ISO 9001:2015, 8.5

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 8.5 Production and Service Provision.

8.5.1 Control of Production and Service

Requirements:

Implement controlled conditions for production and service, including delivery and post-delivery activities. Include these controlled conditions, as applicable:

a) availability of documented information that defines characteristics of products and services;

b) availability of documented information that defines activities to be performed and results to be achieved;

c) monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met.

d) use and control of suitable infrastructure and process environment;

e) availability and use of suitable monitoring and measuring resources;

f) competence and, where applicable, required qualification of persons;

g) validation, and periodic revalidation, of ability to achieve planned results of any process for production and service provision (where resulting output cannot be verified by subsequent monitoring or measurement);

h) implementation of products and services release, delivery, and post-delivery activities.

Changes:

  • Replaces old clause 7.5.1 on Control of Production and Service Provision
  • Changes from “work instructions” to “documented information”
  • Clarifies that documented information defines activities to be performed and expected results
  • Adds verification that control criteria and acceptance criteria are met
  • Use of equipment expanded to use of infrastructure and process environment
  • Adds competence, and where applicable, qualification of persons
  • Moves old clause 7.5.2 on “special processes” into clause 8.5.1.g and lessens its emphasis

8.5.2 Identification and Traceability

Requirements:

Use suitable means to identify “process outputs” (where necessary to ensure conformity of products and services).

Identify status of “process outputs” with respect to monitoring and measurement requirements throughout production and service provision.

Control unique identification of “process outputs” (where traceability is a requirement). Retain any documented information necessary to maintain traceability.

NOTE: “Process outputs” are results of any activities which are ready for delivery to customer or to an internal customer (e.g., receiver of inputs to next process). “Process outputs” can include products, services, intermediate parts, components, etc.

Changes:

  • Replaces old 7.5.3 on Identification and Traceability
  • Changes from use of “product” to “process outputs”
  • Adds NOTE to define term “process outputs”

8.5.3 Property Belonging to Customers or External Providers

Requirements:

Exercise care with property belonging to customers or external providers while under the organization’s control or being used by organization.

Identify, verify, protect, and safeguard the customer’s or external provider’s property provided for use or incorporation into products and services.

Report to the customer or external provider when their property is incorrectly used, lost, damaged, or otherwise found to be unsuitable for use.

NOTE: Customer property can include material, components, tools and equipment, customer premises, intellectual property, and personal data.

Changes:

  • Replaces old clause 7.5.4 on Customer Property
  • Expands to include an external provider’s property
  • Adds reporting if the property is “incorrectly used”
  • Expands the NOTE on examples of property

8.5.4 Preservation

Requirements:

Ensure the preservation of “process outputs” during production and service provision, to the extent necessary to maintain conformity to requirements.

NOTE: Preservation can include identification, handling, packaging, storage, transmission or transportation, and protection.

Changes:

  • Replaces old clause 7.5.5 on Preservation of Product
  • Changes from use of “product” to “process outputs”
  • Moves the types of preservation into a new NOTE
  • NOTE adds transmission and transportation activities

8.5.5 Post-Delivery Activities

Requirements:

Meet requirements, as applicable, for post-delivery activities associated with products and services. Consider in determining the extent of post-delivery activities that are required:

a) risks associated with products and services;

b) nature, use, and intended lifetime of products and services;

c) customer feedback;

d) legal requirements.

NOTE: Post-delivery activities can include:

  • actions under warranty provisions
  • contractual obligations (such as maintenance services)
  • supplementary services (such as recycling or final disposal)

Changes:

  • New clause on post-delivery requirement
  • Expands old clauses 7.2.1.a and 7.5.1.f on post-delivery
  • Includes NOTE from old clause 7.2.1 on determining product requirement

8.5.6 Control of Changes

Requirements:

Review and control unplanned changes essential for production or service (to extent necessary to ensure continuing conformity with specified requirements).

Retain documented information describing:

  • results of review of changes,
  • personnel authorizing change, and
  • any necessary actions.

Changes:

  • New clause on control of unplanned changes
  • Refer to 6.3 on planning of system changes
  • See 8.1 on control of planned process changes