QUALITY MANAGEMENT SYSTEM (QMS)
Enhance success of your quality management implementation
QMS applies to manufacturers involved in design, manufacturing, and distribution of ISO 13485, US QSR, GMP, MDSAP, GDPMD.
ARQon develops quality system documentation certifications for companies to comply with the internationally recognised quality system standards and requirements such as:
ISO 13485 Medical device, Quality management system, Requirements for regulatory purpose;
United States: Quality System Regulation (QSR) Part 820;
European Union: Medical Device Directive (MDD) / Medical Device Regulation (MDR) / In-Vitro Diagnostics (IVD) / In-Vitro Diagnostics Regulation (IVDR);
Good Distribution Practice for Medical Device (GDPMD); and
Good Manufacturing Practice (GMP)
ISO 13485 Consulting and Implementation for Medical Device Manufacturers
ISO 13485: 2016 is a quality system standard meant for medical device manufacturers and suppliers. It covers several elements like Quality Management System, Management Responsibility, Resource Management, Product Realization, and Measurement, Analysis and Improvement. Getting an ISO 13485 certification is essential to comply with regulatory requirements from authorities all over the world (Europe, Canada, Australia, Japan, Korea, Brazil, Singapore and Malaysia etc).
It is also a common requirement imposed by Own Brand Label (OBL) and Manufacturers on their Original Equipment Manufacturers (OEM) and/or suppliers.
ARQon has the experience in setting up ISO 13485 processes and procedures for manufacturers, OEM and suppliers. Contact ARQon for more information.
GDPMDs certification is generally needed for companies dealing with importation or distribution of medical devices in Singapore, Malaysia and others. It can be achieved after the company’s Quality Management System is certified by a certification body.
In order to comply with these requirements, a highly articulated process must be established to ensure the medical device safety and performance is not compromised during the importation, storage and distribution of medical devices. This would involve drafting specific clear and unambiguous procedures, training qualified personnel, maintaining the right infrastructure and ensuring the processes are well-planned and implemented.
Certifying to ISO 9001 does not fully fulfill to GDPMDs requirements as there are specific clauses in GDPMDs that are not present in ISO 9001.
ARQon has helped many companies in achieving Good Distribution Practice by streamlining and drawing on existing resources. Please contact ARQon for more information.
Good Distribution Practice for Medical Devices (GDPMDs)
Medical Device Single Audit Program (MDSAP)
MDSAP is developed by the International Medical Device Regulators Forum (IMDRF). This program is aimed at allowing Auditing Organizations (AO) to conduct a single audit on a medical device manufacturer that will satisfy the relevant requirements from participating authorities. Currently, these participants are:
U.S. Food and Drug Administration
Therapeutic Goods Administration of Australia
Brazil’s Agência Nacional de Vigilância Sanitária
Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
The World Health Organization (WHO) Prequalification of In-Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers
ARQon possessed the knowledge to help manufacturers comply with multiple regulatory requirements without wasting excessive resources. Contact ARQon for more information.
Quality System Regulation (QSR) or 21 CFR Part 820 compliance is necessary for manufacturers who are interested in marketing their medical device in US.
QSR contains several elements from ISO 13485 however they are not exactly the same. There are several specific requirements that are present in QSR that are absent in ISO 13485.
Unlike most countries, US FDA does not require a QMS certification (like ISO 13485 certificate) to prove that the manufacturer is fulfilling to QSR requirements. Instead, US FDA conducts pre-announced inspections personally to check on compliance. US FDA could also perform random unannounced inspections on the manufacturers if they want.
ARQon has the knowledge to do gap analysis on your Quality Management System to ensure that you are fulfilling to both QSR and ISO 13485 requirements. Contact ARQon for more information.
FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers
Cara Distribusi Alat Kesahatan yang Baik (CDAKB)
In Indonesia, one of the rules for the distribution of medical devices is on ‘How to Distribute Good Medical Devices’, also known as CDAKB.
CDAKB is the guideline used in the series of distribution activities and quality control aimed at ensuring that the distributed medical devices meet the requirements set for their intended use.
Since Permenkes 4/2014 in 2014, the Indonesian government introduced CDAKB as an effort to highlight the importance of the distribution of medical equipment that does not affect patient safety. Up till December 2017, only 87 companies are CDAKB certified.
Medical Equipment in the mandatory category are those that involve:
In-vitro Diagnostic health tool
Non-radiation electro-medical appliance
Non-sterile/Sterile non-electro-medical appliance
In order to apply for a IPAK permit (only companies that has license for storage & distribution of medical equipment in large quantities), they must:
Be CDAKB certified
Be in the form of a legal entity which has obtained a business license in accordance with the provisions of laws and regulations
Have full technical responsibilities
Have facilities and infrastructure adequate for their own status with a contract of min. 2 years
Have cooperated with another company in the conduct of after sales warranty