Quality Objectives in MedDev Industry

Quality Objectives Medical Device ISO 13485

What are the quality objectives? Why are they important for the organization? How to define them? Who is responsible for establishing quality objectives? These are a few questions that we will answer in this article.

Purpose of Quality Objectives

In the previous article, we spoke about the Quality Policy. Quality objectives are basically key elements of the Quality Policy. The quality objectives are the main method used by medical device companies to focus the goal(s) from the Quality Policy into plans for improvement. The purpose is to determine conformity to (customer and regulatory) requirements and to enable the effective development and improvement of the Quality Management System.

Quality Objectives as a requirement

Quality objectives are listed as mandatory requirements in the ISO 13485:2016 standard for Quality Management System in the medical device industry. Requirements, customers, and regulatory, used as inputs for the objectives are intended to be met through the quality policy.

Top management’s obligation is to ensure that quality objectives are established at applicable functions and levels within the organization. It includes also those needed to meet applicable regulatory requirements and requirements for the product. Quality objectives are specific, measurable transitional steps to achieve the quality policy, created by rewriting the goals listed in your quality policy and defining statements for planned improvements.

Quality objectives have to be met and followed by employees.  It must be communicated at every organizational level (top management, project teams, functional groups, processes, individuals, etc.), with suitable plans and objectives for each level. The objectives are shaped for every level of the company, a single objective for the QMS as a whole, and individual objectives for each process or product that supports it.

Elements of Quality Objectives

When defining the quality objectives, make sure that they are well-defined and measurable. The goals are meant to be achievable and realistic. Top management is obligated to establish an internal environment and the organizational structure that will motivate employees to achieve the organization’s quality objectives. Also, quality objectives should be bound by time limitations, therefore you could have a clear goal to achieve and you can plan a timeline accordingly. 

The objectives created for products or processes are known as Key Performance Indicators, they represent the main indicators for showing that individual processes are working as planned, and it helps in the measurement of the general QMS objectives.

Examples of Quality Objectives:

  • We develop a medical device that avoids painful measurements of blood sugar and injections of insulin.
  • By the end of the year, we will have studied all relevant publications, patents, and products and have evaluated all known alternatives by means of a benefit analysis.
  • We develop products with which cancer patients can always be treated according to the latest scientific findings.
  • For our customers, we generally solve critical errors in our software as quickly as possible.
  • We increase our productivity by working with the latest technologies.
  • From now on, our employees will be optimally prepared for their tasks also by receiving regular and comprehensive further training.
  • For our customers’ data, we ensure the highest IT security.
  • We gain the trust of our customers through honesty and transparency.

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3 replies to “Quality Objectives in MedDev Industry”

  1. Sofia Nascetti says:

    I would add to the quality objectives the one for each process in the company. Objectives are basically KPIs. When it comes to monitoring and measuring, I have a value to compare the achievements.

  2. Ahmaad J. says:

    Agree Josh. Very well explained.

  3. Josh says:

    This is a really good article. I like how you gave examples!

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