PalCare Enterprises Inc. has completed the Surveillance – 02 audit and has received a favourable recommendation for the continuation of their UAF-accredited ISO 13485:2016 (Medical Devices – Quality Management System). Moreover, the scope of the certification includes the Manufacturing and Marketing of finished Medical Device Products -Vaginal Products- Applicators for Vaginal Gel Application and Oral Spray. A.1.1 – Non-Active Medical Devices.
Apart from this, PalCare Enterprises Inc. can also apply for ISO 14001:2015 for Environmental Management System (EMS) and ISO 9001:2015 for Quality Management System (QMS) to adopt eco-friendly manufacturing practices and achieve sustainable growth. Additionally, the organization can seek ISO 45001:2018 for Occupational Health and Safety Management System (OHSMS) and ISO 41001:2018 for Facility Management – Management System, providing clients, customers, and stakeholders with a hassle-free, smooth facility system while ensuring their safety and well-being.
PalCare Enterprises Inc. can demonstrate compliance with ISO/IEC 27001:2022 Certification and ISO/IEC 27701:2019 Certification to implement the highest information security and data privacy standards.
What is ISO 13485:2016 Certification?
The International Organization for Standardization (ISO) has published ISO 13485:2016 Certification defines the regulatory requirements for medical devices. ISO 13485:2016 is a globally recognized standard for quality management system (QMS) specifically designed for the medical industry involved in the design, production, installation, servicing, and manufacturing
The standard provides a robust risk management framework, enabling organizations to identify and mitigate potential threats. It also ensures companies maintain comprehensive documentation and traceability throughout the product lifecycle. Additionally, ISO 13485 aligns with regulatory requirements, facilitating compliance with international laws and regulations.
Benefits of ISO 13485:2016 for PalCare Enterprises Inc.
PalCare Enterprises Inc. can obtain the following benefits by implementing ISO 13485:2016 standard. These are as follows:
- ISO 13485 aligns closely with international regulatory requirements and helps PalCare Enterprises Inc. meet stringent medical device standards of global markets.
- ISO 13485 requires PalCare Enterprises Inc. to adhere to legal and standard quality regulations to evade legal complications. As a result, it lowers the risk of product defects to ensure that medical devices are safe and effective for patient use.
- Implementing ISO 13485 within PalCare Enterprises Inc. streamlines quality management processes. Hence, it helps the organization in documentation, risk management, and operational consistency.
Conclusion
PalCare Enterprises Inc. received ISO 13485:2016 certification to demonstrate its commitment to quality and regulatory compliance in the medical device industry. Moreover, this certification strengthens the organization’s position in the global market and ensures the safety and effectiveness of its products.
