If you are looking for a way to improve your business and its operation then you are on the right blog. Today we are going to explain the types of quality management systems and which one you should purchase. We know that there are many options in the market, but we are going to focus on the main four.
There are many reasons to have a quality management system. But nowadays, different QMS by which a company is governed are converging to follow procedures and methodologies that prove the quality of its products and services. Knowing how to differentiate them is essential to know which is the most appropriate for each company.
Implementing a quality system is very useful to meet the needs of your audience. Depending on the type of your company, you will need a certain model to claim compliance with the standard from a certification body and, thus, obtain all the benefits it generates.
These Are the Most Common Types of Quality Management Systems
The objective of quality management systems for small and medium-sized companies is aimed at ensuring efficiency, increasing the trust of customers, who increasingly require certifications, and competing with large companies. Thus, quality control in companies is necessary to be able to reach the consumer and repeat it.
First, however, let’s define what a quality system is, so that we can use the word “type” in a way that makes sense. A quality system could be defined as
a set of business activities and documentation that address a list of risks to customer satisfaction as defined in a quality system standard, such as ISO 9001:2015.
Based on this definition, the key components of a quality system revolve around the key points of the definition.
- Your Business Work Flows.
- Your Documentation.
- Risks to Your Customer’s Satisfaction.
- The Standard(s) you use to define the risks.
This brings us to the main topic in terms of “types” of quality systems, of which we think there is only ONE type….Yours
Software tools that propose to help you with your quality system, or any other part of your business, are widely available and have three defining characteristics.
- Are they just a tool for a specific section of the QMS, like equipment calibration and maintenance, or do they propose to put umbrella over the entire QMS?
- How many workflows can they help you manage?
- How well do they help you integrate between workflows?
- How well can they support the continuous improvement of your QMS?
Umbrella Systems (or “Super QMS Apps”) must have Document & Change Control
QMS software that proposes to provide an umbrella over the entire quality system will not be able to make that claim unless there is a robust Documented Management system that can link your documents to almost all other areas of the QMS.
Some of the key areas to look for include links between your procedures and:
- Parts in inventory to synchronize revision control between the two.
- The ISO sections who’s requirements they help address.
- Other documents, not only on the database level, but can you create links from within your documents that will always open the latest revision of the related procedure or work instruction without having to change the link?
- Job descriptions of the employees who need to know them to support training records?
- Risk and Opportunities to conduct and document risk associated with a given process.
- Deviations, so that the history of exceptions can provide insight to changes needed in the procedure.
- Rejected Material records in the event a non-conformance leads to a document change order.
For the control of documented information, the organization must address the following activities, as appropriate:
- Distribution, access, recovery and use.
- Storage and preservation, including preservation of readability.
- Change control (for example, version control).
- Conservation and disposal.
Documented information of external origin, which the organization determines as necessary for the planning and operation of the quality management system, shall be identified, as appropriate, and controlled.
Design a header that can be used throughout your documentation, including your organization’s logo or name, document name, code, date, and version number.
Integrating Risk Management Throughout the QMS
First you must understand that there are risks in every internal process of your business. However, the lack of systems and processes means that risks are often never managed or communicated. Everything stays the same, costs pile up, and employees get frustrated. At the same time, your quality and compliance team is getting little information about risks. The data is never consistent, there is a lack of visibility, and it is difficult to report risks to the board. Ideally your QMS has the ability to link a variety of records in your system to a risk analysis process so that with limited resources you can strategize a plan to address your highest priority risks and initiate that analysis from any area of the QMS, thus allowing the system to adapt to how you want to evaluate risk.
It will not be long after the software is installed that all the little details about your business that was not part of the software development planning will start to float to the surface. For example, data for customer complaints might have a place for the part/product involved with the complaint, but nobody thought of a situation likes yours, which is unique to your business or industry and you need to track multiple products/parts under a single complaint record. Now what? All that money spent and you’re left with a time consuming work around to capture the data you need to capture and what about the downstream reporting? When selecting QMS software, the software itself, and it’s presentation should both make it abundantly clear that they recognize the need to serve the process of evolution much more than the process of just making the sale.
Taking Responsibility for Excellence
Even though QMS stands for Quality Management System, in actuality it would be more accurate to call it an Evolution Acceleration System, or at least that is how we think of it and how we look at The Lean Machine – Quality, Risk, and Material Management software when it’s time to send an update to a customer who has helped us see the next improvement the system needs. This attitude is primarily driven by our sense of responsibility, knowing what a good quality system is supposed to do, and knowing if it can’t improve relatively quickly based on user feedback, then it can’t really evolve. In fact we know of one competitor who has failed to evolve to the point one of our consulting partners just flat out proclaimed that their document control system was simply not compliant with ISO 13845 and 21 CFR Part 11. You are responsible for the evolution of your quality management system so that it can support the success of your company. We highly recommend that you pick a solution provider that understands the need to evolve, and has built modules and features to help you do just that.