The ISO 9001 Environment Clause

Some ISO 9001 requirements simply don’t get as much attention as others. One such example is found in clause 6.4, which relates to work environments. It states: “The organization shall determine and manage the work environment needed to achieve conformity to product requirements.” What exactly does that mean?The organization must give appropriate consideration to multiple factors, including:

• Safety
• Suitability to the process
• Ergonomics
• Heat, humidity, air quality
• Lighting and noise control
• Hygiene and cleanliness

While concerns about safety in manufacturing facilities tend to be the traditional focus of this clause, it’s irrefutable that all organizations have some kind of work-environment considerations. (Note that this clause is situated outside of section 7, the only part of the standard where justified exclusions are allowed. We all have to give appropriate consideration to environmental work issues, regardless of the nature of the organization).
As with most of the requirements of ISO 9001, the manner in which an organization applies the requirement is reliant on the nature of the business. What’s critical in a manufacturing environment may be irrelevant in a financial institution. Some environmental factors protect the integrity of the product; others, the health of workers. Still other environmental factors ensure the efficiency and the effectiveness of the process.

Take a look at each of the factors and consider their applicability in various organizations:

Safety
Does the organization maintain the manufacturing area in a manner that prevents accident or injury? Are the floors clean and free of debris? Is there unnecessary clutter? Are there lock-out/tag-out protocols and are individuals aware of them? Is there adequate storage of hazardous substances? Is there adherence to OSHA regulations?

If the product is being installed, what safeguards are in place to ensure that the environment is sufficiently safe and appropriate for the task to be completed?

Suitability to the process
Some processes simply can’t be carried out in uncontrolled environments without damaging the product. My favorite audit story involves an assessment I conducted years ago at a facility that processed film. The material would arrive in bulk and had to be slit to the appropriate size and then packaged for consumer use. Due to the nature of the material (unexposed film) it was of paramount importance that the process be carried out in total darkness. I was given night-vision equipment to be able to audit the process. The technicians had been trained to work in the dark. As I peered through the night-vision lens at the grainy green images before me, they patiently answered my questions about the quality policy, their process and their maintenance of the work area. This was probably my most extreme experience with auditing the requirements relating to a suitable work environment.

In industries that have different constraints, organizations typically utilize clean rooms or facilities modeled on similar requirements. These are generally found in the manufacture of products where contamination is a critical concern (biomed applications) or where even the smallest particles can render a product unusable (electronic-component manufacturing). Clean rooms are usually certified to a specific class, undergo periodic inspections, and conform to rigorous requirements relating to both the maintenance of the facility and the appropriate gowning of staff.

Another example is found in the electronic-assembly industry. Electrostatic discharge (ESD) precautions can include special floor coatings, grounded mats and storage containers, segregated inventories and wrist or heel straps.

In both cases, environmental factors require interaction with the process owners, who have responsibility for another aspect of the quality management system (QMS): training.

Suitable environments for office or laboratory settings might include quiet areas, free of excess noise or distractions. In a hotel, restaurant or boutique, suitability might involve the aesthetic appearance, since atmosphere is part of the product deliverables.

For an organization that offers off-site record storage, it is impossible to fulfill customers’ requirements without ensuring appropriate environmental controls.

One of my clients had a customer from the biomed industry who required my client’s company to institute protocols for pest control. Despite the fact that my client’s product wasn’t assembled directly into their customer’s, the customer couldn’t afford the risk of insect matter, animal dander or animal droppings coming in contact with even their packing materials.

Ergonomics
While consideration of ergonomic factors is one of the methods management can use to demonstrate their commitment to the wellness of employees, there are also financial benefits. Ergonomically designed work spaces can prevent injuries (which decreases absenteeism and staff turnover), improve efficiency and decrease long-term disability claims resulting from prolonged work-related physical stress.

Heat and humidity
Are there materials that need to be stored within a specific temperature range? Some industries have entire facilities that maintain subzero temperatures. What procedures do you have in place if your facility falls into this category?

Some materials react differently when machined at different temperatures. Is the area for on-site calibration of test instrumentation temperature- and humidity-controlled? Are the thermostat and hygrometer calibrated or periodically checked?

Air quality, lighting, and noise control
Air quality is another factor that can affect both the product, through the introduction of air-borne particles and contaminants, and your employees, through the transmission of germs and pollutants.

Lighting is not only a safety concern. Inadequate lighting can result in failure to detect visual defects, errors in color matching and misreading specifications. Excess noise can cause hearing loss and make it difficult to communicate and understand instructions. Noise is often distracting, which can lead to injury and error.

Hygiene and cleanliness
How clean is the facility? Providing a clean and safe environment demonstrates respect for the workers. Has the organization given adequate consideration to common spaces like meeting rooms, cafeteria and restrooms? While these factors don’t necessarily have a direct effect on the quality of the product, they do influence staff morale. Depending on how much stress is common in your industry, attention to these factors could influence individuals’ abilities to concentrate and to perform at required levels.

Environmental factors are an inescapable dynamic of the workplace. Appropriate consideration to that one-sentence requirement in ISO 9001 can play a major role in assuring consistent fulfillment of customer requirements.

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