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Quality Objectives & Planning - ISO 13485

Quality Objectives & Planning - ISO 13485

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ISO 13485: 2016 +A11 2021 

QMS.5.4.1 – Quality Objectives Template

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

What are Quality Objectives?

Quality Objectives are measurable goals that are consistent with your Quality Policy and need to be established by your company in line with ISO 13485 standards. You can set and use these objectives to turn the targets stated in your Quality Policy into a measurable plan of action. The Quality Objectives Template is used in conjunction with the Quality Policy Template to set your objectives.

How should I choose my organisations Quality Objectives?

As stated above, refer to your Quality Policy and Quality Management System Planning Procedure when setting your Quality Objectives. See 5.3.0 – Quality Policy Template and QMS.5.4.2 – QMS Planning Procedure for more information.

  • Your objectives should be SMART:
    • Specific– target a specific area for improvement.
    • Measurable– quantify or at least suggest an indicator of progress.
    • Assignable– specify who will do it.
    • Realistic– state what results can realistically be achieved, given available resources.
    • Time-related– specify when the result(s) can be achieved.
  • You should focus on areas that relate to showing ISO 13485 and any other applicable regulatory compliance, such as compilation of technical file documents, improving customer satisfaction and issuing employee QMS training.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

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