SIS Certifications Blog

  ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, development, production, installation, and servicing of medical devices. The primary purpose of ISO 13485 is to establish a framework for medical device manufacturers to ensure the consistent design, production, and delivery of safe and effective medical devices that meet regulatory requirements. Key purposes and benefits of ISO 13485 include: Quality Management System (QMS) Compliance: ISO 13485 provides a set of internationally recognized requirements for a QMS specific to the medical device industry. By implementing this standard, organizations can demonstrate their commitment to quality and compliance with regulatory requirements. Regulatory Compliance: ISO 13485 is harmonized with the regulatory requirements for medical devices in various markets, making it easier for organizations to meet regulatory expectations. Compliance with ISO

 ISO 22000 is an international standard for Food Safety Management Systems (FSMS). It provides a framework for ensuring the safety of food products throughout the entire food supply chain. To obtain ISO 22000 certification, follow these steps:   Understand ISO 22000 : Familiarize yourself with the ISO 22000 standard and its requirements. You can purchase a copy of the standard or access it through your local standards organization.   Determine Applicability : Confirm that ISO 22000 is applicable to your organization. This standard is intended for any organization in the food industry, including food producers, processors, distributors, and retailers.   Appoint a Project Manager : Designate a project manager or a team responsible for overseeing the certification process. This person or team will coordinate all activities related to ISO 22000 implementation.   Conduct a Gap Analysis : Assess your organization's existing food safety processes and procedures to identif