ISO 15378 Primary Packaging Certificate for Medical Products

Organizations that want to obtain ISO 15378 Certificate must first conduct a gap analysis within themselves. This analysis provides an understanding of the extent to which companies currently meet ISO 15378 requirements. In this way, it is revealed what kind of deficiencies exist in compliance with the quality management system and good manufacturing practices principles. Then, by correcting these deficiencies and establishing a systematic structure that takes the continuous improvement approach as a reference, preparation for the ISO 15378 certification process can be made.

ISO 15378 Certificate is issued by third-party certification bodies. After making the necessary preparations, companies must apply to these organizations. Then the certification process begins and ISO 15378 verification audits are carried out within the company. Companies that successfully pass the audits are presented with ISO 15378 certificate. It is recommended that companies seek support from a consultancy firm in order to take the right steps at all these stages and have a fast and easy certification process.

It is extremely important for organizations that supply medical products to the market to establish a special management system for the sector and products, provided that they adhere to the principles of ISO 9001. Primary packaging materials are one of the most important components for these products. These products must be designed, produced and supplied in accordance with principles such as customer satisfaction, compliance with legal regulations, and especially protecting consumer health. ISO 15378 describes the common requirements for all these issues and can meet the needs of different stakeholders with a single assessment methodology.
Organizations that implement ISO 15378 can minimize the risks arising from their products. In this way, the problems that will occur after the product is placed on the market and the additional costs based on these problems can be avoided. In addition, it creates a reliable brand image in the market as they go through the verification and certification processes of independent accredited institutions. While this increases the reputation of institutions, it also increases their competitive power.

ISO 15378 describes the quality requirements for primary packaging produced for use in medical products and specifies the principles of Good Manufacturing Practice (GMP). Through the standard, it is aimed to apply GMP principles in the production and control of these products and thus to protect patient safety. Compliance with GMP principles in the production of packaging materials also helps to meet other requirements in the pharmaceutical industry. The ISO 15378 standard has also been prepared in accordance with principles such as customer focus, leadership, process approach, risk-based thinking, evidence-based decision-making, continuous improvement, etc. It is possible to apply this standard in all of the production, design and supply processes of the primary packaging materials of medical products. For more detailed information about the scope of the standard, you can contact Aşan Danışmanlık.

ISO 15378 has a similar concept and structure to the management system standards prepared by ISO on issues such as quality, energy, environment, information security, occupational health and safety, food management, etc. We can summarize the content of the standard as follows:

      1 Scope
      2 Normative references
      3 Terms and definitions: Concepts related to topics such as organization, activity, system, requirement, process, risk detection and management, results and data, etc. are explained.
      4 Context of the organization: Basic information on subjects such as the organization´s field of activity, the demands of interested parties, the quality management system, etc. is conveyed.
      5 Leadership: The leadership of the top management and the duties and responsibilities of other units on the quality requirements and Good Manufacturing Practices (GMP) related to primary packaging are explained.
      6 Planning: It covers the planning and management of risks, opportunities and objectives related to quality management system processes.
      7 Support: It describes the resources, information, communication channels, proficiency level, etc. used in the quality management system of primary packaging materials used in medical products.
      8 Operation: Operational planning and control steps related to the management system, product and service development, procurement process planning, nonconforming product control, etc. requirements are explained.
      9 Performance evaluation: Performance evaluation, inspection and reviews of the quality management system of primary packaging materials used in medical products are discussed.
      10 Improvement: The nonconforming product and service control and continuous improvement approach in ISO management standards is also valid for ISO 15378 Primary Packaging Certificate for Medical Products.