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Legal analysis of the provisions of ISO 9001:2015 “Quality Management Systems” for organizations.

March 12, 2017


Dear Clients and Friends:

With this Information Note allow us to provide you with a brief analysis of ISO 9001:2015 “Quality Management Systems” for organizations (hereinafter ”ISO 9001:2015”), published by the International Organization for Standardization on September 23, 2015.

The relevance of this ISO lies in the adoption of a quality management system as a strategic decision for an organization that is interested in improving its overall performance and providing solid basis for sustainable development initiatives.


On September 23, 2015 the International Organization for Standardization published the new version of ISO 9001:2008, called ISO 9001:2015, which after an established transition period of 3 years, will enter into force in September of this year, and therefore those certifications that have been granted for ISO 9001:2008 will expire and all companies having them, from that date, must comply with the requirements established in this new standard.

It is important to mention that ISO 9001:2015 is based on the quality management principles described in Standard ISO 9000, which are: (i) customer focus; (ii) leadership; (iii) engagement of people; (iv) process approach; (v) improvement; (vi) evidence-based decision making; and (vii) relationship management.


The purpose of ISO 9001:2015 is for companies to adopt a quality management system that supports their overall performance and provides to their customers products and services that comply with the law and legislation, increase customer satisfaction and meet their own requirements. It should be mentioned that ISO 9001:2015 is a new version of ISO 9001:2008. III. MAIN DIFFERENCES BETWEEN ISO 9001:2008 AND ISO 9001:2015

The publication of ISO 9001:2015 makes significant changes to ISO 9001:2008. Among the most important are the following:

  • A change in the structure of the chapters and terminology used in ISO 9001:2015, in order to improve alignment with other management system standards and to provide a presentation consistent with the requirements established in it. This is done through a more simplified language....

  • The incorporation into ISO 9001:2015 of a process-based focus,which in turn is based on the Plan-Do-Check-Act (“PDCA”) cycle of continuous improvement and on risk-based thinking. The focus on processes makes it possible to improve the efficiency of a quality management system and the efficiency of the company in order to achieve the results defined in the quality policy and the strategic management of the organization.

  • The presentation of a preventive focus by requiring an Analysis of Risks and Opportunities, which results in the elimination of the preventive actions, and therefore Strategic Planning becomes an implicit requirement in ISO 9001:2015.

  • A new requirement of “Context of the Organization” is included, which asks companies to determine the external and internal problems relevant for their purpose and strategic management and that could affect their capacity to achieve the desired results in the quality management system.

  • There are more requirements for the quality goals and the process for meeting them, and for control of the processes, products and services provided externally.

  • The requirement of “Performance evaluation” is added, which establishes all the aspects to be taken into account for evaluating the Quality Management System of the organization. In this regard, the organization must be aware of the perceptions of customers of the degree to which it meets their requirements and expectations..

  • The company can determine the form in which it will document the Quality Management System, eliminating the obligation to have a Quality Manual.


Regarding structure, as mentioned two new requirements were added (“Context of the Organization” and “Performance Evaluation”) and the nomenclature of the Standard was changed as follows:

The headings in the structure of ISO 9001:2015 are established as each of the mandatory requirements of the Quality Management System of organizations under this Standard.


To improve the alignment of ISO 9001:2015 with other management system standards and provide a consistent presentation of the requirements established therein, its terminology was changed in the following manner:


  • The new structure and terminology of ISO 9001:2015 allows for its application in the other management system standards that use a common language and results in better understanding for the personnel who verify compliance with it.

  • It increases the productivity and quality of organizations, improving customer satisfaction.

  • The quality of the products and services is integrated into the business goals.

  • It gives greater importance to strategic planning and the processes that should be followed to have better quality control in the company.

  • All the resources of the company are concentrated in the processes of its organization, with a risk-based focus.

  • The company must document all its processes, which brings it greater certainty and protection with the respect to the processes it carries out.


We mention again that as a result of the 3-year transition period of ISO 9001:2015, in order to obtain the certification the following requirements must be observed.

The first applies to organizations certified in ISO 9001:2008, and the second applies to organizations that will be certified for the first time under ISO 9001:2015.

Companies that are already certified in ISO 9001:2008:

  • They could have done the certification audit based on the new ISO 9001:2015 since the day after the publication of the Standards, but they have three years to do so.

  • Those that do not renew their certification according to the new version of the standard will lose the certificate in September 2018.

From September 2015 until March 2017, companies could have decided to do the audit to be certified with the 2008 version or with the new version ISO 9001:2015. Since that date, all certification audits will be done only under the new version of the ISO 9001:2015 standard.

It should be mentioned that beginning in September 2018 the ISO 9001:2008 certificates will no longer be valid, and therefore the organizations that have not reviewed their certification according to the new version will lose their validity.


The implementation of ISO 9001:2015 in Quality Management Systems allows the company to demonstrate its capacity to manage and improve the quality of its products or services through a new certification, in order to ensure customer satisfaction. This Standard is a tool that allows the company to continuously improve the efficiency of the quality management system, by having better control of the points of improvement, and therefore those organizations certified in the Management System based on standard ISO 9001:2015 will be able, in turn, to access other types of certifications associated with Quality Management, such as the Environmental Management System and Information Security Management System, among others.

For more information contact: César Chávez, Junior Attorney:, Lic. Cristina Loera.

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