Training Services

Public Courses

September 2004 - Exton, PA

Understanding and complying with FDA regulations – 2 days
Understanding, transitioning and implementing ISO 13485 – 1 day
The FDA Quality System Inspection Technique (QSIT) – 1 day
Process Auditing – 1 day

Internal Auditing – 2 days
Design Control – 1 day
Process Validation – 1 day
Risk management – 1day
Understanding FMEA – 1 day
Understanding CE Marking – 1 day

ISO9001 - Internal Auditing Practicum

Conduct real audits (No Role Playing)
Hands On - Learn by Doing
Learn process oriented auditing

The standard two-day program is generally appropriate for up to ten trainees who have had some quality systems training. For eleven to twenty, the three-day program is recommended since it affords everyone the opportunity to perform hands-on auditing.

If the trainees have had little or no exposure to quality system requirements, (ISO9000), we can precede the two day program with an additional day devoted to studying ISO9000 requirements. (If you wish, any number of people may attend this ISO9000 study session. So, if you have others who need ISO9000 training, this is an excellent opportunity to "piggyback".) It is very important that your audit leader(s) have a solid understanding of ISO9000 requirements.

The Introduction:
Trainees learn
- the purpose of quality systems audits (what internal audits are/are not),
- the difference between internal and external audits,
- the role of the internal auditor, (and how to stay out of trouble)
- the collaborative nature of internal auditing,
- audit terminology, and
- audit ethics

The Practicum
They learn each step of the audit process by doing them in a "live fire" environment. Using selected company procedures, first they prepare for the audit, and then they conduct it. In a typical two day program 2 to 4 audits will be performed.

Preparing - as a group - Preparation is 80% of every audit.

the importance of knowing "what changed" since the last audit,
how to involve the auditee's manager in the audit planning process,
how to review, summarize and 'flowchart" a procedure,
how to identify the "good" of every process
how to identify process "pulse points",
how to identify and determine the nature and amount of objective evidence,
how to determine who they will interview,
how to drive fear from the audit process,
how to eliminate unwanted interference and avoid personal conflicts,
how to phrase questions and inquiries to gain the maximum amount of information,
how to prepare audit checklists,

Auditing - first as a group, then in teams of 2 through 4, the auditor trainees learn

how to conduct the audit,
how to collect and record audit evidence,
how to make determinations of noncompliance and ineffectiveness,
how to differentiate between minor and major nonconformances,
when to stop auditing
how to write an audit report so that the facts are never in question,
how to present nonconformances and opportunities for improvement, and
how to prepare and verify corrective and preventive action requests

By the way, this approach also trains your people how to be audited.

Auditor Candidates
Auditors should be drawn from all levels of the organization and be mature, open minded, possess sound judgement, good communications skills, high integrity and be able to view operations from a broad perspective. The average organization should plan on having one active auditor for each major department. (Of course, auditors will not be assigned to conduct audits in areas where they have direct responsibility.)

Timing of Training
To ensure success, the procedures which will be audited during the Practicum must be mature, i.e., they have been in effect for at least three months and have yielded a sufficient number of quality records to serve as objective evidence that the system is in compliance and is effective.

Contact Us for further details


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