Information & Training. | Quality Assurance. Quality Management.

The Quality Management System (QMS).

Reference: ISO 9001 2015.

A Quality Management System is a means of identifying, establishing, coordinating, monitoring all the activities of an organization, with the objective of continually improving performance.

For the customer, “improving performance” relates to understanding, shaping, influencing and exceeding customer expectations, …

For suppliers, improving performance means building long term stability in demand, growing levels of business, opportunities to add extra value, …

For management, improving performance will see greater efficiency, growing profitability, enhanced reputation, higher operating margins, …

For staff, improving performance relates to long term job security, greater opportunities for job growth, promotions, opportunity for increased levels of workplace motivation, opportunities for learning, improved challenges in daily job roles, …

Similarly, continually improving performance will positively impact shareholders, the community, the environment.

The Principles of Quality Management
The Quality Manual
Quality Standards and Specifications
The Quality Management System
Revised requirements of ISO 9001: 2015
Design Quality – Products & Processes
Good Manufacturing Practice (GMP)
Documentation
CAPA – Corrective And Preventative Action
Calibration Certification
Change Management and Control
Quality Management Training
Product and Process Validation
Supplier Quality Assurance
Audits & Auditing
Ensuring the Quality Management System is Risk based
Etc. …. Etc. …. Etc. …
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How is all this possible under a Quality Management System?

The limits of achievement of the QMS are defined by the scope, enthusiasm and commitment of management and how effectively the QMS is integrated and pursued across an organization. The QMS can range from a very basic method of control, where the focus is on maintaining defined procedures (SOP’s) for all quality related tasks and hence ensuring a level of process control and stability. In such an approach the focus on driving improvement may be quiet limited. At the other end of the QMS implementation spectrum is the QMS where the focus is on understanding the customer, comprehensively identifying their needs, integrating ongoing and future changes which will impact the customer into a clear strategy for meeting current customer requirements and shaping future customer needs. Under this latter approach, the QMS will often encompass a range of improvement methodologies, such as total quality management, use of statistical analysis, lean process development, risk identification and mitigation, just in time development, competitor benchmarking, team development, etc, … All these tools and techniques will be integral to and complement the quality management system, providing data and feedback which will form the basis for on-going continual improvement efforts.

In summary, the quality management system is used to communicate to all stakeholders the approach, the philosophy, the objectives of the organization towards achieving and continually improving product and process quality.

What purpose does a Quality Management System serve?

✔ Establishes a vision for customers, employees, suppliers, etc., i.e. all stakeholders.

✔ Sets the standards to be achieved for products, processes, services.

✔ Builds motivation within the organization.

✔ Sets goals for the organization.

✔ Defines and orientates the quality culture.

International standards and the ISO 9000 QMS model.

There are a range of quality and regulatory standards which focus on the need for implementing a Quality Management System, however the standard most widely applied is the ISO 9001 family of standards.

ISO 9001:2015 – Details the generic requirements for a Quality Management System.

ISO 9000:2015 – Provides information on the fundamental concepts of a quality system.

ISO 9004:2009 – Provides guidance to an organization on how to continually improve via the application of a QMS.

ISO 19011:2011 – Information and advice on establishing and implementing an internal and external quality audit process.

Other widely used standards which are based on the ISO 9000 standard approach are:

ISO 14001 Environmental Management System.

ISO 27001 Information Security Management System.

AS9000 is a key Quality System Standard in the Aerospace industry.

ISO/IEC 90003 provides guidelines for the application of ISO 9001 to computer software.

TL 9000 is the Telecom Quality Management and Measurement System Standard.

ISO/TS 16949 is an interpretation standard agreed upon by major automotive manufacturers.

Etc.

ISO 9001:2015

This new revision was published on 23^rd September 2015, with a three-year transition period, so organizations had until September 2018 to meet the newer ISO 9001: 2015 requirements.

The 2015 revision is based on having a less prescriptive approach to defining the requirements of a quality management system, strengthening the focus on a “process approach”, having a relatively greater emphasis on risk based decision making combined with a strong focus on continuing improvement.

Organizational context.
More specifically the ISO 9001: 2015 standard requires a management system to consider and reflect the “context of the organization”. This requires management to consider the external environment, customers, stakeholders etc., how they can impact the organization and to develop a QMS which is appropriate to their influences and expectations.

Leadership.
As the success and effectiveness of a QMS ultimately depends on the enthusiasm, commitment and active participation of senior management, the revised ISO 9001:2015 standard places a greater emphasis on the active participation of management in driving the quality management system.

Planning.
The QMS needs to be comprehensively planned with the application of suitable risk analysis, risk evaluation and risk mitigation combined with consideration of the potential opportunities for future improvement. In many organizations the application of a comprehensive SWOT Analysis (strengths, weaknesses, opportunities, threats) to the QMS system, may be an approach to this requirement.

Performance evaluation and support.
As the skills, capabilities, competences, motivation of all staff is critical to an effective QMS, the revised ISO 9001:2105 standard places a greater emphasis on identifying and ensuring the provision of staff competences. In addition, an organization must ensure that staff skill provision, is equally applied to all staff who could impact quality, e.g. in many organizations staff involved in quality activities may be employees of a supplier, a contractor, or peer organizations.

The critical elements or “principles” of a Quality Management System…

Ensuring a continued focus on the customer, understanding their current needs, shaping and anticipating their future expectations.

Providing long term quality orientated leadership.

Involvement of all quality impacting staff both internal and external to the organization.

Maintaining a process approach to all quality impacting activities.

Ensuring management, control and decision “systems” are in place to ensure quality.

Fact based decision making, based on understanding and application of fact based analytical tools and techniques.

Supplier and contractor relationships need to be mutually beneficial.

Continual improvement must be a guiding principle. Problems can and will arise, however continually seeking to improve across all aspects of organizational performance, will ensure continued and growing customer satisfaction and loyalty levels.

Documentation structure of the QMS.

The top level document of the QMS is still widely seen as being the “Quality Manual”. There is no defined format for the Quality Manual but it generally comprises of the following key sections:

Quality Policy

Business Overview

System Elements

Process interrelationships

Procedures Index

The QMS identifies processes (Management and Operations), success criteria, the inter-relationship between processes and the system for checking results. Each process is clearly defined with clear ownership for the activities that relate to the success criteria of the process.

Aspects covered by ISO 9000 series of standards.

The ISO 9000 Quality Management Systems standard covers the entirety of an organization’s activities which have the potential to impact or influence product or process quality or customer satisfaction.

Examples being:

Documentation of processes

Management responsibility

Design & Development

Purchasing activities

Control of processes

Control of defective products & processes

Customer feedback

Analysis of data

Improvement planning and implementation

Human Resources

Benefits of a Quality Management System based on a standard such as ISO 9001.

Increase in an organization’s performance and productivity – a QMS can improve efficiency through reduction of waste and systematic measurement of performance.

Enhanced customer satisfaction – Customers know what to expect from a quality certified company. ISO 9001 systematically tracks errors, forces preventative action, thus reducing the number of customer complains.

Global recognition – ISO 9001 is a globally recognized quality standard that can open new market opportunities for an organization.

Employee engagement – ISO 9001 Quality Management System encourages communication and has the potential to improve morale among employees.

Competitive advantage – Certification provides an advantage over competitors or at least offers the opportunity to compete on the same basis as competitor organizations.

Focus on objectives and customer expectations – Greater emphasis on meeting customer requirements and implied needs through continuous incremental improvement.

Information & Training. | Quality Assurance. Quality Management.

- - - The Principles of Quality Management
    - The Quality Manual
    - Quality Standards and Specifications
    - The Quality Management System
    - Revised requirements of ISO 9001: 2015
    - Design Quality – Products & Processes
    - Good Manufacturing Practice (GMP)
    - Documentation
    - CAPA – Corrective And Preventative Action
    - Calibration Certification
    - Change Management and Control
    - Quality Management Training
    - Product and Process Validation
    - Supplier Quality Assurance
    - Audits & Auditing
    - Ensuring the Quality Management System is Risk based
    - Etc. …. Etc. …. Etc. …
    - Information & Training presentation >>>