Wednesday, April 8, 2009

ISO 9000

ISO 9000

International organization for standardization
Non governmental system
Introduced in 23rd Feb, 1947
ISO is primarily concerned with establishing standards.
ISO 9000 series
ISO 9000:1994
ISO 9001:1994
ISO 9002:1994
ISO 9003:1994
ISO 9004:1994
ISO 9000:1994
Provides the definition of terms and provides overall guidance on the selection and application of ISO 9001:1994, ISO 9002:1994, ISO 9003:1994.
ISO 9001:1994
Model for quality assurance in design, development, production, installation and servicing.
ISO 9002:1994
Quality system model for quality assurance in production
Installation nd servicing
Except “ design control” all other parameters are as ISO 9001:1994
ISO 9003:1994
Quality system model for quality assurance in final inspection and test
ISO 9004:1994
It provides the detailed guidelines on the quality element included in the certification standards

New ISO 9000 family consist of
ISO 9000:2000- quality management system-fundamentals and vocabulary
It cancels and replace ISO 8402: 1994 quality management and quality assurance- vocabulary and ISO 9000: 1994, clause 4 and 5.
ISO 9001:2000- quality management system- requirement
It cancels and replace ISO 9001: 1994
ISO 9002:2000- model for quality assurance in production, installation and servicing.
ISO 9003:2000- model for quality assurance in final inspection and test
ISO 9004:2000- quality management system- guidelines for performance improvement.
It cancels and replace ISO 9004:1994

Advantages over ISO 9000:1994

Number of standards are reduced
More logical structures
These standards are more user friendly
There is increased focus on top management comiitment
Continual improvements
ISO 9000:2000 series is built on 8 quality management principles.

Principle 1- customer focus
Principle 2- leadership
Principle 3- involvement of people
Principle 4- process approach
Principle 5-system approach to managment
Principle 6-continual improvment
Principle 7-factual approach to decision making
Principle 8- mutually beneficial supplier relationships

Applications of ISO 9000 to pharmaceuticals

Design control
Document control
Purchase level
In loan licensing
Product identification and traceability
Qualification of systems and sub systems
Inspection and testing
Inspection, measuring and test equipments
Inspection and test status
Control of noon confirming products
Corrective actionsHandling, storage, packing and delivery

1 comment:

iso 9000 said...

Hey, very nice site. I came across this on Google, and I am stoked that I did. I will definately be coming back here more often. Wish I could add to the conversation and bring a bit more to the table, but am just taking in as much info as I can at the moment.

iso 9000