What we do:

Onanon is an "OEM’s OEM"

Contact Onanon about Quality Management 1-408-262-8990 ext 237

Our mandate is to make quality products for experts. Quality control and assurance is integrated in every procedure at Onanon. From engineering of our automatic machinery, engineering of our product, purchasing material, hiring of employees and designing procedures—quality is our top priority.

Through the use of continuous improvement methods and the effective structure of our QMS, Onanon will meet customer requirements first time, every time.

The system is enhanced through the principles of continuous improvement: quality policy, quality objectives, audit results, statistical process control, analysis of data, corrective and preventive actions and management reviews.

 Onanon has company-wide recognized, documented and implemented its Quality Management System (QMS) established to meet the requirements of ISO 13485:2003.

Onanon QMS has been established and implemented in the following manner:

Level 1 - Quality Management System

  • Identifies the type of QMS implemented.
  • Illustrates methods of continual improvement.
  • Provides structural breakdown of the QMS levels.

Level 2 - Quality Policy Manual

  • Contains quality policy and quality objectives.
  • Illustrates business system overview and explains company profile.
  • Lists key business processes (KP) – KP1 to KP12.

Level 3 - Key Business Process

  • KP defines process inputs, outputs, and responsibilities.
  • Provides criteria for effective operation and control of the key process.

Level 4 - Sub Process under the “Key Process” umbrella.

  • Second tier processes that support key business processes.

Level 5 - Job Traveler /Work Instructions /Operational Method Sheet (OMS).

  • Job Travelers – Summarize purchase order details and set general production sequences.
  • Work Instructions / OMS – Defines in-depth process instructions for specific product.

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