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Elements of Quality Management Systems

• Organizational Structure
• Responsibilities
• Procedures
• Processes
• Resources

The FDA and other accrediting agencies have identified in the QS regulation the essential elements that a quality system shall embody for design, production and distribution, without prescribing specific ways to establish these elements. These elements include:

• personnel training and qualification;
• controlling documentation;
• controlling purchasing;
• defining and controlling inspection, measuring and test equipment;
• product identification / case management and traceability at all stages of fulfillment;
• validating processes;
• product acceptance;
• controlling nonconforming product;
• instituting corrective and preventative action when errors occur;
• labeling and packaging controls;
• handling, storage, distribution and installation;
• records management;
• management of training;
• statistical techniques;

all overseen by Management Responsibility and Quality Audits.

Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to implementing organization to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices.

Scope of Services

A few of the tasks PBSI advisors can assist you with are:

• Current state/gap analysis of your current policies and procedures
• Development of a project plan (or management of the project itself) to correct the deficiencies identified in the current state/gap analysis
• Draft the business case for the selection and implementation of a Quality Management System
• Provide training and technical assistance to process map AS IS /TO BE quality processes in anticipation of process improvement initiatives or selection of a Quality Management System
• Selection and implementation of automated quality management systems
• Provide training in internal auditing guidelines for laboratories
• Lead laboratory process improvement and process mapping initiatives