What's the difference between Excluded and Not Applicable Clauses?
Before diving into specific clauses, let us understand the key difference between "excluded" and "not applicable" clauses in the context of ISO 13485.
• Excluded Clauses:
These are clauses that the manufacturer deliberately chooses to exclude from their quality management system. When a clause is excluded, the manufacturer is still required to justify this exclusion and show that the rest of the standard is still fully implemented. This is often done in the context of specific business models, types of medical devices, or regulatory requirements that do not require compliance with certain aspects of the standard. However, the exclusion must not impact the manufacturer’s ability to consistently provide medical devices that meet regulatory and customer requirements.
• Not Applicable Clauses:
These are clauses that a manufacturer identifies as not relevant to their specific operations or products. In other words, the clause does not apply to their company, but there is no active exclusion. It simply means that the manufacturer does not need to implement the requirements of that particular clause. Not applicable clauses are typically associated with specific processes or device types that the manufacturer does not engage in.
Clauses that can be excluded in ISO 13485
ISO 13485 outlines requirements across several sections, and some of these may be excluded based on the type of organisation implementing an ISO 13485 compliant QMS. Excluding a clause requires that the manufacturer can demonstrate why the exclusion is appropriate and how their QMS still meets the overall requirements of the standard.
Clauses may only be excluded where permitted by the regulators where the manufacturer operates, including where they place product on the market.
Amongst the major regulatory geographic domains, the only clause that is permitted to be excluded is:
Clause 7.3: Design and Development
• Exclusion Reason:
Manufacturers of low risk devices that do not design and develop medical devices, but rather produce devices designed by other entities, may exclude this clause from their QMS.
• Justification:
If a company only manufactures medical devices based on pre-existing designs from another manufacturer, the processes related to design and development are not applicable to them. They must, however, ensure that they follow the design transfer and verification processes defined by their customers.
These exclusions would need to be documented and justified by the manufacturer. Auditors will examine whether the exclusion impacts the effectiveness of the QMS or the ability to meet regulatory and customer requirements.
Clauses that can be identified as Not Applicable
Some clauses might not be relevant to the operations of a specific manufacturer, but they do not necessarily need to be formally excluded. Rather, these clauses can be identified as “not applicable.” Any part of clause 6, 7 and 8 may be considered as not applicable by the manufacturer.
Clause 7.5.5: Particular requirements for sterile medical devices
• Not Applicable Reason:
Manufacturers with products that are not sterile.
• Justification:
If a company only manufacturers non-sterile products, the processes related to the particular requirements of sterile medical devices are not applicable to them.
Remember that legal manufacturers have responsibility for all requirements that apply, even when another entity performs the process, and sufficient oversight needs to be demonstrated.
