It is our strong recommendation that
organizations do not make changes to their quality management systems until the
formal standard is released in 2015.
As a
certified diver, there is probably nothing more satisfying and thrilling than
seeing all of your training and preparation pay off as you gently glide through
the water with harbor seals and sea lion pups frolicking and
dancing around you, begging you to play.
As a father of three certified divers and being obsessively compulsive
about their safety, getting to the play portion can only come after the safety
portion. I have personally sat through
the training program three times when each of my sons became old enough to enter
this whole new world of adventure, and therefore I feel that I have earned the
right to be in charge of all the rules.
As we in the ISO family begin this brand new adventure into an uncharted
world, I can’t help but make some simple connections between ISO and SCUBA.
Before each and every dive there are some safety protocols that each and
every “good” diver should go through. As
a diver, you Begin With Review and Friends (BWRF). This acronym stands for each of the safety
checks that you and your buddy check out on each other’s equipment before each
dive to ensure a successful dive. “B”
stands for BCD, or your Buoyancy Control Device. Does your flotation device
work? “W” stands for weights. Can you
and your buddy easily remove the weights in the event of an emergency and get
to the surface? “R” stands for
regulator. Does your breathing device work? No explanation needed. “F” stands for a final once over for all the
gear that will be going down with you to make sure that nothing is tangled,
loose, missing, or defective. You don’t
want to get to the bottom and find out something isn’t right.
For our adventure into the deeper and uncharted waters of the ISO
9001:2015 Standard, I want to encourage you to use the same acronym but with a
little twist on Begin With Review and Friends, “BWRF”. “B”
stands for Base. What you have already
put in place with your ISO 9001:2008 standard will become the base of your 2015
program. Do not think that you have to
go and start all over again. You do not
have to recreate the wheel. You would
think that this is common knowledge; however, I have already been approached by
organizations to help them redo what has already been determined to be
effective, efficient and compliant with both the 2008 & 2015 Standard. In each of the coming months as we discuss
how to actually begin to implement the new standard, we will always start with
what 2008 has given you as a base before we begin building what 2015 is asking
for.
“W” stands for “Woody is right!” Just Kidding?
“W” stands for What. What does
the new ISO 9001:2015 standard actually require? Already, we have received questions from
clients that indicate that people and organizations are beginning to read into
the standard requirements that simply are not stated in the standard, but are
being drawn out by interpretations. This
can result in far more complex, restrictive and overbearing management systems
that in time may prove to be so cumbersome that the organization fails to
realize the return on investment for their efforts. As we journey through the ISO standard, we
will take just a few statements to clarify exactly what the standard is saying
and what it is not saying. Hopefully
this will keep organizations from getting too deep without enough air to
support themselves.
“R” stands for Reason. Reason
will have a twofold purpose in our coming articles. The first purpose will be an explanation as
to some of the reasons why the ISO 2015 standard is requiring what they are
requiring. The second and most important purpose will be a clear, concise and
logical approach to achieving the requirement.
Many times organization will put in place multiple control features to
ensure compliance in every possible scenario at the expense of time, resources,
money and much frustration and anxiety.
ICH hopes to bring to the table implementation ideas and concepts that
will help your organization fulfill the new requirements without overtaxing the
organization and its resources.
“F” stands
for Final. When we say final, we want to
ensure that organizations do not put anything in place that is not a good
business practice...that if implemented and not a final requirement of the ISO
9001:2015 Standard, would not in any way negatively impact the
organization. With that being said, the
final sections of each of the following news articles will focus on where organizations
can begin to implement the new standard and not be at risk of putting an
unnecessary activity or process in place that is not beneficial to the
organization. We will offer suggestions
for user friendly methodologies for compliance.
We will suggest multiple possibilities as to where the organization can
use systems that are already in place for compliance. We will recommend best practices that have
been identified across the country in the healthcare industry. We will do our very best to make this
transition to the new standard as painless as possible. And as always, we will
be there to lend a helping hand or be a sounding board for any of your
questions.
Who’s ready
to Dive Deeper? Next month we cover
Management Review and Risk Control.
In over my
head and loving it,
“W”
