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Drugs and Health Products

Quality System Framework - Summary

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The Quality System Framework (QSF) outlines a quality system approach for compliance and enforcement activities shared by Health Products and Food Branch (HPFB) and Regions and Programs Bureau (RAPB) of Health Canada. This quality system, under the mandate of the Health Products and Food Branch Inspectorate (Inspectorate), was developed and implemented to ensure strong functional linkages, fairness, consistency and a high standard for quality in all Inspectorate program activities.

The purpose of the QSF is to:

  • describe the structure of the Inspectorate and its activities
  • outline the roles and responsibilities of the Inspectorate
  • communicate the Quality Objective and Quality Policy for the national Inspectorate compliance and enforcement program

The structure is presented both as an organizational chart and description that outlines the roles and responsibilities and the interaction between HPFB and RAPB. The Quality Policy is a commitment to the Quality Management System, in fulfilling the Inspectorate's mandate, and it is demonstrated through the integration and promotion of Quality Management Principles within its organization. The Inspectorate's Quality Objective is uniformity in fulfilling our compliance and enforcement responsibilities to meet the expectations of our clients, partners and stakeholders. The QSF also ensures that the requirements of the applicable International Standard (ISO 9001:2008 and CAN-P-4E (ISO 17025:2005)) are applied uniformly and consistently throughout the Inspectorate's core and related functions.

For a complete copy of the QSF contact the Quality and International Assessment Division.