8.

7 Control of Nonconforming Process Outputs,

Products, and Service
8.7.1 

The organization should ensure process outputs, products,

and services that do not conform to requirements are
identified and controlled to prevent unintended use or
delivery. The organization should take appropriate action
based on the nature of nonconformity and its impact on the
conformity of products and services. This is applicable also to
nonconforming products and services detected after delivery
of products during or after the provision of service. The
organization should deal with nonconforming outputs in one
or more of these ways:
 correction;
 segregation, containment, return, or suspension of the
provision of products and services;
 informing  the customer;
 obtaining authorization for acceptance under concession. 

The organization should verify conformity to requirements

when nonconforming process outputs, products, and services
are corrected.

8.7.2

The organization should retain documented information that

describes the nonconformity, action taken,  concessions
obtained, identifies the person or authority that made the
decision regarding dealing with nonconformity.

ISO 9001:2015-Clause 8.7 applies to processes, products, and services

that do not conform to customer requirements, applicable regulatory
requirements, or your own organization requirements. Nonconformities
may relate to suppliers and outsourced work, your own organizational
activities, or product shipped to customers. Your organization must have
controls and responsibilities to identify, contain i.e. prevent further
processing or use, keep records of the nature and other details of the
nonconformity, notify appropriate personnel and customer, where
appropriate, evaluate what disposition action needs to be taken, carry
out timely disposition, determine policies for release for further
processing or shipment to the customer, obtain customer concessions,
rework and re-verification, establish performance indicators to measure
the effectiveness of the control of nonconformance process, etc.
Product or material found with no identification or its quality status is
not known, should be treated as a nonconforming product and controlled
as mentioned above. If you find that a nonconforming product has been
shipped, without a customer concession, you must take appropriate
action to reduce the immediate and consequential effect of the
nonconformity. Depending upon the seriousness and scope of the
nonconformity, you might consider taking action to eliminate the
nonconformity as well as a corrective action to eliminate the root causes
of the nonconformity. It might be appropriate in specific circumstances
to notify the customer and resolve the situation to your customer’s
satisfaction. A similar rationale may be applied where the product has
been shipped that does not meet regulatory requirements. Depending
upon the seriousness and scope of the nonconformity, you might
consider taking action to eliminate the nonconformity as well as a
corrective action to eliminate the root causes of the nonconformity. You
need to be aware of any reporting requirements imposed by regulatory
bodies and comply with them.
A concession authorization allows you to ship nonconforming products,
under controlled conditions. A deviation authorization allows you to
manufacture a product different from the original specification, under
controlled conditions. In both these situations, make sure that you
obtain these authorizations in writing prior to shipping or manufacturing
the nonconforming product. All product realization processes must show
the interaction with your process for a nonconforming product.
Performance indicators to measure the effectiveness of control of
nonconforming products may include a reduction in cycle time to
evaluate and dispose of nonconforming products, reduced errors in
preventing unintended use or delivery, improved alternate use of the
nonconforming product, and cost recovery, etc.