This procedure defines the process of purchasing materials and services.

This procedure ensures post-market monitoring, systematic collection, and analysis of data for the continued safety and effectiveness of your marketed devices.

This documentation package includes a Nonconformance SOP that defines the process for nonconforming material handling, disposition, and corrective action. Documentation includes standard templates and forms for:

• Control of Nonconforming Materials Standard Operating Procedure

• Nonconformance Report (NCR) Form

• NCR Log

This procedure establishes statistical techniques used to perform statistical analyses on the acceptability of process capability and product characteristics.

This procedure provides a process an independent and objective assessment of the company’s system of internal controls and underlying processes to address the safeguarding of assets, compliance with applicable laws, regulations and standards and achievement of Management’s operational objectives through adherence to the Quality System. 

This documentation package includes a Complaint Handling SOP to define the methods for receiving, logging, reviewing, documenting, investigating, evaluating, trending, and closing complaints for all manufactured products or services in a uniform and timely manner. Documentation also includes a standard form for creating a record of the complaint.

• Complaint Handling Standard Operating Procedure

• Complaint Form

This documentation package includes a Returned Materials SOP for managing the return of used or unused products from customers, clinical sites, and trunk stock. Documentation includes a form for handling the returned materials.

• Returned Materials Standard Operating Procedure

• Return Material Authorization Form

This documentation package includes a Corrective and Preventive Action (CAPA) SOP for a standardized process to initiate, analyze, investigate, identify, implement and verify the effectiveness of CAPA activities. Documentation includes the CAPA SOP, form, and log for creating identification and records for each CAPA.

• Corrective and Preventive Action (CAPA) Standard Operating Procedure

• CAPA Form

• CAPA Log
  

This procedure describes standard sterilization procedures to establish product sterility assurance and demonstrate continued effectiveness of the sterilization processes and doses for the company’s manufactured products. This documentation package includes a sterilization form to indicate the validated cycle or specific cycle parameters.

• Sterilization Standard Operating Procedure

• Sterilization Release Authorization Form

This documentation package includes a Receiving and First Article Inspection (FAI) SOP for performing receiving inspection and first article inspection of purchased materials and products. Documentation templates include:

• Receiving and FAI Standard Operating Procedure

• Incoming Inspection Form

• FAI Form

• Inspection Log

This documentation package includes a Supplier Management SOP for the selection, classification, qualification, evaluation, maintenance, and retirement of Suppliers and Consultants whose products and/or services have the potential to impact the quality of Company products or quality system. Document templates include:

• Supplier Management Standard Operating Procedure

• Supplier Qualification Form

• Supplier Self-Survey

• Supplier Audit Checklist

• Supplier Quality Agreement

This documentation package provides a Control of Inspection, Measurement, and Test Equipment SOP for introducing, qualifying, maintaining, and obsoleting inspection, measuring, manufacturing and test equipment used by the Company. Documentation templates include:

• Control of Inspection, Measurement, and Test Equipment Standard Operating Procedure

• Equipment Identification Form

• Equipment Change Impact Assessment Form

• Equipment Calibration Form

• Equipment Maintenance Form

This documentation package provides a Risk Management SOP that specifies the process activities and tasks to identify hazards associated with the medical device product, to estimate and evaluate risks, to control the associated risks, and to monitor the effectiveness of the controls throughout all the stages of the product life cycle. Documentation templates include:

• Risk Management Standard Operating Procedure

• Risk Management Plan

• System Hazard Analysis

• Design Failure Mode and Effects Analysis (dFMEA)

• Process Failure Mode and Effects Analysis (pFMEA)

This documentation package provides a Training SOP for training employees and consultants to Company procedures and quality management system. Documentation templates include:

• Training Standard Operating Procedure

• Training Requirements Matrix (according to Beacon Launch Partner’s complete QMS package)

• Training Record Form

This Management Responsibility Procedure defines roles and responsibilities for productivity and compliance.

• Defines accountability and roles for project stakeholders.

• Ensures compliance with regulatory standards and improves operational efficiency.

• Facilitates communication and coordination among team members.

This Quality Records SOP defines the process for creating, revising, and storing quality records.

• Fully customizable SOP template tailored for quality records management.

• Includes step-by-step guidance for ensuring compliance with regulatory standards and best practices.

• Designed for ease of use by early-stage medical technology companies wanting to streamline processes.

This procedure defines the process for controlling documents and data, including records, used in the Company quality system. Documentation package includes an example Document Change Order (DCO) form for managing documentation changes.

• Document Controls Standard Operating Procedure

• DCO Form
  

The Quality System Manual accompanies the Beacon template Quality Management System (QMS), which consists of processes, procedures, and organizational responsibilities to ensure products manufactured by the Company meet quality objectives, customer requirements, and regulatory requirements.