Lecture summary: Organizational structure The organizational structure is the definition of hierarchy in the organization and relates to the nature of the organization. Through the structure, you need to describe all the functions, roles, and relations in your company. Although there are no specific requirements…
Lecture summary This part of the ISO 9001 standard highlights risk-based thinking. Why? Because it will help you by directing you to look and see opportunities, to address risks that will guide you to better and safe decisions. Risk-based thinking is a ground base for…
Summary lecture: To clear it out from the beginning – “Quality objectives are measurable goals relevant to enhancing customer satisfaction and are consistent with the quality policy. These objectives are initially established when planning your QMS and redefined in management reviews as needed.” – as…
Lecture Summary: Why is so important to know how to manage and control changes? By effectively handling the changes, you will gain the ability to respond quickly to changes in various circumstances. Those circumstances can be perhaps: What does managing changes essentially mean? It represents…
Lecture summary: The cornerstones of the Quality management system are, in fact, resources, and that’s why you must define, manage, and control all the accompanying resource elements. You have to think of them as critical zones and scopes of the realization process. They should be…
ISO 9001:2015 is the world’s most widely adopted quality management standard, built on the Annex SL high-level structure that also underpins ISO 13485:2016. For medical device companies, this shared architecture matters: the two standards use compatible clause numbering, common definitions, and the same process-based approach…
ISO 9001:2015 organises its requirements around the Annex SL high-level structure shared by all modern ISO management system standards. That structure groups clauses into context of the organisation, leadership, planning, support, operation, performance evaluation, and improvement. For a first-time implementer, this architecture is both a…
