Ensuring the best possible quality is the key role of any quality management system (QMS). A QMS prevents, identifies, and rectifies any shortcomings in product quality, which, in some industries, can be lifesaving.
That’s why it’s essential to have a solid QMS, especially if you must comply with ISO, EU or FDA regulations. This system must have both proactive and reactive measures in place to ensure compliance and to rectify any quality issues swiftly using the correct procedures.
Defining quality terms
At first glance, there may appear to be some overlap or redundancy in the quality terms related to quality management. These areas of quality management do work closely together, but each has a distinct definition and role.
Quality management system
The quality management system (QMS) is the overall system that oversees and ensures the quality of the end product. This system includes quality control and quality assurance, and other steps like risk management and CAPA.
Quality assurance
Quality assurance (QA) is the proactive part of the system. QA ensures the correct procedures are in place to ensure a high quality and compliant product or service.
Quality control
Quality control (QC) is the inspection part of the system where the product or service is assessed to pick up any defects or quality issues.
The quality process: how QC, QA and a QMS work together
Quality control, quality assurance and the quality management system are all vital cogs in the system that ensures production consistency and adherence to ISO, EU or FDA standards and regulations.
They rely on and inform each other to create a system that doesn’t let any non-conformances slip through.
Between the proactive and preventive measures of QA and thorough assessments and quality checks of QC, there should be no gaps in the QMS related to the quality of goods and services.
Differences between quality control and quality assurance
While there are definite similarities between QA and QC, organizations must treat them as separate and distinctive parts of the QMS for them to be effective.
Key differences between QA and QC include the following.
Proactive versus reactive
QA is proactive and involves preemptive steps to ensure a good quality product or service.
QC is reactive and deals with testing and assessing of products and services to determine if quality standards have been met.
Process versus product
QA focuses on processes that must be in place to prevent any quality issues from happening in the first place.
QC focuses on the finished product and flagging any issues that might result in customer complaints or non-compliances.
System versus parts
QA is systemic and is intended to create overarching methods and procedures that prevent issues with quality standards.
QC is granular and digs into parts, raw materials and customer service processes to root out the underlying causes of quality issues.
Team versus individuals
QA systems are quality guidelines for the entire production team to follow.
QC is usually handled by individual quality controllers who are charged with inspecting the final product to identify defects and shortcomings.
Standards and regulations that require a QMS
Every business should consider some form of QMS that includes QA and QC, even the smallest manufacturer. This is good business practice.
However, for businesses in sectors where safety and quality are paramount, such as aeronautics, automotive, pharmaceuticals and medical devices, a QMS with rigorous QA and QC procedures may be a legal requirement.
Some ISO, EU and FDA standards and regulations that require a QMS include:
- ISO 13485:2016 specifies QMS requirements for medical device developers
- ISO 9001 international quality standard for production and service industries
- EU MDR EU medical device regulations
- EU IVDR EU In Vitro Diagnostic Device Regulation
- FDA 21 CFR Part 820 the US medical device regulation
- FDA 21 CFR Part 11 the US medical device regulation for electronic quality management.
A modern QMS software solution from isoTracker
Both QA and QC are vitals parts of an effective QMS. It’s impossible to say which one is more important. They rely on each other to create a solid QMS.
The best way to ensure that QA and QC are playing their roles in your QMS is to ensure you have a reliable software system that offers a user-friendly, centralized, and automated way to monitor these two symbiotic systems.
At isoTracker, we offer cloud-based software that covers all aspects of an effective QMS. Our modular, subscription-based system means you’ll never have superfluous software modules, and you won’t end up paying for more than you need.
Try our free and all-inclusive 60-day trial and get the same access as our customers.
You’ll get access to regular walk-through emails and web-demos to give you a comprehensive experience. If you decide to sign up after 60 days, you get to keep all your accumulated data.
