API has determined that the requirements of a Q1 system must cover all parts manufactured used in the oil and gas industry. They are really enforcing this now. This means all of the controls in place for the Q1 system automatically cover all parts manufactured by a company and sold in the oilfield fall under the scope of the Quality Management System. If you have or are working toward a Monogram program, there are limited exclusions allowed by API for design of product. There is a document provided by API called API Advisory 6 Design and Development Exclusion under the API Monogram Program that explains products that do not have to have a design.
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