Control of Production and Service Provision - ISO 9001

ISO 9001:2015 - QMS.8.5.1 - QP - Control of Production and Service Provision

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 will this template help my organisation?

• The purpose of this procedure is to identify when process validation is required and the steps required to prepare for validation, as well as to provide guidelines defining the format to be used for Process Validation
• The objective of process validation is to show proof, by establishing objective evidence, that the process consistently produces a product that meets its predetermined specifications.

 What does the standard require?

• ISO 9001 requires that your organisation implement a procedure to ensure that production and service provision is carried out under controlled conditions.
• Controlled conditions could include creating documents that define:
• the characteristics of the products to be produced,
• the services to be provided,
• or the activities to be performed,
• the results to be achieved.
• You should also consider the availability and use of suitable monitoring and measuring resources.

If you would like further information on our wide range of templates or have any suggestions for improvements 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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