Why ISO 9001 Certification is Important for Pharmaceutical Industries?
The pharmaceutical industries are the backbone of the healthcare system in any nation. Hence, there is no dearth of regulations that these industries have to comply with. In order to ensure safety and quality of products, these industries already have several processes and controls within their systems. However, gaining ISO 9001 certification makes sure that the organization is compliant to all these regulations.
All the standards published by the International Organization for Standardization (ISO) aim at delivering a good quality and safe product. ISO 9001 certification helps in implementing the Quality Management System (QMS) in an organization. It is quite common knowledge that the manufacturers of pharmaceutical products already implement the controls as required by different regulations. However, it is very important for the suppliers of pharmaceutical products to execute the requirements of ISO 9001 within their organization.
The framework of ISO 9001 certification provides for risk-based thinking, involvement of the top leadership, and effective communication at all levels, among other things. These ensure that the products are of premium quality. The suppliers of pharmaceutical products, who are seeking ISO 9001 certification or claiming their conformance with its requirements must focus on the following five areas in order to gain confidence of their customers and become an important player in the pharmaceutical supply chain:
- Risk-based Thinking
- Process approach
- QMS
- Leadership
- Change
WHAT ARE THE VARIOUS STANDARDS APPLICABLE IN PHARMACEUTICAL INDUSTRIES?
An organization that is involved in the manufacturing, supplying, transporting or retailing pharmaceutical products may go for the following standards, apart from ISO 9001.
ISO 14001 Certification: sets out the guidelines for implementing an Environmental Management System (EMS) in your organization, which is useful for improving your interaction with the environment.
ISO 45001 Certification: standard helps in implementation of Occupational Health and Safety Management System (OHSMS) in an organization which ensures the safety and wellbeing of the workforce.
ISO 50001 Certification: standard aims at establishing an Energy Management System in your organization that helps in limiting your carbon footprint.
It must be noted that the International Organization for Standardization does not certify, it just publishes the ISO standards. An external body performs the certification. SIS Certifications is one such body which has a reputation for being one of the best in the world. Our vast pool of auditors is recognized for their expertise in comprehensively auditing the compliance of your management systems against the required standards and awarding you with the certifications at the end. The smoothness in the process, our integrity, and our commitment to deadlines make us stand apart from other certification bodies.
