ISO 9001:2015, 8.3

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 8.3 Design and Development of Products and Services.

8.3.1 General

Requirements:

Establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

Changes:

  • Introduces new “General” design and development clause
  • Adds that the design and development process is to ensure subsequent provision of products and services

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) required process stages, including applicable design and development reviews;

c) required design and development verification and validation activities;

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

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

f) need to control interfaces between persons involved in the design and development process;

g) need for involvement of customer and user groups in the design and development process; h) requirements for subsequent provision of products and services;

i) level of control expected for the design and development process by customers and other relevant interested parties;

j) documented information needed to confirm that design and development requirements have been met.

Changes:

Expands on old clause 7.3.1 on design and development planning with considerations for:

  • Nature, duration, and complexity of process activities
  • Internal and external resource needs
  • Involvement of customers and user groups
  • Requirements for subsequent provision of products and services
  • Level of control by customers and other relevant interested parties
  • Documented information needed to confirm process requirements are met

8.3.3 Design and Development Inputs

Requirements:

Determine the requirements essential for the specific types of products and services to be designed and developed. Consider:

a) functional and performance requirements;

b) information derived from previous similar design and development activities;

c) statutory and regulatory requirements;

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

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

Inputs must be adequate for design and development purposes, complete, and unambiguous. Resolve conflicting design and development inputs. Retain documented information on design and development inputs.

Changes:

  • Replaces 7.3.2 on design and development inputs
  • Changes form must “include” to must “consider”
  • Adds standards and codes of practice committed to implement
  • Adds potential consequences of failure; “risk”

8.3.4 Design and Development Controls

Requirements:

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

a) results to be achieved are defined;

b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;

c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;

d) validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;

e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;

f) documented information of these activities is retained.

NOTE: Design and development reviews, verification, and validation have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization.

Changes:

  • Adds new controls clause for to group together reviews, verification, and validation
  • Merges old clauses 7.3.4, 7.3.5, and 7.3.6
  • Includes old NOTE from 7.3.1 on Planning
  • Drops validation completing prior to delivery or implementation of product, when practical (validation of services is typically at delivery).

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;

d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

Retain documented information on design and development outputs.

Changes:

  • Replaces old clause 7.3.3 on design and development outputs
  • Expands output to include or reference monitoring and measuring requirements
  • Drops providing information for purchasing, production, and service provision; Replaces with output being adequate for “subsequent processes”
  • Changes from safe and proper “use” to safe and proper “provision” (providing or supplying)
  • Adds to retain documented information on design and development outputs

8.3.6 Design and Development Changes

Requirements:

Identify, review, and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

Retain documented information on:

a) design and development changes;

b) results of reviews;

c) authorization of the changes;

d) actions taken to prevent adverse impacts.

Changes:

  • Replaces old clause 7.3.7 on control of design and development changes
  • Verify and validate changes now covered by use of term “control” (see 8.3.4)
  • Drops evaluating effect of change on constituent parts and delivered product (now addressed by avoiding adverse impact on conformity to requirements)
  • Identifies the specific documented information (records) to be retained

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.