Pharma company - THE ISO COUNCIL

ISO for pharma company

One of the biggest industries across the globe is the pharmaceutical manufacturing industry, which produces medications and drugs which people need to remain healthy. As pharmaceutical products are critical to well-being, this industry has strict procedures to follow and is highly regulated.

ISO certification is vital for pharmaceutical companies as they help them manage their operations as per international standards while remaining compliant with various regulatory obligations. In this article, we will discuss the challenges that the pharmaceutical industry faces and how ISO certifications provide a viable solution to these challenges.

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Challenges the pharmaceutical industry faces

Pharmaceutical manufacturing companies often encounter many challenges in their operations, including:

Reduced research and development investments: Even though many health conditions could widely benefit from more effective and newer drug treatments, many pharmaceutical companies have deducted their invoice, and are hesitant to launch new products due to high drug development costs, high failure rates and low returns on investment. These are extremely discouraging for pharmaceutical companies.
Insurance company and government policies: Different government regulations affect job regulations, making it slow and cumbersome to launch new treatment modalities. Moreover, insurance companies become the deciding factor on setting reimbursement standards and deciding who the payer
Attitudes of the consumers: Majority of the consumers distrust medications from newer brands and are unwilling to try alternative companies. Many consumers are sceptical about the quality of brands that they are unfamiliar with and find comfort with older brands.
Affordability: Due to limitations in health insurance coverage, many medications are not affordable to patients.

Implementing ISO certification can solve many of these problems. We have already thoroughly reviewed ISO for construction and learned about its benefits. Next, we will examine the benefits of ISO certification for pharma companies.

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Integrated Management System

(IMS) combines all aspects of an organisations systems, processes, and standards into one smart system.

including

ISO 9001 ISO 45001 ISO 14001

Benefits of ISO certification for the pharmaceutical company

ISO certifications are extremely beneficial for pharmaceutical companies, as they:

Improve organisational performance

ISO certifications urge the establishment of quality controls which help you run your business more effectively and analyse your business performance as well as improvements to further efficiency.

Compliance with international and federal regulations

ISO certificates help organisations meet all mandatory regulatory obligations in addition to adhering to industry standards.

Lower risk

Similar to other organisations, pharmaceutical manufacturing companies may be hazardous. When your company complies with safety standards, you protect the health of employees involved in the manufacturing process.

Understanding attitudes of consumers

ISO 9001 helps organisations put in place a system to categorise and go through customer interactions, helping them understand the needs of their customers. Additionally, as ISO 9001 is globally recognised, it helps create trust in the eyes of sceptical consumers.

Reduction in energy costs

If your organisation acquires ISO 50001, it leads to reduced energy consumption and increased cost savings. These funds can be redirected towards essential operations.

Better data protection

If organisations implement ISO 27001, their information is secure through a comprehensive Information Security Management System (ISMS) which fosters trust with your employees and customers.

ISO StandardsInternationally agreed by experts

ISO 9001QMS, quality management system

With over a million certified organisations across 170 countries, ISO 9001 is the international reference framework for the development and implementation of a quality management system (QMS).

ISO 14001EMS, enviremental management

With over 300,000 certificates issued worldwide, the ISO 14001 standard provides a framework for the creation of an effective environmental management system (EMS).

ISO 45001OHSAS, occupational health and safety

ISO 45001 is the world’s first international occupational health and safety (OH&S) standard. It sets the requirements for OH&S management to help employers provide a healthy and safe working environment.

ISO 27001ISMS, information security management

ISO/IEC 27001 sets out the requirements for establishing, implementing, maintaining, and continually improving an information security management system (ISMS) to protect the security of information assets.

ISO standards for pharmaceutical companies

Some ISO certifications that pharmaceutical companies should consider include:

ISO 9001 pharma company

ISO 9001 is a widely utilised quality management standard that provides a framework as well as a set of principles for organisation to manage their product/service quality. This certification helps your organisation achieve customer and stakeholder satisfaction, and can easily be integrated with other management systems such as ISO 14001 and ISO 45001.

ISO 13485 for pharma company

ISO 13485 is a standard that focuses on the management of medical devices. All medical devices need to adhere to various patient needs and regulatory compliance laws, so this standard guides organisations on meeting these requirements during the manufacturing phase. Adhering to this standard allows companies to create a more effective work environment, while managing legal and safety risks.

ISO 55001 for pharma company

ISO 55001 assist organisations manage their assets which involve numerous physical resources or substantial capital. Examples of such assets include utilities, manufacturing, distribution and transportation units. By following the requirements outlined in the standard, you can improve your asset maintenance, so that they become an advantage instead of a burden for you.

ISO 37001 for pharma company

ISO 37001 help companies implement and maintain measures to detect, prevent and resolve bribery in their business activities. This started can be utilised in conjunction with other management systems such as ISO 9001 or ISO 27001. Acquiring this certificate helps to enhance the company’s credibility and builds its trustworthiness in the eyes of stakeholders and customers.

ISO 27001 for pharma company

ISO 27001 provides a framework for information security management system, so that your information is available, honest, legally compliant and confidential. It helps organisations to respond appropriately to various security threats such as fire, theft, cyber crimes or data breaches.

Compliance with this standard helps pharmaceutical companies keep their organisation, client and employee information private and confidential.