COMPLIANCE AUDIT:

We will perform pre-assessment audits to the ISO 9000 standard Or to Quality System Regulations (formerly GMPs) to help prepare your company for ISO or FDA inspection. The number of auditors and number of days will be determined on the size of the facility.

CONTAMINATION CONTROL AUDITS:
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This audit will focus only on the aspects of the Quality System Regulations that affect contamination control. Areas audited include manufacturing processess and environmental control, cleanroom gowning and protocol, material handling, and cleaning procedures. Often, chronic contamination problems can be solved quickly during a contamination control audit.

CONSULTATION:

We can visit your facility to consult on specific contamination problems. These include particulate, chemical and microbiology problems.

TRAINING:

The following ISO 9000 training classes are available:

• Introduction to ISO 9000
• Technical Writing
• Auditor Training
• Total Quality Management
• Quality Systems Development
• Quality Planning

ISO 9000 training classes are generally held at your facility. Call for specifics of class sizes.