Preparing For ISO 9001 2000 Registration

The steps need to be taken to prepare anwhich, of course must be compliant with ISO 9001
organization for ISO 9001 2000 registration:Whilst the2000.These records will be used as evidence to
following text is not exhaustive in its content itprove to your ISO assessor that you are operating
should give you a reasonable idea of what's involvedyour Quality Management System in accordance with
in setting up an ISO 9001 2000 registration within anyour documented procedures and ISO 9001 2000.
organization.First and most importantly you shouldDriso's Easy ISO 9001 2000(R) software will record,
either purchase a copy of the ISO 9001 2000control all of your organisations training records in an
standard or read a copy at your local library.At firstISO 9001 2000 compliant format.As your processes
glance many of the terms referred to in the standardevolve you must start internal quality management
sound quite confusing but if you study the contentsystem audits so as to satisfy your organization that
of this web site you will soon become familiar withit is in fact operating its processes in accordance with
the terminology used.Now that you are a little moreits own documented procedures and the
familiar with the ISO 9001 2000 Quality Managementrequirements of ISO 9001 2000.Your ISO 9001 2000
Standard and its terminology you should start toauditor will look at the records generated by your
analyze the current practices of your organization tointernal audits. ISO 9001 2000 relies on Quality
those documented within the ISO 9001 2000Management System audits to provide assurance
standard,This process is known as a gap analysisthat the organization is meeting the requirements of
audit. You can either carry this process outthe ISO 9001 2000 standard.An audit includes an
yourselves or employ the skills of an ISO 9001 2000inspection of the documents and records that make
consultant to carry out the task for you.It is veryup your quality system.
important to get this audit right as the results will beMost importantly it is an inspection of the way the
used to set the direction of your organization on itspeople in the organization work and the knowledge
route to full ISO 9001 2000 registration. In short ifthey have about the operation of the quality
this audit is wrong or incomplete your organization willmanagement system. management reviews must be
happily steam along in the wrong direction, wastingcarried out by the top management in your
resources as it goes, until someone tells youorganization to ensure that your Quality Management
otherwise. If I were to give one piece of advice hereSystem is working effectively and that it is geared to
it would be to recommend using a professional, aproduce continual improvement of your products or
small amount of money spent at this stage couldservice.Registration requirements vary slightly
save you unnecessary expenditure if you were tobetween the various certification bodies but it is usual
get it wrong.As the gap analysis audit on yourto have a Pre-Assessment.
organization progresses you will be able to identifyA pre-assessment is a mock audit similar in duration
the processes which are already documented, andto a full registration audit which your organization
those that are not. It will be useful to yourneither passes nor fails.
organization to compile a list of documents that youThe important feature of a pre-assessment is that it
will need for the Quality Management System as youwill provide a full list of any short falls between the
complete the gap analysis audit, there is no sense inrequirements of the ISO 9001 2000 standard and
doing the same job twice.It is important toyour Quality Management System.As a senior lead
remember that just because a process isauditor I would always advise an organization to opt
documented does not necessarily mean it is compliantfor a pre-assessment.You now need to select a
with the requirements of the ISO 9001 2000registration agency.There are many registration
standard. Almost certainly your organization will haveagencies to choose from and in theory they are
to tweak existing processes and or instigate newsimilar inthe services they provide, chiefly because
ones in order to comply with the documentedthey all have to abide by the same to EN standards,
requirements of the ISO 9001 2000 standard.For thisEN45011 and EN45012. In practice they offer
purpose you may decide to bring together a team ofdifferent service levels, response times and
employees and have them review the processes andre-assessment periods. So my advice would be to
suggest improvements which will make the processchoose your registration body very carefully.Finally
compliant with ISO 9001 2000. Alternatively you maythe day has arrived for your registration rudit. This is
wish to employ an ISO 9001 2000 consultant towhere an auditor from the chosen certification body
carry out this task for you. Whilst a consultant mayvisits your organization and carries out a
initially seem expensive he or she will have thecomprehensive audit of your organization.When the
experience to complete the task expediently andauditor identifies a discrepancy or non-conformance
cost effectively.Now that the organizations processesbetween the work that is being performed and the
and any short falls against the ISO 9001 2000requirements of ISO 9001 and how you say you
standard have been identified they have to beoperate your processes the discrepancy or
documented in a within a controlled document controlnon-conformance will be written up. There is no
system. Whilst there is not a definitive, prescribedspecific number of non-conformances that have to
method to document an ISO 9001 2000 Qualitybe raised for your organization to either pass or fail.
Management System there are, as with most things,It depends on how serious each point raised is or if a
easy and hard ways of doing this.number of minor issues are all raised against one
If you are unsure how to do this there is anclause of ISO 9001 2000, say for example design.For
example procedure here or once again you canexample: If only a few minor non-conformances are
employ a consultant to complete this taskfound during the registration audit, the registration
expediently.Design and implement the Qualitybody will issue a certificate of registration to ISO
Management System to comply with the9001 2000 stating that your organization complies
requirements of ISO 9001 2000.This will typicallywith the requirements of the ISO 9001 standard. If
require:Establishing a quality policy and measurablehowever a major non-conformance is raised this
quality objectives.Documenting a quality manual,results in your organisation being told that you must
describing your Quality Managementcorrect the non-conformance(s) and re-apply for
System.Documenting procedures which describe theanother registration audit. This is why I would always
processes in your organization.Creating a documentrecommend that you have a consultant carry out a
issue, withdrawal and re-issue of documentsPre-Assessment audit on your business, re-applying
system.Documenting test and inspectionfor a complete re-assessment from a registration
methods.Documenting a corrective and preventivebody can be a very expensive business.Once a
action process.Identification of training needs andcertificate of registration is issued it typically expires
necessary job skills.Calibrating and controllingafter three years, however some registration bodies
measuring and test equipment.Measuring andcertificates never expire.
monitoring customer satisfaction.Measuring process,All registration bodies typically require Quality
and product conformity.Training employees on theManagement System surveillance audits of your
operation of the quality management system.Planning,organization at six months intervals to maintain the
conducting and following up internal Qualityvalidity of the certificate.At this point, you deserve
Management System audits.Continual improvement ofto celebrate your accomplishments!
the Quality Management System.As each process inHowever, once the certificate is issued you need to
your organization is revised, documented andcontinue to monitor your own Quality Management
implemented you need to ensure that yourSystem to ensure you continue to comply with the
employees are trained accordingly in the operation ofrequirements of ISO 9001 2000.Driso provide ISO
the revised process and that their documented9001 2000 consultancy, auditing, software, and
training records are updated. All employees musttraining Services.
have had at least basic ISO 9001 2000 training soThey also supply Easy ISO 9001 2000(R) software
that they can demonstrate that they understandfor initially setting up an ISO 9001 2000 compliant
what is required of them. You can either attempt thisQuality Management System or improving upon an
training your self or employ a consultant trainer to doexisting one.To contact Driso Consultancy Services
this task for you.You must generate and keepvisit the web site below and see what they can do
documented records of employee training infor you and your business.
accordance with your new processes proceduresContact: for more details.