quality consulting for ISO industry standards

9001:2015 QUALITY SYSTEM

The ISO standard for companies that design, manufacture, market, and distribute products. This standard is the base for many other ISO standards. The 2015 revision added requirements for external/internal interested parties, organizational knowledge, and emphasis on risk-based thinking.

13485:2016 medical devices

Companies that manufacture and distribute medical devices with higher risk levels usually require compliance to this ISO standard from their customers. Without this certification, the customer will not purchase your medical device. This requirement also applies to virtual manufacturers.

AS9100D aerospace

Organizations that manufacture flight-critical parts for the aerospace industry require certification to this standard. This standard is similar to the 9001:2015 Quality Management System with additional requirements specific to aerospace. Companies who are in compliance can be found on www.iaqg.org

Medical device single audit
program, MDSAP

REGULATORY REQUIREMENTS IN A CONNECTED WORLD

MDSAP, the Medical Device Single Audit Program, was initiated by the International Medical Devices Forum in 2012. It is a single audit performed by an authorized organization to assess a company's compliance with the regulatory requirements of MDSAP member countries. As of this date, the MDSAP member countries are the USA, Canada, Australia, Brazil, and Japan.

MDSAP aligns with the ISO 13485:2016 Medical Device requirements and includes additional country-specific regulations required for the products sold in the US, Australia, Brazil, Canada, and Japan. The certification demonstrates that a company complies with regulatory requirements of the MDSAP participating countries in which it sells products.

The structure and scope of the MDSAP audit are similar to ISO 13485:2016 Medical Device. However, the process areas are Management; Device Marketing Authorization and Facility Registration; Measurement, Analysis, and Improvement; Medical Device Adverse Events and Advisory Notices Reporting; Design and Development; Production and Service Controls and Purchasing.

If your organization is certified to ISO 13495, you will need to determine which QMS procedures and processes need to be updated to comply with the requirements of the MDSAP.

european medical device
directive & REGULATION

medical device regulations in the european union

The European Medical Device Directive, MDD 93/42/ECC, has transitioned to the Medical Device Regulation, MDR 2017/745. Companies that sell medical devices in the European Union must comply at a minimum, to Article 120, "Transitional provisions". The requirements relating to post-market surveillance, market surveillance, vigilance, and registration of economic operators apply as of May 26, 2021.

The obligations of manufacturers will increase under the MDR. New requirements under the MDR include additional requirements for post-market surveillance, registration of economic operators, liability for defective devices, new requirements for technical files, and the designation of a person responsible for regulatory compliance.

Companies will discover that many of their Quality Management Procedures will require an update to comply with the MDR 2017/745. For example, there are new definitions for recall, withdrawal, incident, and serious incidents.