QUALITY SYSTEM/MANAGEMENT AUDITS
The FDA or ISO requires regular scheduled internal audits.
An adjunct to this schedule is a third party inspection.
The outside audit puts new and objective eyes on your system. Since your Quality System is a living document and may undergo changes purposely or sometimes inadvertently. Subtle changes or more obvious ones may occur without recognition and documented change to your SOPs / Policies / Work Instructions. From our experience, countless procedures consists of gaps leading to actual procedure that do not match. Our objective is to identify those non-conformances that may occur by omission or commission and assist your company in correcting any anomalies.
Pre-Audit Preparation for Inspections
A pre-audit can assist your company in preparing for your planned audit, identify any trouble spots and resolve them before the audit rather than responding to FDA or ISO observations after the audit.
Can I have a consultant during an audit?
Yes. Most companies do not realize that they may have a third party representative for their company during an FDA/ISO inspection, as an observer and also to assist in the response if any observation should occur.
HSMS Consulting Services represents companies as an on-site consultant during inspections.
The FDA or ISO or Health & Safety inspector just called for an inspection next week, but my Quality or HSMS System is not complete…now what?
And what a feeling that is to be ill prepared for a surprise inspection. We can help you fill in your Quality System gaps or provide an entire QS with our Implementation-Ready Quality System
Are you prepared for a scheduled inspection?
A pre-audit can assist you in preparing for your audit, identify any trouble spots and resolve them before the audit rather than responding to observation non-conformances.
We service all sized companies and classifications within your budget.
Enforcement Discretion: FDA issued revised requirements for high risk COVID-19 Devices- we can assist you move forward with your registration