ISO 9001:2015, 8.5

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 8.5 Production and Service Provision.

8.5.1 Control of Production and Service

Requirements:

Implement production and service provision under controlled conditions. Include, as applicable:

a) availability of documented information that defines:

1) characteristics of

  • products to be produced,
  • services to be provided,
  • activities to be performed;

2) results to be achieved;

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

c) implementation of monitoring and measurement activities at appropriate stages to verify:

  • criteria for control of processes or outputs, and
  • acceptance criteria for products and services,

have been met;

d) use of suitable infrastructure and environment for operation of processes;

e) appointment of competent persons, including any required qualification;

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

g) implementation of actions to prevent human error;

h) implementation of 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
  • Adds actions to prevent human error
  • Use of suitable equipment expanded to use of infrastructure and environment for operation (see 7.1.3 for more on infrastructure and 7.1.4 for more on environment)
  • Adds appointment of competent persons, including any required qualification
  • Moves old clause 7.5.2 on “special processes” into clause 8.5.1.f and lessens its emphasis

8.5.2 Identification and Traceability

Requirements:

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

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

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

Changes:

  • Replaces old 7.5.3 on Identification and Traceability
  • Changes from use of “product” to “outputs”

Comment: Outputs can be product, service, or process output

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 customers’ or external providers’ property provided for use or incorporation into products and services.

When customer or external provider property is lost, damaged, or otherwise found to be unsuitable for use

  • report this to the customer or external provider, and
  • retain documented information on what occurred.

NOTE: 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
  • See 8.5.2 for more on property identification
  • See 8.4 for more on property control
  • Expands the NOTE on examples of property to include materials, components, tools, equipment, and premises

8.5.4 Preservation

Requirements:

Preserve outputs during production and service provision, to the extent necessary to ensure conformity to requirements.

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

Changes:

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

8.5.5 Post-Delivery Activities

Requirements:

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

a) statutory and regulatory requirements;

b) potential undesired consequences associated with products and services;

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

d) customer requirements;

e) customer feedback;

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
  • Adds consideration of:
    • legal requirements; customer feedback
    • potential undesired consequences
    • nature, use, and lifetime of products and services
  • Includes NOTE from old clause 7.2.1 on determining product requirement
  • See 8.2 on product and service requirements

8.5.6 Control of Changes

Requirements:

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

Retain documented information describing:

  • results of review of changes,
  • persons authorizing change, and
  • any necessary actions arising from review.

Changes:

  • New clause on control of changes
  • Refer to 6.3 on planning of changes
  • 6.3 is more proactive, strategic, system-wide
  • 8.5.6 is reactive, tactical, operations-related
  • See 8.1 on operational planning and control

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.