Infrastructure, Work Environment and Contamination Control Procedure - ISO 13485

ISO 13485 2016 +A11 2021 

QMS.6.3.0 – QP – Infrastructure Work Environment & Contamination Control

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.

How should QMS.6.3.0 – QP – Infrastructure Work Environment & Contamination Control be used?

• The purpose of this template is to be used to describe how your organisation manages the resources required for infrastructure, work environment and contamination control.
• Top management can use this template to determine a procedure for allocating resources as appropriate and relevant to the medical device activities being undertaken by the company.

What parts of ISO 13485 does this template relate to?

• The infrastructure such as buildings, equipment, IT, and other resources required to perform the operations described in the QMS and ISO 13485.
• The work environment shall be resourced according to required Health and Safety national or regional regulations appropriate for the type of tasks performed by the business relating to medical devices.
• Contamination control shall be planned and implemented according to the medical device activities being undertaken by the organisation.

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