ISO 9001:2015, Clause 8.2

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 8.2 Requirements for Products and Services.

8.2.1 Customer Communication

Requirements:

Communicate with customers to:

a) provide information relating to products and services;
b) handle inquiries, contracts, or orders, including changes;
c) obtain customer feedback relating to products and services, including customer complaints;
d) handle or control customer property;
e) establish specific requirements for contingency actions, when relevant.

Changes:

  • Replaces 7.2.3 on customer communication
  • Moved customer communication before determining requirements
  • Adds requirements for possible contingency actions
  • Includes handing or controlling of customer property
  • See 8.5.3 for more on customer property

8.2.2 Determining the Requirements for Products and Services

Requirements:

Ensure when determining the requirements for products and services to be offered to customers that:

a) requirements for products and services are defined, including:

1) any applicable statutory and regulatory requirements;
2) those considered necessary by the organization;

b) organization can meet its claims for products and services offered.

Changes:

  • Replaces old clause 7.2.1 on determination of requirements related to the product
  • Expands that must meet “claims” for products and services offered to customers

8.2.3 Review of the Requirements for Products and Services

Requirements:

8.2.3.1 Ensure the organization has the ability to meet requirements for products and services to be offered to customers. Before committing to supply products and services, conduct a review to include:

a) requirements specified by the customer, including requirements for delivery ad post-delivery activities;

b) requirements not stated by the customer, but necessary for te specified or intended use, when known;

c) requirements specified by the organization;

d) statutory and regulatory requirements applicable to the products and services;

e) contract or order requirements differing from those previously expressed.

Ensure that contract or order requirements differing from those previously expressed are resolved.

When the customer does not provide a documented statement of their requirements, have the customer confirm their requirements before acceptance.

8.2.3.2 Retain documented information, as applicable:

a) on the results of the review;
b) on any new requirements for the products and services.

Changes:

  • Replaces old clause 7.2.2 on review of requirements related to product
  • Clause 8.2.3.1 replaces old clause 7.2.2.c on ability to meet defined requirements
  • Merges in requirements from old clause 7.2.1.a, b, and c.

8.2.4 Changes to Requirements for Products and Services

Requirements:

Ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.

Changes:

  • includes requirement from old clause 7.2.2 on review of product requirements
  • gives own sub-clause for focus on changes
  • same text, except for addition of term “services”