Updated: Sep 9, 2021
We are all too familiar with the word’s “compliance” and “quality assurance” and all the other terminology and prescripts for running a successful business, and especially with the outbreak of the global COVID-19 pandemic, suddenly there are unprecedented protocols for safety measures and stringent compliance adherence to the extent that as employers and employees, we are rather covid “fatigued” by now.
But this is not what this article is about. I set out to explore the myths and truths about the implementation of a Quality Management System; if it really does make a difference and whether it does contribute to the organizational performance?
If you are heading on a journey the first decision that is made is reaching a consensus of the destination. By identifying the destination, other decisions can be taken regards the planning of the route, designating drivers and assigning the vehicle(s) that are trustworthy enough to get to the destination.
Without knowing what the destination is, this would be far less easy to make any of the subsequent decisions and can lead to some interesting journeys and all sorts of variables within your operations. There might be detours, breakdowns and some ending at a completely different destination.
However, one might argue that with Google Maps it is as easy as plugging in the destination and allowing Google to guide you, and yes you might be on the right route in terms of direction, but you are hardly going to get far if your driver has no clue regards the rules of the road or the vehicle is an old jalopy that has not had a service since the yellow number plates system.
It is fine and fair to have a well-written mission and vision statement which looks good and sounds impressive (i.e., a strategic destination), but what does it mean to your organization?
Is everyone even aware of these statements and do they realize how they contribute towards the achievement of the vision and mission (i.e., who are the drivers, have the vehicles been assessed etc.)?
In most cases, I can safely assume the answer is no.
This is how I discovered the true value of an implemented QMS by addressing some of the most common myths:
Myth no 1: QMS is only applicable to larger organizations where there are complex processes and team dynamics
Myth no 2: QMS is only relevant to production and manufacturing industries where there are statutory and regulatory requirements that must be met and where quality can be measured in terms of the standard of products that are delivered.
An effective QMS is applicable to all organizations, regardless of size, complexity and or industry and should be considered as a basic element to all as it contains information that is relevant to the specific organization and not necessarily the industry. Smaller organizations can benefit as much as the larger organizations as a documented QMS forms the basis of:
Understanding the Context of the organization (ISO 9001: 2015 Clause 4) – defining the quality policy, objectives, and identifying of interested parties, their needs, and expectations as well as issues provides valuable insight in terms of identifying and highlighting the factors that has a significant role in determining the strategic direction of the organization.
ISO 9001: 2015 has adopted the fundamental approach of risk-based thinking with the focus on customer satisfaction, thereby promoting a proactive rather than reactive response to risks which in this context, risks and issues allows for the identification of opportunities rather than threats that is traditionally associated with concepts such as “risk” and “issues”
Another justification for why QMS is not only applicable to larger or specific industries is that it promotes conformity and prescribes the organization’s processes and procedures as identified and dictated by the organization.
Ironically, in my experience, smaller businesses is at a greater risk of falling into the “silo mentality” than their larger counterparts. Individuals in a smaller organization tend to do things according to personal preference which can be as seemingly trivial as saving documents that they are responsible for using their own folder directory with a naming convention that is unique to them, sharing only when requested to do so.
This trend is more evident especially within the now largely adopted – remote working. The greatest risk in this approach is that if that person becomes ill, leaves the organization and or experiences some kind of equipment failure i.e. device crashing or gets stolen or damaged – that information is lost to the organization.
Another risk that the “silo mentality” poses is nonconformity of business activities, without prescribed processes, individuals resort to their own initiatives and while innovation and proactivity are positive contributions to any business, this can lead to confusion by external interested parties such as customers who might receive information where content is similar, but the presentation of content is vastly different.
Myth no 3: A QMS requires additional dedicated resources that act as watch dogs to assure that all quality protocols are followed, and quality controls are in place for if there is something that goes wrong.
The adoption of an effective QMS and the responsibility of quality is applicable to all resources, ISO 9001: 2015 requires that every employee understands their role, responsibility, and authority in terms of quality, thus contradictory to popular belief – the responsibility of ensuring Quality is on every individual within an organization.
The Standard does not mandate that there are dedicated resources responsible for the QMS, however it does prescribe that if the organization has dedicated “quality” resources – such appointments be made in writing and their roles and responsibilities clearly defined and understood.
Myth no 4: Quality is the responsibility of Top Management and has no effect on the rest of the organization.
While ISO 9001:2015 (Clause 5: Leadership), does require the involvement of Top Management, the expectation and mandate on Top Management is their commitment to the QMS and the effective implementation, maintenance, and review of the effectiveness of the QMS, it does not suggest that Top Management are exclusively responsible for the QMS, but that they have a responsibility to providing the required resources to ensure the effectiveness thereof.
Myth no 5: Implementation of QMS ISO 9001:2015 is only essential if it is part of the strategic direction of the organization to become ISO 9001:2015 certified.
Adoption of the ISO 9001:2015 Standard can be used as a valuable tool for all organizations and while Certification might be the ultimate objective, it remains an option for organizations to apply for certification, it is not a requirement of the standard to be certified.
An effective QMS can provide a systematic approach to lean process improvement. It can assist in the identification in quality issues, eliminate unnecessary activities, and close gaps in performance.
The purpose of a Quality Management System is to provide a formal system of tools and processes that allows for organizations (big and small, across all industries) to adopt a risk-based thinking approach and to implement the PLAN – DO – CHECK – ACT cycle in their identification and implementation of the organizational processes. Process improvement and being lean go hand in hand.
An effective QMS can have important benefits such as improvements in:
A QMS helps establish important operational, strategic goals while providing a means to monitor, measure and review how well your organization reaches these goals.
A key objective of all organizations is to satisfy its customers to survive; incorporating customer feedback and or evaluation into a QMS allows you to make informed decisions relevant to customer satisfaction improvements.
Incorporating compliance into documentation, measurement and reporting, and internal auditing systems will eliminate some challenges of meeting key prescribed and mandatory standards and regulations.
An effective QMS establishes, communicates, and aligns operational activities with organizational goals and priorities, so all employees are involved and aware of their roles, responsibilities, and expectations in the adoption of the QMS.
A QMS defines how critical processes and objectives are documented, thus ensuring that important knowledge is available throughout the organization and is standardized across all activities and or departments within the organization.
A QMS is the maestro of all organizations to adopt to ensure that their destiny is defined, communicated, understood, and ultimately achieved.
It is the navigation system with the relevant tools to define destination, plan the organizational routes and allocate the relevant resources to achieve success.