Introduction ISO 9001 , one of the series of quality management system standards, is by far the world's most established quality framework being used by more than 750,000 organizations in 161 countries / regions around the world. Not only for the quality management system, had ISO 9001 also set up standard for the total management system. The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems. 1. ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems. 2. ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction. 3. ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system. The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties. 4. ISO 19011 provides guidance on auditing quality and environmental management systems.
Specification 1. On Seven quality management principles as the standard theory, reflects the most common application of quality management, the general rule is widely used in quality management fields. 2、The standard is moderately simplified after four revisions, which is simplified in content and quantity, the requirements for mandatory documents are greatly reduced, and the flexibility and operational guidance of the standard is better. 3. In accordance with risk-based thinking, process approach and PDCA cycle modeling, the quality management system shall be established, implemented and maintained and continually improved its effectiveness. 4. The compatibility with EMS and OHSMS is enhanced and bring greater benefits to the organizations.
Significance 1. Quality management systems can assist organizations in enhancing customer satisfaction and help organizations demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements and enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. 2. It will break through the prevention of non tariff trade technology barrier, in terms of quality and international standards, become the "pass" for international market. 3. The establishment of quality management system, can effectively improve the management level and the overall performance of the organization. 4. Help to mobilize the enthusiasm of all staff, improve the quality of full consciousness, law consciousness
WHO SHOULD USE THE ISO 9001:2015 REVISION? ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems. Organizations of all types and sizes find that using the ISO 9001 standard helps them:
- Organize processes
- Improve the efficiency of processes
- Continually improve
All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others. As of September 14, 2018 organizations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard. Guidance on transitioning from ISO 9001:2008 to ISO 9001:2015 can be downloaded from the International Accreditation Forum (IAF).
What topics does ISO 9001:2015 cover? ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on many topics, such as: Requirements for a QMS, including documented information, planning and determining process interactions Responsibilities of management Management of resources, including human resources and an organization’s work environment Product realization, including the steps from design to delivery, Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action Changes introduced in the 2015 ISO 9001 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include: The introduction of new terminology Restructuring some of the information An emphasis on isk-based thinking to enhance the application of the process approach Improved applicability or services Increased leadership requirement
WHAT ARE THE BENEFITS OF ISO 9001? ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees. Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:
- Organize a QMS
- Create satisfied customers, management, and employees
- Continually improve their processes
- Save costs
ISO 9001 CERTIFICATION ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001:2015 certification means that an organization has demonstrated the following:
- Follows the guidelines of the ISO 9001 standard
- Fulfills its own requirements
- Meets customer requirements and statutory and regulatory requirements
Maintains documentation Certification to the ISO 9001 standard can enhance an organization’s credibility by showing customers that its products and services meet expectations. In some instances or in some industries, certification is required or legally mandated. The certification process includes implementing the requirements of ISO 9001:2015 and then completing a successful registrar’s audit confirming the organization meets those requirements. Organizations should consider the following as they begin preparing for an ISO 9001 quality management system certification: Registrar’s costs for ISO 9001 registration, surveillance, and recertification audits Current level of conformance with ISO 9001 requirements Amount of resources that the company will dedicate to this project for development and implementation Amount of support that will be required from a consultant and the associated costs
Training in the ISO 9001 Standard Training can provide an opportunity to review the ISO 9001:2015 standard and apply quality management principles in a practice environment. Professionals responsible for developing, implementing, auditing, and managing an ISO quality management system or quality professionals interested in updating their documented ISO 9001-based QMS can take ISO 9000 training courses, which include courses focused on ISO 9001 and quality management systems. Additionally, organizations looking to improve employee performance and employees looking to continually improve will also find ISO 9000 training relevant.