gies to meet the other requirements. “The standard
says, we still want you to have satisfied customers
at the end of the day. We want to make sure you can
do it in the way that works best for your company.”
There is a decreased emphasis on documentation
and increased emphasis on achieving value for or-
ganizations’ customers, Jenrich added.
This is a new requirement. A company must now understand its context before establishing its management system. This means it must consider factors
that are relevant to its purpose and strategic direction and how they influence those factors and are
influenced by them.
For example, “context” means that an organization seeking ISO 14001: 2015 must not only consider the impact of its activities on the environment,
but also the impact of the environment on its activities, such as anticipated impacts from climate
change, raw material scarcities, energy management, and so forth, Lutz said.
Context is already very germane to 14001 environmental standards, given that a company must
consider its impact on water, air, energy, material
resources, emissions, ground contamination, and
its community in general.
However, context is a little harder for companies
to understand and apply to the 9001 standard,
Jenrich said. Where are you in your industry sector compared to your competitors? Where are you
within your customers’ supply chains? Who are
all your company’s interested parties—
stakeholders, stockholders, employees, neighbors, people
in your industrial sector? All of those comprise the
context of your organization, he said.
Under Clause 4. 4, companies still must devise
a management system, but now they must also
assess risks and opportunities and assign authority for processes. “Most companies don’t understand their capacity—or their capabilities. Let’s
say a company takes on an order for a product it
doesn’t know if it can make. So, what’s the risk of
doing that? It’s a new product. New customer. New
technology. New supplier. All those risks have to be
considered. You have to go through that process.
And that’s what ISO wants with risk management,”
He added that the risk management process is
similar to a SWOT analysis that assesses strengths,
weaknesses, opportunities, and threats.
for ISO 9001, 14001
align with other standards
Quality, environmental management standards
harmonized, less prescriptive, more risk-conscious
The newest International Standards Organization (ISO)
standards revisions are restructured to have the same
10 clauses as other management systems, making them
simpler for manufacturers and other organizations to
integrate their standards and certification efforts.