Comprehensive quality assurance is essential for the manufacture of devices in the life science industry. But what are the requirements, functions and regulatory standards that affect quality assurance? Quality assurance has absolute priority in the life science industry 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 assurance 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).
Quality Assurance or Quality Control?
In practice, the difference between quality assurance and quality control lies in the fact that the area of assurance concerns the legal requirements that must be complied with, as well as the resulting processes. Control, on the other hand, as the name suggests, concerns the finished product and evaluates it according to the valid legal standards. Quality assurance is thus upstream of control and usually concerns proactive measures to maintain quality.
In order to map the area of “Quality Assurance” as well as “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 goal is to guarantee to all stakeholders involved in the business process that the company’s medical device product consistently meets quality requirements and conforms to the demanding standards of a particular market.
What is Quality Assurance?
In 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 assurance is about avoiding problems in the quality control of products. Various methods exist for this purpose. Manufacturers implement quality assurance by planning and documenting the quality assurance process in detail and, for example, creating checklists for compliance.
The tasks of quality assurance include all requirements, standards as well as regulations to ensure the functionality and effectiveness. The requirements for testing technology, testing software and documentation are correspondingly high. The aim is to minimise the risks for patients and to ensure their long-term health.
Quality Assurance Requirements
Because the quality of devices in the life science industry is so important, the requirements are not only high, but cover the entire production cycle. This begins with the supply of materials and ends with the delivery of the finished controlled 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 sector. 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 Assurance Tasks
Traditionally, quality assurance has involved a number of tasks and responsibilities aimed at proactively preventing the manufacture of defective products. In practice, separate departments and individuals such as the Quality Assurance Manager, Quality Representative or Quality Engineer are responsible for these tasks. To carry out their tasks, they use quality management specifications that define the quality of the end product. Each organisation is free to define these specifications according to its own needs.
The following tasks, among others, belong to the area of quality assurance:
- Document control
- Change control
- Nonconforming material investigation and disposition
- Supplier assessment and monitoring
- Supplier corrective action
- Internal quality audits
- Sampling plan development
- Complaints handling
- Labelling control
Conclusion: In summary, the area of “quality assurance” 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 control is also part of the quality management system. Neither system can function properly without the other.
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