Leveraging Good Manufacturing Practices (GMP) for Successful ISO Certification Clone

Article by Alexander Sullivan

Introduction:

Adhering to Good Manufacturing Practices (GMP) is not only a best practice for businesses but also a valuable asset when preparing for ISO 9001 Quality Management System certification. This blog aims to shed light on the benefits that businesses may have overlooked by following GMP guidelines, emphasizing the time and cost savings in the process of obtaining internationally recognized ISO certification. Understanding the correlation between GMP and ISO 9001 can provide a strategic advantage for businesses seeking certification and continuous improvement. Read on to discover why leveraging GMP can be a beneficial strategy for your company, and how our expert team can assist you in the certification process.

People:

Employees play a vital role in any manufacturing company or business, and aligning their roles and tasks with the company’s objectives is crucial for meeting ISO certification standards. By creating a training plan, identifying skill gaps, and conducting regular performance reviews, businesses can enhance employee capabilities, bridge talent gaps, and boost productivity and performance. ISO 9001 encourages organizations to have a competent workforce, making the alignment of GMP’s focus on people a valuable step toward meeting certification requirements.

Products and Primary Materials:

The quality of the products and primary materials used in the manufacturing process is paramount for both GMP and ISO 9001:2015. Implementing Quality Control measures at all stages of production ensures that risks are identified and minimized. ISO 9001 employs a risk-based approach, requiring businesses to conduct risk assessments at each step of the process, from receiving raw materials to delivering the final product. GMP provides the tools to control or mitigate identified hazards, ensuring robust Quality Assurance processes, including constant or periodic sampling, testing, and evaluation. By aligning GMP and ISO 9001 requirements, businesses can reduce losses, waste, and risks while safeguarding the company’s reputation.

Processes:

Documented processes are essential for both GMP and ISO 9001. Consistent processes that are properly recorded and communicated to employees help identify and control risks, monitor variances, and maintain quality at all stages. ISO 9001‘s Clause 7.5 and GMP emphasize the need for defined procedures, guidelines, flowcharts, and steps for key activities or processes. Having standardized procedures allows businesses to trace, analyze, and rectify substantial deviations during manufacturing, ensuring consistent outcomes. Well-defined procedures, along with trained operators and proper record-keeping, facilitate compliance with both GMP and ISO 9001.

Premises and Equipment:

ISO 9001 requires a suitable working environment, and GMP provides guidelines for facility management. Designing facilities and equipment that can be effectively cleaned, preventing cross-contamination, is a key aspect of both GMP and ISO 9001. Adequate electrical power, lighting, temperature, humidity, and ventilation are necessary to ensure product and personnel safety. Implementing pest control programs, drainage systems, and regular equipment maintenance and calibration are critical for meeting GMP and ISO 9001 requirements. By aligning premises and equipment management with both standards, businesses can ensure a safe and efficient working environment.

While GMP focuses on country-specific rules, ISO certification holds global recognition. Acquiring ISO certification opens doors to international business opportunities, expanding market reach beyond national borders. Even if operating solely within the domestic market, ISO certification adds value by validating adherence to rigorous global quality standards. By aligning with ISO 9001, businesses can streamline operations, reduce risks, and continuously improve their management systems and overall performance. Implementing GMP is a significant step towards meeting ISO 9001 requirements, making the path to certification more efficient and effective.


I AM INTERESTED IN ISO CERTIFICATIONS AND TRAININGS:

If you are interested in obtaining ISO certification for your organisation, or train your staff, we invite you to schedule a complimentary consultation with one of our knowledgeable representatives at Global Standards Assurance. To request your free consultation, please contact us, and we will provide guidance on the most suitable ISO standard and training for your organisation. Let us assist you in embarking on your path towards ISO certification.”