Regulatory Focus™ > News Articles > With Eye on Improving Quality, Indian Regulator gets First ISO Certification

With Eye on Improving Quality, Indian Regulator gets First ISO Certification

Posted 24 February 2015 | By Michael Mezher 

With Eye on Improving Quality, Indian Regulator gets First ISO Certification

India’s regulatory authority has announced that one of its offices has become the first in the country to become certified by the International Organization for Standardization (ISO).

In a press release, the Central Drugs Standard Control Organization (CDSCO) said that its Ahmedabad office received ISO 9001:2008 certification for its quality management system (QMS) on 16 February 2015.

Background

ISO 9001 is a set of standards for QMS in organizations where it is important to be able to demonstrate their ability to meet customer and regulatory requirements. The provisions of ISO 9001 are general, and can be applied to organizations of all types and sizes. Due to its general nature and applicability, ISO 9001 is one of the most common ISO certifications in the world. According to ISO, more than 1.1 million ISO 9001 certificates have been issued globally.

CDSCO and ISO 9001

While ISO 9001 is not specific to regulatory functions, the move to gain ISO certification is a sign of India’s determination to make its regulatory authority more credible and accountable. In recent months, CDSCO has announced a number of initiatives to improve its regulatory processes.

The Ahmedabad CDSCO office is responsible for a number of regulatory functions that are important to carrying out its mission. These tasks include processing applications for manufacturer licenses and quality evaluations for drugs and cosmetics, as well as issuing Certificate of Pharmaceutical Product (COPP) based on World Health Organization (WHO) good manufacturing process (GMP) guidelines.

CDSCO says implementing an ISO 9001 compliant QMS will help the office improve in a number of ways. In particular, CDSCO says adhering to these standards will provide the following benefits:

  1. “Increases effectiveness and efficiency of the organization through continual improvement in system and services.”
  2. “Improved risk management through greater consistency and traceability of services.”
  3. “Improve operational efficiency and effectiveness of the organization by encouraging well defined and documented procedures.”
  4. “Public satisfaction through delivery of services that consistently meet their requirements.”
  5. “Increases employee motivation as work process will be well defined.”
  6. “Improved stakeholder’s relationship.”

To gain ISO 9001 certification, the Ahmedabad office was audited by the notified body TUV Rheinland Cert GmbH, a global certification company.

 

CDSCO Press Release


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