Work Environment as per ISO 13485
ISO standard sets requirements for the work environment. Standard requires that medical device companies control work conditions. Here will be explained what are the elements that need to be identified and what is required from them.
Usually, the work environment consists of the buildings and locations where employees are performing activities according to their job description. It’s expected that the working environment will be with the right conditions and realization processes that have a direct influence on the successful production of the medical devices. But the environment is not just buildings, but equipment and materials used during production.
In order to keep working conditions on a certain level, it has to be monitored. Its aim is to control, explain, straight, monitor, regulate, document, and organize the conditions of the work environment and events.
In general, the work environment is divided into a group of conditions that support work processes. These conditions are separated into several categories:
- Factors that may influence the processes and activities
- Physical elements of workspaces
- Resources that are invested in the processes or operate the activities in the workspaces
The following may influence the medical device on four levels
- The quality of the medical device
- The safety of the resources
- The ability of activities and actions and their outputs to achieve the product requirements
- The safety of medical devices or users
Definition and determination of the working environment
When you want to identify all the elements that might have any impact on product or processes, you must conduct a full review, examination of all the activities and processes. For proper identification of the working environment, you have to understand a relationship between the product, employees, and facilities. The next thing would be to review the controls of the working environment. This review includes the questioning and observation of employees’ activities, the analysis of their tasks, performance, effort, around the workplaces and work stations, to understand how these may affect the surroundings.
Cleanliness requirements of Environment
To maintain cleanliness, it must be eliminated any substances or process representatives from the medical device before preceding processes or before the delivery. The principles for doing so are:
- To identify the source of contaminants
- To plan test and controls so these levels can be proved
- Process agents have to be removed
- Documentation of the requirements and provision of the records
- The requirements of the records have to be documented
- To define levels of cleanliness that will be required for the medical device
So, to summarize, certain levels of cleanliness have to be maintained by defined activities.
The controls of the workplace and human resources have to be planned in order to correlate with these requirements. It has to support cleanliness goals.