ISO9000
for
Small and Medium Scale Enterprises
About
ISO
ISO
stands for International Organisation for
Standardisation. It is based in Geneva,
Switzerland
and was formed in the year 1947. The
organisation consists of representatives from over 140 countries. Each country is
represented by its standard body. ISO
comprises more than 180 technical committees,
covering many industrial sectors and products.
These technical committees, as far as
possible, try to address the requirements of
the member countries while formulating their
standards. It aims at harmonization of
standards at the international level with a
view to minimise trade and technical barriers.
ISO publishes both product and system
standards.
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ISO9000
Standards
ISO9000
is a series of standards for Quality
Management and Quality Assurance. While
ISO9001 is meant for certification purpose,
ISO9000 and ISO9004 provide vocabulary and
guidelines. The latest revision of the
standard has taken place in December 2000. The
ISO9001 (Version 2000) replaces the old
version (1994 version) of ISO9001, ISO9002 and
ISO9003.
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Who
can apply ?
Any
legal entity having manufacturing / service
operations can apply for ISO9000 certification.
Manufacturers, Service Organizations, Trading
Houses, Banks, Hospitals, Educational
Institutions etc. are eligible for applying.
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Benefits
of ISO9000 certificate
For
Small and Medium Scale companies, which normally
do not enjoy much of brand image,
ISO9000 certification helps to build confidence
in the minds of customer organisations. This is
particularly true in case of Tenders and
other contractual situations involving
institutional buyers.
In
India, where the Government is a prominent
buyer, many of the public sector organisations
have already started insisting on ISO9000
registration for vendor enlistment. In private
sector also, the situation won't be different in
the due course of time.
Other
benefits of ISO9000 registration are:
- Clarity
in definition of authorities and
responsibilities
- Enhanced
corporate image and market positioning
- Better
records and documentation in case of
litigation
- Use
of recognized mark (of certifying agency) on
stationary and advertisement
- Reduction
in the need for multiple second party
assessments
- Better
traceability to root causes of quality
problems
- Rectification
of errors at the earliest stage
- No
repetition of errors
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Steps
involved in ISO9000 Certification
The
steps involved in any ISO9000 certification
project are the following:
- Gap
Analysis:
Assessment of existing quality
management practices vis-a-vis ISO9001
requirements.
- Orientation
Training:
Top/Senior Management orientation on ISO9001
requirements and action plans.
- System
Documentation:
Preparation of quality manuals and design of
quality record formats.
- System
Implementation:
Implementation of quality system as per the
quality manuals.
- Company-wide Training:
Training on ISO9000 clauses, Statistical
Quality Control Techniques, and Quality
Audit.
- Internal
Quality Audits:
Periodic assessment of quality system
implementation and corrective actions.
- Pre
assessment:
Initial audit by Certifying agency, and,
implementation of corrective actions.
- Final
Assessment:
Certification audit by the Certifying agency
and recommendation for certification
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Major
cost elements
There
are three major cost elements in any
ISO9000 project. They are:
1.
Cost of purchase/calibration of
measuring instruments.
2. Fees to be paid to external consultants.
3. Fees to be paid to certifying agency.
The
above costs depend on the size and complexity
of operations of the applicant company.
In India, for a small company having a
manpower of around 20, with factory and office
located in one place, the total cost falls in
the range of Indian Rupees 60,000 to 80,000 only.
Yes, it doesn't cost so much as one might
think.
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Choosing
a consultant
Before
deciding on your ISO9000 consultant, consider
the following:
Formal
Qualifications:
As in the case of medical / financial
services, look for formal qualifications. At its
minimum level, a graduate engineer with
degree/diploma in Quality Assurance and
Management may be acceptable. (Today, there are
many reputed institutions in India that conduct
degree/diploma courses in Quality Management).
Apart from knowledge of ISO9000, your consultant
should have adequate knowledge of Statistical
Techniques (SQC, SPC, Design of Experiments
etc.)
Relevant
Experience:
Your
ISO9000 consultant should have at least three
year experience handling two to three
ISO9000 projects independently or as the
principal consultant. Avoid those with long
experience in other fields and little exposure
to ISO9000.
Willingness
to help in documentation:
Your
ISO9000 consultant should prepare first draft
of at least the Quality Manual and
Quality System Procedures. This would help in
quick implementation of the system. (99.99%
cases of project dragging is due to
incomplete documentation !)
Support till
certification:
Get
firm commitment from your consultant that he
shall provide support till your company gets
certified.
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Choosing a Certifying Agency
This
job is also very important. Usually, your
ISO9000 consultant suggests a name. But, do not
forget to ask your friends in the industry and
verify the credibility of certifying agency. As
ISO9000 is more relevant in contractual
situations, your customer can be well aware of
the standard of certifying agencies.
Another
point is regarding recognition of certification.
In case your buyers are from a different
country, it is better to select an auditing
agency well recognized in the buyers' country.
Cost
is yet another factor. Due to stiff competition,
certification fee has come down a lot. However,
there can be hidden costs like cost of flying
down an auditor from a remote location. In that
case, hidden cost can be more than certification
fees. So, always go for a credible agency with
sufficient number of auditors stationed locally.
BIS, BSI, BVQI, DNV, IRQS, LRQA, SGS, STQC, TUV, and UL are some of the ISO9000 certifying
bodies operating in India.
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