ISO 9000 Certification

By ICS |

This article is the first in a four-part series looking at ISO 9000 certification, its importance to manufacturers and how ICS is on the forefront of meeting these stringent industry guidelines to improve manufacturer satisfaction and patient safety.

 

W. Edwards Deming, known as the father of total quality management, once said, “If you can’t describe what you are doing as a process, you don’t know what you’re doing.”

Quality Management Systems (QMS) are meant to do just that — define and improve the procedures, processes and resources needed to deliver products and services at the highest level of performance excellence.

The International Organization for Standardization (ISO) is a very highly regarded standardization body. This form of standardization is designed to help organizations ensure that they meet the needs of customers and other stakeholders. It’s based on eight key principles, including:

  1. Customer focus
  2. Leadership
  3. Involvement of people
  4. Process approach
  5. System approach to management
  6. Continual improvement
  7. Factual approach to decision-making
  8. Mutually beneficial supplier relationships

The U.S. Food and Drug Administration also supports the role of quality management.

Why does certification matter to manufacturers?

ICS, a division of AmerisourceBergen Specialty Group, is the leading third-party logistics (3PL) provider for the pharmaceutical manufacturing industry, focused on improving the quality and efficiency of the supply chain for pharmaceutical products that require special handling. When the FDA embraced the use of “modern quality management“ in September 2003, ICS identified a need. They discovered that some competitors had received quality certification for parts of their business — a single distribution center or even the headquarter office — but no other company was fully certified across its entire range of offerings.

ICS wanted to define a standard of excellence in their market space. In a highly competitive environment, it’s these standards that make a difference. By providing high-quality service, ICS demonstrated to clients that the company is prepared and highly capable of managing complex logistics requirements.

ICS chose to obtain ISO 9000 series certification because it provided a standardized approach to continuous improvement that encompasses all areas of the organization. It provided a framework for demonstrating to clients and supply chain partners a way to define and continuously improve quality throughout the entire organization, from risk management to distribution to accounts receivable and IT. The certification also extends to all locations where the organization is represented, including its two distribution centers in Reno, Nevada and Brooks, Kentucky, as well as World Courier with offices in 52 countries. ICS has been ISO-certified since 2004, and is currently the only 3PL provider in the pharmaceutical industry that is ISO-certified across the entire enterprise.

In addition, these standards were entirely consistent with the AmerisourceBergen mission, vision, values and quality policy already set in place. ICS was one of the first companies in the country to be certified to the 2008 version of ISO 9001 standard.

By providing customers with truly exacting standards, ICS helps companies focus on what matters most: your people, your patients and your products.

Next week, in part two of this four-part series, we will discuss ISO 9000 certification in-depth, why it’s crucial to manufacturers and how ISC’s certification sets them apart as a 3PL.

To explore other practical analysis on topics ranging from health policy and informatics to social media in retail pharmacies, visit us online at knowledgedriven.com.