DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES IN FORTHCOMING ISO 9001:2015 QMS

K. R. SINGHAL

Design and development is a set of processes that converts or transforms needs and expectations for an object or entity (such as product, service, process, person, organization, system, resources) into more detailed requirements (needs and expectations). The words 'design' and 'development' and the term 'design and development' are sometimes used synonymously. Forthcoming ISO 9001:2015 QMS standard mentions requirements for design and development of products and services in its clause 8.3 that has following sub-clauses:

8.3.1 - General
8.3.2 - Design and development planning
8.3.3 - Design and development inputs
8.3.4 - Design and development controls
8.3.5 - Design and development outputs
8.3.6 - Design and development changes

General

Organization needs to establish, implement and maintain a design and development process consisting of:
- Design and development planning
- Design and development inputs
- Design and development controls
- Design and development outputs
- Design and development changes

Design and development planning

Organization needs to determine stages and controls for design and development for which the organization must consider the following:
- Nature of design and development activities
- Duration of design and development activities
- Complexity of design and development activities
- Required stages for the design and development process
- Applicable design and development reviews
- Verification activities for design and development
- Validation activities for design and development
- Responsibilities and authorities involved in design and development process
- Internal and external resource needs for design and development process
- The need to control interfaces involved between person involved in design and development process
- The need for involvement of customers and users in the design and dvelopment process
- Requirements for subsequent provision of products and services
- What customers expect for the level of control on design and development process
- What interested parties expect for the level of control on the design and development process
- What documented information needed that can demonstrate meeting design and development requirements

Design and development inputs

Consider the following:
- Functional and performance requirements
- Information from previous similar design and development activities
- Legal requirements
- Standards to implement
- Codes of practice to implement
- Potential consequences of failure because of nature of the products and services

Determine:
- Requirements essential for the products and services that are to be designed and developed

Ensure:
- Input requirements to be adequate, complete and unambiguous
- Resolving the conflicting design and development inputs

Retain
- Documented information on design and development inputs


Design and development controls

Apply controls to design and development process

Ensure:
- Defining of results to be achieved
- Conducting reviews to evaluate the ability of results of design and development and meeting requirements
- Conducting verification activities to ensure that the design and development outputs meet the design and development inputs requirements
- Conducting validation activities to ensure that resulting products and services meet the requirements for the specified application and intended use
- Taking any necessary actions on problems determined during design and development control activities (i.e., during review, verification and validation activities)
- Retaining documented information of design and development control activities


Design and development outputs

Ensure the following:
- Design and development outputs meet the input requirements
- Design and development outputs are adequate for the subsequent processes
- Design and development outputs include or mention (i) appropriate monitoring and measuring requirements, and (ii) acceptance criteria
- Design and development outputs 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


Design and development changes

Indentify:
Design and development changes

Review:
Design and development changes

Control:
Design and development changes to ensure no adverse impact on conformity to requirements

Retain:
- Documented information on identified design and development changes
- Documented information on results of reviews
- Documented information on authorization of the changes
- Documented information of actions taken


Design and development in ISO 9001:2008 vs ISO 9001:2008

Design and development in ISO9001:2008 has following seven sub-clauses:
- Design and development planning (7.3.1)
- Design and development inputs (7.3.2)
- Design and development outputs (7.3.3)
- Design and development review (7.3.4)
- Design and development verification (7.3.5)
- Design and development validation (7.3.6)
- Control of design and development changes (7.3.7)

Requirements of design and development process have been restructured and earlier seven sub-clauses have been reduced to following six sub-clauses in ISO 9001:2015:
- General (8.3.1)
- Design and development planning (8.3.2)
- Design and development inputs (8.3.3)
- Design and development controls (8.3.4)
- Design and development outputs (8.3.5)
- Design and development changes (8.3.6)


Please note:
International Organization for Standardization (ISO) has released ISO/FDIS 9001:2015 for voting to be completed on 9 September 2015 and thereafter ISO 9001:2015 QMS standard will be published. This article is based on the draft versions of the forthcoming standard and there may be some changes after the final standard is published.