ISO 9001 FRAMEWORK IN THE

PHARMACEUTICAL INDUSTRY?
A need to have an effective and modern approach for a pharmaceutical Quality Management System
(QMS) It is worth noting that the pharmaceutical industry is behind the mark in quality management
practices, compared to other industries. The international organisation for standardisation develops
worldwide standards to help make industry more efficient and effective.

The ISO 9000 suite of standards is focused on quality management and is intended to help organizations
become better managed, more efficient, and more customer-focused. In India. Food and Drug
Administration’s (FDA) current Good Manufacturing Practices (cGMP), and many aspects of FDA’s
Quality System Regulations (QSR), are modeled around ISO 9000 standards.

ISO 9001 is the one standard within the ISO 9000 system that defines the requirements for a quality
management system and helps businesses and organizations to be more efficient, improve customer
satisfaction, and specifically for pharmaceutical manufacturers, to help improve patient safety.

Why the ISO standard was revised

The International Organization for Standardization reviews, as necessary, and updates its standards
regularly to ensure they address current business and operational challenges. Increased globalization
and more complex supply chain changes, coupled with increased customer expectations and more
access to information, were the drivers for the new ISO 9001:2015 standards.

ISO now requires risk assessment as one of the major areas addressed in the new standard. To achieve
certification, organizations must now identify and document both the positive impact of anticipating and
mitigating risks before they occur, as well as identifying risks that have occurred and adjusting processes.

Benefits to pharmaceutical manufacturers

The new version of the ISO standard delivers three critical benefits to manufacturers:

 Greater emphasis on leadership engagement

 Increased prominence on risk-based thinking by addressing organizational risks and
opportunities in a structured manner
 Addresses supply chain management more effectively

This need for compliance, quality and safety provides a good rationale for pharmaceutical managers to
consider ISO 9001:2015 certifications. Pharma companies strive to provide their customers with
consistent, high quality goods and services and to ensure that their customers are satisfied. The
International Standards Organization (ISO) as a whole aims to ensure that products and services are safe
as well as reliable by producing standards that can be incorporated into any organization — large or
small, complex or simple in the nature of the products/services offered. Certification to ISO 9001:2015
demonstrates that a specific set of criteria for the quality management system has been created,
maintained and supported by top management. 2

Several elements of ISO 9001:2015 are already present in robust pharma quality systems included from
regulations (domestic and international), regulatory guidance, best practices and industry expectations.

Therefore, the focus of this article will not be how to incorporate ISO 9001:2015 into a pharmaceutical
organization’s quality system, but rather on supplier quality where ISO 9001:2015 plays an important role
in setting a quality system standard for suppliers.

This standard is recognized internationally and numerous excipient and packaging component suppliers
already possess the ISO 9001 certification, so updating to ISO 9001:2015 will be valuable.
ISO 9001 FRAMEWORK IN THE
PHARMACEUTICAL INDUSTRY?
While ISO 9001 certification is not required it is desired by pharmaceutical companies to ensure that
suppliers possess a documented Quality Management System (QMS). ISO 9001:2015 certification entails
audits performed by registrars that are qualified by an ISO governing body (direct fee paid for
certification), while CGMP compliance is enforced

The new revision of ISO 9001:2015 offers a number of benefits such as providing clarity, enhanced
leadership involvement in the management system, risk-based thinking, simplified language, common
structure and terms, as well as aligning QMS policy and objectives with the strategy of the organization.1

However, the following should be the top five (5) areas of focus --not necessarily in order of importance
— for the pharmaceutical industry’s suppliers that are certified to or at very least, claim conformance to
(while pursuing certification) and when assessing their suppliers:

1. Risk-based Thinking
2. QMS
3. Change
4. Process Approach
5. Leadership

Risk-based thinking is critical in every facet of business to achieve the best possible outcome. This
concept has always been present in ISO 9001, but is now more apparent in ISO 9001:2015, with
additional emphasis on potential areas that would have a direct impact on the operation and overall
performance of the QMS.

Additionally, risk-based thinking is incorporated in the overall management system, applying the process
approach. There are requirements in the standard to determine its QMS process and identify/address its
risks and opportunities, define responsibilities of top management to promote awareness of this concept--
and most importantly — determine and address risks and opportunities which can affect product/service
conformity.

Risk-based thinking provides multiple benefits to an organization, such as improved governance and a
proactive culture of improvement and compliance.3

For a packaging supplier, if there was a single source identified for a critical material required for
production, it would be the supplier’s responsibility to have that risk identified and a plan to mitigate such
risk — for example, qualifying additional suppliers of said material.

As a customer who relies on the packaging supplier, wouldn’t you want to ensure that analysis is
performed to ensure there is a consistent, conforming supply of the components your organization
requires to service the marketplace?

It is important to note that the standard does not require a formal risk management program, but in
performing supplier assessments, it makes sense to explore what mechanisms they have and determine
if they are acceptable to your organization.

As an additional reference, ISO 31000 Risk management – Principles and guidelines may be a tool (not
required for ISO 9001:2015 certification) when seeking a formalized risk management program.
ISO 9001 FRAMEWORK IN THE
PHARMACEUTICAL INDUSTRY?
The QMS requirement has always been in existence. Does more need to be said as a matter of
importance? A quality management system must include strategic vision and full support by senior
leadership.

In the 2015 edition of ISO 9001, Section 5 Leadership, 5.1.1, “Top management shall demonstrate
leadership and commitment with respect to the quality management system …:”5 followed by ten (10)
direct commitments to ensure that there is focus on support, management, continuous improvement,
resourcing, communication and effectively integrating the requirements of the QMS into the organization’s
business processes.

From a consumer perspective, senior leaders (not just those focused on quality) should be held
accountable for the QMS and its outputs. When you are assessing your suppliers, it is critical to examine
the objective evidence, which demonstrates top management commitment and dedication to the QMS.

In ISO 9001:2015, there are new requirements for change. Specifically, there are 4 — 6.3 Planning of
changes, 8.1 Operational planning and control, 8.3.6 Design and development changes and 8.5.6 Control
of changes.

Once a QMS and processes are established in an organization, there may be changes necessary to
mitigate risk as well as implement continuous improvement. The mechanism in which change is assessed
and implemented must be “carried out in a planned and systematic manner”6 and consider several areas,
including why the changes are being made and possible outcomes, how the QMS may be affected, as
well as how this change will be resourced appropriately6.

In the pharma industry’s quality systems, these stipulations (as well as several others) are already
incorporated, however, for some businesses this may be a new way of working. In many change control
processes, an interesting consideration is the potential for “unintended consequences” that result from the
change being implemented.

The process approach integrates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking to enable
an organization to plan its processes and their interactions. Simply stated as per the standard, the PDCA
cycle allows an organization to ensure that its processes have sufficient (managed) resources and
opportunities for improvement are identified and resolved5.

Many organizations across all industries focus on structured, documented processes and strict
compliance to appropriate standards, but sometimes a very critical element is stated, but yet not practiced
holistically. Alas, that is not management per se, but leadership.

As noted previously, top management has a defined set of responsibilities for the QMS. Evidence of
those responsibilities must be present. How that is documented or demonstrated by objective evidence
remains the organization’s decision, but there must be evidence of this being accomplished. The
increased responsibilities of leadership are not only the responsibility of quality management, but top
management.

Although every day we live in the world of regulations, which govern the manufacturing and distribution of
pharmaceutical products, attention should be given to ISO 9001:2015, with particular emphasis on
presence/absence of certification as well as how your suppliers demonstrate adherence.

The goal is the same for both supplier and industry — customer satisfaction, and consistent, conforming
(quality) goods and/or services. Visit for more information on ISO 9001:2015, visit ASQ Quality
Management Standards.
ISO 9001 FRAMEWORK IN THE
PHARMACEUTICAL INDUSTRY?
References:

1 Implementation Guidance for ISO 9001:2015. International Organization for Standardization.

2 What are the benefits of ISO International Standards? www.iso.org
3 ISO 9001:2015 Risk-based thinking. ISO/TC 176/SC 2/N1283
4 The Process Approach in ISO 9001:2015. International Organization for Standardization
5 ISO 9001:2015 Quality management systems – Requirements
6 How Change is addressed within ISO 90014:2015. International Organization for Standardization.