ISO 9001 Clause 8.7 Control of nonconforming outputs
- wilkshireconsulting
- 20 hours ago
- 4 min read
In ISO 9001 8.7 - Control of nonconforming outputs focuses on how organizations properly manage nonconforming outputs to prevent their unintended use or delivery. Nonconforming outputs are products or services that do not meet requirements. This clause helps identify, control, and correct defective products or services while ensuring compliance with customer, legal and regulatory requirements.
In this blog post we will be discussing the following:
· Identification of Nonconforming outputs
· Control and Disposition of Nonconforming outputs
· Documentation and Records
· Preventing Reoccurrence
· Why is 8.7 important?
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements
8.7 Control of nonconforming outputs
8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.
The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.
The organization shall deal with nonconforming outputs in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession.
Conformity to the requirements shall be verified when nonconforming outputs are corrected.
8.7.2 The organization shall retain documented information that:
a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in respect of the nonconformity.
Identification of Nonconforming outputs
Organizations must be able to identify and segregate nonconforming products or services to prevent them from being used or delivered.
· Inspection, testing and verification should be conducted to detect nonconformities.
· Marking, labeling, or tagging should be used to clearly identify nonconforming items.
· Segregation of defective products in a quarantine or controlled are may be required.
An example of this would be if you are a car manufacturer and you detect that a batch of engines has a faulty component and you’d tag them as nonconforming, preventing them from being installed in vehicles.
Control and Disposition of Nonconforming outputs
Once identified, the organization must decide how to handle nonconforming products pr services. These possible actions include:
· Correction: Fix the defect so that the product/service meets requirements.
· Rework: Modify the product/service to meet specifications.
· Use as-is (Concessions): Allow the product/service to be used despite the defect (with approval).
· Scrap or Disposal: Permanently discard unusable products.
· Return to Supplier: Send defective materials back to the external provider for correction.
An example of this would be a pharmaceutical company finds that a batch of medicine does not meet purity standards and decides to dispose of it to avoid health risks.
Documentation and Records
The organization must maintain records of nonconformities, including:
· Description of the issue – what as wrong.
· Actions taken – to correct the problem.
· Approval of disposition decisions – who authorized rework, concession, or disposal.
· Evidence of compliance – after corrective action such as retest results.
An example of this would be an aircraft manufacturer finds a structural defect in a wing component and records all testing and corrective actions before approving it for use.
Preventing Reoccurrence
Organizations must analyze why nonconformities happened and take steps to prevent future occurrences through:
· Root cause analysis – Identify underlying reasons for defects.
· Process improvement – Updating procedures, training, or equipment to prevent recurrence.
· Supplier evaluations – Ensuring suppliers meet quality expectations.
An example of this would be a food processing company finds that temperature fluctuations caused spoilage. They upgrade storage systems to prevent future issues.
Why is 8.7 important?
· Prevents defective products/ services from reaching customers.
· Reduces rework, waste, and costs.
· Improves process efficiency and quality control.
· Enhances customer satisfaction and compliance with legal and regulatory requirements.
In conclusion, implementing Clause 8.7 Control of nonconforming outputs ensures organizations can minimize quality issues, reduce risks, and ensure that only conforming products/ services reach customers. In the next blog post we will be diving deeper into ISO 9001 Clause 9 Performance Evaluation.
Related blog posts –
ISO 9001 Clause 8.5 Production and service provision
ISO 9001 8.4 - Control of externally provided processes, products and services
ISO 9001 Clause 8.3 Design and development of products and services
ISO 9001 Clause 8.2 Requirements for Products and Services
ISO 9001 8.1 Operational planning and control
ISO 9001 - 8 Operation Clause 8: 8.1 – 8.7
ISO 9001 – 7 Support Overview Clause 7: 7.1 – 7.5
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