Audit Evidence and Applicable ISO 9001:2015 Clause 8.3 Extracts
Half of all new products launched in the past 12 months were late. The Product Development Manager explains he has not got enough people on his team to cope with the demand for new products. → ISO 9001 Clause 8.3.2 e) – “…internal resource needs for the design and development of products and services…”
The Product Development Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT. → ISO 9001 Clause 8.3.5 – “…retain documented information on design and development changes…”
The Product Development Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT. → ISO 9001 Clause 8.3.6 – “…retain documented information on design and development outputs…”
The Product Development Manager shows you evidence of consumer trials that are carried out for some new products before a full-scale launch. → ISO 9001 Clause 8.3.4 d) – “…conducted to ensure that the resulting products and services meet the requirements…”
The Product Development Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development. → ISO 9001 Clause 8.3.2 e) – “…external resource needs for the design and development of products and services…”
ISO 9001:2015 Clause 8.3 (Design and development of products and services) requires organisations to plan, control, review, verify, validate, and document design and development activities to ensure products meet requirements.
Explanation of clause alignment:
Clause 8.3.2 e) requires the organisation to determine both internal and external resource needs . Lack of personnel causing late launches directly evidences internal resource shortfalls, while the use of an external laboratory demonstrates control of external resources.
Clause 8.3.5 requires organisations to control design and development changes and retain documented information describing those changes, which is demonstrated by controlled updates in SWIFT following retailer confirmation.
Clause 8.3.6 requires retention of documented information on design and development outputs , including customer approvals, which are evidenced by stored emails in SWIFT.
Clause 8.3.4 d) requires design and development activities such as verification and validation , ensuring outputs meet requirements. Consumer trials prior to launch clearly meet this requirement.
ISO-aligned conclusion:
The evidence provided demonstrates structured control of product design and development, including planning, resourcing, change management, validation, and retention of documented information, all mapped directly to ISO 9001:2015 Clause 8.3 requirements .
