ISO 13485 is a sector-specific quality standard for theMedical devices come in close contact with patients and range from minor support for medical conditions to lifesaving capability. As such, they demand high criteria. Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. Registration to ISO 13485 requires accountability, compliance with regulations medical device industry. The standard's full name is ISO 13485, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
Good Manufacturing Practice (GMP) Certification
Good Manufacturing Practices (GMP) certification from ACS ensures the integrity of your food manufacturing process as well as your compliance with food safety regulations. Assurance of the safety and quality of food is an important consideration for consumers today. A GMP is an important enhancement to your food safety management system, which increases your customers' confidence in your commitment to trading and producing safe, high quality food.
Compliance with GMP requirements entails minimum common sense sanitary and processing requirements applicable to all food processing establishments. Many food industry companies have implemented the GMP certification scheme for food processing as the foundation upon which they have developed and implemented other quality and food safety management systems, including HACCP, ISO 22000, SQF and ISO 9001.
A Good Manufacturing Practices (GMP) certification scheme provides independent verification and certification that the basic manufacturing practices and prerequisites necessary for the implementation of an effective Hazard Analysis Critical Control Point (HACCP) food safety program are being followed.
Certifying your food safety management system against Good Manufacturing Practices requirements with ACS is an excellent way to prepare for inspections by regulatory authorities and other stakeholders. The process will help you to ensure regulatory compliance while demonstrating your knowledge of the importance of producing and trading safe, quality food.
Goods Distribution Practice for Medical Devices
The Good Distribution Practice for Medical Devices (GDPMDS) is a mandatory audit for any organizations involved with importing, wholesale and distribution of medical devices prior to their license application. Certification against GDPMDS qualifies that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation or product specification.
In an effort to provide such assurance, organizations will require more than a few quality manuals. Organization needs to include appropriate procedures, suitably qualified personnel, correct processes / facilities / equipment as well as clear and timely documentation, to credibly demonstrate the consistency of quality assurance.
Organizations certified to ISO 13485 will not need to apply for GDPMDS and will find that they have partially fulfilled the GDPMDS requirements, if the scope of their ISO 13485:2003 certification covers storage and distribution of medical devices.