Why ISO 9000 Certification Matters to Manufacturers

 

Understanding ISO 9000 certification

Pharmaceutical manufacturers often hear the term “ISO certification,” but they might not fully understand what this means to their business. The ISO 9000 certification is established through the International Organization for Standardization (ISO) and is inclusive of the U.S. Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMP). Many aspects of FDA’s Quality System Regulations (QSR) were actually modeled around ISO standards.
These certifications provide a framework for demonstrating to clients that a documented Quality Management System (QMS) exists throughout an entire organization. The initial certifications are only the beginning of a committed process; the standard also sets requirements for continuous improvement that are verified through rigorous third-party audits.

Why does certification matter?

 

When a pharmaceutical manufacturer works with a third-party logistics (3PL) provider to handle their products between production and sale to consumer, they need to be assured that their products and customers will receive the highest care.

Some companies have received some sort of certification for parts of their business — an example might be a distribution center that is Verified-Accredited Wholesale Distributors (VAWD) certified. ICS maintains VAWD certification for our Distribution Centers and have also chosen to ISO certify every aspect of their service offering. Their customer service, training, program management, accounts receivable and information technology groups etc. are all subject to the same third-party audits as their distribution centers.

ICS is the leading 3PL provider for the pharmaceutical manufacturing industry, focused on continuously improving the quality and efficiency of their supply chain for pharmaceutical products that require special handling.

A little history: When the FDA embraced the use of “modern quality management” in September 2003, ICS identified that need. ICS wanted to define a standard of excellence in their market space. In a highly competitive environment, it’s the ability to establish a demonstrated reputation for excellence that sets companies apart. By providing high-quality service, ICS demonstrates to clients it is prepared and highly capable of managing complex commercialization requirements. In addition, these standards are entirely consistent with the vision, mission and values of its parent company.

ICS was one of the first companies (across all industries) in the country to be certified to the 2008 version of ISO 9001 standard. The certification also extends to all locations where the organization is represented, including its three fully certified distribution centers in Reno, Nevada and Brooks, Kentucky, and its World Courier partners in 52 countries around the world.

ICS has been ISO-certified since 2004, and is the only known pharmaceutical company offering our full suite of services to maintain such certification. This sets us apart and offers value to manufacturers. ISO certification coverage includes DEA Class I-V vaulting/caging/shipping, a full order-to-cash process including chargebacks and multiple locations as a component of a comprehensive disaster recovery plan.

Certification itself

 

Certification is performed by an external registrar and is a rigorous process. ICS receives assessment audits every six months. In addition, there is a “ground-up” re-certification every three years where all aspects of the company are examined for continuous improvement and compliance with the standard. These stringent audits mean that certified companies must be constantly “polishing” their methods and systems.

The standards in place through ISO are generic in scope, requiring full organizational involvement in the quality assessment process. This system delivers a structure for continuous improvement and supports empowering the associates to implement change.

Certainly, when ICS received high ratings from its triennial audit, this good news was shared with clients. But it’s not the specific number that clients care about. To them, ISO represents a standard of excellence. When ICS carries the ISO certification logo, it means that there’s a level of discipline that competitors don’t have.

The bottom line for manufacturers is confidence in their 3PL: because they know any company with full ISO 9000 certification has excellent business practices and standards in place. By providing manufacturers with truly exacting standards, ICS helps companies focus on their core goals.

 

What ISO 9001:2015 means for pharmaceutical manufacturers

Aristotle once said, “Quality is not an act, it is a habit.” That sentiment holds true today as a yardstick that pharmaceutical manufacturers can use to measure their 3PL. One of the best ways to measure the habits of quality is through International Organization for Standardization (ISO) 9000 certification.

That’s because it examines operations and quality management over time, so manufacturers can be certain their third-party logistics (3PL) provider meets stringent guidelines that are assessed regularly. Manufacturers are then free to focus on other core needs.

Bringing value to manufacturers

With this bottom-line value, ISO 9000 is viewed as the gold standard in the industry. In fact, only one American 3PL is fully certified from top-to-bottom in every location and offers its range of services: ICS. There are other 3PLs that have ISO 9001:2008 certification in areas of their business, but none in the U.S. offer full certification and the focus on improving the quality and efficiency of the supply chain for pharmaceutical products that require special handling.

ICS’ certification covers all locations where the organization is represented. This means ICS is entirely focused on quality throughout its entire organization, from program management and customer service to distribution and accounts receivable. Supporting functions like quality, IT and project management are also covered under the certification.

How ICS is different

ISO 9001:2008 certification differentiates ICS and offers great value to manufacturers. It provides a framework for proving to clients and supply chain partners that they are working to define and continuously improve in all business areas. These include:

• Secure controlled substance vault. Improves management of narcotics with full medication accountability by providing 24/7 inventory management, as well as an automated audit trail to comply with regulatory standards and increase efficiency

• Full order-to-cash for receiving and processing customer sales. Dedicated teams of logistics, accounting and customer service associates utilize their experience and extensive training to facilitate a smooth path, from order receipt to customer receipt and revenue capture

• Multiple locations. Three fully-certified distribution centers in Reno, Nevada, and Brooks, Kentucky, and World Courier partners in 52 countries around the globe

• Comprehensive disaster recovery plan. Full data redundancy through offsite servers

• Multiple storage sites.

• Ability to transmit orders utilizing alternative methods.

• Contract Management and Chargeback Processing.

This sets them apart, and offers “gold standard” value to manufacturers, one that proves quality that is a habit.

In the final installment of this series, we will look at the specifics of ISO 9000 certification, like audits and expectations.

ICS explains the specifics of ISO 9000

The International Organization for Standardization (ISO) has that as its basic philosophy, stating, “The adoption of a quality management system should be a strategic decision of an organization.” ICS has adopted such an approach in designing its systems to serve its clients through its ongoing ISO 9000 certification and scope of services.

ISO 9000 certification is all about preparation: It requires a rigorous pre-assessment process to determine the level of the organization and a continuous follow-up process. ICS, a third-party logistics (3PL) provider, has designed and created its processes and systems with its clients clearly in focus.

How does ICS comply and earn certification

While ICS has multiple business focuses, continuous improvement is a basic underpinning of all operations. Continuous improvement is taught as a cornerstone of new associate training and is incorporated into the culture throughout the organization.

Continuous improvement is most often conveyed through the idea of “plan, do, check and act.”

PLAN: A plan is developed around any potential service offering

DO: The planned activity is then performed

CHECK: An in-process evaluation or audit is performed to measure the efficacy of the planned activity

ACT: Based on the outcome, appropriate action is taken. The most important attribute of this is that the process must always continue. And it always does at ICS.

The role of internal auditors

The internal audit function at ICS reflects the continuous improvement ethos within the organization. Auditors are developed within different operational areas of the company. Those who are able to pass multi-phased credentialing administered by the American Society for Quality (ASQ) become part of the internal auditing team.

Additional standards of excellence

Key to identifying and driving training requirements are the associates of ICS themselves. Any associate, at any level, can identify an area for improvement or a training need and document it for mandatory action in the ICS system. Supervisory personnel approve all submitted requirements.

In addition, ICS utilizes an integrated documentation application to store and update its training and process documentation across the enterprise, from top to bottom.

We hope this article has helped you better understand ISO 9000 certification, the specifics of its application and why it matters so much that pharmaceutical manufacturers demand full certification of their 3PL providers. ICS takes their ISO 9000 certification seriously, and takes pride in the continuous improvement the process requires.