Product Quality Management and Stable Supply

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 handled by JLL are classified as highly controlled medical devices that involve patients' lives, and a strict quality assurance system based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Pharmaceutical and Medical Device Act), related regulations, and ISO 13485:2016 (the international standard for quality management systems for medical devices) is required.

The Quality Assurance Department takes the lead in maintaining and improving the quality management system (QMS: Quality Management System) in compliance with ISO 13485 and ensures the effectiveness and safety of the products. In addition, the quality control departments of each factory perform manufacturing and inspections in accordance with QMS, building a system to supply products whose quality is guaranteed.

MDSAP Certification

JLL has obtained MDSAP (Medical Device Single Audit Program) certification. 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 strengthen our framework for exporting proprietary products by maintaining MDSAP certification and improving our QMS.

Product Quality Management

In our manufacturing processes, trained workers perform tasks according to established procedures to maintain quality. To prevent contamination or foreign substances from adhering to products, we strictly enforce rules such as handwashing, changing clothes, cleaning procedures, and prohibiting the entry of unnecessary items to maintain the work environment. Especially in clean rooms, where strict environmental control is required, we regularly conduct tests for cleanliness and airborne bacteria to monitor the work environment.

In the inspection process, JLL uses properly managed measuring instruments to confirm compliance with inspection standards. We also undergo regular audits by external inspection agencies to confirm that JLL’s quality management system complies with laws and regulations.

Handling Defects

JLL collects information on defects and health problems related to product use from all over the country and utilizes it to improve quality. If any issues with the product occur after shipment, we promptly report to the authorities in accordance with the Pharmaceutical and Medical Device Act and related laws, and conduct investigations and corrective actions. In the event of serious health damage, we report to administrative authorities and provide information to medical institutions in accordance with laws, and work to prevent recurrence.

Secure Stable Supply of Products

Formulation of Business Continuity Plan (BCP)

At JLL, we have formulated a business continuity plan (BCP) to prepare for business interruptions caused by earthquakes or natural disasters. In addition, to enhance the effectiveness of the BCP, we conduct desk-based simulation training and are working to establish a system that enables early resumption of business operations.

To ensure continued product supply even if business continuity at a specific manufacturing site becomes difficult, we are promoting the duplication of production lines for major products while also providing education and training for multi-skilling of workers and for skill retention related to products transferred to partner companies, to enable prompt alternative production.

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.