Comprehensive quality control is essential in the manufacture of devices in the life science industry. But what are the requirements, functions and legal standards that affect quality control? Quality control is an absolute priority in the life science industry. This is because most products – such as vials, syringes, implants or diagnostic devices – could have a direct or indirect effect on the human body, which has a direct impact on a person’s state of health. If a device does not work properly or at all, the consequences can be far-reaching. The requirements for quality control are correspondingly high and strictly regulated. These include certification and approval, as well as quality management from production through to individual processes. Manufacturers and, in some cases, suppliers and service providers of products for the life science industry are therefore generally bound by the relevant legal regulations if they wish to offer their products on the European market. This is at least the case if the product is a medical device according to § 3 of the Medical Device Law (MPG).
What is the Difference between Quality Control and Quality Assurance?
In practice, the difference between quality assurance and quality control is that assurance concerns the legal requirements that must be met and the processes that result from them. Control, on the other hand, as the name suggests, is concerned with the finished product and evaluates it against the applicable legal standards. Quality assurance is therefore upstream of control and usually concerns proactive measures to maintain quality, while quality control is downstream during or even after production.
To cover the area of “quality control”, many manufacturers have implemented a comprehensive Quality Management System (QMS) in accordance with ISO 9000:2015. The QMS is a set of business processes, methods, guidelines, documented information and tools that run through an entire company. The aim is to provide assurance to all stakeholders involved in the business process that the company’s medical device product consistently meets the quality requirements and the demanding standards of a particular market.
What is Quality Control?
In the life science industry itself, there is no fixed and generally applicable definition of the term “quality”. However, the definition according to the quality management standard has become established. Quality control takes place after the quality assurance process has been defined. The control is product-related and aims to ensure that the finished product has no defects and that the quality requirements are met according to the conditions and specifications of the respective market. Control is therefore reactive, as any product defects that may exist are identified at this stage. Once these have been found, they can be corrected accordingly before delivery.
In the field of “Quality Control”, comprehensive testing and inspection procedures are used to monitor the quality of a manufacturer’s products.
Quality Control Requirements
Because the quality of a product is so important, the requirements are not only high, but also encompass the entire production cycle and precisely the final inspection of the finished product. The requirements for manufacturers are prescribed throughout Germany and Europe and are checked in conformity assessment procedures.
Binding standards apply to the life science industry. A distinction is made between process and quality standards. These specify the minimum standard for products. Important standards include DIN EN ISO 13485 as a standard for medical devices and ISO 9001 as a quality management standard. In addition, the Medical Device Regulation, MDR for short, came into force in 2017. The previously applicable Directive 98/79/EC on in vitro diagnostic medical devices (IVD), on the other hand, has not been incorporated into the Medical Device Regulation. It was replaced by a separate new EU regulation, the In-vitro Diagnostic Medical Devices Regulation (IVDR).
Quality Control Tasks
Traditionally, quality control has a number of tasks and responsibilities that are designed to reactively detect and sort out defective products based on inspections and tests. These are the responsibility of separate departments and individuals such as the quality manager, quality representative or quality engineer. To carry out their tasks, they use quality management specifications that determine the quality of the end product. Each organisation is free to define these specifications for itself and its own requirements.
The following tasks, among others, belong to the area of quality control:
- Material testing
- Material transport and storage
- Defective material inspection and sorting
- Return authorisation
- Control and calibration of monitoring and measuring equipment
- Production Control and Product Testing
- Control of finished product
- Environmental monitoring
- Labelling control
Conclusion: In summary, the area of “quality control” in medical technology is a core aspect of the quality management system, which is a useful tool for manufacturers as well as for suppliers and service providers to optimally meet quality requirements. Quality assurance is also part of the quality management system. Neither system can function properly without the other. All contribute to bringing defect-free products to the market. Quality assurance and quality control, as inseparable components of a quality management system, play a key role in reducing the total cost of quality. They are also the guarantors of patient protection and essential to a brand’s image.
Are you looking for quality control personnel or would you like to develop your career in this area? Do not hesitate to contact us – we will find the perfect match in your specific field, according to your individual circumstances.
