It is our strong recommendation that
organizations do not make changes to their quality management systems until the
formal standard is released in 2015.
“Just when
you thought it was safe to go back into the water…” It wouldn’t surprise me that many of you are
feeling this way as the new ISO 9001:2015 standard looms on the not so distant
horizon.
When you think about it, isn’t that what ISO has been preaching for years, Continuous Improvement? It is refreshing to know the International Organization for Standardization practices what they preach.
When you think about it, isn’t that what ISO has been preaching for years, Continuous Improvement? It is refreshing to know the International Organization for Standardization practices what they preach.
When people
ask my goal as a consultant, teacher and auditor, I reply that my job is to
ensure the organization sees Return on Investment, Litigation Security and most
importantly, Patient Safety or Customer Satisfaction. When you look at the new standard you can’t
help but notice the heightened awareness to RISK. Risk that an organization might face can come
in the form of a thousand different possibilities like little piranhas that can
swiftly eat away at the success of an organization or it can come in the form
of a great white shark that can immediately devastate an organization.
What the new
standard is attempting to accomplish is to set up a series of life guard stands
for an organization whereby the threat can be identified far off in the
distance before it can do any real harm.
In section 4 of the ISO 9001:2015 standard the organization is asked to
take a good hard look at itself, its customer and any other interested parties
that play a relevant role in the success of the organization.
As the
organization begins to evaluate their context, “the pool of water that they are
swimming in” they very quickly discover that they themselves may be the cause
of some of their greatest risks. Maybe
due to resource constraints, equipment constraints, facility constraints, etc.,
they may have reached their capacity to fulfill customer needs. The ISO standard simply asks us to identify
and then, in a controlled fashion, mitigate those risks. Maybe we take swimming lessons and develop a
stronger stroke so that we can stay ahead of the competition.
In our current
culture customers demand higher levels of quality without additional expense.
As an organization clearly identifies these needs and expectations, the risk to
the organization will be revealed.
If we
identify what it is that our customers truly want and expect, we can now begin
to address these issues, not only for the good of the customer, but also for the
financial strength of the organization. An organization can maintain cost and
see a nice profit, if they change their culture. To begin to change this culture, an
organization needs to improve processes and build quality into the process,
instead of inspecting it into their processes. They must work to reduce the number
of process failures to consistently and reliably reproduce the product. By doing
this, we can feed the sharks what they want instead of letting them eat away at
our success.
“Interested
party” is the name the ISO standard has given to all others who hold a relevant
role in the success of an organization. This category can be large; however they are not
very difficult to manage. Regulatory
bodies want their codes to be complied with; investors want their money; suppliers
want their invoices paid. The smart
organization will identify, assess and mitigate the threat that each interested
party plays in their success. If my
supplier, my “swim coach”, isn’t helping me stay ahead of the competition, I
have to get a new swim coach/supplier.
If I ignore the “Do not swim in shark infested waters” sign I may need
to get a bigger sign or put up larger barricades. Identifying risk from interested parties can
keep our organization healthy and safe.
When you
believe in your organization strongly enough you will see that Identifying,
Assessing and Mitigating the RISKS to your organization is something that you
will grow to appreciate.
See You in
2015 and enjoy your safe swim.