ISO 13485 & MDR Knowledge base

Setting good quality objectives for ISO 13485

In clause 4.2.1, ISO 13485 lists quality objectives as being mandatory for a Quality Management System (QMS) in the medical device industry, which begs the questions: What are quality objectives, what is their purpose, and why are they so important? The real question we should be asking is how we can set good quality objectives that not only fulfill a requirement, but also bring real benefit to our company.

The short answer is that quality objectives are a great tool to highlight essential elements in your quality policy, while giving employees a framework for achieving continual improvement. Wasn’t improvement one of the main reasons you chose to implement a QMS in the first place?

Quality objectives: What are they, and why do we need them?

Where a quality policy is your forum for setting goals for your Quality Management System, quality objectives are the method by which you translate those goals into plans for improvement. Both customer and regulatory requirements are used as inputs for the quality policy, and then the quality objectives set out to meet these requirements through the quality policy. Basically, to create quality objectives, you simply take the goals you have listed in your quality policy, and rewrite them into defined statements for planned improvements.

Take, for example, the quality policy of a defibrillator manufacturer. A customer required that their order be delivered on time, with zero defects, which the manufacturer recognized as a top priority for all customers. So, a goal was set in the quality policy to “deliver defibrillators to each customer within agreed timelines, with zero defects, in every shipment.” The manufacturer could break down this goal into two quality objectives: one involving improvement of timely delivery, and the other dealing with the issue of defective product. So, these objectives could read:

  1. To increase the rate of on-time delivery by 5% in the next 12 months.
  2. To decrease the rate of defective product shipped to customers by 1% in the next 12 months.

Through this method, the company has connected any improvement stemming from the quality objectives directly to customer requirements.

But, if employees aren’t aware of these quality objectives, then how can they strive to meet them? Quality objectives must be communicated at every organizational level, with appropriate plans and objectives for each, in order to fulfill the overall objectives. Formats like a Balanced Scorecard can be useful for these communications.

So, objectives are created for every level of the company, all the way down to the product level (that is, a single objective for the QMS as a whole, and individual objectives for each process or product that supports it). These “sub” objectives for products or processes are known as Key Performance Indicators, or KPIs. These KPIs represent the main indicators showing that individual processes are functioning as planned, which helps in the measurement of the overall QMS objectives.

Making your quality objectives work for you (and not the other way around)

Once your organization has determined which products and processes to monitor, measure, and improve, you need to make sure that your quality objectives effectively address the necessary improvements. For this, you should design “S.M.A.R.T.” objectives (that is, Specific, Measurable, Agreed, Realistic, and Time-based) that are relevant at every level of the organization, so that every single employee understands how his/her job supports the overall QMS goals. Here’s how you do this:

Specific. If you hope to meet an objective, then you have to make sure that it is precise and well-defined. Rather than striving “to improve product quality,” a specific objective might be “to reduce product defects in defibrillators assembled on the second line”—that is, if the second line has been identified as the main source of product defects. “Product defects” is much more specific than “product quality.”

Measurable. Without measuring it, how can you determine if an objective has been met? An effective quality objective must be measurable. So, you take your Specific objective “to reduce product defects in defibrillators assembled on the second line,” and make it measurable: “to reduce the number of product defects in defibrillators assembled on the second line from 10% to 7%.” Now you can measure how many defects are present, and make plans to decrease that number.

Agreed. Objectives can’t be created in a vacuum if they are to be achieved. Top management needs to be involved in setting quality objectives, and then these objectives must be communicated to employees at every organizational level, along with specific plans for meeting them. All levels of the organization need to agree that the plan is achievable; otherwise, they are less likely to do their part to meet objectives, and the whole plan breaks down.

Realistic. No one wants to waste time working towards an unreachable goal. You aren’t going to motivate your employees by telling them you want to go from 25% defective product to zero, particularly if your plans don’t support this level of improvement. It’s always better to set realistic objectives and surpass them, than to set lofty goals and always come up short.

Time-Based. Finally, to make your objectives truly effective, they need to be bound by time constraints. If your objective is simply “to reduce the number of product defects in defibrillators assembled on the second line from 10% to 7%,” then how long will you allow your organization to work towards meeting it? Two weeks? Twenty years? But, if you change this to “reduce the number of product defects in defibrillators assembled on the second line from 10% to 7% within the next 12 months,” you now have something concrete to strive toward, and you can plan a timeline accordingly.

Communicating the quality objectives

Your final step in the implementation of quality objectives, as mentioned previously, is communicating them to individuals at every level of the organization. Not only this, but you also need to make sure that every employee understands how his or her performance contributes to the overall effectiveness of the QMS. For our example above, each employee who works on defibrillators on the second assembly line needs to be aware of the objective, as well as how it will be measured, the plans for ensuring it is met, and his or her impact on its achievement.

While good ideas for improvement are a great start, they can never be put into action without having each employee consciously striving toward improvement in the way they work. Not only will this lead to process improvements, but an increase in employees’ morale and their feelings of empowerment, too.

For a graphical representation of the implementation process, check out this free Diagram of ISO 13485:2016 Implementation Process.