Writing SOPs

A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. SOPs lies at the heart of QMS and are very important both for ISO certification and registration and for running the business as efficiently as possible. In addition to SOPs, BioReg can also help you with business process management (BPM), which can be linked to ISO standardization.

Writing SOPs includes the following services:

• Analysis of a specific quality standard (e.g., ISO 13485)
• Development of documentation architecture to achieve standards
• Creation of specific SOPs that must be written
• Writing specific SOPs and their implementation

BioReg can build a complete ISO 13485-compliant QMS for your company, write specific Standards Operating Procedure (SOP) as requested, or only review your existing SOP for its compliance.

We identified 12 quality procedures (SOPs) that every company should include in their QMS according to MDR:

• Strategy for regulatory compliance – which may include quality objectives, processes for identification of relevant legal and GSPR requirements, choice of conformity assessment procedures, and others (see MDCG 2019-7)
• Handling communication with competent authorities, notified bodies, other economic operators, customers, or other stakeholders
• Management of corrective and preventive actions
• Documentation control
• Change control
• Organizational structure, the responsibilities of the managerial staff as to critical procedures, and their organizational authority
• System for recording and reporting incidents and field safety corrective actions (art. 87 and 88) and their analysis (art. 89)
• Procedure to keep up to date the post-market surveillance system (art. 83)
• Procedure for the clinical evaluation (including clinical evaluation plan) per Article 61 and Annex XIV, including PMCF
• Resource management, including selection and control of suppliers
• Risk management (Section 3 of Annex I)
• Identification and traceability of devices (art. 25)

For more information, please contact the BioReg team.