PMI Blog

ISO Certification and Quality Management System

by | Oct 31, 2018 | Uncategorized | 0 comments

At PMI, our commitment to quality guides each team member and, ultimately, differentiates us as an organization. Initially developed to better meet, coordinate and mirror the quality standards systems of our clients, our ISO certified Quality Management System (QMS) consists of two essential modules:

  • The Quality Management System, which contains guidelines for maintenance of our quality system
  • Service Realization Procedures, which specify Standard Operating Procedures (SOPs) for delivery of our services

We work with you at project initiation to clearly identify and establish processes and procedures to facilitate an efficient trial. Then, we integrate our procedures into customized plans, which specify how and when they will be used and documented. The study plans and procedures are formally reviewed regularly and updated as necessary to accommodate changes that occur during project duration.

We also offer clinical study compliance education seminars online, onsite or in a central location. Our seminars emphasize content and practical applications and are designed to enhance rapid uptake by attendees. These seminars can be customized to address specific issues within our clients’ medical specialty/therapeutic areas.

Areas included in our Quality Management System:

Quality Management System
Quality Management System Requirements
Documentation Requirements
Control of Documents
Control of Quality Records
Management Responsibilities
Management Responsibility
Quality Planning
Responsibility and Authority
Management Representative
Management Review
Resource Management
Resource Management
Human Resources
Service Realization
Service Realization Planning
Client Related Processes
Client Communications
Service Realization Process Controls
Service Realization Process Validation
Measurement, Analysis & Improvement
Client Satisfaction
Internal Audits
Monitoring and Measurement
Control of Nonconforming Material
Analysis of Data
Continual Improvement
Corrective and Preventative Action