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In the last article we
discussed in detail the pros and cons of first party certification
via self-declaration of conformity. We explained how to utilize
the first party certification option as a viable and in many cases
the only necessary certification process to fulfill internal as
well as customer requirements.
Where do we find this mystical first party certification option,
(which no one seems to know about or dares to talk about)? To put
it simply, the first party certification option is a European invention
(along with the ISO 9000 standards that were first published in
1987). This first party certification option is stated in every
EC/EU directive that accompanies a contract or purchase order which
requires a CE mark on the product. The original manufacturer is
required to pass on these requirements to its subcontractor. These
EC/EU directives spell out in detail what to comply with in regard
to quality and/or product conformance. The main concern is how the
product would affect the safety of the end user and/or how it would
impact the environment, while producing and/or using the final product.
As in the case of toys, the main concern in essence is the safety
and protections of the end user.
EC/EU directives provide first party certification as the first
option out of eight certification options. Directives can require
conformity assessment for both the product and the quality system
the product has been manufactured under, or the assessment can be
required only for compliance of the product against the product
specification and/or standard the contract originally called out
for. Various assessment modules will indicate which conformity assessment
is required and may be used. If you are interested in more detailed
information on EC/EU conformity assessments you can find this information
in my book " How to Win With ISO 9000", published in 1994 by QCSS.
Or if you like, you may order any EC/EU directive which your product
falls under, which will explain in detail the assessment modules
and its requirements. At the end of the article we will provide
you with sources where you can purchase such EC/EU directives.
The second party certification option is a sensible next step after
first party certification has been accomplished. How do you go about
it? You contact your customer and let them know that you have a
documented and implemented quality system in place. There will be
a good chance that your customer may want to verify your claim of
system compliance by asking permission to evaluate a copy of your
quality system manual or by conducting an onsite quality system
audit, verifying that you have actually implemented your documented
procedures. After your customer finds the quality system in compliance
you carry official second party certification status, which you
should proudly advertise. If your customer dictates no other requirements
then this may very well be all that you will have to do for system
certification. An important fact to remember is that this second
party certification is usually performed at no cost to you by your
customer. The only drawback to this option is that other customers
may want to conduct their own additional audits of your system.
However, if you have been approved by a large customer such as the
Department of Defense, the FAA, the FDA, one of the automotive,
aerospace or other industry giants, then it is most likely that
your other smaller customers will accept this second party certification
status without having to repeat the audit process.
To summarize, here is a brief outline of the steps necessary to
gain second party assessment:
- You contact your customer
and ask for second party certification assessment or audit.
- You provide the customer
with requested material such as your level one and two quality
manual.
- Your customer's quality
representative will review your quality manual.
- After acceptance of
the manual they will conduct an on site audit at your company.
- After you pass the
audit and the customer accepts your quality system they will issue
second party certification.
You derive two major benefits
from second party certification. First, you have complied internally
with all quality system requirements as outlined in your quality system
manual under Section 4.17-Quality Audit, and you have demonstrated
that you are able to work with that system in order to achieve your
quality objectives as outlined in your quality policy. Secondly, you
have now officially acquired second party certification status without
incurring dramatic costs. In fact the audit conducted by your customer
is usually free of charge. You now have a marketing tool that will
help keep your customer happy, and perhaps will help increase your
business by encouraging new customers to come on board.
As a final option we now come to the third party certification audit
and registration. This option is carried out in the same manner as
first party and second party quality system assessment and audits.
But instead of your customer carrying out the assessment and audit,
it is carried out by an independent accredited auditing body, and
the audit process has to be paid for, that is you.
The following is a short outline on the steps to a third party process:
- You contact the Registration
Accreditation Board (RAB) which accredits auditing bodies (companies)
and ask them for a listing of accredited auditing companies.
You contact several of the listed auditing companies which provide
services and have the expertise in your product line (see applicable
SIC Codes in that listing) and ask for details and a price quote.
- After you come to
an agreement on price and terms you will have to submit a level
one and two quality manual for evaluation.
After acceptance of your manual the auditing team will come out
and conduct an audit on your quality system.
- After compliance,
they will issue a certificate of compliance along with an assigned
registration number, identifying your company as a certified and
registered ISO 9000 company.
- After you have been
certified and registered you normally will be required to pay
semiannual maintenance fees that are above and beyond the initial
fees you paid to get audited and certified. Then, every three
or four years (depending on your product and system compliance)
the process repeats itself and you will have to get re-audited
and recertified once again, and of course you have to pay for
it all over. When getting a quote, be sure you negotiate not only
the initial fees, but the semiannual maintenance fees. Know what
fees you are committing to. There are registrar companies now
which offer small business rates, which are very affordable. For
more information you may call us and we will provide you with
a current listing.
What are the benefits
of a third party audit? Theoretically it should eliminate multiple
audits, but in reality it has not always worked out that way. More
importantly, if the product or services are critical enough to affect
the health and safety of the personnel manufacturing the product
, and it protects the consumer using the end product, or it protects
critical environmental issues, and the system proves to be effective,
then the third party independent audit has fulfilled its objective.
A good example where a third party independent audit is a viable
option and is beneficial, is the manufacture of medical products,
or critical aerospace components, or highly toxic chemical product
processes.
In conclusion, I think it is now clear that all the three audit
options have their place. It is high time that the quality associations,
and in particular the task groups which are involved and responsible
for developing these ISO 9000 standards, address the certification
options more clearly and directly. One solution is to qualify and
assign "risk levels" for products, as has been done in the medical
device industry, where four levels of risk are assigned to respective
medical devices (level one posing the least risk, etc.). What will
this do for the industry in general? It will restore a much needed
trust and confidence for companies in the use of the ISO 9000 quality
and auditing schemes. In particular, it will help smaller companies
to utilize the applicable ISO 9000 quality models without incurring
unreasonable and in many cases unnecessary cost. Once this has been
established then truly all industry branches large and small can
be winners, including the consumer that uses the end product.
At this time we like to thank our readers for the support you have
shown this past year.
Quality
Control Systems and Services is dedicated to assisting companies
achieve quality system certification by providing implementation
and training services, including a large spectrum of quality related
books, standards, EC/EU directives, Quality Manuals and Guidelines.
For more information please visit our web page: www.qcss.com and
log on to our e-commerce catalog. For comments or for more information
on the article contact Gunther B. Gumpp at (949) 388-7686. Copyright
(c) 1999, Gunther B. Gumpp, QCSS.NMW
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