BURGEON PHARMACEUTICALS PVT LTD

ISO
9001:2000
ISO means?
The Company goes for certification

– I S O 9001
– I S O 9002
– I S O 14000
I S O was latest amended in the year

– 1994
– 2000
I S O head quarters is in

– Geneva
– Bombay
– Chennai
I S O explains

– Quality
– Systems
– Standards
Implementation of I S O is the
responsibility of

– Management
– All employees
– Auditors
I S O improves

– Process efficiency
– Production increase
The purpose of I S O is

– Customer satisfaction & Continuous

improvement
– Cost control
M R means

– Manufacturing Range
– Management Representative
– More Right
There are main requirements in ISO
9001:

 Quality Management System

 Management Representative
 Resource Management
 Product Realisation
 Measurements, Analysis & Improvement.
Will you agree the above five points?
– Yes
– No
I S O leads to T Q M, Will you agree?

– Yes
– No
Is there any difference between Q. A. &
Q. C.?

– Yes
– No
Quality means “The totality of features
and characteristics of a product or
service that bear on its ability to
satisfy stated or implied needs.”
Will you agree?

– Yes
– No
Who approves Quality Policy of the
organization?

– M. R.
– H. R.
– M. D.
Quality system in the organization
talks about

– Share Holders Development.

– The organizational structure, responsibilities,
procedures, processes and resources for the
discharge of quality – management
responsibilities.
NON Conformity means

– Non – fulfillment of a requirement.

– Non – cooperation of employees.
Preventive action means

– Prevent the action on the work.

– Action to eliminate the cause of a potential non
conformity or other undesirable situation.
Corrective action is

– Action to eliminate the cause of a detected non-

conformity or other undesirable situation.
– To correct the employees attitude.
We need I S O 9001 because
– Competitive advantage.
– Improvement Customer Demand
– Protect Your Business:
– Your Competitors Are Doing It
– New Prospects
– Easy & Cost Effective:
– Quality for Government Contracts
– Increased Credibility
– Develop New Customers
– Don’t Be Left Behind
– All the above
Is there difference between Records &
Format?

– Yes
– No
Documents are to be controlled as per
I S O 9000 is it true?

– Yes
– No
Obsolete copy of documents means

– Usable documents.
– Old and non-usable documents.
Internal Quality audit is done by

– External agency.
– Employees.
– Government.
Customer means from the view point
of employees

– External buyers
– Internal buyers
Satisfaction comes out of

– Quality.
– Cost.
– Packing.
– On time delivery.
– Communication.
– All the above.
Quality means

– Performance.
– Quality.
– Cost.
– Packing.
– On time delivery.
– Communication.
– All the above.
Resources include manpower, do you
agree?

– Yes
– No
Training will improve process
capability;

– Yes
– No
Standards & Quality

– Both are same

– No. Standard leads to quality
Continuous improvement is made
through

– Employee involvement
– Rules & Regulations.