Control of Work Environment [ISO 13485 Cl 6.4.1]
Section 6.4 of ISO 13485:2016 helps organizations ensure that their work environment is suitable for producing medical devices that meet safety and performance requirements. This refers to the physical space where medical devices are developed, manufactured, stored, and distributed. Clause 6.4.1 emphasizes its role in supporting contamination control (Clause 6.4.2). The standard requires organizations to determine and manage the work environment needed to achieve conformity to product requirements. This includes considerations such as:
Environmental Cleanliness: Ensuring the work environment is clean to prevent contamination of products.
Environmental Conditions: Controlling temperature, humidity, and other environmental factors that could affect product quality.
Frequently Asked Questions
Explain Environmental Conditions applicable to this section
Does Cleanliness and Contamination Control applicable to this section?
Yes. Establish cleanliness requirements for the work environment, particularly in areas where product quality is important. Implement procedures to control contamination and maintain cleanliness (e.g., cleanroom protocols, gowning procedures).
What is the evidence to provide during an ISO 13485 audit?
- Documented procedures for work environment control.
- Records of environmental monitoring and maintenance activities.
- Training records for personnel on work environment practices.
- Records of cleanliness and contamination control measures.
- Evidence of compliance with environmental control requirements (e.g., calibration certificates for monitoring equipment).
ISO 13485 Audit questions refer to the below table.