ISO 9001:2015, 8.7

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), clause 6 (Planning for the Quality Management System), and Clause 7 (Support).

Clause 8, Operation, has seven sub-clauses:

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

This article is on 8.7 Control of Nonconforming Process Outputs, Products, and Service.

8.7 Control of Nonconforming Process Outputs, Products, and Service

Requirements:

Ensure process outputs, products, and services that do not conform to requirements are identified and controlled to prevent unintended use or delivery.

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

Deal with nonconforming “process outputs”, products, and services in one or more of these ways (as applicable):

a) correction;

b) segregation, containment, return, or suspension of provision of products and services;

c) informing customer;

d) obtaining authorization for:

– use “as-is’ or acceptance under concession
– release, continuation, or re-provision of products and services

Verify conformity to requirements when nonconforming process outputs, products, and services are corrected.

Retain documented information on:

  • actions on nonconforming process outputs, products, and services
  • any concessions obtained
  • person or authority that made decision regarding dealing with nonconformity

Changes:

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