ISO 9001:2015, 8.2

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 8.2 Determination of Requirements for Products and Services.

8.2.1 Customer Communication

Requirements:

The organization must establish the processes for communicating with customers in relation to:

a) information relating to products and services;
b) inquiries, contracts, or order handling, including changes;
c) obtaining customer views and perceptions, including customer complaints;
d) the handling or treatment of customer property, if applicable;
e) specific requirements for contingency actions, when relevant.

Changes:

  • Replaces 7.2.3 on customer communication
  • Moved communication before determining requirements
  • Customer feedback clarified as views and perceptions
  • Adds requirements for possible contingency actions
  • Includes handing or treatment of any customer property
  • See 8.5.3 for more on customer property

8.2.2 Determination of Requirements related to Products and Services

Requirements:

Establish, implement, and maintain a process to determine the requirements for the products and services to be offered to potential customers.

Ensure that:

a) product and service requirements (including those considered necessary by the organization), and applicable legal requirements, are defined;

b) organization has the ability to meet the defined requirements and substantiate the claims for the products and services it offers.

Changes:

  • Replaces old clause 7.2.1 on determination of requirements related to the product
  • Expands that must substantiate claims for products and services
  • Clause 8.2.2 b replaces old clause 7.2.2.c on ability to meet defined requirements