Strategies for ensuring product quality
MBL has established and operates a quality management system (QMS)*1 in line with its mission of providing customers with accurate/reliable and safe products.
The company’s QMS requires factory personnel to define procedures for every step, from process design and development through shipment, and to unfailingly keep records of actions taken and outcomes achieved in the production of diagnostic reagents at predefined levels of quality. Every incidence of non-conformance or deviation needs to be properly addressed, and corrective measures must be promptly instituted to improve factory operations on a daily basis.
The QMS is periodically inspected by the in-house auditor to confirm correct implementation of the system and to identify areas for further improvement.
The QMS stipulates not only manufacturing and quality control procedures but also those for procurement of materials, designing and development of production processes prior to commercial production, rigid management of transportation of shipped products, and the active involvement of management as the responsible persons for the assurance of product quality. The QMS regulations are expected to be further reinforced in light of their importance.
Over many years, MBL has been successful in implementing consistent quality management and systemic improvement, and it has received favorable audit reviews from external auditors.
MBL will continue to appropriately and faithfully execute the procedures defined in the QMS, recognizing this as a key responsibility for a public entity and the basis for earning the trust of customers and society.
*1 Quality management system (QMS): A set of policies, processes and procedures required for the management of corporate organization for quality assurance.
MBL’s QMS conforms to ISO13485:2016,*2 an international standard for quality management systems for medical devices, and the Ministerial Ordinance on QMS*3 (full title: “Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents”).
MBL exports its products to the U.S. where device establishment inspection is the most rigorous in the world. In preparation for inspection by the FDA,*4 MBL has incorporated regulations of the U.S. QSR*5 into the company’s own QSR. The system has twice been highly rated in recent inspections. Similar but independent quality regulations are enforced in other areas, such as Europe and China. MBL also complies with regulations in those regions to which its products are shipped.
*2 ISO 13485: A standard that specifies requirements for QMS of companies involved in the medical device industry which need to consistently manufacture and provide safe and useful medical devices and related services in compliance with applicable regulatory requirements in each region or country.
*3 Ministerial Ordinance of QMS: The Ministerial Ordinance implemented based on ISO13485 and issued in line with the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices (Pharmaceutical and Medical Device Act).
*4 FDA: FDA stands for Food and Drug Administration. Marketing of drugs in the United States requires pre-marketing approval, notification, registration, or authorization from the FDA.
*5 QSR: QSR stands for Quality System Regulation. It is the medical device GMP regulated by the U.S. FDA, with which manufacturers of medical devices are obliged to comply for exporting medical devices to the U.S.
Medium- to long-term vision How MBL can contribute to the health of the general public and to medical progress
MBL implements the following plans concerning the production system and quality control, in accordance with its corporate philosophy and medium- to long-term management plan.
Laying solid foundation for the quality control system
Quality control testing before shipment is carried out based on established in-house release specifications which are more stringent than product specifications, and only products that meet the release specifications are shipped. The specifications and test methods are routinely reviewed and updated in order to ensure that the highest possible level of quality is maintained in testing to enable consistent supply of quality products.
Reinforcement of compliance with overseas regulations
As a leading global niche company, MBL develops and supplies a broad range of diagnostic products. The European Union (EU) intends to strengthen medical device regulations by replacing the current In Vitro Diagnostic Medical Devices Directive (IVDD) with the In Vitro Diagnostic Medical Devices Regulation (IVDR) in May 2022. MBL is preparing for that deadline according to the in-house schedule. In addition, the company is carefully preparing itself for legislative revisions in other countries or regions that may occur in association with the strengthening of the regulation in the EU.
- Research and development of raw materials for diagnostics
- Research and development of reagents
- Clinical performance study and pharmaceutical licensing application
- Production system
- Quality management
- Product examples