Quality Management System Documentation Pyramid

Published 3 jul 2019.

Quality management system documentation pyramid. A qms helps to coordinate and direct an organization s activities to meet customer and regulatory requirements and continually improve its effectiveness and efficiency. A quality management system qms is defined as a formalized system that documents processes procedures and responsibilities for achieving quality policies and objectives. To incorporate a robust quality system encompassing good documentation practices including but not limited to. The documentation of a quality management system is typically based on four tiers as described below and depicted in the quality documentation pyramid.

B documented information determined by the organization as being necessary for the effectiveness of the quality management system. It also provides guidance on the structure and contents of each document. The following is a summary of some of these iso. Design controls continuous improvement auditing management review and risk management.

A documented information required by this international standard. Includes quality policy statement quality policies information on quality related processes listing and location of second tier documentation and. 4 2 5 navigation is key. The following recommendations take into consideration the iso 10013 guidelines.

The international standard iso 10013 2001 guidelines for quality management system documentation gives directions for effective dimensioning of the qms documentation as well as an overview of recommended contents and structure of the different qms document types. This standard has been developed to be applied to a range of sectors and by implementing this standard the organizations will have a lot of benefits. Globally iso 14001 is the most recognized international standard for environmental management systems and also one of the most used standards. Clause 7 5 1 general explains that the quality management system documentation shall include.

Quality management systems in radiotherapy based on iso. A quality management system qms is a formalized system that documents processes procedures and responsibilities for achieving quality policies and objectives and thus consistently delivering a quality product or service to the customer. Your quality management system that documentation system used just document thanks for sharing information about documentation structure for iso 9001 8 03 2012 as your documentation covers all requirements of the quality system. Documentation hierarchy based on iso 14001 health safety and environment 2017 05 25.

The document system pyramid is a bit of. Considerations for quality management to incorporate an approach to doing business that stresses building in quality through techniques such as. Good documentation is the foundation of a qms. A qms helps coordinate and direct an organization s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous.