(508) 212-6700

ISO9001 QMS DEVELOPMENT AND SUPPORT

PROBLEM - Product Based or Manufacturing Company experiencing:

Need to be recognized as a global supplier of quality products
Assure repeatable results
Reduce waste and underperformance
Reduce returns and improve turnaround time
Improve Customer Satisfaction
Every product becomes a "lab experiment"


OUR SOLUTION

We review existing practices and foreseen plans and changes with executive management and become familiar with current operations at all levels.

We determine what is already in place and what needs to be developed.  This is typically done with middle management and their reports.

If a quality system is already in place, a gap analysis to the requirements in ISO9001 is performed based on the provided information and other insights.  The results are shared with all of management.

A plan for the development of the ISO9001 QMS is produced and presented to Senior Management, and after agreements is implemented.

Depending upon the size, complexity and number of sites involved, the development cycle, and ultimately registration, can last about six to eight months.  Complex situations can increase that time and will be estimated as part of the plan development.

Throughout the development and implementation process, we work closely with all members of the team.  As needed, the required "Quality" functions are also provided up to registration.  If needed additional services are provided post registration.

Develop, establish and implement robust and repeatable business practices modeled after the ISO9001 Quality Management System Standard, and attain registration.  

Support includes Internal Auditing, Management Review, Surveillance and Re-Assessment Audit support, and when needed, fulfilling the Quality functions.


Work Instructions / SOPs are written with the input and aid of the experts of the affected processes.