QM: 4 Quality Management System (4.1: Introduction)

Form this point onwards management’s commitment for implementation of QMS and policy adopted for fulfilment of each and every clause of the Standard are explained. Detail of the information provided in the quality manual (QM) depends upon the complexity of the organizations processes & interaction and structure & complexity of documentation system. For a simple documentation system all the quality procedures can be explained in detailed in a QM and thus the manual becomes the only document for implementation of QMS. In a complex documentation system, policy and brief description of implementation of requirements of each clause are given in the manual along with the reference of the document containing detailed description.

4	QUALITY MANAGEMENT SYSTEM
4.1	INTRODUCTION

4.1 Introduction:

The company has established, documented, implemented and maintains a Quality Management System in accordance with requirements of ISO 9001:2008 and applicable regulatory (FDA, EU, MHRA…) and statutory requirements.

or

This Quality Manual and its associated policies and procedures establish and document the means by which the company implement, maintain and continually improve its QMS. It is not a stand-alone system, but is integrated within companies operating discipline which encompasses the policies, requirements, and work processes of (applicable regulatory requirements- FDA, EU....), (applicable pharmacopeia BP/USP....), (applicable statutory and regulatory requirement of product), Environment (applicable laws), Health, Safety, Human Resources (applicable laws and rules) and Quality.

(Company’s design/model of QMS system) The system is maintained and continually improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action and management review. The company also has a system in place to review, evaluate, and address customer satisfaction.

4.1.1 The processes needed for the QMS and their application throughout the organization have been determined (Description of the process flows can be given at this point or annexed to the manual).

4.1.2 The sequence and interaction of these processes has been determined. (Sequence of the interaction can be given at this point or annexed to the manual)

4.1.3 The company has determined criteria and methods needed to ensure that both the operation and the control of these processes are effective and documented them in quality plans, procedure and work instructions and controlled through Measuring, Monitoring and Analysis.

4.1.4 The management ensures the availability of resources and information necessary to achieve planned results and continual improvement of these processes, including the development of appropriate departments to handle defined responsibilities as part of the Quality Management System.

4.1.5 The company has established a system to monitor, measure, and analyze these processes.

4.1.6 The company has established processes for identification and implementation of actions necessary to achieve planned results, maintain effectiveness and continual improvement of these processes.

4.1.7 Additional processes may be added to the determined process, as new customer products and/ or regulatory requirements are introduced.

(Control over outsourced processes) The company ensures that outsourced processes are managed within the umbrella of QMS. All requirements and specifications of outsourced processes are identified for the better control over the outsourced processes. All outsource parties are selected and approved as per the supplier qualification procedure. Controls and requirements of outsourced processes are outlined in the applicable Supplier Qualification procedure(s) (Cite Procedure No).

Outsourced processes and services may include the following (provide list of outsources processes/services):

1.

2.

3.

Supplier history information is maintained and monitored. Records regarding the control of outsourced processes are maintained in the applicable supplier files. The company works closely and has regular communication with the suppliers of these outsourced services.

Process Flow and sequence of Interaction between the processes:

The process flow of each determined process within the umbrella of QMS can be prepared separately.  Process can be explained in a block diagram with interacting process in side arm, e.g.:

Or an exhaustive process flow depicting all the processes and their interactions can be prepared. 

Process interaction matrix chart can be prepared as follows: