Framework overlap

Does ASIS SPC.1-2009 cover ISO 13485:2016?

You hold ASIS SPC.1-2009 and have been told to do ISO 13485:2016. Here is how much overlaps, control by control.

15% of ISO 13485:2016 you already have

ASIS SPC.1-2009 already covers about 15% of ISO 13485:2016, leaving 61 of 72 controls as genuinely new work.

Already covered 11 Likely covered 0 New work 61

What is genuinely new work

Nothing in ASIS SPC.1-2009 reaches these. This is the list to scope.

4.1
General requirements
4.2.2
Quality manual
4.2.3
Medical device file
5.1
Management commitment
5.2
Customer focus
5.3
Quality policy
5.4
Planning
5.4.1
Quality objectives
5.4.2
Quality management system planning
5.5
Responsibility, authority and communication
5.5.1
Responsibility and authority
5.5.2
Management representative
5.5.3
Internal communication
6.1
Provision of resources
6.2
Human resources
6.3
Infrastructure
6.4
Work environment and contamination control
6.4.1
Work environment
6.4.2
Contamination control
7.1
Planning of product realization
7.2
Customer-related processes
7.2.1
Determination of requirements related to product
7.2.2
Review of requirements related to product
7.3
Design and development
7.3.10
Design and development files
7.3.2
Design and development planning
7.3.3
Design and development inputs
7.3.4
Design and development outputs
7.3.5
Design and development review
7.3.6
Design and development verification
7.3.7
Design and development validation
7.3.8
Design and development transfer
7.3.9
Control of design and development changes
7.4
Purchasing
7.4.1
Purchasing process
7.4.2
Purchasing information
7.4.3
Verification of purchased product
7.5
Production and service provision
7.5.1
Control of production and service provision
7.5.10
Customer property
7.5.11
Preservation of product
7.5.2
Cleanliness of product
7.5.3
Installation activities
7.5.4
Servicing activities
7.5.5
Particular requirements for sterile medical devices
7.5.6
Validation of processes for production and service provision
7.5.7
Particular requirements for validation of processes for sterilization and
7.5.8
Identification
7.5.9
Traceability
7.6
Control of monitoring and measuring equipment
8.2.1
Feedback
8.2.2
Complaint handling
8.2.3
Reporting to regulatory authorities
8.3
Control of nonconforming product
8.3.2
Actions in response to nonconforming product detected before delivery
8.3.3
Actions in response to nonconforming product detected after delivery
8.3.4
Rework
8.4
Analysis of data
8.5
Improvement
8.5.2
Corrective action
8.5.3
Preventive action
Show the 11 you already have
4.2
Documentation requirements
4.2.4
Control of documents
4.2.5
Control of records
5.6
Management review
5.6.2
Review input
5.6.3
Review output
7.2.3
Communication
8.2
Monitoring and measurement
8.2.4
Internal audit
8.2.5
Monitoring and measurement of processes
8.2.6
Monitoring and measurement of product

How this is calculated

Already covered means a mapping runs from a control in ASIS SPC.1-2009 to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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