ISO FAQ
What is ISO 9001?
In short, ISO 9001 is a voluntary Quality Management System
standard that helps organizations ensure they are meeting customer
requirements. Note that the key word in the title is "Management."
The intent of the 9001 standard is to implement systems that Management can use
to better run the business.
Apart from the Quality Management System standards, there are
many other standards that are maintained by the International Organization for
Standardization located in Geneva, Switzerland, and their 158 member countries
4. What are the benefits of certification?
Apart from the obvious benefit of opening up market
opportunities where ISO 9001 certification is a requirement, the biggest
benefits stem from having a structure to improve your processes. Because the
standard is really based on best practices for organizations, it provides management
with the tools to objectively decide where things are working well, and where
to best apply resources to make things run more smoothly. So - ideally, ISO
9000 helps your management team maximize the effectiveness of your business,
thereby enhancing growth and reducing cost. From your customers' perspective,
it gives them confidence that you have an organization that can consistently
meet their needs.
My company is very small. Can I get certified?
Absolutely. We've worked with companies of one or two people who
decided to get certified. The processes that you'll put in place would have the
same intent as a much larger company; it's just that the implementation will be
simpler. We work with organizations to assist them in balancing the appropriate
level of documentation with what's necessary to meet requirements
6. How much will this cost?
The answer depends on a number of factors. There are costs to
implement, cost related to the Registrar and costs to maintain. In terms of
costs to implement, if you choose a full do-it-yourself approach, the only real
costs will be in the time for resources dedicated to the implementation process
and in time spent writing documents and training your staff. If you have little
experience with ISO 9000, or have limited internal resources, you might choose
to get some outside professional help or a consulting company like us.
Costs of registration are dependent on the size of your
organization as well. Most registrars charge a certain rate per day to be
on-site at your facilityTo maintain your certification, the Registrar must
return at least annually to audit a portion of your system. Those costs will be
less than the original visit, since the time spent will be shorter. Once every
three years, the Registrar returns to audit your entire system.
7. Does ISO apply to my industry?
The ISO 9000 standards are general enough to apply to any
industry. We have clients in industries ranging from manufacturing to
government and defense contractors; from education to call center operations to
software development and they can all apply the standard to their business
model.
Do I need a consultant?
Many companies choose to attain ISO certification on their own,
so having a consultant is not a mandatory but highly advisable. We do believe
that having access to a consultant's knowledge and expertise can be very
helpful as you try to sort out how to apply ISO in your business. And if you
have an urgent need to attain certification and limited resources, using a
consultant is often the most practical approach. We provide several flexible
options to meet most needs
What is the Process Model?
The process model is based on the idea that an organization is a
system of interlinked processes. The ISO 9001:2000 Standard is designed to
manage and improve those processes. First, you identify your key processes.
Second, you define quality standards for those processes. Third, you decide how
process quality will be measured. Fourth, you document your approach to
achieving the desired quality, as determined by your measurements. Fifth, you
evaluate your quality and continuously improve
.
Are process flow charts required?
Flow charts are not specifically required, but more than likely
expected by your registrar. The standard requires that you identify your
processes and determine the sequence and interaction of the processes. This is
most easily accomplished by preparing flow charts of your product realization
processes
How many procedures are we required to write?
The standard specifically requires six procedures:
Control of Documents Control of Records Internal Audits Control of
Nonconforming Prod cut Corrective Action and Preventive Action
That may not be enough: the standard also asks that you prepare
any other documents you need to for planning, operation and control of your
processes. The standard also asks that you have available the work instructions
you feel are necessary. The answer to how many procedures or work instructions
are required: you must decide this
What records are required by the standard?
The standard specifically requires records for the following
items:
Management reviews Education, training, skills and experience Evidence
that processes and product or service meet requirements Review of customer
requirements and any related actions Design and development including: inputs, reviews,
verification, validation and changes Results of supplier evaluations
Traceability where it is an industry requirement Notification to customer of
damaged or lost property Calibration Internal audit Product testing results
Corrective action Preventive action Records you need to provide evidence of
following your processes.
How often should we have management review meetings?
There is no specific requirement for frequency of management
review meetings. We recommend quarterly meetings. This allows you to stay on
top of upcoming issues and yet collect data between meetings that is
meaningful. We have found annual meetings are not acceptable to all registrars.
With annual meetings you may not be able to prevent issues or resolves issues
in a timely manner. Management Review
Are job descriptions required?
No, there is no requirement for job descriptions. You are
required to do two related tasks: define responsibility and authority and
define competency in terms of education, experience, skills and training. Job
descriptions are one way of accomplishing this. There are other ways including
preparing organizational, job responsibility lists, and competency matrices.
What is process auditing?
Recently we have been receiving questions regarding process
auditing and what it means. If you are auditing your quality management system
by area or department and then auditing all the applicable ISO elements while
in that department, you are doing process auditing. If you are auditing your
quality system by ISO elements throughout the organization you are not set up
currently for process auditing. Process Auditing.
How often should we audit each area?
There is no specific requirement for audit frequency. The audit
schedule should be based on the importance of the area and on what previous
audits have uncovered. In a new system, you will want to audit frequently,
perhaps monthly, to make sure everything is implemented and working. In a
mature, audits can be performed much less frequently. For a mature system (in place
for several years) we recommend every six months to one year. Taper down your
audits over time. If you start at monthly, try quarterly for a while and see if
it is working. Do not audit less than annually.
Of course this depends upon several factors such as: how large
your organization is; how complex your processes are; what procedures you may
have in place already, etc. For a smaller company (less than 100 employees) an
implementation can take 4-8 months; for a larger company (more than 100
employees) the process can take 12-18 months. The process also depends on the
time and resources your company can apply to implementation.
One note about the timeframe - once you have met the
requirements, there is some time needed for your systems to mature and to
produce records that show evidence the systems are working. Most registrars
prefer to see 2-3 months’ worth of records after you've implemented everything.
That time needs to be figured in your overall timeline upfront, especially if
you have to meet a deadline for registration.
2. How many documents will I need? What are the requirements?
Many people are hesitant to begin the certification process,
because they incorrectly believe that they will need mounds of paperwork to
comply. In fact, the ISO standard only requires a quality manual and six
written procedures: Control of Documents, Control of Records, Internal
Auditing, Control of Nonconforming Product, Corrective Action, and Preventive
Action. Beyond those requirements, it's really up to you how much additional
documentation you need to plan, operate and control your business effectively.
Some companies find the need to add extra controls they didn't have previously;
some use the process to delete older documents that are redundant or not
worthwhile to maintain
3. My customer is asking me to become ISO certified...or...I
need to bid on a project that requires ISO certification. How can I do this
quickly?
You can certainly be ISO certified in as little as 4 months. It
requires focused attention on your part and often the help from an experienced
outside consulting resource. Another option to speed up your ISO project would
be to utilize a template-based documentation package like we provide on the
9000World website.
Do I need a full-time person dedicated to run my ISO program?
There are several factors that dictate how much time to dedicate
to the Quality System. Factors such as size of the organization, complexity of
the process, manual administrative systems verses automated or electronic
systems (ex: Document Control) all have a role in determining if there is a
need for a full-time person. Of course, during the set-up of the Quality
Management System there is more of a time commitment than after you are
certified. For most small companies, it is a part time role.
In addition to these
if you are looking at answers to the following questions, get in touch with us
for the answers.
·
How does the certification
process work?
·
What's the difference between being
certified and registered?
·
Can you certify us?
·
How does the certification
process work?
·
Can you certify us?
·
Can I say I am compliant
without getting certified?
·
How do I find a Registrar?
·
Can I argue with the Registrar
if I don't agree with an audit result?
·
Can I be certified as an
individual?
·
Will my product be certified?
·
Does the whole company need to
be certified or just a department?
·
How does it work with multiple locations?
·
What are the most common
findings in a Registration Audit?
·
What is the difference between
a "major" and a "minor" nonconformance?
·
How much money does it normally
cost to hire a Registrar to conduct the certification?
·
Do I need to purchase a copy of
ISO 9004 along with the ISO 9001 standard?
·
Who is the governing body for
ISO certifications and registrations?
·
Does ISO certification include
sub-divisions of a company housed in the same facility or does each division
need its own certification?
·
Our vendor is QS9000,ISO9001
and TS16949 certified and is concerned about tracking, shelf life and aging of
the fire retardant materials.
·
Are we able to be certified to handle certain
part numbers (fire retardant materials) only and not other items that are
unnecessary?
·
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