ISO 13485 Clause 7 – Product Realization
Clause 7 of ISO 13485, titled Product Realization, outlines the structured approach medical device manufacturers must take to design, develop, produce, and deliver devices that meet customer needs and regulatory requirements. It covers a wide range of operational activities, including design controls, purchasing, production, and service provisions—all with a strong emphasis on risk management, documentation, and traceability.
As the U.S. FDA transitions from the legacy Quality System Regulation (QSR, 21 CFR Part 820) to the new Quality Management System Regulation (QMSR), ISO 13485:2016 becomes the foundational standard for FDA compliance.
Clause 7 is especially significant in this transition because it closely mirrors many of the requirements found in Subpart C (Design Controls), Subpart E (Purchasing Controls), and Subpart G (Production and Process Controls) of the QSR, while extending expectations in areas like risk-based thinking, software lifecycle management, and supplier evaluation.
Therefore, understanding the product realization elements and requirements is essential for manufacturers in order to align with the QMSR. It represents not only a continuation of many core principles from the QSR but also introduces a more globally harmonized, risk-based approach that requires formal planning, performance monitoring, and process validation across the entire product realization lifecycle.
Overview of Changes
QMSR Info Request Form
Definitions
Affected Regulations and Standards
Assembling the Puzzle
Implementation Strategies
Small Manufacturers
Summary of Key Gaps / Differences:
- ISO is more risk-based: ISO 13485 requires risk management throughout product realization, starting from planning. QSR references risk more lightly (mainly in design validation).
- Labeling (820.120): QSR has a specific section on labeling; ISO expects labeling to meet regulatory requirements but doesn’t detail it in Clause 7.
- Service provision (7.5.1): ISO includes service-related activities (e.g., device calibration), which the QSR does not unless it directly impacts device quality.
- Sterile product handling: ISO has a separate clause (7.5.5), QSR treats this under general environmental and process controls.
| Clause 7 Subclause | Title | Relevant QSR Sections | Notes/Key Differences |
|---|---|---|---|
| 7.1 | Planning of product realization | 6.1 says the organization must determine and provide resources. | ISO is more explicit in integrating risk management during planning. QSR mentions planning but less formally integrates risk. |
| 7.2 | Customer-related processes | 820.30(c) (Design inputs), 820.50 (Purchasing controls) | ISO includes determination of customer requirements, including statutory/regulatory requirements. QSR addresses this within design inputs and supplier management. |
| 7.3 | Design and development | 820.30 (all subsections) | This is the most direct mapping — QSR's 820.30 aligns well with ISO 7.3, though ISO adds more detail on changes and transfer. |
| 7.4 (general) | Purchasing | 820.50 (Purchasing controls) | Strong alignment. ISO adds clarity on the evaluation and re-evaluation of suppliers and defines requirements more broadly. |
| 7.5.1 | Control of production and service provision | 820.70 (Production and process controls), 820.75 (Process validation) | Full overlap. ISO expands on service provision, which QSR doesn’t address unless it's directly related to the device. |
| 7.5.2 | Cleanliness of product | 820.70(h) | Both require cleanliness where necessary for device safety and performance. |
| 7.5.3 | Installation activities | 820.170 (Installation) | Direct correlation. ISO expects documented procedures and records of installation and verification. |
| 7.5.4 | Servicing activities | 820.200 (Servicing) | Directly aligned. Both require documented servicing procedures and feedback handling. |
| 7.5.5 | Particular requirements for sterile medical products | 820.70(g) (Environmental controls) | ISO is more explicit about sterile barrier systems. QSR covers sterile processing under environmental and production controls. |
| 7.5.6 | Validation of processes | 820.75 (Process validation) | Nearly identical expectations on validation of processes that cannot be fully verified later. |
| 7.5.7 | Traceability | 820.60 (Identification), 820.65 (Traceability) | ISO requires traceability based on risk, QSR mandates it only for certain devices (implantables, life-supporting/sustaining). |
| 7.5.8 | Identification | 820.60 (Identification) | Both require identification through all stages of production. ISO links identification more directly with traceability and status. |
| 7.5.9 | Preservation of product | 820.130 (Handling), 820.140 (Storage), 820.150 (Distribution) | ISO focuses on maintaining conformity. QSR similarly requires protection during handling, storage, and shipping. |
| 7.6 | Control of monitoring and measuring equipment | 820.72 (Inspection, measuring, and test equipment) | Fully aligned. Both require calibration, maintenance, and traceability to standards. |
| Additional Sections | Additional QSR Sections | 820.80 (Receiving, in-process, and finished device acceptance), 820.86 (Acceptance status), 820.120 (Labeling), 820.160 (Distribution) | These QSR sections span across ISO 7.5 (production control), and 8.2.4 (product monitoring). Labeling (820.120) is implicitly required by ISO under product realization and customer communication but not called out as its own clause. |