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Euro Cert has established certain minimum expectations for companies who
wish to register their Quality Management Systems (QMS) to ISO 9001:2008.
These expectations are based upon our understanding of the requirements
of the standard and the requirements for third party registration/certification
to the standard gained through our collective experience in auditing quality
management systems of many varied applications.
The Justification Study identified the need for an amendment, provided that
the impact on users would be limited and that changes would only be
introduced when there were clear benefits to users.
The key focuses of the ISO 9001:2008 amendment were to enhance the
clarity of ISO 9001:2000 and to enhance its compatibility with ISO
14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was
created to assist the drafters of the amendment in deciding which changes
should be included, and to assist in the verification of drafts against the
identified user needs. The following decision making principles were applied:
• Provides clarity
• Increases compatibility with ISO 14001.
• Maintains consistency with ISO 9000 family of standards.
• Improves translatability.
Benefits
If you are the quality representative (often the Quality manager) then it is
also an ideal opportunity for you to influence the workings of the company
for the better, most auditors will be happy to raise non-conformities and
suggestions for improvement in areas that you identify need to be improved.
Most management teams place a lot of weight on correcting the independent
auditor’s findings, so initiatives that would have otherwise encountered huge
resistance can be pushed through with greater ease by using the auditor’s
findings!
The audit process is itself quite simple; if this is your first audit then you will
have what they call a “document review” audit. During this audit the auditor
will review all of the documentation that forms your quality management
system to ensure that you have covered all aspects of the ISO 9001
requirements within the documentation. The auditor will also discuss with
you the best way to conduct the audit of your actual process for your initial
audit.
The initial audit will cover all aspects of your quality management system
covered by ISO 9001; the auditor will plan a series of visits to each process
to follow your processes through the company. He will ask questions and
observe what you actually do, gathering evidence from records and other
documents to support his findings. This audit can take just 1 or 2 days to
several days with more than one auditor depending on the size of your
organization.
The findings of this initial audit will be fed back to your management team at
a closing meeting and if no major non-conformances have been found the
auditor will recommend you for certification. The report will be sent back to
the head office where it will be reviewed and within a few days you should
receive your certificate to ISO 9001.
If the auditor finds issues with your system then he may issue a non-
conformance, if these non-conformances are of a serious nature or they are
multiple then it could delay your certification. The auditor will wish to see
evidence of the closure of these problems before recommending you for
certification, either by a follow up audit or through you sending the evidence
if that is possible.
Once you are certified the certification body will audit you thereafter on a six
monthly or annual basis, reviewing your entire system over a period of
usually 3 years. They will expect to see evidence of continual improvement
over this period as well as to find that you are following your system.
Audit Process
ISO 9001 is easy even for absolute beginners simply follow our 5 Easy Steps
to implement ISO 9001 and achieve ISO 9001 certification:
STEP 1: Preparation
Realistically, if you are new to the ISO 9001 standard you are probably going
to need some guidance and where appropriate, we can provide access to
good-practice examples and guides. When you're ready, we’ll discuss your
requirements with you and provide you with a Fixed Price quotation so you
can budget accurately. Your quotation will be based on factors like what you
do, how many locations you operate from and how many people you employ
(if any).
STEP 2: Application
Once you decide to go-ahead, we'll assign a Lead Assessor to you. He or she
will be your principal contact throughout the registration process and
beyond. They will build up detailed knowledge of your organisation and will
be able to answer any questions you may have.
Documented Procedures:
• 4.2.3 Control of documents
• 4.2.4 Control of records
• 8.2.2 Internal audit
• 8.3 Control of nonconforming product
• 8.5.2 Corrective action
• 8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the
requirements of clause 4.2.3
REQUIRED DOCUMENTS
Certification process requires the certification request to the Certification
Body. At the Audit all the below are checked:
License of the Company and the accompanying documents
Other permits required
Organizational Structure / Chart
Objectives
Procedures and
Instructions for External Documents (e.g. Legislation)
Files