Reviewing the Requirements of ISO 9000 Series in Quality Management Systems

Abstract:

The quality, safety, and efficacy of pharmaceutical products have been a concern
for the World Health Organization (WHO) since its establishment. Today, the
focus on these aspects has increased as people are more concerned about the
quality and safety of pharmaceutical products. The Quality Management System
(QMS) plays a crucial role in ensuring quality, safety, and efficacy in the
pharmaceutical industry. To maintain these standards, companies follow various
guidelines such as USFDA, GMP, GLP, ICH, and ISO. This review primarily
focuses on ISO 9000, a widely used quality management standard across the
globe. The objective is to highlight the most important ISO 9000 requirements for
establishing an effective QMS and to provide a helpful resource for further
research.

Introduction:

Pharmaceutical Quality Management System:

A pharmaceutical quality management system helps organizations in the

pharmaceutical industry ensure the quality of their products and improve their
processes. It is applicable to all drug products, including biotechnology and
biological products, throughout their entire life cycle.

Elements of a pharmaceutical quality management system:

The fundamental elements for an effective pharmaceutical quality management

system include process performance and product quality monitoring, a corrective
action and preventive action (CAPA) system, a change monitoring system, and
management review of process performance and product quality.

Applicable Pharmaceutical QMS Regulations:

Some key regulations used in pharmaceutical quality management systems

include ISO, cGMP, ICH guidelines Q10, and 21CFR (part211).
ISO (International Organization for Standardization):

ISO is a non-governmental organization that develops and publishes

internationally recognized and accepted standards. Some of the well-known ISO
standards include ISO 9000 (Quality Management), ISO/IEC 27001 (Information
Security Management), ISO 45000 (Occupational Health and Safety), ISO 14000
(Environmental Management), and ISO 17025 (Testing and Calibration
Laboratories).

ISO 9000:

ISO 9000 is a series of international standards on quality management and

quality assurance that can be adopted by all types of organizations involved in
the production and supply of products and services. The ISO 9000 family includes
standards such as ISO 9001, ISO 9002, ISO 9003, and ISO 9004.

Core Principles of ISO 9000:

The core principles of ISO 9000 include customer focus, leadership, engagement
of people, process approach, improvement, evidence-based decision making, and
relationship management.

ISO 9000 Requirements:

The requirements of ISO 9000 include management responsibility, quality system

establishment, contract review, design control, document and data control,
purchasing, control of customer-supplied products, product identification and
traceability, process control, final inspection and testing, control of inspection,
measuring and test equipment, control of non-conforming products, corrective
and preventive action (CAPA), handling, storage, packaging, preservation, and
delivery, control of quality records, internal quality audits, training, servicing,
and the use of statistical techniques.

Impact and Benefits:

Implementing ISO 9000 requirements can have a significant impact on
organizations, improving their quality, competitiveness, customer satisfaction,
and employee effectiveness. The benefits of ISO 9000 include establishing
consistent quality control, assisting improvements in production processes
through CAPA, building customer confidence and strengthening relationships,
aiding in decision-making through internal audit management reviews, acting as
a powerful marketing tool, providing universal credibility, reducing overall costs
of quality, and improving business performance.

Conclusion:

This review provides an overview of quality management systems in the

pharmaceutical industry and highlights the requirements of ISO 9000 standards
certification. ISO 9000 certification can provide organizations with a competitive
advantage and ease of operations. Establishing and implementing a quality
system document is key to achieving excellence.