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Chapter
7:
Assessment and certification
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Introduction
Implementing
the ISO 9000 quality system confers long-term benefits. However,
an immediate goal for most companies is certification by an
independent body.
The advantages of certification are:
It provides reliable evidence to the company's customers
(buyers) that its quality system has been examined
and found acceptable by an independent and internationally
recognised third party.
Customers can dispense with their own audit or surveillance
systems and rely on the certification obtained
by the supplier as a guarantee of quality, thus reducing their
costs.
Certification improves the company's image and the marketability
of its products and services.
It puts small and medium-sized
companies on par with large companies in both domestic
and foreign markets.
The following
provides information on how to select a certification body,
the steps taken by these agencies and the likely causes
of failure to obtain certification.
How to select a certification body
Certification bodies approved by the following accreditation
institutions offer their services in India:
1. Raad voor Accreditatie, The Netherlands
(RvA)
2. United Kingdom Accreditation Service
(UKAS)
3. Registrar Accreditation Board (RAB),
USA
First the company seeking certification must determine which
accrediting agency or agencies is relevant to its markets
for wide acceptance by its customers, although all three
agencies named above have mutual recognition agreements
the world over.
Then the company may select one of the registrar companies
accredited by the selected accrediting agency or agencies
situated in India as close to its site as possible so as
to minimise logistic costs for audits.
Typical certifying registrars operating in India are:
1. British Standards Institution, Quality
Assurance (BSI QA)
2. Bureau Veritas Quality International
(BVQI)
3. Lloyd's Register Quality Assurance
Ltd (LRQA)
4. Indian Register Quality Systems (LRQS)
5. National Quality Assurance Quality
Systems Registrar (NQA QSR)
The company can obtain quotes from more than one agency
giving its requirements and decide on the most appropriate
agency to suit its markets.
Preparing for assessment
A quality system cannot be realistically assessed until
it has operated for a certain period. Most assessors (certification
bodies) require a minimum of about three months from the
formal implementation date of the quality system to the
certification audit. It is necessary to have completed at
least one complete internal audit of all parts of the system
and taken necessary corrective actions and pursued audit
closure. At least one management review must have taken
place after the audit and its decisions proved effective.
This enables the company itself to identify problems and
to solve them before the assessor can pick them up.
Pre-assessment audit
The pre-assessment audit is a full dress rehearsal of the
certification audit in order to avoid any surprises in the
certification audit. Most certifying agencies agree to do
this at cost on request. The pre-assessment identifies problems
and enables the company to benefit from the advice of the
assessing officer on how to eliminate those problems.
The assessment process
The formal assessment is in two parts:
Documentation or adequacy audit. The assessment of the
quality system to determine whether it addresses
the requirements of the relevant standard.
Implementation audit. The assessment of practices to establish
that the documented system is being implemented
and that the practices satisfy the requirements
of the standard.
It is very common for the adequacy audit
to be done as a desk exercise using the company's quality
manual and related procedures. The Implementation audit
is an on-site assessment with the auditors interviewing
Specific auditees as per plan to find the extent of compliance
with respect to the company's own procedures as well as
the standard. This is usually structured into an opening
meeting with the company's management review committee,
the on-site assessment, followed by a closing meeting with
the same committee to discuss both positive and negative
points needing attention. On completion of the assessment
the
Lead Auditor presents the formal report and sets the agreed
time for removal of any nonconformities considered important
for certification.
Recommendations
The audit team submits its recommendations to the certifying
body either to grant certification straightaway or to withhold
certifications until identified major nonconformities, if
any, are completely rectified and reaudited for closure.
Nonconformities
The ISO standard does not define major and minor nonconformities.
All nonconformities should be identified with a relevant
element and the clause of the standard. The nonconformity
statement should be concise, accurate and supported with
objective evidence. It should enable one to take remedial
action to eliminate the nonconformity. A major nonconformity
is one, which results in the breakdown of the system. It
is a total non-compliance with a clause of the standard
or the corresponding procedure.
For example, a failure to carry out final inspection, a
failure to specify correctly in a purchase order for an
important item can be a major nonconformity.
A single lapse, which does not have a major impact on quality
system, is a minor nonconformity. Several such lapses in
several locations can be considered as a major nonconformity.
All major nonconformities must be remedied before certification
can be granted. Some minor nonconformities can be remedied
and closed during surveillance audits without affecting
the certification.
Award of the ISO 9000 certificate
If all goes well with the certification audit, the lead
auditor will inform the closing meeting that certification
is being recommended. It may take a few weeks before the
certificate can be received after the approval of the certifying
authority. The certificate is normally valid for three years
subject to surveillance audits every six months finding
the system complying. At the end of three years, a fresh
certification audit may be required.
Certification agencies normally allow their clients to use
the logo of their accreditation body on stationery and publicity
material. The certification is pertaining to the system
and therefore no claim should be made as to the quality
of products. The company may be allowed to:
Advertise the award in print media
Publicise press coverage of award ceremony
Advertise ISO 9000 certification as part
of company's long-term advertising strategy.
The number of companies so far certified
world over has surpassed 300,000 as per ISO statistics and
India has about 3000 certified companies.
Surveillance audits
The objective of the surveillance audits is to verify that
the quality system is still working and continues to meet
the relevant ISO standard. The one-day audit normally covers
only a part of the system. Internal audits, corrective and
preventive actions and management review records are audited
every time. The discovery of a major nonconformity during
surveillance audits can lead to withdrawal of the certificate;
the company will however be given official notice of such
action.
Any major complaint from a customer who has fulfilled his
responsibilities in the contract, lodged with the certifying
agency may result in a surprise audit and if justified in
the cancellation of the certificate and publicising thereof,
although such extreme actions are rare.
Why some companies fail to obtain certification
The causes of failure to obtain ISO 9000 certification include
the following:
Top management is not committed to obtaining certification.
The company has not given sufficient time and effort to
implementing the standard before applying for
certification.
The management representative has many other functions
in addition to that of maintaining the ISO 9000
quality system.
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uality
management
