Clause 8.3 of ISO 9001:2015 applies when the detailed characteristics of a product or service, or some part of it, are not yet fully defined or need to be defined by the organization. If your organization designs products or services (or elements of them), this clause is mandatory. If you do not perform design, it can be excluded from your QMS scope with justification.
8.3.1: General — Design and Development Planning
Establish, implement, and maintain a design and development process. During planning, consider the nature, duration, and complexity of design activities, required process stages (including reviews), required design verification and validation activities, responsibilities and authorities, internal and external resource needs, interface management, the need for customer and user involvement, and subsequent requirements for production and service provision.
8.3.3: Design and Development Inputs
Determine the requirements essential for the specific types of products and services being designed. Inputs must include functional and performance requirements, information derived from previous similar design activities, statutory and regulatory requirements, standards or codes of practice the organization has committed to implement, and potential consequences of failure.
8.3.4: Design and Development Controls
Apply controls to ensure that the results to be achieved are defined, reviews are conducted to evaluate the ability to meet requirements, verification is conducted to ensure outputs meet input requirements, and validation is performed to ensure the resulting products and services meet the requirements for their intended application or use.
8.3.5/8.3.6: Outputs and Changes
Design outputs must meet input requirements, be adequate for subsequent processes, include or reference monitoring and measurement requirements and acceptance criteria, and specify the characteristics essential for safe and proper use. Design changes must be identified, reviewed, controlled, and documented.
Best Practices
- Use design review checklists at each stage gate
- Maintain a design history file (DHF) for each product or service
- Ensure verification (did we build it right?) and validation (did we build the right thing?) are distinct activities
- Control design changes with the same rigor as original design
- Retain documented information on inputs, reviews, verification, validation, and changes
Common Pitfalls
- Confusing verification (output meets input) with validation (product meets intended use)
- Not controlling design changes after initial release
- Incomplete design inputs leading to quality issues in production
- Failing to consider regulatory requirements as design inputs
Related Ecesis Solutions
Document Management
Version-controlled procedures and records
Audits & Inspections
Schedule, conduct, and track audit findings
Nonconformity Tracking
Report, investigate, and resolve nonconformities
Training Management
Track competence requirements and records
Change Management
Structured review of planned changes
Compliance Obligations
Track requirements and evaluation schedules
