Compare cost of conformance and non-conformance when consider

                    the implementation of QA to your company.



 Cost of Conformance


Cost of Non-conformance 

 Training and indoctrination



 Process control



 Product design validation


Additional material or inventory

 Process validation


Warranty expenses

 Test and evaluation


Complaint handling

 Quality audits


Liability judgments –possible legal actions

 Maintenance and calibration


Product recalls



Product corrective actions







There are numerous benefits for companies that are ISO 9001 certified. Some are listed below:


  • Improve business processes and save money by increasing process efficiencies, reducing waste and improving product quality.

  • Qualify for new customers. Many companies require ISO 9001 certification as an essential requirement for conducting business with a new vendor.

  • Enter global markets. ISO 9001 certification is required in many countries. Medical Devices company are required to be ISO 13485 certified in order to sell their class II, III and IV devices on the global market.




Maria Persoglia M.Sc., P. Eng., Consultant


Meinardo Boizan PhD., P.Eng., Consultant




We have extensive experience in the areas of Chemical Engineering, Pharmaceutical and Medical Devices Industries.

Our experience includes but is not limited to:Total Quality Management (TQM), Good Manufacturing Practice (GMP), Food and Drugs Administration (FDA) and Canada Medical Devices Regulations requirements and audits, as well as requirements for the implementation of ISO 9001, ISO 13485, and ISO 27001.

In addition, our experience includes knowledge of Federal and BC Privacy Laws (PIPEDA, PIPA, and FIPPA).



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