Product Quality Management
Product Quality Policy
We have established a common quality policy for our head office and our plants with the aim of supplying safe and secure products to the medical field and responding to the trust of patients and medical professionals.
Product Quality Policy
In order to implement our mission, we will strive to develop and manufacture our own products that accurately reflect the needs of the medical professionals, and introduce cutting-edge medical devices overseas under the quality management system as a manufacturer most closely tied to the medical field. We will promote business activities with the aim of contributing to the healthcare sector not only in Japan but around the world.
Quality Assurance System
Many of the medical devices we handle are classified as “highly controlled medical devices” that directly impact patients’ lives. Therefore, we are required to have a system in place to ensure strict quality control as per the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter Pharmaceutical and Medical Device Act), related laws, and ISO 13485:2016 (the international standard for quality management systems for medical devices).
Our Quality Assurance Department leads in the establishment, maintenance, and improvement of the quality management system (QMS) in accordance with ISO 13485 to ensure the effectiveness and safety of our products to the required standards. Each factory’s quality control department manages the manufacturing process and performs inspection tasks based on QMS, constructing a quality assurance system that supplies only quality-assured products to the market.
MDSAP Certification
In May 2023, our Headquarters and three of our factories in Japan obtained MDSAP (Medical Device Single Audit Program) certification as we prepare to export our in-house products to other nations. MDSAP certification demonstrates compliance with regulatory requirements of member countries (U.S.A., Australia, Brazil, Canada, and Japan) through a single audit. We will continue to maintain and improve QMS and strengthen our system for global exports.
Product Quality Management Activities
In our manufacturing processes, trained workers perform tasks following established procedures to maintain product quality. To avoid contamination of products by foreign substances or adhesion of these substances to products, we set rules such as designating work clothes, handwashing, changing clothes, cleaning, and prohibiting the entry of unnecessary items into the work area, thereby maintaining the factory quality. Particularly in clean rooms, which require high levels of cleanliness, we regularly test cleanliness and airborne bacteria to monitor the work environment.
In terms of product inspection tasks, skilled workers verify compliance with inspection standards using established procedures and properly managed measurement equipment. Inspections are conducted at each stage of component reception, assembly, packaging, and pre-shipment. Only products that pass all inspections will be shipped. Also, regular audits by external inspection agencies are conducted to ensure that our internal quality control system complies with regulatory requirements.
Quality Improvement
We systematically gather information on device defects and health-related issues that arise from the use of our products nationwide. It is crucial for our on-going efforts to enhance product quality and safety. In the event of a quality issue after shipment, we promptly report it to the authorities in accordance with the Pharmaceutical and Medical Device Act and related laws, and conduct an investigation to identify the cause, taking corrective measures immediately to prevent further damage. In every defect cases, we abide with law and authorities, and provide necessary data to physicians and hospitals, as we work sincerely to prevent future cases.
Secure Stable Supply of Products
Creation of Multiple Production Lines
Many of the medical devices we handle are “highly controlled medical devices” that are critical to the lives of patients. These products hold a high market share. Therefore, ensuring the stable supply of products to medical facilities is our social mission.
We are strategically duplicating manufacturing lines for our key products to ensure a sustainable supply even in the event of business interruptions caused by natural disasters or other emergencies. Additionally, since a level of technical proficiency is required to manufacture our products, we continuously educate and train workers to prepare for rapid alternative manufacturing during emergencies.
Formulation of Business Continuity Plan (BCP)
At JLL, we have formulated a business continuity plan (BCP) to prepare for business interruptions caused by earthquakes and natural disasters.
In FY3/2024, we reviewed the initial response manual and held BCP briefing sessions for all employees to enhance the effectiveness of the BCP. We are building a system that enables early resumption of business after a disaster through company-wide collaboration.
Malaysia Factory
Supply Chain Management
Procurement Policy
The JLL Group works with suppliers in line with the Procurement Policy to maintain product quality and ensure a stable supply of products.
Procurement Policy
Fairness Global opportunities for fair transactions
We will provide fair opportunities for competition to all suppliers globally.
Advanced Secure the latest technological capabilities and product safety
We will constantly search for the latest and most appropriate technology that makes our products different. We aim to ensure product safety through cooperative relationships with our suppliers.
Compliance Abide by laws, regulations, and social norms
We will comply with relevant laws and regulations. We do sound and fair procurement activities with social norms.
Win-Win Collaborate with suppliers with trust and integrity on the long-term
We will build long-term relationships of trust with our suppliers and strive for mutual development through study and cooperation.
Main Items for Selecting Suppliers
Our suppliers should:
1. Comply with laws, regulations, social norms, etc., and care human rights and environmental issues.
2. Be financially sound.
3. Meet the quality, price, and delivery time of materials and services at an appropriate level.
4. Be able to provide a stable supply and respond to changes in supply and demand in a flexible manner.
5. Have technical capabilities to contribute to increase our product values.
6. Be able to maintain supply even if unexpected disasters, etc. occur.
Requests to Suppliers
We ask our suppliers to:
1. Comply with laws, regulations, and social norms
2. Care for human rights and occupational health and safety
3. Care for the environment
We will give preference to suppliers who are actively engaged in environmental conservation and will select materials with less environmental impact.
4. Continue sound business management
5. Ensure excellent quality
We request that suppliers meet the standards of our quality assurance system. In addition, we ask suppliers for their cooperation with designated procedures for change management (production discontinuation and specification change).
6. Provide products at reasonable prices
We expect suppliers to offer market-competitive prices and do activities to reduce cost.
7. Ensure reliable delivery dates
We expect suppliers to meet delivery deadlines and to establish a flexible supply system that can respond to fluctuations in supply and demand.
8. Strengthen technical capabilities that can help our product development
We expect suppliers to make efforts for further cutting-edge technological capabilities
9. Continue supply even if any unexpected disasters, etc. occur
We ask suppliers to make appropriate BCP to prepare for unpredictable events such as natural disasters, and cooperate if any emergency events occur. We also ask for cooperation in risk management initiatives to minimize possible risks at normal times.
10. Protect confidential information
We will disclose information necessary for business transactions to suppliers. We ask suppliers to appropriately manage and protect confidential information that they obtained.
Supply Chain Risk Management
We regularly conduct surveys on risk management with our suppliers. Based on the survey results, we conduct risk assessments for each company and take measures such as considering the diversification of purchasing sources for important components or those with high supply suspension risks.
Furthermore, for third-party products, we always maintain a certain level of inventory and increase inventory as necessary to prepare for supply difficulties due to manufacturing or logistics disruptions.
In the fiscal year ended March 2024, we conducted a “Human Rights Survey” designed for our major suppliers and third-party product providers. We are assessing the status of our business partners’ efforts regarding human rights and evaluating the likelihood and severity of human rights risks. Moving forward, we will work with each company to reduce the risk of human rights violations in the supply chain.
