Revision history of ISO9001:2015 standard
To keep pace with the times and better guide users in the application of quality management concepts and tools, since the formal birth of ISO 9000 in 1987, the standard has undergone three formal revisions:
The redesign occurred in 1994. It retained the concept of quality assurance, with the traditional manufacturing imprint still quite evident.
The second revision was in 2000. It was a significant change, whether in concept, structure, or content. It introduced fundamental principles such as "customer focus" and "process approach," elevating the system from quality assurance to quality management, and also softened the original manufacturing traces, making it more adaptable.
In 2008, the third revision was made, forming the fourth standard version, which is currently in effect. This revision was defined as an "editorial modification" and did not result in significant changes.
In the practice of ISO9001 certification audits, it is often found that many clients can self-identify issues such as internal audits, evaluations, inspections, returns and exchanges, and complaints. They have also taken some measures, but many of these measures are merely perfunctory, addressing the issues at hand and merely correcting the non-conformities. Subsequently, there are often repeated occurrences. For instance, the surface oil污 issue with injection molded parts. Clause 8.5.2 of the ISO9001 standard clearly outlines requirements for corrective actions. When problems are identified, not only should they be improved, but they should also be improved effectively. If resources are invested to address an issue, it should be resolved thoroughly. To effectively resolve problems, it is essential to eliminate the root causes.
The Role of ISO9001 Procedure Documents.
Maintain control over quality activities. Establish specifications for all activities affecting quality; - Define the methods and criteria for evaluating these activities to ensure they are under control.
Define the responsibilities, authorities, and relationships of personnel involved in quality activities: duties, authorities, and interrelations.
As the basis for executing, verifying, and reviewing quality activities. The provisions of the program are implemented in actual operations; evidence of execution should be retained; actual operations are to be reviewed against the program to ensure compliance.
During the implementation of ISO 45001 certification, senior management should conduct reviews of the organization's occupational health and safety management system at planned intervals to ensure its ongoing suitability, adequacy, and effectiveness.
The management review should consider the following matters:
Previous status of actions taken in management reviews; Changes in internal and external issues related to the ISO 45001 Occupational Health and Safety Management System, including: stakeholder needs and expectations; laws, regulations, and other requirements; the organization's risks and opportunities.
IT Systems Integrators and Software Developers
These companies adopt the ISO 20000 IT Service Management System standards and provide standardized services for the soft/hardware products they offer. They ensure high-quality services and continuous support throughout the entire lifecycle of the products.
Internal IT service provider or IT operations support department
Banks, telecommunications, real estate, and other large state-owned enterprises and publicly-listed companies. These organizations typically have massive IT systems with a high level of reliance on IT for their operations. As the complexity of their internal IT systems grows exponentially, they urgently need to enhance their IT service management to provide robust support for business stability and growth. They usually achieve this by signing Service Level Agreements (SLAs) with business departments to clarify the delivery of IT services, make services measurable, and ensure sustainable improvements in internal IT service capabilities.
Purpose of ISO 9001 Certification
As a basis for third-party certification. During third-party quality system certification, the supplier and the certifying body should reach an agreement on which quality assurance standard to use as the criterion for certification. The chosen model should be suitable for the technical requirements of the products covered and should not mislead the supplier's customers. For example, if an organization has design capabilities and the products covered by the system certification applied for are self-designed by the organization, it is particularly important to decide whether to choose GB/T19001-ISO9001 or GB/T19002-ISO9002. When design quality is particularly important in forming product quality and it is difficult to fully verify during product inspection and testing, GB/T19001-ISO9001 should be chosen. Generally, for products that an organization designs and manufactures itself, selecting a quality system certification model is appropriate.
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