The 3 key Challenges of ISO 9001 Implementation for SMEs
Implementing
a ISO
Certification For Quality Management in an SME (small- to
medium-sized enterprise) using the requirements of ISO 9001 Certification
can bring
a lot of benefits. The problem is that there are also some challenges that are
not as easy for an SME to overcome as they are for larger businesses. In this
article I will discuss three key questions that you will need to consider, and
some ideas on how to overcome these challenges.
1) How much do you document?
This may
seem like an easy question, but it really is not. It is a question of balancing
employee competence with having detailed, documented procedures. It is true
that there are some mandatory pieces of information that need to be documented
according to the ISO 9001:2015 standard
requirements. Those requirements aside, it is up to you to decide what
procedures need to be documented for your unique QMS. The main question to ask
is, “If I don’t document this procedure could I have a nonconformity?” For the
SME, there are a few extra things to consider that larger organizations will
not run into:
·
Is only 1 person doing this job? – If so, it is best to document
the procedure, even if it is fairly simple for that one person to do. If that
person is not available and you need to cover for them, then a documented
procedure will be very useful.
·
Is this procedure used very rarely? – There are a lot more
procedures that are not routinely used in an SME, than there are in a large
business. With these procedures, it is best to document them so that you can
ensure consistency, even if the procedure is only used once a year.
·
Is the competence level needed more important? – With some processes, the level
of competence needed is just too much for a procedure to relay. Focusing more
on how you can get employees to gain this competence is more important than
writing a document.
Remember,
the less you document the more flexible and responsive your processes can be to
improvement opportunities, so try to only document what makes sense for you.
2) How do we deal with outsourced
services?
With an
SME, there tends to be a lot more outsourced services than are found in larger
companies. This can often lead to the impression that the company has less
control over how these processes happen. How do you show that you have control
over your production and service processes if they are not done in your
building? This can be a struggle for SMEs.
The trick to showing this control in
an SME is in the use of many different control vehicles. Well-documented
service level requirements, second party audits, well thought out monitoring
methodologies and follow-up activities for outsourced services are all great
controls to have in place. The fact is that you do have a way to control
your outsourced service. You can’t just hope for the best, so you
need to identify how you have this control so that you can demonstrate it
during your QMS audit. This will be documented in the records you keep for all
of the control vehicle activities that are listed above.
3) How do you handle ongoing internal
audits?
One of the
key methods of ensuring performance evaluation of your process is the ongoing
internal audit process. Using an internal audit, you take a look at each of
your processes at regular intervals to see what is actually happening with the
process. Through a review of records and meeting with the participants of the
process, you can then compare this with the planned arrangements of the process
to ensure that events are happening as expected. Auditing is a skill that needs
to be learned and used to ensure it is sustained.
This is where the concern comes for
SMEs; how do we choose, train and sustain the skills of internal auditors if
they are not used routinely? For large businesses, keeping an internal
audit department makes sense, but this may not be the case for a smaller
company. Since there are companies that will perform this service for you, you
will need to ask yourself: is it better to hire an external company to perform
our internal audits for us? If you do hire an external company, remember this
is an outsourced service that you need to keep control over as identified
above.
The QMS should be a benefit, not a
financial burden
One thing
to keep in mind when overcoming these challenges is this: implementing the
requirements of ISO 9001:2015 Certification are intended to provide you
with a QMS that will benefit your company and help you focus on enhancing
customer satisfaction and improving your processes. The intent is not to cost a
lot of money for little gain. With that in mind, design your QMS to give you
the benefits of your improvement activities, and ultimately reap the financial
gains you want from your quality management system.
For more information about ISO 9001 Certification Body and the role we can play in your
efforts to achieve certification to it, feel free to contact us. To get started with the
certification process, you can also request a quote.
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