Quality - SOP - Writing a Standard Operating Procedure

Quality - SOP - Writing a Standard Operating Procedure

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This procedure defines the method of creating (content and format) Standard Operating Procedures (SOPs) and illustrates the format design (refer to SOP Template) and guidelines for the preparation of all SOPs to ensure compliance with ISO 13485, 21 CFR 820 and EU MDR/IVDR.

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Purpose of Document

This procedure defines the method of creating (content and format) Standard Operating Procedures (SOPs) and illustrates the format design (refer to SOP Template) and guidelines for the preparation of all SOPs.

Policies and procedures are business critical documents required to ensure your company and regulatory compliance to ISO 13485, 21 CFR 820 and EU MDR/IVDR; consistency in quality, performance, and specifications; to serve as a training tool; and to provide transparency in execution of working procedures to external customers.

Scope of Document/s

This procedure applies to all internal company SOPs written or revised following the effective date of this procedure. Suppliers shall use their own quality management system and document management SOPs (unless specified otherwise).

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