Our Services

My goal is to help your company meet compliance requirements with maximum benefits, in a reasonable timeframe, with minimized hassle and cost. This includes helping you update to the newest version of the standards (ISO 9001:2015 and the changes to the related standards)

Companies decide to implement a compliance program for various reasons. Common reasons include a customer specified requirement (such as General Motors or Xerox), a requirement for a market segment (ISO 9001, IATF 16949, AS9100, ISO 13485, ISO 14001), in response to government requirements (FDA) or sometimes there is an internal need for process control and regulation. There are specific compliance standards for each situation and I can help you choose what standard best meets the needs of your company.

ISO 9001 asks each company to define key customer oriented processes (such as sales, purchasing, and manufacturing), set specific, measurable goals for each process and implement procedures to ensure the customer is protected from non conforming products or services.

IATF 16949 goes a step beyond ISO 9001 by adding automotive production specific requirements, such as PPAP (Product Part Approval Process), Control Plans, APQP (Advanced Product Quality Planning) and customer specific requirements.

ISO 13485 takes the ISO 9001 requirements and adds specific medical component manufacturing requirements such as risk assessment, increased traceability and cleanliness requirements. ISO 14001 addresses the environmental side of your business and asks each company to identify what they are doing that helps or hurts the environment, rate each of these according to the risks represented and take appropriate action steps to mitigate these risks.

For each of these standards, I have experience assessing the current position of a company, determining an action plan for certification and implementing the plan with the company to ensure compliance, satisfaction and future success.