The Quality Manual in ISO 15189:2022:An Essential Artifact or a Relic of the Past?
In the realm of medical laboratory quality management, the introduction of ISO 15189:2022 ushers in a wave of change, casting a spotlight on the Quality Manual’s evolving role. Is it time to reconsider its value?
A Historical Cornerstone
For years, the Quality Manual in ISO stood as the linchpin of the Quality Management System (QMS), a comprehensive document that encapsulated an organisation’s dedication to quality. It was the blueprint, the very DNA, of an organization’s quality endeavours, serving as a crucial resource for auditors, assessors, and anyone eager to grasp the essence of an organization’s commitment to quality.
What is a Quality Manual, and why is it important?
Prior to the release of ISO 9001:2015 and ISO 15189:2022, the older versions of the standards had required a controlled document named “Quality Manual”, narrated as follows:
“The organisation shall establish and maintain a quality manual that includes:
a) The scope of the quality management system, including details of and justifications for any exclusions,
b) The documented procedures established for the quality management system, or reference to them, and
c) A description of the interaction between the processes of the quality management system.”
Previously, there was little flexibility on how the organisation’s QMS should be structured, a typically seen documentation structure is a pyramid structure, where the Quality Manual is the backbone of the organisation’s QMS, supported by Standard Operating Procedures (SOPs) and/or Work Instructions.
Having a clear documentation structure for all controlled documents within the organisation is beneficial; it helps the reader to navigate the QMS and also helps the organisation maintain an effective QMS. A Quality manual could often help serve the above purpose, providing a concise overview of the system, a location to store policies, scopes, and objectives, etc. However, this comes with its challenges – how lengthy is your Quality Manual? Is it practical for the size of your organisation and the QMS? Is it effectively serving its purpose?
Embracing Flexibility
The narrative around the Quality Manual is changing with ISO 15189:2022. The standard’s latest iteration reflects a paradigm shift towards greater flexibility and pragmatism in quality documentation. This evolution from a mandatory to a voluntary requirement
signifies a broader trend towards efficiency and adaptability, encouraging a focus on the essence of QMS rather than on the upkeep of specific documents. Since the change in the standards, some organisations may choose to neglect the old-fashioned Quality Manual and use multiple individual policy documents for higher agility. This change also introduces a new challenge: prioritise which documents are essential for your unique QMS. Determining which documents are most relevant to your organisation’s specific context, processes, and risks require careful consideration. It is about considering your organisation and readers and determining the best method.
The Balancing Act: Benefits vs. Drawbacks
Despite the shift, the Quality Manual retains its potential as a powerful tool. It can succinctly encapsulate the essence of an organisation’s QMS, guide employees to understand better the purpose of the QMS, and underscore an organised approach to quality during audits.
Yet, this coin has another side. The risk of the Quality Manual becoming a long, overly detailed, rarely updated, seldom-read document looms large, challenging its practicality and relevance.
When writing a Quality Manual, it is essential to remain concise, providing a general overview of the structure of the QMS instead of describing each process. References could be used as appropriate to direct the reader to relevant controlled documents which describe the process in detail. The art is to balance the depth of information with the amount of content: Can your 2-page Quality Manual deliver the message? Is your 50+ pages Quality Manual effective?
Reflections and Visions
The conversation around the Quality Manual is far from black and white. It prompts us to question its impact on our quality management practices and envision its future. Could the traditional Quality Manual be reimagined as an interactive, digital dashboard, offering
real-time insights into the QMS? With the rapid changes in modern business, environment and society, how can we ensure the QMS is agile enough to embrace the pace of the changes? This prospect invites a broader discussion on innovation and adaptability in quality documentation.
Let’s Talk
As we navigate this new landscape, your insights and experiences are invaluable. The Quality Manual’s role in the era of ISO 15189:2022 is a topic ripe for discussion. Whether you see it as an indispensable tool or a document ready for re-evaluation, your perspective can contribute to shaping the future of quality management.
What’s your take on the Quality Manual today?
Do you believe it still holds value within your QMS, or have you embraced alternative methods to demonstrate your commitment to quality? Share your thoughts and contact us with any questions.