By developing, maintaining, and improving a Quality Management System (QMS), the organization sets up the quality policy, procedures, processes, internal guidelines, resources
and responsibilities in order to reach the quality objectives of the company.
QMS is more than just documentation, by being the frame of both preventive and reactive quality methods and processes, contains the Quality Manual (QM) of the organization and
describes the quality policy throughout which the entity intends to reach the quality objectives and to meet the quality requirements of the customer.
Several QMS principles exist that lay down the requirements and general rules how to set up a proper, sustainable and logical QMS. The most widely known QMS related standard
is the ISO 9001
that specifies the requirements of a quality management system, with exceptional focus on customer satisfaction, management
roles and responsibilities, detailed quality planning
and the continuous improvement of the whole system. The latest ISO 9001:2015 has
ten major chapters, summarizing all requirements of a QMS, integrated into the PDCA
- 1) Scope - The scope of the standard is to specify the requirements of a universally usable Quality Management System, focusing on customer satisfaction and improvements.
- 2) Normative References - Referring to the "ISO 9000:2015 Quality Management Systems - Fundamentals and Vocabulary" document that contains the full fundamental concepts, terms and definitions.
- 3) Terms and Definitions - See ISO 9000:2015 Terms and Definitions
- 4) Context of the Organization - Comprehending the expectations of interested parties, determining the scope and the processes of the system.
- 5) Leadership - This sections summarizes the establishment and communication of the quality policy, the roles and responsibilities, and a very major part: management commitment.
- 6) Planning - The section is focusing on risks, opportunities, and the planning process to achieve the quality objectives.
- 7) Support - The chapter is consulting on the needed resources to create and maintain the QMS, including: competence, resources, communication (information sharing), and documentation (with the
control of documented information).
- 8) Operation - The chapter takes all operational fields into account, including: planning and control, product requirements, design and development, control of external suppliers and service providers,
release of products and services, production and service provision, traceability, control of non-conforming products, etc.
- 9) Performance and Evaluation - The section considers all control functions, such as management review, monitoring, audits, measurement and analysis.
- 10) Improvement - The final section is about proactive and reactive improvements, such as non-conformity / corrective action and the continual improvements.
ISO 9001 in the PDCA cycle (Source: ISO.org)
QMS must be reviewed frequently, as it interacts with the continuous improvement process, and the Total Quality Management (TQM) of the organization.
By forming and filling up the QMS with content, the business entity decreases the occurrence of failures and non-conformities, and increases the chance to detect any
non-conformities which may occur.
Several QMS principles exist, that lay down the requirements and general rules how to set up a proper, sustainable and logical QMS. The most widely known QMS related standard
is the ISO 9001:2015 that specifies the requirements of a quality management system, with exceptional focus on customer satisfaction, management roles and responsibilities, risk based thinking and the continuous
improvement of the whole system.
Source: qMindset.com; ISO.org
In general, quality management has more sub-fields in focus (such as a comprehensive QMS). Most multinational companies divide their quality organization into departments
based on the separated sub-fields, while some companies merge them (e.g. the quality engineer is responsible for both internal production and for customer management). The major sub-fields from organizational
point of view are:
The organization using and maintaining the QMS (Source: qMindset.com)
An effective QMS contains the following elements:
- Quality manual and policy.
- Management commitment (deeds and not only words).
- Properly defined effective processes, and their interaction with each other (not only the manufacturing processes, but all supporting functions as well).
- Continuous revisions and monitoring of the system, and the interventions if needed.
- Training of all participants and key players to know their roles and responsibilities in the whole system.