7.1.4 Environment for Operation

A company’s environment consists of the conditions that exist in its workplace. The conditions required by ISO 9001 are referring to an organization’s process to achieve the conformity of their product or service. Some examples of environmental conditions are the arrangement of workspace, lighting, temperature, noise, contamination, and overall employee health and safety. The necessary work environment varies greatly depending on the product or service being provided by the organization. 

Typical Controls of a Work Environment

• Temperature and Humidity. Gages for monitoring, records of conditions and calibration.
• Safety Hazards. Identification of hazards, prioritization of risks, job safety procedures, monitoring of compliance, regular meetings to discuss safety.
• Lighting, Noise, and Vibration. Specification of characteristics, maintenance of specifications.
• Housekeeping. Procedures for management, defined responsibilities, training of personnel, corrective action on nonconformities.
• Personal Hygiene. Policies for personnel, recurring training, counseling for employees. 

In all cases, the environment for operation is based on the processes that are required by the organization in order to produce their product.  ISO 9001 states that organizations must determine and maintain the environmental conditions necessary, whether they are social, psychological, or physical.  The purpose of process environment control is to determine, define, direct, monitor, regulate, coordinate, and, where appropriate, document the process environment conditions. This will be accomplished by exposing the environment to predetermined activities and controls. 

Defining the essential conditions and implementing process environment controls must include all areas and scopes of the realization processes. To reach and identify all elements of the process environment that may affect the goods, services, personnel, or processes, a review, analysis, and assessment of all realization activities and processes, as well as their outputs, is required.

Why? What are the benefits?

The premise for risk management of environment is to assess scenarios that may pose risks to the realization of products and services at particular points, assess their severity, implement controls and procedures to eliminate or reduce the risks, and assess the effectiveness of these controls. Creating a proper environment for operation will mitigate risks and their likeliness to occur while increasing the effectiveness of the overall workflow in an organization.

Having adequate resources is essential to ensure product conformity & satisfy customer requirements, as many organizations experience QMS issues as a result of insufficient or improper utilization of resources. 

The infrastructure of an organization consists of physical assets that allow them to maintain their operations. These assets will differ depending on the organization and the nature of their offerings.