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Q: What is ISO 9001?
ISO is a kind of acronym for the
INTERNATIONAL ORGANIZATION for STANDARDIZATION. They gather input from business leaders
and quality groups around the world to create
internationally accepted standards for quality.
The ISO 9001:2000 standard
(formerly 9001, 9002, and 9003) is the most widely accepted quality standard
in the world for manufacturers, and is the result of years of painstaking
global consensus-building.
Q: Why should my company be
ISO certified?
ISO 9001, when implemented correctly, causes the quality of your products
and services to continually improve …almost automatically! Its built-in
problem checking and correction elements steer your business down an
ever-narrowing channel of quality, slowly weeding out imperfections and
process glitches from your business operations. Things will go smoother and
smoother over time, and your employees will have an increasingly more
positive morale.
The ISO 9001 standard also
focuses on your customers’ PERCEPTION of your quality. This means that by
satisfying the requirements of ISO, over time more and more of your
customers will maintain a positive opinion of your company.
And of course, the ISO
standard provides a globally acceptable method for proving to the world that
your company is trustworthy, conscientious, and deserving of their valuable
contracts and hard earned capital. In today’s global market, many
manufacturers experience significant growth as a result of their ISO
certification.
Q: How much does it cost?
Costs will depend on the size and logistics of your company. By implementing
an efficient quality system you can save money and manpower for your
company. Outsourcing to a consulting firm such as ours to set up your
quality system, train your employees and keep your system running smoothly
is a cost efficient alternative to hiring full-time staff for QA (Quality
Assurance). Contact us for a free estimate.
Q: How does it work?
Basically, your company creates a
system for controlling the quality of your products and services. This is
called a Quality System. This include a Quality Manual, which outlines
certain criteria for work processes and commitments by Management to
maintain and improve these processes.
Many companies outsource consulting firms (such as
ours) to set everything up, train the employees, and keep everything running
smoothly, as an alternative to hiring costly additional full-time QA
(Quality Assurance) employees.
As part of your Quality System,
the ISO standard requires you to have a qualified individual spot-check
everything once in a while to make sure the system is working. These people
are called internal auditors. The auditor goes around your facility, talking
to people and inspecting things like calibration stickers and documentation.
You can train someone in-house for this, or you can schedule your consultant
to come out and do the audits once or twice per year, reporting any problems
found so you can fix them.
Also once or twice a year, an
RAB (Registrar Accreditation Board)
Certified Auditor is sent out by your
Registrar for a "Surveillance" audit. This auditor cannot be closely
affiliated with your consultant, lest there be a conflict of interest.
Just like with internal audits,
any problems found by the Surveillance Auditor(s) are reported to you so you
can fix your system. However with these audits, if you don't fix minor
problems within a reasonable time, or if problems are found which completely
negate the effectiveness of your quality system, the Auditor may
recommend to the RAB that your certification be discontinued.
At that point, you'd have to remove all
references to the RAB and ISO Certification from your company's websites,
marketing materials, business cards, etc., until you get re-certified. It's
far better to have the internal auditor find these problems first, and help
you fix them.
Q: Do we have to change how
we operate?
Usually, not much. Most companies
already have some system of quality control in place, or they probably
wouldn't still be in business.
The real trick is to find ways
to provide measurements and evidence of the system's effectiveness without
forcing employees to spend costly man-hours jumping through hoops and documenting everything
they do "for ISO". That
kind of simplification up front can save your company loads of money.
(...and happens to be our specialty here at QA California!)
Q: What is a
Registrar?
Your Registrar is your link to ISO
certification. You are free to choose your own Registrar. You should discuss
Registrar criteria with your quality consultant.
Basically, ISO creates a quality standard. Then,
accreditation bodies like the RAB audit
and certify Registrars according to the new standard. These Registrars, in
turn, send out surveillance auditors periodically to verify your
company's continued compliance with the standard.
Good Registrars also provide information and
other helpful, ISO-related services.
Q: What is the RAB?
The Registrar Accreditation Board is
a for-profit company that handles the certification of Registrars and
Auditors for ISO. (All our auditors and trainers are RAB certified.)
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