Quality management systems help direct and coordinate the activities of organizations, using defined internal procedures, processes, and responsibilities. Thus, they help organizations define quality objectives and policies, meet customer and regulatory requirements, and continuously optimize efficiency and effectiveness.
The International Organization for Standardization (ISO) is comprised by the national standards bodies of over 160 countries. It has set forward the international standard ISO 9001, which provides guidelines to organizations for establishing successful and effective quality management systems. Fulfilling these requirements ensures that appropriate processes are established in an organization to deliver high-quality products and services. ISO 9001 was last updated in 2015 to the ISO 9001:2015 version.
To achieve an ISO 9001 certification, a company must implement the requirements outlined in ISO 9001:2015 and successfully undergo a registrar’s audit. An ISO 9001:2015 certification can enhance the credibility of an organization by helping it demonstrate compliance with ISO 9001’s guidelines, proper documentation management, and the ability to meet the requirements of regulatory agencies and clients. Moreover, it helps ascertain the consistent delivery of high-quality products and services, which is beneficial for all stakeholders, including management, customers, and employees.
Organize internal processes– Quality management systems provide guidelines for handling documentation, process interactions, and management responsibilities.
Define a process-oriented approach, which specifies algorithms to manage resources (including human resources) and organize the work environment.
Optimize process efficiency by identifying, reviewing, and documenting procedures, responsibilities, and structures that can optimize the quality management of an organization.
Improve customer, employee, and management satisfaction by helping deliver products and services of consistently high quality.
Continually improve operations from product design through product delivery, thus promoting the realization of products.
Save costs by optimizing operations, product manufacturing, and services.
Perform quality control regularly – Quality management systems can be maintained and optimized using internal and external audits and re-certification. For example, an internal audit can be performed each year before the yearly external audit takes place, and a re-certification can follow after every 3 years.
In addition, Good Manufacturing Practice (GMP) refers to a set of guidelines that were created to ensure consistent high-quality manufacturing of drugs and active pharmaceutical ingredients (APIs) in compliance with quality standards, including requirements for quality control. To achieve GMP compliance, a manufacturer must meet certain criteria not only during the production process, but also for purchased products, outsourced processes, and other necessary resources (such as human resources). GMP regulations differ across countries and geographical regions. If a company wants to sell a final product (drug) in certain countries or regions (such as the European Union or worldwide), the production and all contributing processes should comply with country-/region-specific guidelines. For example, the “EU-GMP-regulations/EU-GMP-Leitfaden” need to be met in the European Union, whereas the “Current Good Manufacturing Practice (CGMP) regulations” of the Food and Drug Administration (FDA) should be followed in the United States.
To ensure that we are a manufacturer of high-quality products, and that we continue to improve to maintain customer satisfaction, FUJIFILM Wako is ISO 9001:2015 certified. The certification covers a wide range of activities, including the design, development, manufacture, and sales of chemical products, reagents, pharmaceutical raw materials, and equipment as well as the maintenance and inspection of equipment and compliance with quality assurance procedures. In addition, ourspeciallylicensed FUJIFILM Wako production sites adhere strictly to GMPs in both manufacturing procedures and personnel training.
To learn more about FUJIFILM Wako’s manufacturing practices, follow the link below.