ISO9001:2015 Quality Management System is based on the principle that an organization should be able to demonstrate that it is capable of consistently providing products and services that meet customer requirements and expectations. To meet this standard, an organization must implement a quality system that includes processes for planning, implementing, reviewing, and improving its operations.
ISO13485:2016 Medical Devices , is based on the principle that an organization should be able to demonstrate that it is capable of consistently providing medical devices that meet customer requirements and expectations, as well as regulatory requirements. To meet this standard, an organization must implement a quality system that includes processes for planning, implementing, reviewing, and improving its operations.
US, AUSTRALIA, BRAZIL, CANADA, JAPAN
MDSAP allows manufacturers to undergo a single audit by an accredited auditing organization, rather than undergoing separate audits by each regulatory jurisdiction in which they operate. The audit covers the manufacturer's quality management system and assesses the manufacturer's compliance with the relevant regulatory requirements in each jurisdiction.
MDSAP is designed to streamline the regulatory process for medical device manufacturers, while also helping to ensure the quality and safety of medical devices. The MDSAP is currently recognized by several regulatory jurisdictions, including the United States, Brazil, Canada, Australia, and Japan.
Aerospace StandardsAS9100D, AS9120B, AS9110C, AS9102C, AS5553D and AS6462C
SAE Aerospace Standards include requirements for aviation, space and defense organizations AS9100D; specific standards for organizations performing maintenance AS9110C; organizations who are distributors AS9120B; Aerospace First Article Inspection FAI requirements AS9102C; and counterfeit avoidance and detection to address risk of counterfeit parts entering the supply chain AS5553D, AS6462C.
The Quality System Aerospace standards include ISO 9001:2015 quality management system requirements such as understanding the needs and expectations of interested parties. An important concept which determines the internal and external issues which affect the quality management system.
Quality serves as the backbone of reliable, safe, and effective products, meeting customer needs and expectations. Neglecting quality management systems can lead to severe repercussions such as reputational damage, regulatory penalties, and decreased sales. At ISO-AID LLC, we prioritize quality system implementation to safeguard businesses against such risks.
ISO-AID LLC understands that different industries have unique challenges and requirements. Our services are tailored to meet the specific needs of various sectors, including manufacturing, healthcare, and service industries. We provide industry-specific expertise to ensure that your quality system implementation and internal audits are relevant and effective.
Enhance your organization's quality management practices with ISO-AID LLC's Standards Audited Services. Contact us today to learn more about how our quality system implementation and comprehensive internal audits can benefit your organization. Together, we can drive continuous improvement and ensure sustained operational excellence.
Quality matters because it is an essential component of delivering products that are reliable, safe, and effective, and that meet the needs and expectations of customers. Failing to prioritize quality can have serious consequences for businesses, including damage to their reputation, regulatory penalties, and lost sales.
The QSR establishes requirements for a quality management system (QMS) that medical device manufacturers must follow in order to ensure that their products meet the necessary standards for quality and safety. The QSR also establishes requirements for the design, development, production, and distribution of medical devices, as well as requirements for record keeping and reporting.
The QSR is based on the principle that medical device manufacturers should be able to demonstrate that they are capable of consistently providing products that meet customer requirements and expectations, as well as regulatory requirements. To meet the QSR, an organization must implement a QMS that includes processes for planning, implementing, reviewing, and improving its operations
Organizations that are subject to the QSR are required to undergo regular inspections by the FDA to ensure that they are in compliance with the regulations. Non-compliance with the QSR can result in regulatory action, including warning letters, fines, and product recalls.
The QMSR is now in the transitiion period. In February of 2024, the FDA 21 CFR Part 820 Quality System was amended to incorporate the ISO 13485:2016. The QMSR Rule will be effective in 2026. The intention was to harmonize and modernize the FDA 21 CFR Part 820 regulation with international quality standards ISO 13485:2016. The FDA will not require ISO 13485 certification. However, companies which are ISO 13485 certified will be better able to navigate the new requirements of the QMSR.
The MDR Medical Device Regulation establishes requirements for a quality management system (QMS) that medical device manufacturers must follow in order to ensure that their products meet the necessary standards for quality and safety. The MDR also establishes requirements for the design, development, production, and distribution of medical devices, as well as requirements for record keeping and reporting.
The MDR is based on the principle that medical device manufacturers should be able to demonstrate that they are capable of consistently providing products that meet customer requirements and expectations, as well as regulatory requirements. To meet the MDR, an organization must implement a QMS that includes processes for planning, implementing, reviewing, and improving its operations.
Organizations that are subject to the MDR are required to undergo regular inspections by EU regulatory bodies to ensure that they are in compliance with the regulations. Non-compliance with the MDR can result in regulatory action, including warning letters, fines, and product recalls.
In vitro diagnostic medical devices are products that are used to examine samples of substances taken from the human body, such as blood or tissue, in order to diagnose or monitor diseases or other medical conditions. Examples of IVD medical devices include diagnostic test kits, imaging devices, and medical laboratory equipment.
The IVDR establishes requirements for a quality management system (QMS) that manufacturers of IVD medical devices must follow in order to ensure that their products meet the necessary standards for quality and safety. The IVDR also establishes requirements for the design, development, production, and distribution of IVD medical devices, as well as requirements for record keeping and reporting.
The IVDR is based on the principle that manufacturers of IVD medical devices should be able to demonstrate that they are capable of consistently providing products that meet customer requirements and expectations, as well as regulatory requirements. To meet the IVDR, an organization must implement a QMS that includes processes for planning, implementing, reviewing, and improving its operations.
Organizations that are subject to the IVDR are required to undergo regular inspections by EU regulatory bodies to ensure that they are in compliance with the regulations. Non-compliance with the IVDR can result in regulatory action, including warning letters, fines, and product recalls.
