ZHH certification
Ensuring the best quality is a key role for any Quality Management System (QMS). A quality management system can prevent, identify, and correct any defects in product quality that, in some industries, can save lives.
That's why it's crucial to have a reliable quality management system, especially if you have to comply with ISO, EU, or FDA regulations. The system must take both proactive and reactive measures to ensure compliance and quickly correct any quality issues using the right procedures.
At first glance, there seems to be some overlap or redundancy in quality terminology related to quality management. These areas of quality management do work closely together, but each has a different definition and role.
A Quality Management System (QMS) is the overall system for monitoring and ensuring the quality of the final product. The system includes quality control and quality assurance, as well as other steps such as risk management and CAPA.
Quality assurance (QA) is an active part of the system. QA ensures that the right procedures are in place to ensure a high quality and compliant product or service.
Quality control (QC) is the inspection part of the system that evaluates a product or service to find any defects or quality issues.
Quality control, quality assurance, and quality management systems are all critical cogs in the system to ensure production consistency and compliance with ISO, EU, or FDA standards and regulations.
They rely on each other and notify each other to create a system that doesn't let any non-conformities slip away.
There should be no gap between the proactive and preventive actions of QA and the comprehensive assessment and quality check of QC, and the QMS related to the quality of goods and services.
While there are certain similarities between QA and QC, organizations must consider them as separate and distinct parts of QMS for them to be effective.
The main differences between QA and QC include the following.
QA is proactive and involves pre-emptive steps to ensure a high-quality product or service.
QC is passive and is responsible for the testing and evaluation of products and services to determine whether they meet quality standards.
QA focuses on processes that must be in place to prevent any quality issues from occurring in the first place.
QC focuses on the finished product and flags any issues that could lead to customer complaints or non-compliance.
QA is systematic and aims to create overarching methods and procedures to prevent problems with quality standards.
Quality control is fine-grained and penetrates deep into the parts, raw materials, and customer service processes to address the root cause of quality issues.
The QA system is the quality criterion to be followed by the entire production team.
Quality control is usually handled by a separate quality control officer, who is responsible for inspecting the final product to identify defects and shortcomings.
Every business should consider some form of quality management system, including quality assurance and quality control, even for the smallest manufacturers. This is good business practice.
However, a QMS with strict QA and QC procedures can be a legal requirement for businesses in industries where safety and quality are critical, such as aviation, automotive, pharmaceutical, and medical devices.
Some of the ISO, EU, and FDA standards and regulations that require a QMS include:
ISO 13485:2016 specifies QMS requirements for medical device developers.
ISO 9001 is an international quality standard for the production and service industry.
EU MDR EU Medical Device Regulation.
EU IVDR EU In Vitro Diagnostic Devices Regulation.
FDA 21 CFR Part 820 U.S. Medical Device Regulations.
FDA 21 CFR Part 11 U.S. Electronic Quality Management Medical Device Regulations.
What is the job of a Quality Management Representative?
Why was the ISO 45001 standard created?
The 6 levels of autonomous vehicle driving explained.
What is a self-driving car?