ISO Standard 9001_2008

1. ISO 9001 STANDARD
Submitted by:
Aarushi Mahajan (A1)
ZEE LABORITIES

2. Zee Pharma Ltd.
◦ SCOPE : Manufacture and Supply of Allopathic Medicines-
Tablets(Betalactum & Non Betalactum), Capsules (Betalactum & Non
Betalactum), Dry Powder, Liquid Oral, Soap, Ointments (Ext.), Injectables
and eye drops.
◦ Exclusion : ISO 9001: 2008 Std. Section 7.3 & 7.5.4
◦ Why does it need ISO standard ?
-To maximize customer satisfaction and add value.

3. WHAT IS ISO 9001 STANDARD ?
ISO 9001:2008 specifies requirements for a quality management system
where an organization
◦ needs to demonstrate its ability to consistently provide product that
meets customer and applicable statutory and regulatory requirements,
and
◦ aims to enhance customer satisfaction through the effective application
of the system, including processes for continual improvement of the
system and the assurance of conformity to customer and applicable
statutory and regulatory requirements.
◦ All requirements of ISO 9001:2008 are generic and are intended to be
applicable to all organizations, regardless of type, size and product
provided.
◦ Where any requirement(s) of ISO 9001:2008 cannot be applied due to
the nature of an organization and its product, this can be considered for
exclusion.

4. WHYTHE COMPANY OPTED FORTHIS
?
◦ Quality Objectives:
◦ To deliver right products and services within specified time on 98%
basis.
◦ No Batch Failure in the year.
◦ Max. 2 Customer Complaints in a year.
◦ To Maintain max 20 Hrs down time of Machines in a year.
◦ Monitoring of Quality system and product characteristics for the
continual improvement.
◦ The quantification of objectives shall be done, the same will be
maintained and discussed in the MRM during the MR meeting .

5. Measurement, Analysis & Improvement
:
◦ General:
◦ The measurement and monitoring process needed to assure conformity
in the operations performed in the organisation have been defined.
◦ The Process improvement is an on going activity and may sometimes
need additional measurement and monitoring. These measurements are
also planned and implemented while executing the improvements.
◦ In order to obtain the scope of improvement and hence the continuous
improvement, problem solving tools are be used.
◦ The continuous improvement & its effectiveness can be ensured by
using the process monitoring charts.

6. HOW HAS IT BENEFITTEDTHE
COMPANY ?
◦ Understanding and meeting customer and regulatory requirements
◦ Reducing process variation (Standardization of process
◦ Actively managing process
◦ Betterment of business results
◦ Investing in employee development

7. -THANK YOU-