The ISO 13485 Standard requires that the organization will manage its infrastructures, resources and the working environment which are related to the realization process and the product. Like we said before in our recent articles: the ISO organization doesn't like to leave anything open for any questions!

Within working environment you are required to refer to factors such as noise, working arrangements, heat, humidity, lighting, poisonous gases, radiation and any other factor that might affect the product or the service.

What is included under the working environment? Working environment includes all the spaces and halls that serve the organization for operation and product realization. Working environment includes:

• Logistic centers
• Manufacture halls
• Stores
• Meeting rooms
• Dressing rooms
• Offices
• Service centers
• Information systems
• And more…

The ISO 13485 Standard requirements for managing infrastructures and working environments obtain with control over them. Infrastructures and working environment require resources. Infrastructures and working environment support your processes. The infrastructures and the working environment are supposed to supply you with the optimal conditions for the realization processes. They have a direct affect over your medical device. Therefore they must be under your Quality management system. Just like all the rest.

Definition for working environment
Within the working environment your definition must include:

• A description of all spaces and halls required to realize the product (or the service).
• Definitions related to the working environment. The purpose of the definitions is to clarify crucial topics for behavior, conducting and utilization around the working environment in order to ensure the appropriate conditions for realization. For example in a chemical factory, you should define exactly what must be done after any process in order not to mix chemicals and to prevent disasters. 
• Within any working environment, you must define who is authorized and who is restricted to use it. The ISO 13485 Standard requirements apply for external visitors as well as internal. External visitors may be customers, suppliers, auditors etc. For example, in a food factory, you should define who is authorized in the manufacturing halls and who is not! Otherwise you might find there some unwelcomed guests tasting the food direct from the oven...
• Reference is required to physical factors that might affect the product – storage requirements, dust, ESD (for electronics components), light, dress requirements (at labs or clean manufactures halls) etc. You are not required here for the employees' security. This topic is covered within the human resources management (chapter 6.2.2) and the OHSAS 18001 Standard with more details. 
• Reference is required to any regulatory requirements regarding the working environment – allowed opening hours, environmental requirements or any other regional requirements. 
• When there is a safety hazardous that threatens, harm, would damage the employee or cause him to fail achieving the products requirements, it would be considered as non-conformity.

While the ISO 9001 Standard requires a control over the work environment but does not indicate how and in which cases, his though cousin, the ISO 13485 Standard indicate almost, specific cases, where documentation and control must be obtained:

1. Cleanliness requirements - When cleanliness of product is required by any requirement (customer's, health or regulatory requirements) - the requirements regarding the work environment shall be documented and controlled.  For example, if the organization is required to sterilize the product, besides the requirement for the product sterilization, the organization must maintain documented requirements for the work environment: clear off any biohazard waste, sterilize work equipment, and don’t forget to take out the garbage at the end of the shift – requirements regarding the work environment. The specific requirements for cleanliness are specified in paragraph 7.5.1.2.1 – cleanliness of product and contamination control.  In chapter 6.4 are the control and documentation requirements.    
2. Work environment requirements - When work environment conditions may affect the product's quality, the organization must document the requirement and activities required to monitor and control the work environment. For example, if a medicine factory is required to store the products under certain requirements (such as temperature, light, and humidity) these requirements must be documented and controlled. The ISO 13485 Standard specifically indicates that work instruction or procedure must be maintained. The specific requirements for the work environment are specified in paragraph 7.5.1.2.1 – cleanliness of product and contamination control.  In chapter 6.4 are the control and documentation requirements.
3. Personnel requirements -   when employees must perform certain activities to maintain the work environment (in order to provide the requirements), they must be trained or supervised by someone trained. These trainings must be documented as specified in paragraph 6.2.2. 
4. Elimination of contamination requirements – in order to eliminate any risk of product contamination, the organization shall maintain specific activities and measures regarding the work environment, to distinguish nonconforming products from conforming products in order not to contaminate the work environment. In some industries this requirement is crucial. In simple words, the organization must take specific measures not to mix returned or disqualified products with appropriate products and to maintain a clean uncontaminated work environment. These requirements must be documented. The ISO 13485 Standard refers us to paragraph 7.3.5.1 – where the identification requirements of medical devices are specified. When the organization defines the method for identification, it shall refer to the work environment as well and so eliminate the risk of work environment contamination.