Quality Management System (QMS) Primer – How Does ISO 9001 Relate to Quality Management Systems

A Quality Management System (QMS) is a collection of processes and procedures that set out how an organization will consistently meet both regulatory and customer requirements. It is a formalized system that completely aligns with the organization’s purpose and strategic direction. It encompasses the aspirational objectives of the organization, the policies that regulate operations, the processes and procedures that describe how operations must be performed, the informational resources required to support the quality management system, and the people resources required to operate and maintain the quality management system.QMS Quality Management System and Quality Management Systems

Although simple in concept, the implementation and operation of a QMS is complex. In line with any system of continuous improvement, the QMS itself is subject to change over time. It must adapt to embrace process improvements, policy changes, changes to organizational objectives, regulatory changes and resource changes. Even the process of change is formalized. Failure to adapt in a controlled way can lead to an arbitrary and inconsistent QMS that mis-directs efforts and dilutes quality management. Likewise, failure to adapt quickly to critical drivers for change can result in wasted effort and can lead to non-compliance.

 

 

ISO 9000 Family of Quality Management Standards

ISO 9001:2015 is the most widely implemented standard for QMS. It specifies the principles and processes for an organization relating to the design, development and delivery of products and services.  ISO 9001:2015 has nine major changes over its predecessor:

  1. Adoption of the High Level Structure (HLS) as set out in Annex 11 of ISO Directives Part 1
  2. Risk based thinking to support and improve the application of the process approach
  3. Fewer prescribed requirements
  4. Less emphasis on documents
  5. Improved applicability for services
  6. A requirement to define the boundaries of the QMS
  7. Increased emphasis on organizational context
  8. Increased leadership requirements
  9. Greater emphasis on achieving desired outcomes to improve customer satisfaction

ISO 9001 is a certification process to demonstrate compliance to ISO 9001:2015 It includes a requirement for continuous improvement of the QMS and includes other QMS components such as FMEA (Failure Mode and Effects Analysis).

QMS Failure Mode Effect Analysis

Guidance only – ISO 9000:2005 covers QMS fundamentals and the vocabulary used.

Guidance only – ISO 9004:2009 quality management guidance for sustained success.

Key Benefits of Quality Management Systems

A well designed and implemented Quality Management System can deliver a number of key benefits to the organization:

  1. Consistent and repeatable processes for product or service delivery, underpinned by effective quality management influences customer confidence and satisfaction. This creates opportunity to derive repeat business and new customer referrals.
  2. Complying with regulations. An increasing number of organizations are operating in regulated industries. Effective regulatory compliance protects the organizations operating licence, minimizes the risk of fines or sanctions.
  3. Minimizing or eliminating health and safety risks for your personnel, suppliers and customers, and the consequential damages or sanctions that the organization would face in the case of an adverse event.
  4. Help defend organization when dealing with adverse events. Whether in the judicial courts or in the court of public opinion, traceability and evidence trails from the QMS illustrating the considered efforts applied continuously, combined with the provable strategy of continuous improvement, can help to drive the defensive narrative. This, in turn, can help mitigate adverse effects on the organization.

Implementing and Maintaining a Quality Management System

The basic implementation steps center around a continuous cycle of Design, Build, Deploy, Control, Measure, Review, and Improve. These steps repeat forever.

QMS Design

The process starts with QMS design. There are many factors to consider when designing a QMS. These include:

  • The strategic and commercial objectives of the organization
  • The nature of the products and services supplied by the organization
  • Customer needs and expectations
  • The overall production process and high-level sub-processes
  • Policies
  • Areas of known risk
  • Supply chains – participation, risk
  • Facilities and tools
  • Personnel
  • Corporate culture
  • Regulation & standards
  • Reputation
  • Health and safety
  • Efficiency
  • Consistent results
  • Evidence
  • Flow of management information

QMS Build

QMS build covers the creation of the Quality Manual for the organization along with a suite of integrated processes that address all of the relevant design factors above. It includes implementation and deployment plans along with review policies and schedules. It addresses the range of skills and level of resources required to properly implement the QMS and encompasses records and control processes.

QMS Deploy

Training is arguably the most onerous undertaking in deployment of QMS, particularly in regulated industries. Everyone who plays a part in quality management must be provided with access and training. Access is required to:

  • The documented procedures they are required to implement
  • Policy documents that relate to their role
  • Forms and systems for recording their activities

Training is required to:

  • Ensure familiarity with policy
  • Ensure familiarity with procedure
  • Ensure familiarity with forms and systems
  • Ensure all personnel are qualified and hold all necessary certifications to legally carry out their role

QMS Control and Measure

Control and measurement go hand-in-hand in Quality Management Systems. Audits, systematic recording of variables, and testing of process outputs are the primary mechanisms for measuring. Control seeks to minimize risk by ensuring that those processes that represent higher risk for the organization or its customers are measured, or outputs from a process are sampled more frequently than lower risk processes. This elevated frequency reduces the time interval in which an adverse event in a high-risk process would likely be detected and shortens the time for corrective action and preventive action to be taken.

QMS Review and Improve

A key objective of Quality Management Systems is to deliver continuous improvement. Reviews consider the audit and measurement data, including details of adverse events and the outcome of investigations into their root cause. The goal is to determine whether a process is adequate in its current form, or whether a process can be improved or changed to mitigate or eliminate one or more aspects of risk, to increase efficiency, or to deliver an improved output. Where improvement is deemed possible and worthwhile, the desired improvements are documented and fed back to the design process, thereby completing the loop.

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