ISO 9001 standard is the most popular management standard belongs to the ISO 9000 family of standards developed by International Organization of Standardization for quality management system and voluntarily adopted by over 1.3 millions of business of organization worldwide .
In Accordance to the ISO 9001 standard there a number of system requirements which an organization needs to establish, implement, maintain and continually improve which includes meeting meeting customer, regulatory and statutory obligations. Ensuring customer satisfaction through the quality management system is a main purpose of the standard which aims at producing consistent quality of products and services ,fis time and every time. The ISO 9001 standard also includes elements that involve monitoring and measurement of processes and continual improvement.
Benefits of ISO 9001
- Enhanced level of customers confidence that the organization has processes in place to produce and deliver consistent quality of products and services meeting their needs and expectations
- Increased efficiency and operational excellence
- Improvement in quality management processes
- Positively impact on business reputation with customers
- Increase in customer satisfaction and their trust level will increase
- Consistently gain new customer and continual improvement in business
- Improved supplier performance and increased in revenue
- Reduce waste, inefficient use of resources and save money
- Development of professional environment within the organization
Main Difference between ISO 9001:2015 and ISO 9001:2008
ISO 9001 is developed by International Organization for standardization established in 1987 in Geneva Switzerland. This standard is revised by standing technical committees and advisory group based on the responses from the professional those are responsible for implementing the standard. After the interval of every five year a new version of ISO 9001 is released. The recent version of ISO 9001 published in September 2015. There is a long transitional period of three years after the publication of new version. Organization those who are using ISO 9001:2008 must implement the requirement of the new standard ISO 9001:2015 before September 2018
Following changes in the new standard ISO 9001:2015 when compared to the ISO 9001:2008 are mentioned below :-
The main difference between ISO 9001:2015 and ISO 9001:2008 is the structure; the new version ISO 9001:2015 has ten major elements instead of eight elements that makes ISO 9001:2008. ISO 9001:2015 based on Annex SL (High Level Structure). This is common framework for all quality management system ISO 9001, ISO 14001, ISO 22000, OHSAS 18001 therefore all the same from now on. It will become easier for organization who wishes to integrate various management systems such as ISO 9001, ISO 14001, ISO 27001 or ISO 22301.
The scope is the fundamental part of quality Management system and the standard, as it defines the scope of your business set in your organization. There are no major changes to this clause as compared to ISO 9001:2008.
Normative References –
This section references other relevant standards, which are requisite for the application of the document and will also be unique. ISO 9001:2015 is revision of the ISO 9001:2005. It outlines the Quality Management Systems-Fundamentals and Vocabulary
Terms and Definitions –
All the terms and definitions outlined in ISO 9001:2015 – Quality management fundamental and vocabulary
Context of the Organization –
This section is about understanding the organization purpose as well as stakeholders and ensures effective communication and alignment between them; the organization system and organization strategies and purpose.ISO 9001:2015 focused on the need to identify and satisfy mainly customer needs but the new standard seems set to expand on the range of stakeholders whose needs should be considered.
ISO 9001:2015 more emphasis on leadership and management responsibilities, this clause places requirements on top management needs to demonstrate leadership and commitment has responsible for the effectiveness of the QMS.
- QMS effectiveness is accountable and top management is responsible for assessing this.
- Relating the objectives to the strategy of the organization is in place as per the guidance of top management level
- Ensure the output of the quality management system
- Promoting the continual improvement and supported by the organization
- Organization maintains the customer satisfaction is the primary focus
- Organizational roles, responsibilities, and authorities are assigned to that role may now be assigned to any role or split across several roles.
Planning is now a section on its own to the high level structure includes risk and opportunities, the setting of the goals and objectives are carefully plan changes in the quality management system.
This section builds upon the current ISO standard for competence and awareness, it requires an organization to determine and present the compulsory resources to establish, implement, maintain and continually improve the QMS.
This is a comparatively short section, which fundamentally says “Do a good job” at whatever your management system is demanding for. This clause deals with the execution of the plans and processes that enable the organization to meet customer requirements and design products and services.
Performance Evaluation –
This section is similar requirements to the existing ISO 9001:2008 standards evaluation includes monitoring, measurement and analyzing the requirements.
Improvement covers nonconformity and corrective action, as well as continual improvement, all of which are outlined in section 8 of the existing standard. There is no preventive action section any more as efficiently it is replaced by “risk” under planning – improvement is now defined as a proactive planning activity.
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