Clause 8.3.1 General

ISO 9001:2015 requires organisations to establish, implement and maintain an appropriate design and development process that ensures the subsequent provision of required products and services.

Clause 8.3.2 Design and development planning

The following points must also be considered when planning the stages and controls for design and development:

1. Design and development activities complexity, nature, and duration,
2. Any process stages required, including design and development reviews,
3. Design and development verification and validation activities needed,
4. Responsibilities and authorities of personnel involved in the design and development process to be defined,
5. Both internal and external resource needs, to effectively execute the design and development of products and services,
6. The identification and control of interfaces between personnel involved in the design and development process,
7. The level of customers and user's involvement in the design and development process,
8. Any requirements for subsequent provision of products and services,
9. Customers and other relevant interested parties' expectations regarding the level of control exercised over the design and development process,
10. Any documented information required to demonstrate that design and development requirements have been fulfilled.

Comment:

Note the following points are specifically referenced:

• Consideration of the design and development activities complexity, nature, and duration,
• The requirement to consider other interested parties including customers (and their involvement) in the design and development process and any control over the design that they will have.

Although this clause refers only to an organisations design and development activities in relation to products and services, some organisations may benefit from the application of the same methodologies to their process design, this is not specifically a requirement under the standard however.

Note that even if an organisation outsources its design function, this activity must still come under its scope of operations as discussed in article 4.3. (Determining the scope of the quality management system.)

Also note that under article 4.3 we considered that design may be a candidate for exclusion if not applicable for organisations who do not engaged in design and development. See also the care point in article 4.3 regarding exclusions for service oriented businesses however.

Audit Check:

Where organisations cannot demonstrate that requirements for products and /or services have been established or defined by the customer, auditors will look for a design and development process within the management system.

Auditors may request to review a selection of planned, current and completed design and development projects, in order to be able to audit all stages of the design process. A typical audit on design and development planning may look for:

The overall process flow of the design planning process,

A requirement to identify appropriate resources and competencies, and designation of authorities in the process,

Consideration of any subcontracted or outsourced elements of the design process and how they will be controlled,

The requirement to consider other interested parties including customers (and their involvement) in the design and development process has been addressed including any control over the design that customers and other relevant interested parties will have, (although input requirements may zero for many businesses.)

Communication and interface plans, both internally and with any external parties (IE Customers, outsourced resources,)

Designation of design verification, validation and review milestones / gateway points, in the timeline,

Monitoring and progress tracking built into the process (IE gateway reviews etc,)

That consideration of the design and development activities complexity, nature and duration is evident in the process,