Setup and anchoring of iso-certified quality system at pharmaceutical wholesaler

Aim

From a wholesaler, one of GPP Support’s partners received the request to set up an ISO-certifiable quality system and then to implement it. Anchoring of continuous monitoring and adjustment of the quality system were important spearheads in this.

Approach

In our role as project manager, auditor and quality manager, in consultation with the client, we approached the setting up, implementation and anchoring of the quality system in the following way:

• reference measurement
• develop project plan and implement it through to certification
• process and organisational description
• prepare quality manual
• test audit and adjustment
• set up internal audit organisation
• anchor in management cycle
• implement internal audits
• project management of improvement processes

Result

The quality system with an audit team of trained auditors is operational and ISO-certified.