Author: Gerardo Zarate | Multistandard Lead Auditor The international standard 15378 specifies the requirements to implement ISO 9001:2015 in the design, manufacturing and supplying of primary packaging materials for pharmaceutical products. This includes as the main pillars the following: Good Manufacturing Practices (GMP) Risk management Quality control Customer Satisfaction Coming up next, meet some of

Authors: D. Pena and C. Valenzuela. I Technical DeveloperRecently, the US Food and Drug Administration (FDA) made a historic decision to banthe use of the artificial color known as Red No. 3 in food and medicine. This coloring iswidely used to give a vibrant red color to a variety of products, including candies,sweets, cereals, beverages,

Authors: D. Pena and C. Valenzuela.   Training in occupational health and safety, including mental health, is a priority for modern organizations. It is not only a legal requirement but also essential for the well-being of employees and the organization’s success [1]. In this blog, we will see why investing in these training programs is

Authors: D. Pena and C. Valenzuela    The current way in which workplaces are perceived by society has led organizations to incorporate, as fundamental aspects within their policies, the health, safety, and welfare of workers. These aspects, in addition to demonstrating their commitment to society, enable organizations to improve their productivity, competitiveness, and economic performance. 

Environmental risk management has become a central issue for organizations in a world increasingly affected by climate change, overexploitation of natural resources, and pollution.    Environmental risks, such as increased greenhouse gas emissions, biodiversity loss, as well as water and air pollution, affect the environment and the global economy [1].    Regardless of their size,

Different approaches are used to determine the applicability of design and development in management systems and certification scopes, so it is necessary to understand the intent of the standard’s requirements.    ISO 9000 defines Design and Development as the set of processes that transform requirements for an objective into more detailed requirements for that objective.  

By Diego Ayala.   Do you remember the first audit you did? Was it satisfactory? was it frustrating? was it friendly? Was it effective? Did you feel that you did not do your job because you did not leave non-conformities, or did you leave delighted because you left quite a few non-conformities? Indeed, before starting

Authors: D. Peña and C. Valenzuela.   The quest for a more sustainable future has become a global priority, and one key concept in this effort is “Net Zero.” This approach is becoming a cornerstone of environmental policies and organizational strategies worldwide.   What is Net Zero?   The concept of “Net Zero” implies that

Author: Mario Quintana   “Organizations want to work and collaborate with companies that can be trusted, and that trust is built with a company culture of doing the right thing […] “   This is according to Howard Shaw, the former ISO 309 technical committee chairman who developed this standard.   In a constantly developing

Authors: D. Peña and C. Valenzuela   The world of work has become such a fast-paced, ever-changing environment that organizations must be able to keep up with the pace and even stay one step ahead to preserve the safety and health of their employees.   Under the current scenario, data from the International Labor Organization