TOP > About Us > Quality and Environment

Values and Responsibility

Quality & Environmental Policy

Quality Policy

Our company maintains the effectiveness of the quality management system by the documentation and establishment in accordance with ISO 9001 specification throughout the design, development, production and sales of the products and service as well as the implementation of the following basic actions:

Principal

1.Full dissemination of customer first

Santec understands fundamentaly that our quality is for our customers and always pursue the activity seriously and faithfully to comply with the customer’s needs.

2.Research, development and application of the latest technologies

Santec challenges itself to build fully original fiber optic technologies based on our research and development and the quality system must keep in step with our development. The products generated by this activity must provide the trust, reliability and satisfaction to cope with the requirements from our customers that change from day to day.

3.All members’ participation to the quality assurance activity

"Quality is produced in process." All of our members must assure their own process quality by the best effort of their creativeness and originality.

Basic Policy

1.To improve the customer’s satisfaction by our business philosophy of customer first.

To aim improving our customer’s satisfaction at each stage of the business process from inquiry to acceptance of the order.

2.To establish the quality objective

To fully disseminate the quantitatively established quality objective that is accordance with the each task that must be achieved by each division, based on our quality policy and president’s yearly policy.

3.To clarify the responsibility and authority

To fully disseminate the clearly clarified responsibility and authority of each organization to our quality control.

4.To comply the laws and industry-led regulations

To control the applicable requirement from laws and industry –led regulations that must be clearly clarified. To cope with this policy, we shall implement the through prior verification by the reviews and so on.

Medical Device Quality Policy

Our company maintains the effectiveness of the quality management system by the documentation and establishment of the quality management system in accordance with ISO 13485 (EN ISO 13485) specification throughout the design, development, production and sales of the products and service as well as the implementation of the following basic actions shown by the slogan.

Principal

1.Full dissemination of customer first

Santec understands every quality is for our customers and always promotes the activity seriously and faithfully to comply the customer’s needs.

2.Research, development and application of the latest technologies

Santec goes through the new challenge of our quality improvement based on the research and development of the fully originated fiber optical technologies. The products generated by this activity must provide the trust, reliability and satisfaction to cope with the requirements from our customers that change from day to day.

3.All member’s participation to the quality assurance activity

‘Quality is produced in process.’ All of our members must assure their own process quality by the best effort of their creativeness and originality.

Basic Policy

1.To improve the customer’s satisfaction by our business process of customer first

To aim improving our customer’s satisfaction by that each process from stage of inquiry・acceptance of the order to production achieve its own objective.

2.To establish the quality objective

To fully disseminate the quantitatively established quality objective that is accordance with the each task that must be achieved by each division, based on our quality policy and president’s yearly policy.

3.To clarify the responsibility and authority

To fully disseminate the clearly clarified responsibility and authority of each organization to our quality control

4.To comply the laws and industry-led regulations

To control the applicable requirement from laws and industry –led regulations that must be clearly clarified. To cope with this policy, we shall implement the through prior verification by the reviews and so on.

Environmental Policy

Philosophy

Santec embraces the belief that businesses are responsible for maintaining good environmental practice, operating in a sustainable manner and working in harmony with the environment.
We are therefore committed to reducing our impact on the environmental and continually improving our environmental performance as an integral and fundamental part of our business strategy and operating methods. In addition, we hope our high technology optical products will have a positive impact on reducing society’s environmental impact.

Policy

1.Legislative Compliance

To wholly support and comply with or exceed the requirements of current environmental legislation and codes of practice.

2.Effective Utilization of Natural Resources

To minimize energy and water usage in our buildings, vehicles and processes in order to conserve supplies and minimize our consumption of natural resources. To further minimize our waste and reuse or recycle as much of it as possible.

3.Environmentally Aware Design

To recognize the environmental impact of any new products or processes we intend to introduce and from the initial design and development stage take steps to minimize their impact on the environment.

4.Continual Improvement of Environmental Management

To continuously monitor and improve our environmental management program, reviewing and revising its aims and targets on a regular basis.

5.Promotion of activities that consider biodiversity conservation

In business activities, we strive to maintain harmony with the natural environment and reduce the impact on "Biodiversity" for a sustainable society. 

6.Understanding and Awareness

Through training and education ensure that all employees understand and comply with our environmental policy. The policy is stated publicly.

Green Procurement Guidelines

Aim

It is in the company’s interest to minimize damages to the environment through good business practices. Santec’s environmentally friendly procurement system has the following key principles:

1) In addition to improving quality, price and delivery times, materials with the least detrimental effect on the environment have been carefully selected.
2)  Preference toward suppliers that positively promote good environmental practices.

Implimentation

These guidelines apply to all of Santec’s products and the materials used in the production, processing and packaging of Santec’s products. This includes OEM products.

(※OEM :Original Equipment Manufacturing:Products manufactured by a partner company and sold under Santec’s brand name.)

Environmental Management System

We request one of the following from our suppliers

  1. (1) A recognized environmental management system such as the internationally recognized ISO-14001.
  2. (2)  A clear policy regarding working towards a sustainable environment.

Environmental Consideration of Material Supplies

In addition to the quality, reliability, specification, function, price, service and support the environmental sustainability is taken into account when selecting products and materials for purchase.

  1. (1) Chemical Substances

    • Through its quality assurance system, Santec ensures that no substances banned by Japanese law are present in the products and materials purchased. In addition, these banned substances are not used in our manufacturing processes.
    • A system is in place to ensure that any materials with restrictions on the permissible quantity are controlled. Records are available on request.

    (2) Legislative Compliance

    All materials purchased must:

    • Be compliant with Japanese laws regarding recycling and energy efficiency.
    • Generate minimal toxic waste on disposal (e.g. air pollution, water pollution, soil pollution).
    • Not generate excessive noise, vibration or foul odours.

    (3) Energy Conservation, Resource Conservation and Recycling

    • All materials purchased must be designed to enable recycling and be manufactured with the minimum practical material and energy usage.
    • All materials purchased must be designed for recycling.

    (4) Packaging

    • The packaging of all materials purchased must be recyclable and have consideration for energy and material conservation in its design.

    (5) Information Provision

    • All materials purchased must be supplied with appropriate information relating to its environmental impact. The details of any substances contained in the materials must be disclosed.

Requirements for the Supply of Materials

Santec requests all suppliers to complete a survey detailing the chemical substances present in the materials, compliance with RoHS (Restriction of Hazardous Substances) directives and compliance with WEEE (Waste Electrical and Electronic Equipment) regulations. The survey is also required before the purchase of any new materials.
Please contact us immediately if there are any further directives from public institutions.

The survey to request information on chemical substances present in procured materials conforms to the JGPSSI (Japan Green Procurement Survey Standardization Initiative) survey guidelines dated 22 July 2003 and the related manuals are followed.
Information on the JGPSSI is available on the JEITA (Japan Electronics and Information Technology Industries Association) web page. The link is given below. These tools and manual should be referred to when responding.

*JGPSSI Green Procurement Survey Manual and Tools

ChemSHERPA

Other

These guidelines may be updated according to changes in legislation and generally accepted codes of practice.

ISO Certification Registration

ISO 9001 and ISO 14001


Santec obtained ISO 9001 certification on April 30, 1997, and then obtained ISO 14001 certification on July 23, 2004.
We will continue to make efforts to contribute to an environmentally friendly society through further environmental impact reduction activities based on our environmental policy.


ISO9001の認証登録
ISO14001の認証登録

 ISO 9001 Certificate:English / Japanese
 ISO 14001 Certificate:English / Japanese

 

ISO 13485

Santec has obtained ISO 13485: 2016 certification for quality management systems in the medical device industry from Germany TÜV SÜD within the scope of certification (development and design, manufacturing and distribution of OCT equipment).
We will continue working to improve quality through ISO 13485 certification acquisition and maintenance, and contribute to society by delivering highly reliable medical equipment to customers.


ISO13485の認証登録

ISO 13485 Certificate:English