Maps to
QMSR / ISO 13485: §820.20(d)
ISO 13485: §7.1
Requirement text
Processes needed for product realization must be planned and developed. Planning must determine quality objectives and requirements, product-specific processes and documentation, required verification and validation activities, acceptance criteria at each stage, and records needed to provide evidence of conformity.
What changed
Part 820 section 820.20(d) addressed quality planning at the QMS level, requiring that each manufacturer establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The requirement was brief and high-level, embedded within the management responsibility section of Part 820 rather than in a product realization context.
ISO 13485:2016 clause 7.1 provides a substantially more detailed framework for product realization planning. It requires the organization to plan and develop the processes needed for product realization, and this planning must be consistent with the requirements of the other processes of the QMS. During planning, the organization must determine: quality objectives and requirements for the product, the need to establish processes and documents specific to the product, required verification, validation, monitoring, measurement, inspection and test activities specific to the product, acceptance criteria, and records needed to provide evidence of conformity. The clause also requires that the output of planning be in a form suitable for the organization's method of operations — meaning the quality plan must be actionable, not just a compliance document.
The QMSR adopts ISO 13485 clause 7.1. The practical impact is significant: where Part 820 required a general quality plan, ISO 13485 expects product-specific quality planning that integrates with design controls, risk management, and production. Each device type should have a quality plan (or product realization plan) that defines the specific processes, documents, verification and validation activities, acceptance criteria, and records applicable to that device. This is a shift from a system-level quality plan to product-level planning.
Atomic constraints
- •Quality objectives and requirements for each product must be planned and documented.
- •Required processes, documentation, and resources for product realization must be determined.
- •Verification, validation, monitoring, and inspection activities must be planned.
- •Acceptance criteria for each stage must be defined.
- •Records needed to provide evidence of conformity must be identified.
Common gaps
No Product-Specific Quality Plan
moderateThe company has a system-level quality plan or quality manual but no product-specific quality plans defining the processes, verification activities, acceptance criteria, and records applicable to each device type. ISO 13485 clause 7.1 requires product-level planning, not just system-level quality objectives.
Quality Plan Not Linked to Design Controls and Risk Management
moderateThe quality plan exists but does not reference design control deliverables, risk management outputs, or regulatory requirements specific to the product. ISO 13485 clause 7.1 requires planning to be consistent with the other QMS processes, meaning design outputs and risk controls should feed into quality planning.
Missing 'Product Realization Plan'
moderateThe QMS has 'Design Plans' and 'Quality Plans' but lacks an overarching 'Product Realization Plan' for the device lifecycle. ISO 13485 §7.1 requires this planning.
Risk not integrated in realization planning
moderateThe Product Realization Plan fails to reference the Risk Management Plan (ISO 14971). ISO 13485 §7.1 requires risk management in product realization.
Acceptance Criteria Not Defined Per Product in Quality Plan
minorThe quality plan does not specify product-specific acceptance criteria for each verification, validation, and inspection stage. Generic acceptance criteria (e.g., 'meets specifications') are used without defining what specifications apply at each stage for each product.
Evidence signals
- •
FILE_EXISTS
(Quality.*Plan|Product.*Realization|Development.*Plan|Project.*Quality)
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CONTENT_MATCH
Does this document define product-specific quality objectives, required processes, verification activities, and acceptance criteria for product realization?
Audit defense
Product realization for [your product] is planned in [your document ID]. The quality plan defines product-specific objectives, required processes and documentation, verification and validation activities, acceptance criteria, and required records per ISO 13485 7.1.