Table of Contents:-
- What is quality management system?
- Quality Management System Meaning
- Objectives of Quality Management System
- Process of Implementing a Quality Management System
- Benefits of Quality Management System
- Requirements of quality management system
- Implementation of quality management system
What is quality management system?
Quality Management refers to all activities within the overall management function that determine the quality system’s quality policy, objectives, and responsibilities. The quality system includes the organizational structure, procedures, processes, and resources needed to implement quality management. ISO 9001:2000 is one of the latest and most popular quality management system. An ISO certificate is provided to organizations with a quality management system meeting the standards’ scope.
Quality Management System Meaning
A Quality Management System (QMS) or Quality System (QS) can be seen as a complex system consisting of all the parts and components of an organization dealing with the quality of processes and products. A QMS can be defined as the management structure, responsibilities, procedures, methods, and tools implemented to achieve the principles and action lines necessary to fulfil the quality objectives of an organization.
According to ISO 9000:2005, “A quality management system is a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives we achieved”
According to QSR (Quality System Regulation), a quality management system can be defined as “The organisational structure, responsibilities, processes, procedures, and resources for implementing quality management.”
There are many definitions of a QMS, but most do not offer more insight than a “quality management system.” The definition of a QMS is evolving into that of effective management. It’s an addition to an organisation and an integral part of its management and production processes.
A good QMS does not make an organisation more profitable, efficient or customer-focused, but it will allow it to do anything better, from production to sales.
Objectives of Quality Management System
The objectives of QMS are:
1) Continual Improvement: This entails continuously improving products, services, the working environment, staff development, and management and production processes.
2) Reduced Waste: This reduces wasted products, repeated or corrective work, and unnecessary processes.
3) Customer Focus: This involves actively reviewing customer needs through dialogue, making customers aware of new products and services, ensuring the organization knows customer needs, and taking corrective action when the service fails to meet expectations.
The components for achieving these objectives are:
1) The active and positive commitment of senior management.
2) Documentation that supports the above initiatives.
3) Staff development that provides the correct level of competence for each job and offers opportunities for staff to progress.
4) Simple, efficient monitoring systems that enable all levels of management to identify bottlenecks and waste.
Process of Implementing a Quality Management System
There are five critical steps involved in implementing a Quality Management System (QMS):
1) Analyze the Business: Break down the business into key areas crucial to customer satisfaction. Senior staff should determine the business needs and design the system accordingly.
2) Plan the Approach: Decide which resources are needed and discuss the effectiveness of existing processes with staff.
3) Determine if New Processes are Necessary: Evaluate if new processes are necessary, inform staff about them, and provide training if needed.
4) Ensure the Processes are Working: Appoint someone responsible for the system and ensure proper procedures are followed. Set targets for how each process contributes to achieving business goals.
5) Revise Processes: Revise processes as needed and regularly review them.
Senior managers must be committed to the implementation of a QMS. With this support, convincing employees of the benefits will be more accessible.
Benefits of Quality Management System
1) Better Employee Morale: Factors such as management accountability, clearly defined roles and responsibilities, established training systems, and a clear understanding of how roles impact quality and overall company success contribute to motivating and satisfying staff.
2) Factual Approach to Decision Making: ISO 9001:2000 Quality Management System standards provide clear process review and audit instructions, facilitating decision making and data-driven information gathering.
3) Effective and Structured Documentation: Documentation of processes, discrepancies, errors, and changes ensures accountability and consistency throughout production, with traceable records available for raw materials and non-compliant products.
4) Enhances Customer Satisfaction: ISO standards build client confidence through company efficiency, consistency, and dedication to quality service.
5) Increased Revenue: ISO-certified companies experience improved financial performance and productivity compared to uncertified counterparts producing similar products.
6) Increased Efficiency: Companies undergoing ISO 9001:2008 Quality Management System certification aim to maximize the quality and efficiency of their processes. Once certified, guidelines are established that can be quickly followed by all employees, making troubleshooting, transitions, and training more manageable.
7) Achieve International Recognition: ISO (International Organization for Standardization) is globally recognized as the authority on quality management.
8) Improves Supplier Relationships: ISO certification fosters mutually beneficial supplier relationships by ensuring quality raw materials and thoroughly evaluating new suppliers before changes are made.
9) Consistency Across Processes: ISO emphasizes consistency across all business processes, from research and development to production and shipping, minimizing errors and maximizing efficiency.
10) Fact-based Improvement Processes: ISO 9001:2008 Quality Management System outlines audit processes, management reviews, and improvement processes based on data analysis, ensuring well-planned and implemented improvements.
Requirements of quality management system
There are three general requirements and five specific requirements, numbered as such:
This specifies requirements for a quality management system where an organization has to demonstrate its ability to consistently provide products that meet customer and applicable regulatory requirements, aiming to improve customer satisfaction through the practical application of the system.
2. Normative Reference
This refers in the standard to the latest versions of the documents ISO 9000:2001, Quality Management System, Fundamentals, and Vocabulary.
3. Terms and Definitions
Terms and definitions related to quality and quality management systems are provided. Quality is the degree to which a set of inherent features fulfils needs. A quality management system is the management system that directs and controls an organization about quality.
4. Documentation Requirements
Requirements are identified for establishing, documenting, implementing, maintaining, and continuously improving the quality management system documentation. This documentation shall at least include quality policy, quality objectives, quality manual, documented procedures, and the documents necessary to ensure the effective operation and control of its processes.
5. Management Responsibility
Top management shall commit to developing and improving its quality management system. They shall communicate within the organization the importance of meeting customer and regulatory requirements, setting policies and objectives, and leading the organization by providing necessary resources and conducting management reviews.
6. Resource Management
Personnel responsible for implementing the quality management system shall be competent to carry out the assigned tasks. This can be achieved through training, education, skills, or experience.
7. Production Realization
Organizational processes must be planned and developed consistently with other requirements.
8. Measurement, Analysis, and Improvement
Quality Policy: Top management shall ensure a quality policy appropriate to the organization, providing a framework for setting, reviewing, and meeting requirements. The policy should reflect that it:
- Is appropriate to the purpose of the organization.
- Includes a commitment to comply with requirements and to improve effectiveness continually.
- Provides a framework for reviewing and establishing quality objectives.
- Is understood and communicated within the organization.
- Is reviewed for continuing suitability.
Quality Policy: We are committed to fulfilling the needs and expectations of our esteemed customers and delighting them with the quality of our products and prompt and efficient services. We shall do this by complying with customers’ and statutory objectives and establishing and reviewing quality policies and objectives.
Quality Manual: The organization will require a quality manual, including the scope of the quality system.
Control of Records: In the case of documents, a documented procedure is required to prepare, maintain, and dispose of records.
Implementation of quality management system
Different steps in the implementation of a quality management system are described below briefly:
1. Decision by Management
2. Formation of Steering Committee/Project Group/Task Force
Depending on the nature and size of the organisation, a two or 3-tier structure needs to be set up to oversee the entire project.
3. Awareness and Training
Awareness and training at various levels are necessary from the initial stage of system implementation.
4. Defining Quality Policy
Once the decision to implement the system is made, the first step is to define the organisation’s commitment to quality by establishing its quality policy and making it known to all.
5. Initial Assessment and Diagnostic
The second stage involves reviewing the practices being followed within the organisation before installing the system.
6. Preparation of Action Plan
After the initial assessment and analysis, an action plan needs to be drawn up listing various tasks to be carried out and the persons responsible for these tasks.
7. Establishment of Quality Objectives
Quality objectives are established at relevant organisational functions and levels.
8. Development of Documented System
Documentation includes any written or pictorial information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results. Such documents have quality manual procedures, customer contracts, product standards, statutory records, regulatory documents, customer specifications, and service-level agreements.
9. Implementation of Documented Systems
It can be done in phases in different areas, or all areas can be covered simultaneously if the organisation is small.
10. Appraisal and Review of the Implemented System
Internal auditing and management review are divided into two sub-phases.
11. Pre-assessment or Trial Assessment
When system deficiencies are no longer visible from an effective internal audit and management review, the company/organisation can apply for certification. However, the organisation should organise a pre-assessment by a certified body before the final audit.
12. Quality Management System Certification
In this case, the audit is conducted by a third-party agency, and it provides a certificate of conformity that a product, system, or service conforms to specified requirements.