Example Quality Objectives

As per the requirements of ISO 13485, 9001 and any ISO standard as a result of Annex SL - all quality systems in line with this require the establishment of Quality Objectives.

Now comes the dilemma, what should my quality objectives look like?

All ISO standards including ISO 9001, 13485 and 27001, call out the need for objectives.

If you’re working to ISO 9001 Quality Management Systems or ISO 13485 Quality Management Systems for Medical Devices then you set Quality Objectives.

If you’re working to ISO 14001 Environmental Management Systems then you set Environmental Objectives.

If you’re working to ISO 27001 Information Security Management Systems then you set Information Security Objectives.

Makes sense doesn’t it?

Many organisations have quality objectives such as:

• Improve customer satisfaction

• Reduce errors from manufacturing

• Make sure the staff are happy

• Improve our supplier performance

• Make more money.

However, ISO 13485 for example specifies a requirement that “quality objectives shall be measureable”. If we keep this in mind to amend the above example quality objectives, we can see they become much more meaningful:

• Improve customer satisfaction to 98% from 95%

• Reduce errors from manufacturing from 4% to 2%

• Make sure the staff are happy - Using internal staff surveys to improve staff satisfaction to above 80%.

• Improve our supplier performance - reduce nonconforming product from suppliers to 0.

• Make more money - increase revenue to £1,000,000 annually.

Make your objectives based upon SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) methodology and you’ll be fine.