ISO 9001:2015, 8.3

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 8.3 Design and Development of Products and Services.

8.3.1 General

Requirements:

Establish, implement, and maintain a design and development process.

(where detailed requirements of products and services are not already established, or not defined by the customer or by other interested parties, such that they are adequate for subsequent production or service provision).

NOTE 1: The organization can also apply the requirements given in 8.5 to the development of processes for production and services provision.

NOTE 2: For services, design and development planning can address the whole service delivery process. Can choose to consider the requirements of clauses 8.3 and 8.5 together.

Changes:

  • New “General” clause that defines when a design and development process is required
  • Need design and development process if product or service requirements not established or provided (explains when 8.3 is not applicable; like old clause 1.2)
  • Note adds that Services organization can consider requirements of 8.3 and 8.5 together (8.3 is Design and Development; 8.5 is Production and Service)

8.3.2 Design and Development Planning

Requirements:

“Consider” in determining the stages and controls for design and development:

a) nature, duration, and complexity of the design and development activities;

b) requirements that specify particular process stages, including applicable design and development reviews;

c) required design and development verification and validation;

d) responsibilities and authorities involved in the design and development process;

e) need to control interfaces between individuals and parties involved in the design and development process;

f) need for involvement of customer and user groups in the design and development process;

g) necessary documented information to confirm that design and development requirements were met.

Changes:

  • Expands on old clause 7.3.1 on design and development planning
  • Must “consider” nature, duration, and complexity of process activities; “complexity” relates to “risk”
  • Involve customer and user groups in process
  • Adds documented information to confirm process requirements are met

8.3.3 Design and Development Inputs

Requirements:

Determine:

a) requirements essential for the specific type of products and services being designed and developed, including, as applicable, functional and performance requirements;

b) applicable legal requirements;

c) standards or codes of practice the organization has committed to implement;

d) internal and external resource needs for design and development of products and services;

e) potential “consequences of failure” due to the nature of products and services;

f) level of control expected of the design and development process by customers and other relevant interested parties.

Ensure inputs are adequate, complete, and unambiguous. Resolve conflicts among inputs.

Changes:

  • Replaces 7.3.2 on design and development inputs
  • Includes internal and external resource needs as new inputs
  • Adds potential consequences of failure; “risk”
  • Drops the old reference to similar designs

8.3.4 Design and Development Controls

Requirements:

Apply controls to the design and development process to ensure that:

a) results to be achieved by the design and development activities are clearly defined;

b) design and development reviews are conducted as planned;

c) verification is conducted to ensure that the design and development outputs have met the design and development input requirements;

d) validation is conducted to ensure that the resulting products and services are capable of meeting the requirements for the specified application or intended use (when known).

Changes:

  • Adds new controls clause for reviews, verification, and validation
  • Merges old clauses 7.3.4, 7.3.5, and 7.3.6

8.3.5 Design and Development Outputs

Requirements:

Ensure that design and development outputs:

a) meet the input requirements for design and development;

b) are adequate for the subsequent processes for the provision of products and services;

c) include or reference monitoring and measuring requirements, and acceptance criteria, as applicable;

d) ensure products to be produced, or services to be provided, are fit for intended purpose and their safe and proper use.

Retain the documented information resulting from the design and development process.

Changes:

  • Replaces old clause 7.3.3 on design and development outputs
  • Output expanded for monitoring and measuring requirements
  • Adds to keep documented information resulting from process

8.3.6 Design and Development Changes

Requirements:

Review, control, and identify changes made to design inputs and design outputs

(during the design and development of products and services, or subsequently)

to the extent that there is no adverse impact on conformity to requirements.

Retain documented information on design and development changes.

Changes:

  • Replaces old clause 7.3.7 on control of design and development changes
  • Review, verify, and validate changes now covered by “control” (see 8.3.4)
  • Drops evaluating effect on constituent parts and delivered product.
  • Requirement now addressed by avoiding adverse impact on conformity