Manage exceptions to your quality, security, and operational standards with control and accountability using this ISO-compliant Concessions/Deviation Form.

Not every non-conformance requires immediate rejection or correction. Sometimes the most practical solution is to accept or use a product, service, or process that deviates from specified requirements — but only when that decision is properly justified, authorised, and documented. This Concessions/Deviation Form gives your organisation a structured, auditable mechanism for evaluating and approving temporary or one-time deviations from established standards, ensuring that exceptions are managed with the same rigour and governance as conforming activities.

Designed to meet the requirements of ISO 13485, ISO 27001, and ISO 9001, this form guides users through the full concession evaluation process — from describing the deviation and its potential impact, through risk assessment and justification, to formal authorisation by qualified personnel and documentation of any corrective or preventive actions required. The result is a clear decision trail that demonstrates due diligence, protects your organisation from uncontrolled risk, and satisfies regulatory and certification audit requirements.

For quality managers, compliance officers, and operations leaders, this form is an essential governance tool. It prevents ad hoc, undocumented exceptions from undermining your management systems while still allowing the flexibility needed to keep operations moving when circumstances demand it. It also creates visibility over deviation patterns, enabling your organisation to identify recurring issues and address root causes before they become systemic problems.

The form is fully customisable to your organisation's approval workflows, risk criteria, and specific ISO compliance requirements, and is designed to integrate seamlessly with your existing quality management, information security, or product development processes.

Suitable for: Manufacturing, medical device, IT, and service industries | ISO 13485, ISO 27001, ISO 9001, FDA QMSR, MDSAP| Quality assurance and compliance teams | Product release and exception management