ISO 9000 is a series of standards for quality management systems. It defines the required elements of an effective quality system for manufacturing and service industries. To get ISO 9000 certified, a company must first document its quality procedures and standards, implement the quality system, conduct internal audits, and take corrective actions. Then an accredited certification agency will audit the company and, if the quality system meets ISO standards, issue certification. Maintaining certification requires periodic reviews and updates to the quality system.
2. ISO
• ISO 9000 is a series of standards, developed and
published by the international organization for
standardization.
• Defines the required elements of an effective
quality management system for manufacturing
and service industries.
• Quality refers to all those features of a product
(or service) which are required by the customer.
• ISO Can be applied to any company.
3. History of ISO
• 1946 London - delegates from 25 countries
decided to create a new international
organization "the object of which would be to
facilitate the international coordination and
unification of industrial standards
• 1947 - ISO began to officially function
• 1951 - The first ISO standard was published
• National standardization activity started in India
in 1947
4. Cont…
• The establishment of the Indian Standards
Institution (ISI) as a society under the Societies
Registration Act 1860, to prepare and promote the
adoption of national standards.
• In 1952, the Institution was also given the
responsibility of operating a certification marking
scheme under an Act of Parliament
• In 1986 the national authorities made a review of
the structure and status of ISI and the Government
of India felt that a new thrust had to be given to
standardization and quality control activities
5. Cont…
• The Government of India therefore decided to
create a statutory organization as the national
standards body which was named as the Bureau
of Indian Standards (BIS).
• The Bureau of Indian Standards Act was passed
by the Parliament in 1986 and BIS came into
being on 1 April 1987.
6. Essence of ISO
• Plan & Document what you do.
• Do what you document & Record What you did.
• Check the results.
• Act on the difference.
• Do this periodically.
7. How to get ISO 9000?
• The two phases of ISO-9000 certification are
1. Documentation.
2. Certification.
8. DOCUMENTATION
• The documentation involves procedures,
standards and forms, which can be done in
house (or by the help of a consultant).
• An Organization needs to develop a documented
quality system, which satisfies the requirements
of the chosen ISO model.
• The organization needs to implement this
quality system.
9. CONT…
• Audit of the implementation needs to be
done regularly and in a timely fashion.
• Preventive and corrective actions need to be
identified and taken.
• Implementing the quality management systems,
there are three levels of documents.
▫ Quality manual.
▫ Procedure.
▫ Standards, forms and quality records.
10. CERTIFICATION
• The certification is done by an agency accredited
in this regard:
▫ The certification agency should be independent of
your organization.
▫ The certification agency should have sufficient
experience in certifying companies operating in a
similar business situation and environment as
yours.
▫ The certification agencies have a scope with in
which they can operate and give accredited
certificates.
11. CONT….
▫ Track record of the certification agency is also
critical for you to establish trust.
▫ The certification agency should be accredited to
EN 45012 ( or equivalent) which is the standard
applicable to them and the standards they should
be conforming to are ISO 10011-I,II,III.
▫ The geographical coverage of the organization has
probability of its acceptance internationally is
more if it is international.
12. DURATION FOR CERTIFICATION
• 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 action and
preventive action.
• At least one management review must have
taken place after the audit.