ISO9001:2008
Quality Management System Certification
About
ISO
ISO
stands for International Organisation for
Standardisation.
It is an international body based in Geneva,
Switzerland and was formed in the year 1947. The
organisation consists of representatives from over 160 countries. Each country is
represented by its national standards body. For example, India is represented by the Bureau of Indian Standards.
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 System. While
ISO9001 is meant for certification purpose,
ISO9000 and ISO9004 provide vocabulary and
guidelines respectively. The latest revision of the
standard has taken place in November 2008. The
ISO9001 (Version 2000) replaced the older
version (1994 version) of ISO9001, ISO9002 and
ISO9003. Now, the 4th edition of the standard (ISO9001:2008) replaces ISO9001:2000.
ISO9001:2008 is based on the eight principles of quality management, and is modelled on 'process approach'. It advocates the P-D-C-A (Plan-Do-Check-Act) cycle for continual improvement and customer satisfaction. Please note that ISO9001:2008 certification is for quality management system, and NOT a product certification scheme.
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Who
can apply ?
Any
legal entity having manufacturing / service
operations can apply for ISO9001 certification.
Manufacturers, Service Organizations, Trading
Houses, Banks, Hospitals, Educational
Institutions, Government Agencies, NGOs, etc. are eligible for applying.
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Benefits
of ISO9001 certificate
For
Small and Medium Scale companies, which normally
do not enjoy much of brand image,
ISO9001 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 ISO9001
registration for vendor enlistment. In private
sector also, the situation is not much different.
Other
benefits of ISO9001 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 ISO9001 certification
The
steps involved in any ISO9001 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 ISO9001 clauses, Statistical
Quality Control Techniques, Housekeeping (Japanese 5-S), 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
ISO9001 project. They are:
1.
Cost of purchase/calibration of measuring instruments (if required)
2. Cost of training resources and fee to be paid to external consultants, and
3. Fee to be paid to the 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 50,000 to 60,000 only.
Yes, it doesn't cost so much as one might
think.
Good News: Indian firms with permanent Small Scale Industry (SSI) registration can avail 75% (or Rs 75,000/= whichever is lower) reimbursement of the above costs from the Government of India. This scheme is valid upto 31st March 2012.
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Choosing
a consultant
Before
deciding on your ISO9001 consultant, please consider
the following:
Formal
Qualifications:
As in the case of medical / financial
services, look for formal qualifications. At its
minimum level, a graduate in science/engineering with additional
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 ISO9001, your consultant
should have adequate knowledge of quality improvement techniques (SQC, SPC, Six Sigma, Design of Experiments,
etc.).
Relevant
Experience:
Your
ISO9001 consultant should have at least three
years experience of handling two to three
ISO9001 projects independently or as the
principal consultant. Avoid those with long
experience in other fields and little exposure
to ISO9001.
Professional Ethics:
Do not sign-up those ISO9001 consultants who claim to represent a particular certifying agency and/or offer package deals. Also, do not go with those document forgery experts who assure you the ISO9001 certification within ridiculously short time span (say, fifteen days). When you expose your personnel to such unethical people during project implementation, it would cause irrepairable damage to your organizational culture.
Please keep in mind that any organisation (big or small) with genuine commitment to quality and customer satisfaction can achieve ISO9001 certification.
Willingness
to help in documentation:
Your
ISO9000 consultant should prepare the first draft
of at least the Quality Manual, Quality System Procedures, and Standard Forms for QMS record keeping. 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 ISO9001 consultant suggests some reputed names. But, do not forget to ask your friends in the industry and verify the credibility of the certifying agency. As ISO9001 is more relevant in contractual situations, your customer can be well aware of the standard of certifying agencies. Although there are over 700 ISO9001 certifying agencies worldwide, only a few have good reputation ! Also, you must insist on signing the service agreement between the Certifying Agency and the Organization applying for certification and pay the audit fees directly to the Certifying Agency. Reputed certifying agencies do not sign-up or bill via a third party like a consulting / accounting / manpower placement agency.
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.
BVQI, DNV, SGS, TUV, and UL are some of the reputed ISO9001 certifying bodies operating globally.
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Useful ISO9001 resources
The following products and services could be helpful in understanding the requirements, developing the system documents, implementing the system, and getting the coveted ISO9001:2008 certification:
- ISO9001:2008 Awareness Training Kit (Product Codes: M0003A / M0003B)
- ISO9001:2008 Documentation Kit (Product Codes: M0001A / M0001B or M0002A / M0002B or M0006A / M0006B)
- Management System Audit Training Kit (Product Codes: M0005A / M0005B)
- FBM Tools: Management System module - a computer software for ISO9001:2008 implementation and record keeping (Product Codes: S0007A / S0007B)
- FBM Tools: Calibration Management module - a computer software for calibration tracking of measuring instruments & gauges and Measurement System Analysis (Product Codes: S0006A / S0006B)
- Project eConsulting Service for ISO9001:2008 Certification (Service Codes: C0021 / C0022)
Please visit our eShop to know more about these resources and to purchase them right away.
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