qualitywise.pl, Agata Lewkowska

The project scope

The project scope was to adjust remote location processes (purchasing and supplier management, HR, IT, risk management, logistics, sales) in Quality Management System of Synthos Group certified to ISO 9001:2015 to the requirements of the automotive industry standard IATF 16949:2016. Those remote location processes took place at the recently purchased manufacturing plant in Schkopau, Germany. The challenge was that those processes were already established in former QMS with its own system solutions but were supposed to be totally transferred to the hugely different new QMS.


The target was to prepare centralized Quality Management System at headquarters with their processes. They shall be performed as a remote location and in initial stage were designed to meet only ISO 9001:2015 requirements. At the end the goal was to pass successfully the IATF 16949:2016 3rd party audit.

Major Milestones:

– Review processes in QMS at headquarters and in plant at Schkopau

– Review and update of Quality Management System procedures, work instructions and templates

– Review risk analysis with emphasis of meeting the requirements for contingency plan

– Review process monitoring based on KPI’s

– Review system mechanisms in QMS

Value added for the customer

Qualitywise.pl, Agata Lewkowska

QMS Procedures

– Over 10 process description review and updated

– More than 120 documents review and updated

Qualitywise.pl, Agata Lewkowska

Process owners support

– Collect relevant data and create appropriate documents for each process

– Preparation of the documentation for the IATF audit

Qualitywise.pl, Agata Lewkowska

Processes Review

– 5 internal audits performed

– Key performance indicator in process reviewed

– Risk analysis reviewed and updated including contingency plans


The common work with process owners in communicating the IATF 16949 requirements and proposing changes in the processes let the customer to successfully pass the 3rd party audit with no major nonconformities.


Qualitywise.pl, Agata Lewkowska, references