ISO 9001:2015 QUALITY MANAGEMENT SYSTEM
ISO 9001, the internationally recognized Quality Management System standard (QMS), is a powerful tool for business improvement. It can be used by any organization of any size.
ISO 9001 is a quality management system that will allow you to continuously monitor and manage the quality in your company so you can identify improvement areas. The ISO 9001 Quality Management System is widely recognized as the most widely used QMS in the world. It is the system of choice for quality systems.
If you certify ISO 9001, you’ll join more than a million companies around the world who have improved their business with this standard.
ISO 9001:2015
QUALITY MANAGEMENT SYSTEMS
What is ISO 9001? ISO 9001 is an international standard for creating a Quality Management System (QMS) published by ISO (the International Organization for Standardization). ISO 9001 was updated most recently in 2015. It is also known as ISO 9001:2015. ISO 9001 was released and updated after a majority vote of all member countries agreed to it. This made it an internationally recognized standard that is accepted by a large number of countries.
What are quality management system? ISO 9001 is defined as a standard that provides QMS requirements for implementing in a company who wants to develop policies, processes and procedures to meet the needs of customers and regulators and to improve customer satisfaction. The foundation for quality assurance is the quality management system.
QUALITY MANAGEMENT SYSTEM & ITS GOALS
ISO 9001, with more than a million certificates issued in 189 different countries, is the most widely-used quality management standard. ISO 9001, the only standard within the ISO 9000 family that is certifiable (although certification isn’t mandatory), defines seven quality management concepts, including a customer-focused approach and continuous improvement.
- Customer Confidence: This standard is designed to increase customer satisfaction and trust by ensuring that the organization has robust quality control procedures in place.
- Effective resolution of complaints ISO 9001 provides guidelines to resolve customer complaints quickly and satisfactorily, resulting in timely problem solving.
- Process Improvement: This standard is used to identify and eliminate waste, streamline operations and improve informed decisions, which results in cost savings.
- Ongoing Optimization: ISO 9001 encourages regular audits and reviews to help organizations improve their quality management system, remain competitive and achieve success.
PRINCIPLES OF ISO 9001
ISO 9001 implementation is based on the principles of quality management. These core principles form the foundation for your quality management, helping you to improve performance and comply with standards. ISO 9001 quality management principles include:
- Engaging people Aligning and engaging people at all levels in your organization to create and deliver procedures and processes that will add value and elevate your business.
- Customer Focus We know that the customers are at the heart of every business. This principle places your customers at the core of your business.
- Leadership Strong leaders are more consistent and provide better quality. Management processes ensure that everyone is on the same page.
- Process Approach An interrelated process approach across all your business processes will ensure consistency and efficiency.
- Continuous improvement Analyse and review your business process on a regular basis. It will allow you to achieve a continuous improvement in your business, which can be sustained both on a short-term basis and a long-term basis.
- Factual approach to decision-making Data drives optimal results, so any decisions taken must be in your best interest.
- Relationship Management Establishing and maintaining strong relationships between clients and suppliers will improve business performance.
Each of the seven principles for quality management has a specific goal and benefits that are associated with it. They are not ranked in any particular order. Each one is equally important and has a relative value for your organization, depending on what type of organization you are. Below, we’ll go into more detail on each of these principles.
WHY IS ISO 9001 CERTIFICATION REQUIRED?
- We require a method of operation that we can follow consistently if we are to be effective in whatever we do.
- Any organization has too many activities to get distracted and lose track of stuff. Simple to share. To maintain order, managers require an excellent system.
- Activity systematization is a common occurrence. We frequently engage in it in our personal, professional, or public lives.
- Most importantly, the government acknowledges it.
BENEFITS OF ISO 9001 TO THE CUSTOMERS
- Increased Efficiency– Implement processes and procedures which are based on a quality focus.
- Increased Revenue– win more contracts and tenders, whilst streamlining your processes and identifying opportunities for cost savings.
- Greater Employee Morale– by ensuring that all employees are working to one agenda you can reduce errors and increase productivity.
- International Recognition– recognised in approximately 188 countries, ISO 9001 can help you to access international trade.
- Factual Approach to Decision Making– ensure the business decisions you make are beneficial long term by basing them on facts.
- Better Supplier Relationships– business has credibility through the reputation of ISO 9001, providing suppliers with greater confidence in what you do.
- Improved Record Keeping– as with any management system, ISO 9001 ensures you document your processes from start to finish. Helping you to handle customer complaints and improve process efficiency.
- Improved CustomerSatisfaction – ensure you have a feedback system in place which will help you to understand your customers’ needs, identify areas for improvement and reduce wasted resources.
- Continuous Improvement– using non-conformity reporting and trend analysis, you can spot areas for improvement and stay ahead of the competition.
Frequently Asked Questions
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ISO 9001 is a standard that can be used by any organization who wants to improve their quality management system and meet applicable statutory and regulation requirements. It also helps them increase customer satisfaction. The standard is applicable to organizations of all sizes and covers industries such as manufacturing, services and healthcare. It also applies to government and non-profit organisations. ISO 9001 is also used by certification bodies and other third parties for assessing an organization's compliance with the International Standard.
ISO has a number of quality management standards that are based upon ISO 9001, and tailored to specific industries and sectors.
These include:
- ISO 13485 for medical devices
- ISO/TS 54001: Elections at all Levels of Government
- ISO 18091 for local government applications
- ISO 22163: Railway sector applications
- ISO 29001 for petroleum, petrochemical, and natural gas related products
- ISO/IEC/IEEE 90003 on computer software
The ISO 9001 standard specifies the establishment and maintenance requirements, as well as continual improvement for a Quality Management System. This covers a range of topics, including:
Context of the organization: ISO 9001 requires that organizations determine the external and inner factors that influence their ability to achieve their intended results with their quality management system.
Leadership The standard stresses the importance of leadership when implementing and maintaining an effective quality management system.
Planning: The quality management system should include measures to meet the organization's objectives for quality and continually improve its effectiveness.
Support: ISO 9001 covers issues like resources, competences, awareness, communications and documented information.
Operation: Plan, implement and control the processes required to increase customer satisfaction and meet customer needs.
Performance Evaluation: This standard requires that organizations monitor, measure and analyse the performance of their quality management systems and evaluate its effectiveness.
Improvement: ISO 9001 stresses the importance of continually increasing the effectiveness and efficiency of the quality management systems based on performance evaluations and other data sources.
ISO 9001 is a comprehensive standard that helps organizations manage the entire quality of their products, services and processes. It focuses on the customer and the continuous improvement of the quality system.
ISO 9001 and ISO 14001 both have international standards for management, but their goals are different. ISO 9001 is a standard that helps organizations to improve their customer satisfaction and quality management. ISO 14001 is a tool that helps organizations to reduce their environmental impact, and promote sustainability. ISO standards examining various types of management systems such as ISO 9001, for quality, and ISO 14001, for environmental management are all organized the same. It is therefore easy for companies that use one ISO management standard to integrate other organizational management aspects into their management system.
Both ISO 9001 and ISO 13485 define requirements for quality systems. However, one standard has a much broader audience than the other. ISO 9001 is a framework for quality management that can be applied to any organization, regardless of size or industry. ISO 13485 was developed for the medical devices industry, with a particular focus on regulatory compliance. The standard is designed to ensure safety and effectiveness for medical devices. It includes risk management, process validation, and traceability. ISO 13485 contains more requirements than ISO 9001 for organizations that work in the medical device life cycle. ISO 9001 elements not relevant to regulatory requirements do not appear in ISO 13485.
The website of the ISO 9001 auditing practices group provides support for auditing quality management system. This informal group is made up of ISO/TC 176 experts in quality management systems, auditors and practitioners.
