Quality Management System Certification
stands for International Organisation for
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
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 September 2015. This latest edition (ISO9001:2015) replaces the ISO9001:2008 standard.
ISO9001:2015 is based on the new seven principles of quality management, and is modelled on 'process approach' and 'risk-based thinking'. It advocates the P-D-C-A (Plan-Do-Check-Act) cycle for continual improvement and customer satisfaction. The new standard also stresses on taking the organizational context into account while developing an organization's quality management system. Please note that ISO9001:2015 certification is for quality management system, and NOT a product certification scheme.
can apply ?
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.
of ISO9001 certificate
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
India, where the Government is a prominent
buyer, most 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.
benefits of ISO9001 registration are:
in definition of authorities and
corporate image and market positioning
records and documentation in case of
of recognized mark (of certifying agency) on
stationary and advertisement
in the need for multiple second party
traceability to root causes of quality
of errors at the earliest stage
repetition of errors
involved in ISO9001 certification
steps involved in any ISO9001 certification
project are the following:
Assessment of existing quality
management practices vis-a-vis ISO9001
Top/Senior Management orientation on ISO9001
requirements and action plans.
Preparation of quality manuals and design of
quality record formats.
Implementation of quality system as per the
- Company-wide Training:
Training on ISO9001 clauses, Statistical
Quality Control Techniques, Housekeeping (Japanese 5-S), and Quality
Periodic assessment of quality system
implementation and corrective actions.
Initial audit by Certifying agency, and,
implementation of corrective actions.
Certification audit by the Certifying agency
and recommendation for certification.
are three major cost elements in any
ISO9001 project. They are:
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.
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 40,000 to 60,000 only.
Yes, it doesn't cost so much as one might
deciding on your on-site / off-site ISO9001 consultant, please consider
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,
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
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 without much difficulty.
to help in documentation:
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 !)
firm commitment from your consultant that he
shall provide support till your company gets
Choosing a Certifying Agency
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.
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.
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.
BV, DNV, SGS, TUV, and UL are some of the reputed ISO9001 certifying bodies operating globally.
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 ISO9001:2015 certification:
- ISO9001:2015 Awareness Training Kit (Product Codes: M0003A / M0003B)
- ISO9001:2015 Implementation Kit (Product Codes: M0051A / M0051B or M0052A / M0052B or M0053A / M0053B)
- Management System Audit Training Kit (Product Codes: M0005A / M0005B)
- 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 ISO9001:2015 Certification (Service Codes: C0021 / C0022)
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