ISO 9001 Control of Nonconforming Outputs: Clause 8.7 Guide

What the control of nonconforming outputs requirement is, and why it exists

Executing ISO 9001 control of nonconforming outputs requires organisations to ensure that products or services failing to meet specified requirements are systematically identified and controlled. Implementing ISO 9001 control of nonconforming outputs under the ISO 9001 standard prevents the unintended use, delivery, or processing of defective items. This requirement applies universally to all certified entities, whether providing tangible manufactured goods, digital software, or ongoing service provisions under Subclause 8.7.1.

The primary rationale for Clause 8.7 is safeguarding customer satisfaction and maintaining operational integrity across the supply chain. When an unmonitored defect bypasses operational checks, it threatens customer trust, causes financial loss, and can lead to severe regulatory noncompliance. Under Subclause 8.7.1, organisations must take appropriate action based on the nature of the nonconformity and its potential effect on overall conformity. This requirement applies both during internal production and after delivery or during service provision.

Under ISO 9001:2015, the verbal form "shall" indicates a mandatory requirement ("must"), whereas "may" indicates a permission ("may"). Organisations must establish operational mechanisms to deal with nonconforming outputs in one or more specified ways, including correction, segregation, containment, return, suspension, customer notification, or obtaining acceptance under concession. While organisations may select the most suitable combination of disposition actions, retaining detailed documented information under Subclause 8.7.2 remains strictly mandatory.

Step-by-step procedure for controlling nonconforming outputs

Managing nonconforming outputs effectively requires compliance leads and shop floor supervisors to execute a standardized containment and disposition routine. Following a structured procedure prevents accidental mixing of conforming and nonconforming items across operational areas.

• Identify and mark nonconforming outputs: Immediately apply physical tags, digital status flags, or hold labels to defective items upon detection under Subclause 8.5.2 and Subclause 8.7.1.
• Execute segregation and containment: Move nonconforming physical products to designated quarantine holding areas or suspend service delivery under Subclause 8.7.1.b to prevent further processing or shipment.
• Determine appropriate disposition action: Evaluate the defect severity and decide whether to perform correction, return items to external providers under Subclause 8.4.1, suspend provision, or seek acceptance under concession.
• Obtain necessary concessions and customer notifications: Authorize acceptance under concession under Subclause 8.7.1.d if nonconforming outputs remain functionally safe, and inform the customer under Subclause 8.7.1.c if defects affect delivered items.
• Re-verify corrected outputs: Conduct mandatory re-inspection and testing under Subclause 8.7.1 whenever nonconforming outputs undergo correction to confirm full compliance with acceptance criteria.
• Retain documented evidence and evaluate root causes: Log defect descriptions, actions taken, concessions granted, and deciding authorities under Subclause 8.7.2, triggering corrective actions under Subclause 10.2.1 when necessary.

Evaluating Clause 8.7 requirements against audit evidence

Auditors examine physical holding zones, digital tracking systems, and retained records to verify that nonconforming outputs are controlled rigorously. Organisations must present documented information demonstrating that unauthorized product release under Subclause 8.6 is strictly prevented.

Example

During a surveillance audit at an automotive stamping plant, an auditor reviewed Subclause 8.7.1 regarding the control of nonconforming outputs. The auditor observed three pallets of cracked metal brackets stored in an open production lane without identification tags or quarantine labels. A review of shop floor records revealed that production operators set aside the defective brackets but failed to log them in the nonconformity system or move them to a secure quarantine zone. Consequently, a forklift driver inadvertently moved two boxes from the unlabelled batch to the final packing line for customer shipment.

The compliance lead logged an immediate nonconformity under Subclause 10.2.1, halted shipment under Subclause 8.7.1.b, and re-inspected all packed containers. The plant updated its nonconformity procedure by establishing locked quarantine cages and training material handlers on mandatory status tagging under Subclause 8.5.2. When re-audited, the plant demonstrated complete segregation controls and presented verified nonconformity records under Subclause 8.7.2.

Before your audit

• Confirm that physical quarantine areas are clearly identified, secured, and controlled under Subclause 8.7.1.
• Verify that status identification tags or digital flags clearly distinguish nonconforming outputs under Subclause 8.5.2.
• Ensure that all corrected products undergo documented re-verification prior to release under Subclause 8.7.1.
• Retain documented information describing the nature of all nonconformities encountered under Subclause 8.7.2.a.
• Check that records detail all actions taken, including containment, segregation, or returns, under Subclause 8.7.2.b.
• Inspect concession records to verify proper authorization by designated internal authorities or customers under Subclause 8.7.2.c.
• Retain documented information identifying the specific authority deciding the disposition action under Subclause 8.7.2.d.
• Confirm that customer notifications are documented whenever nonconforming outputs are detected after delivery under Subclause 8.7.1.c.

Questions people ask

What is iso 9001 control of nonconforming outputs?

ISO 9001 control of nonconforming outputs is a mandatory process under Clause 8.7 that ensures defective products or services are identified and controlled. It prevents unintended use or delivery through segregation, correction, customer notification, or concession authorization.

How does an organisation handle defective products detected after delivery under ISO 9001?

Under Subclause 8.7.1, when defective products or services are detected after delivery or during service provision, the organisation must take action appropriate to the effect of the nonconformity. This includes informing the customer, containing further distribution, and executing corrective actions under Subclause 10.2.1.

What is a concession under ISO 9001 Subclause 8.7.1?

A concession under Subclause 8.7.1.d is formal authorization to use or release a product or service that does not conform to specified requirements. Concessions must be authorized by a relevant authority and, when applicable, by the customer, with records retained under Subclause 8.7.2.

What documented information must be retained for nonconforming outputs?

Under Subclause 8.7.2, organisations must retain documented information that describes the nonconformity, details the actions taken, and records any concessions obtained. These records must also identify the specific authorized person deciding the disposition action.

Reference documents

• ISO 9001:2015 Quality management systems — Requirements