Learn about the importance of Quality Objectives (QO), how are they important for a medical device company’s Quality Systems, and how to draft accurate Quality Objectives intended to drive improvements, customer satisfaction, and product quality, while being in line with the Quality Policy (QP) of the Organization.

What are Quality Objectives?

Quality Objectives are a set of goals put in place by the top management of a company to ensure that their Quality Management System (QMS) is constantly monitored and improved. QO’s are derived from the Quality Policy, and help in transforming the Quality Policy into measurable and monitorable goals. The QO’s define specific points for development and improvement.

How to Write a Good Quality Objective

A Quality Objective should be clear, concise, achievable and measurable. It should effectively describe what needs to be completed or improved. Quality Objectives should be S.M.A.R.T (specific, measurable, achievable, realistic and time-based) and be always derived from the Quality Policy.

Things to take into account for Quality Objectives:

⦿ Deduce the individual aspects of the quality policy into measurable aspects.
⦿ Identify an accurate and time-based method to measure each objective.

⦿ Leverage internal established procedures to demonstrate progress against quality objectives over time.

⦿ Utilize the trend analysis approach to ensure that there are quantitative methods to monitor and measure the objectives defined.

There are several aspects to be kept in mind while writing Quality objectives, a few are listed below: 

⦿ While drafting a QO, one must ensure that a QO is relevant to the particular year/time frame it is set for.

⦿ QO’s can be set for a particular department or set of departments to monitor its specific goal which in turn monitors the organization’s overall goal(s).

⦿ Keep in mind that QO’s are set within achievable limits and within a reasonable time frame.

⦿ Cross verify with the QP while writing QO’s and make sure that the QO reflects the QP and what the QP aims to achieve.

⦿ QO’s must be drafted such that it is stated in action terms with values or limits.

Some objectives like the following, for a fiscal year, can be meaningful for a medical device company -

⦿ To attain an incoming inspection rejection rate of less than 1%

⦿ To maintain customer satisfaction of at least 90%

⦿ To achieve regulatory authorization for sales in Canada

If a company has specific product lines or products for which they’d like to customize the quality objectives they can always mention so.

Next time you build your quality objectives for an ISO 13485 certification, MDSAP, or 21 CFR Part 820 compliance, feel free to reach out to a regulatory or quality partner like Elexes to work with you in designing meaningful and applicable objectives that truly drive improvements.

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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