Managing engineering changes effectively is crucial for maintaining product quality, regulatory compliance, and clear communication across teams. This template ensures that all change requests are documented, reviewed, and approved in a standardized way, reducing errors and avoiding missed steps.

• Simplifies and standardizes the change management process

• Ensures full documentation of design, process, and specification changes

• Improves collaboration between engineering, quality, and manufacturing teams

• Provides a clear record for audits and regulatory requirements

• Suitable for engineering, medical device, manufacturing, and quality teams

Tracking CAPAs is a critical part of maintaining ISO 9001, ISO 13485, FDA, and other regulatory compliance programs. This template simplifies the process by providing a centralized, easy-to-use format to log, monitor, and close CAPAs while ensuring documentation is complete and audit-ready.

• Keeps CAPA actions organized from issue identification to resolution

• Reduces risk of missed deadlines and incomplete documentation

• Provides a clear structure for root cause, corrective actions, preventive measures, and verification step

• Suitable for use across industries: engineering, medical devices, and manufacturing

• Ready to print or use digitally

Internal audits are essential for maintaining ISO 9001, ISO 13485, and other regulatory certifications. This checklist provides a ready-made format to evaluate documentation, training, processes, and controls, ensuring that nothing is overlooked. By using this tool, teams can identify gaps early, correct issues proactively, and be fully prepared for external inspections or certifications.

• Provides a consistent, organized approach to auditing

• Covers quality management systems, training, documentation, and process compliance

• Helps prepare for external audits and regulatory inspections

• Suitable for engineering, manufacturing, medical devices, and consulting environments

• Can be printed or completed digitally

Risk Assessment Matrix – a clear, structured tool to evaluate risk severity and likelihood, helping teams prioritize actions and stay compliant.

• Visual tool to rate risks by severity and likelihood

• Supports ISO, FDA, and quality system standards

• Editable – print or use digitally Helps prioritize corrective actions

Risk Assessment Evaluation Template – structured, ISO-aligned tool to identify, assess, and mitigate risks efficiently.

• Structured template for identifying and documenting risks

• Evaluates severity, probability, and mitigation planning

• Aligns with ISO 14971, ISO 9001, and ISO 13485 standards Editable format – print or complete digitally

• Designed for engineering, manufacturing, and quality teams

• Speeds up compliance documentation and audit readiness

Helps compliance teams and engineers efficiently plan, schedule, and track internal audits throughout the year. This template ensures all audits are logged, responsibilities are assigned, and timelines are met, supporting ISO 9001, ISO 13485, and other regulatory requirements.

• Structured format for audit planning
• Tracks responsibilities and dates
• ISO 9001 & ISO 13485 aligned
• Editable for digital or print use

• Plan audits by department, process, and timeline
• Assign auditors and track completion status
• Provides clear structure for recurring and special audits
• Strengthens audit readiness and quality system compliance

Simplifies the documentation of issues requiring corrective action. This template guides users through identifying the problem, documenting actions taken, and ensuring resolution is verified—all in a professional, compliant format.

• Streamlines CAR documentation and tracking

• Ensures proper follow-up and accountability

• Aligns with ISO, FDA, and QMS compliance requirements

• Ready to use and customizable for your organization

• CAR log and follow-up template

• Tracks corrective action details

• ISO and FDA aligned

• Editable and printable

helps teams analyze issues systematically and identify the true cause of problems. It uses structured RCA techniques (5 Whys, Fishbone, etc.) to guide investigation, ensuring corrective actions address root causes, not symptoms.

• Standardizes RCA documentation and analysis

• Reduces recurrence of issues by addressing root causes

• Enhances quality system compliance and effectiveness

• Applicable to engineering, manufacturing, and service environments

• RCA documentation form

• Structured for 5 Whys/Fishbone

• Improves corrective action effectiveness

• Printable or digital format

Designed for medical device teams and quality professionals who need to comply with ISO 14971. This comprehensive template provides a structured framework for risk identification, assessment, control, and review.

• Ensures compliance with ISO 14971 requirements

• Provides structured sections for risk analysis and control measures

• Simplifies documentation and updates for audits and technical files

• Ideal for medical device risk management teams

• Risk management plan and log

• ISO 14971 aligned

• Tracks risks, controls, and reviews

• Printable and editable

A comprehensive tool that helps engineering and technical teams stay organized, audit-ready, and aligned with regulatory requirements. Whether you work in medical devices, manufacturing, or electronics, this checklist ensures that every part of your quality system is documented and compliant with ISO, FDA, and CE standards.

• Ensures no gaps before audits or regulatory inspections

• Provides a structured, repeatable process for compliance

• Saves hours of manual preparation by consolidating requirements in one document

• Ideal for ISO 9001, ISO 13485, FDA QSR, and CE marking readiness

Streamline Your Procedures with a Professional SOP Template The Design2Comply Standard Operating Procedure (SOP) Template gives you a structured, professional document format to ensure that every procedure in your organization is documented consistently and ready for audits.

• Editable, structured template in Word + PDF (easy to customize)

• Pre-defined sections:

o SOP Title, Number, Revision, and Approval tracking

o Purpose and Scope

o Roles and Responsibilities

o Detailed Procedure Steps

o Safety/Compliance Notes

o References and Revision History

• Clean, professional layout with built-in version control

• Suitable for ISO 9001, ISO 13485, FDA QSR, and CE compliance