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Introduction:

ISO 9001:2008 is an internationally recognized standard for the certification


of Quality Management System for various businesses / systems. These
apply to the businesses and processes that create value and provide control
to the products / services in an organization. This standard prescribes
systematic control of activities to ensure that needs and expectations of
customers are met and a healthy and safe environment is maintained for the
benefit of the customers, workers who produce these products and services
as well as people at large in the adjoining vicinity. These are designed and
intended to apply to virtually any product or services, made by any process,
anywhere in the world.

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.

In order to claim conformity with ISO 9001:2008, the organization has to be


able to provide objective evidence of the effectiveness of its processes and
its quality management system. Objective evidence does not necessarily
depend on the existence of documented, it is up to the organization to
determine what records are necessary in order to provide objective
evidence.

Background to the ISO 9001:2008 revision process

In order to assist organizations to have a full understanding of the new ISO


9001:2008, it may be useful to have an insight on the revision process, how
this revision reflects the inputs received from users of the standard, and the
consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management


system standard, ISO/Guide 72:2001, Guidelines for the justification and
development of management system standards recommends that a
“Justification Study” is prepared to present a case for the proposed project
and that it outlines details of the data and inputs used to support its
arguments. In relation to the development of ISO 9001:2008 user needs
were identified from the following:

• the results of a formal “Systematic Review” on ISO 9001:2000 that was


performed by the members of ISO/TC 176/SC2 during 2003-2004
• feedback from the ISO/TC 176/Working Group on “Interpretations”
• the results of an extensive worldwide “User Feedback Survey on ISO
9001 and ISO 9004” by ISO/TC 176/SC 2/WG 18 and similar national
surveys.

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:

1. No changes with high impact would be incorporated into the standard;

2. Changes with medium impact would only be incorporated when they


provided a correspondingly medium or high benefit to users of the
standard;
3. Even where a change was low impact, it had to be justified by the
benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in


terms of impact into the following categories:

• No changes or minimum changes on user documents, including


records
• No changes or minimum changes to existing processes of the
organization
• No additional training required or minimal training required
• No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following
categories:

• Provides clarity
• Increases compatibility with ISO 14001.
• Maintains consistency with ISO 9000 family of standards.
• Improves translatability.

Benefits

Most organizations want ISO 9001 certification to qualify for a tender or to


achieve preferred supplier status: typically for a Local Authority or for a
supply chain requirement. However, whoever you decide to choose as your
Certification Body, make sure they are UKAS accredited. It could prove a
costly mistake if you don’t. There are many benefits to achieving ISO 9001
certification, including:

• Preferred status for tenders


• Improved internal working
• Winning more business
• Less costly errors and re-work
• Enhanced status
• Better communications and motivated staff
• Improved customer satisfaction and loyalty
• Preferential insurance premiums
• Increased profitability
• Competitive advantage

The audit process is an independent check of your systems and procedures


to show if you are doing what you say that you should do and if it meets the
requirements of ISO 9001, failure to this could potentially cause defective
services and products to reach your customers or for internal processes to
be inefficient costing you money. In addition to just auditing conformance
the certifications auditor will also highlight opportunities for improvement
and suggest where there may be better ways to do things.

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!

ISO 9001 Certification Audit Process

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.

STEP 3: Pre-Audit Assessment (known as Stage 1)


Your Lead Assessor will visit you to explain the standard and undertake a
conformity evaluation of your current arrangements for quality management.
You will then receive a detailed report including all required actions.
Together, you will then determine the appropriate timetable for your Audit
Assessment.

STEP 4: Audit Assessment (known as Stage 2)


Once you are ready for your formal Audit Assessment, your Lead Assessor
will make the required arrangements for you. On completion, you will be
informed of the Auditor's recommendation before he or she leaves your
premises.

STEP 5: Registration & Certificate


Following the Auditor's recommendation, your registration will be reviewed
and if approved your certification will be confirmed. Soon after, your
certificate of conformity to the ISO 9001 standard will be issued and sent to
you.
STEP 6: Continual Assessment
Having achieved certification, you will want to maintain your registration and
your Lead Assessor will remain on hand to undertake the required annual
reviews to ensure you continue to meet the requirements of ISO 9001.
ISO 9001: 2008 Required Documentation
Quality Documents
• Quality policy (clause 4.2.1.a)
• Quality objectives (clause 4.2.1.a)
• Quality manual (clause 4.2.1.b)

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

Records required by ISO 9001:2008


Clause Record required
5.6.1 Management reviews
6.2.2 (e) Education, training, skills and
experience.

Must maintain records of education,


training, skills, and experience; there
is a procedure
7.1 (d) Evidence that the realization
processes and resulting product fulfill
requirements.

Records needed to provide evidence


that the realization (existing)
processes and resulting product
(service) meet requirements.
7.2.2 Results of the review of requirements
related to the product and actions
arising from the review.

The organization shall review the


customer requirements of the
service. This review must be
conducted prior to commitment to
customer. Need records of the results
of the review.
7.3.2 Design and development inputs
relating to product requirements
7.3.4 Results of design and development
reviews and any necessary actions
7.3.5 Results of design and development
verification and any necessary
actions
7.3.6 Results of design and development
validation and any necessary actions
7.3.7 Results of the review of design and
development changes and any
necessary actions
7.4.1 Results of supplier evaluations and
any necessary actions arising from
the evaluations.

Records of evaluating suppliers must


be maintained
7.5.2 (d) As required by the organization to
demonstrate the validation of
processes where the resulting output
cannot be verified by subsequent
monitoring or measurement

Need records to validate a process


where you cannot monitor or
measure easily
7.5.3 The unique identification of the
product, where traceability is a
requirement
7.5.4 Customer property that is lost
damaged or otherwise found to be
unsuitable for use

Must maintain records re: customer


property issues
7.6(a) Basis used for calibration or
verification of measuring equipment
where no international or national
measurement standards exist
7.6 Validity of the previous measuring
results when the measuring
equipment is found not to conform to
requirements
7.6 Results of calibration and verification
of measuring equipment
8.2.2 Internal audit results and follow-up
actions
8.2.4 Indication of the person(s)
authorizing release of product.

Need a record of how service gets


released (approved). This could
include daily inspection records, etc.
8.3 Nature of the product
nonconformities and any subsequent
actions taken, including concessions
obtained
8.5.2 Results of corrective action
8.5.3 Results of preventive action

Documents which are not necessarily required but can be offered as


supporting the organization’s processes. This documentation should
be minimized.
• Process maps, process flow charts and/or process descriptions
• Organization charts
• Specifications
• Work and/or test instructions
• Documents containing internal communications
• Production schedules
• Approved supplier lists
• Test and inspection plans
• Quality plans

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

TIME ISSUE AND VALIDITY OF CERTIFICATE


If the Audit of assessment of Food Safety Management System is successful
and there is a positive recommendation by the inspection team, then the
Certificate is been issued in a short time. The certificate is valid for three
years and this period is supported by two annual surveillance audits.

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