Quality Assurance

A successful Quality Management System (QMS) cuts costs and ensures a healthy functioning of your organization. Save resources by eliminating waste, refunds, and rework. Convey your company’s mission and vision and engage the employees in working toward clear and meaningful goals.

Our Quality System
services include:

Editing, and content
management for QMS

Making the QMS documents drafted by various process owners sound as one voice

Internal Audits

Conducting the mandatory internal audits for your organization, according to:
ISO 9001
ISO 13485 + 21 CFR 820
21 CFR 211
21 CFR 11

Second-party Audits

Conducting tailored audits of suppliers according to ISO 9001, ISO 13485, other standards, and customized specs, as well as SME support for supplier audits (translation/interpreting)

Language service provider
auditing and qualification

Supporting the language service provider selection and qualification by veteran translators and auditors specializing in the language service field

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