YSI 2300 Gold Analyzer Owner’s Manual
- June 1, 2024
- YSI
Table of Contents
Quality Manual
1700/1725 Brannum Lane, Yellow Springs, OH 45387
937 767 7241 FAX 937 767 9320
Quality Policy
We maintain a quality management system to provide our customers with quality, innovative products and services that meet or exceed expectations. To support this, we will:
- Establish, measure, and achieve quality objectives as an integral part of our business decision making process.
- Utilize the Quality Management System to support our strategic direction.
Environmental Policy
Achieve company environmental objectives by:
- Protecting the environment through prevention of pollution and waste, and from harm and degradation that could be caused from the company’s activities, products, and services.
- Fulfilling compliance obligations and legal requirements
- Continually improving the environmental management system for enhancement of environmental performance
- Providing strategic focus to the company’s impacts, risks, opportunities, and influence for competitive advantage and to support the company’s strategic direction and scope.
Quality Management System Process model
The Quality Manual is the foundational framework by which YSI enables continual optimization of products and services, customer satisfaction, business operation excellence, and compliance. This manual:
- Establishes the quality policy that sets consistent expectations and responsibilities for the company,
- Defines the scope of compliance with applicable regulatory, standards, industry, and business requirements,
- Defines roles and responsibilities for ensuring consistent process effectiveness, suitability, and adequacy, and
- Describes the key processes of the quality system and their interaction, and identifies the documentation established for the processes.
Scope
Develop, design, manufacture, distribute, and service instrumentation that provides high quality and reliable data for laboratory, water quality, water quantity, and bioprocessing analysis.
Mission
We provide technology solutions to protect water resources for all generations.
Applicable Standards & Regulations
| Standard Regulation | Business Unit |
|---|---|
| ***Life Sciences | All Others |
| ISO 9001 | |
| IS013485 | ** |
| ISO 14001 | |
| 21 CFR Part 820/830 |
**Cleaning procedures or sterilization not required, section 7.5.2, 7.5.5, and
7.5.7 do not apply. The device is not implantable, section 7.5.9.2 does not
apply.
*** YSI Model 2300 was discontinued in July 2016. There are no installation or
design clauses associated with this unit.
Role/Responsibilities
Management responsibilities are defined within the Management Responsibility
procedures.
Top management is accountable for the quality and environmental management
system, which is integrated with business processes and compatible with YSI’s
business strategy.
QS Documentation Architecture *
| Level | Definition |
|---|---|
| Quality Manual | Defines policy, intent, and structure |
| Quality System Processes (Procedures & Policies) | A sequence of procedures |
used across the company to fulfill the requirements
of the quality system.
Standard Manufacturing Processes
(SMPs)| Defines activities required to perform activity within a business
unit.
Process Work Instruction| Specific steps required to perform an activity.
Documented Information(Records)| Outputs of QSM processes and activities that
service as objectives evidence of
compliance.
Quality Manual Brochure.docxRev AB
Date 04/17/2024