Quality Policy the base of the organisation

1. Quality Policy
By Jigar Swami
Author of Pharma Funs Blogspot

2. WHAT IS QUALITY POLICY

3. What is Policy
3
•We have seen Quality Policy on a board,
outside or just at entry point of our each SPIL
sites.
•The Quality Policy is the common message for
everyone in the organization from top to
bottom.
•It should be written by the Managing Director
(Highest position of the company) with
feedback from the work force and be approved
by the quality council.

4. REQUIREMENT OF QUALITY POLICY

5. Requirement of Quality Policy
5
• The requirement of Quality Policy is
mentioned in the ISO9001:2015 clause
no. 5.2 which describes the requirements
of quality policy.
• In which it is state that the quality policy
should appropriate to the purpose and the
context of the organization and supports
the strategic direction of the organization.
• It is also required as per the ICH Q10
“Pharmaceutical Quality Systems”.

6. HOW QUALITY POLICY MAINTAINED

7. How Quality Policy Maintained
7
• The Quality Policy must be available as
documented information, maintained
properly and communicated to every
employee, customer and supplier.
• It must be clearly understood by everyone
in the organization so that every
employee could contribute to the
implementation of the quality policy to
every corner of the organization.

8. WHAT TO COVER IN QUALITY POLICY

9. Four Parts of Quality Policy
9
Quality Policy
1.
Mission of the
organization
2.
Commitment
to compliance
3.
Commitment
to customer
satisfaction
4.
Commitment
to continual
improvement.

10. Description of Four Parts
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• The 1st part of the quality policy describes the information
about the mission of the organization, such as product or
service of the organization, who are the customers, and how
the organization delivers its products or services.
• The 2nd part describes the information about the commitment
to compliance with all requirements of all applicable standards
such as QMS and other government rules and regulations.
• The 3rd part provides the information about the commitment to
the customer satisfaction of both internal and external
customers such as defect free products, new technology and
understanding of knowledge.
• The 4th part showcases the commitment to continual
improvement. This implies the organization committed to
improve.

11. Thank you