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Wednesday, April 21, 2021

Business Management System - Integrated Management System (IMS). ISO 9001:2015 & ISO 14001: 2015 & ISO 45001:2018

QMS – Quality Management System

A quality management system of an organization or company is a set of policies, processes and procedures required for planning and execution (production, development, service) in the core business area of an organization, (i.e., sections that can impact the company’s capability to meet customer requirements).

  • ISO 9001:2015 is an example of a Quality Management System (QMS).
  • ISO 9001 Quality Management Systems
  • AS9100 Aerospace and Defense
  • ISO 13485 Medical Devices
  • IATF 16949 Automotive

This IMS serves to formalise the policies, processes and operating Standards (OS) that will apply to the Company’s workers, partners, contractors and other stakeholders.

External and Internal Issues of the Organization

The company regulate the external and internal issues of the organization that are related to its objective & intent and critical & strategic direction and that affect its competency to attain the predetermined results of the IMS.

Consideration is given to the Following:

  1. Positive and negative factors or conditions.
  2. Organizational external context and matters, for example legal, regulatory, technological, competitive, cultural, social, political and economic environments.
  3. Company/Organizational Internal context and issues, such as values, culture, organisation structure, knowledge and performance of the business.
  4. Decisions and requirements of the needs and expectations of interested parties relevant to the IMS.
  5. Authorization and capability to drill control and influence.
  6. Activities, products and services relevant to the business of the organization.
  7. Documented information is kept/contained as record to assist that the context of the company has been taken into account in the Integrated Management System (IMS).


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