ISO 9001:2015, 8.7

Clause 8, Operation, has seven sub-clauses:

8.1 Operational Planning and Control
8.2 Requirements for Products and Services
8.3 Design and Development of Products and Services
8.4 Control of Externally Provided Processes, Products, and Services
8.5 Production and Service Provision
8.6 Release of Products and Services
8.7 Control of Nonconforming Outputs

This article is on 8.7 Control of Nonconforming Outputs.

Requirements:

8.7.1 (untitled) Ensure process outputs that do not conform to their requirements are identified and controlled to prevent unintended use or delivery.

Take appropriate corrective action based on the nature of the nonconformity and its effect on conformity of products and services (applies also to nonconforming products and services detected after delivery of products, during or after provision of services).

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.

Verify conformity to requirements when nonconforming outputs are corrected.

8.7.2 (untitled)

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.

Changes:

  • Replaces old clause 8.3 on control of nonconforming product
  • Changes from “product” to “outputs”
  • Clarifies it also applies to services
  • Includes segregation, containment, return, or suspension
  • Adds informing customer as a possible action
  • Drops the requirement for a documented procedure

You can enroll in one of our 2.0 day “ISO 9001:2015 Requirements and Transition Guidance” public classes at this web page.

You can arrange for the course to be taught onsite at your facility by contacting Larry Whittington at larry@whittingtonassociates.com, or 770-862-1766770-862-1766.