QUALITY MANAGEMENT SYSTEM (QMS)

For implementation and maintenance and of Quality Management System (ISO 9001:2015) there are several documented information which are mandatory. As required by International standard ISO 9001:2015, these documents are mandatory for compliance of Quality Management System and obtaining ISO 9001:2015 certification. Refer here for details regarding mandatory documented information and non mandatory documented information as per requirements of international standard. While structuring Quality Management System, an organization can be divided into several departments for smooth running of organization's activities. Departmentalizing an organizations brings clarity regarding who's gonna do what. Every department is responsible and accountable for certain tasks.  In doing so, a defined set of documents helps each department to perform and control its tasks in an effective way. These set of documents not only ensure easy going of department's activities but also helps in conform...

While implementing QMS(ISO 9001:2015), it is important to understand the required documented information. The documented information can be used for communicating information, knowledge sharing, to demonstrate what was planned and and what has been done and to disperse and preserve organizations know how to conduct its processes. As per the requirement of standard(ISO 9001:2015), following documents are mandatory for compliance and obtaining ISO 9001:2015 certification: Non mandatory documents There are several documented information which are non mandatory but can be used during implementation of ISO 9001:2015. These documents are: Quality Manual Process Mapping, Process Flow Diagrams Organizational Chart Procedure for addressing risks and opportunities Procedure for change management Procedure for training Procedure for control of documented information Procedure for design and development Procedure for handling of non conformity and corrective action Procedure for internal audit...

Quality management professionals face enormous difficulty while implementing quality management system in organization where there was  no former existence of QMS. Its's not an easy task to do.  The most challenging part is to break the existing corporate culture that was built over the years. Employees and in some cases top management are resistant to changes. For employees, new system and related documentation is an added burden and work load. Top management see them as increase in overhead cost and often it is feared that with such activities it will be difficult to achieve production targets. Let us now discuss in detail the challenges faced and tips to overcome them: Challenges faced during Implementation:   Existing corporate culture:   This is the most challenging part. A settled practice of work is hard to give up. Employees are habituated to work in a culture which was built over the years and find it difficult to adopt new system and changed ...

Before hitting the Quality Management System as a whole, let's first understand the concept of associated terms; Quality, Management & System. Quality: In simple words, Quality referrers to all those features of a product or service which are required by the customer. Management:  Management is a process of administering and controlling the affairs of the organization. It applies a set of principles to achieve organizational goals. System: System is a set of defined policies or procedures according to which something is done in an organized way. Now, Quality Management System may be defined as a set of coordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance. It comprises of collective policies, plans, practices and the supporting infrastructure by which an organization aims to reduce and eventually eliminate non-conformance to specifications, standards and cus...