8% of ISO 9001 you already have
ISO 13485 already covers about 8% of ISO 9001, leaving
44 of 48 controls as genuinely new work.
Already covered 0
Likely covered 4
New work 44
No control in ISO 13485
maps directly to one in ISO 9001. Everything counted as covered is covered because both
map to the same third standard, which is what a crosswalk is, but it is an inference rather
than a lookup.
What is genuinely new work
Nothing in ISO 13485 reaches these. This is the list to scope.
9001-10.1Improvement General
9001-10.2Nonconformity and Corrective Action
9001-10.3Continual Improvement
9001-4.1Understanding the Organization and its Context
9001-4.2Needs and Expectations of Interested Parties
9001-4.4QMS and its Processes
9001-5.1Leadership and Commitment
9001-5.3Roles, Responsibilities, and Authorities
9001-6.1Actions to Address Risks and Opportunities
9001-6.2Quality Objectives and Planning
9001-7.5Documented Information
9001-8.1Operational Planning and Control
9001-8.2Requirements for Products and Services
9001-8.3Design and Development
9001-8.4Control of Externally Provided Processes, Products, Services
9001-8.5Production and Service Provision
9001-8.6Release of Products and Services
9001-8.7Control of Nonconforming Outputs
9001-9.1Monitoring, Measurement, Analysis, Evaluation
9001-9.3Management Review
ISO9001-01Cl. 4.4 Quality management system and its processes - quality policy and objectives
ISO9001-02Leadership commitment to quality
ISO9001-03Risk-based thinking and planning
ISO9001-04Cl. 7.1.1 Resources (general) - resource management for quality including people, infrastructure, and organizational knowledge
ISO9001-05Organizational roles and responsibilities
ISO9001-06Cl. 8 Operation - operational planning and control for products and services
ISO9001-07Requirements for products and services
ISO9001-08Design and development controls
ISO9001-09Control of externally provided processes
ISO9001-10Production and service provision controls
ISO9001-12Internal audit program
ISO9001-14Customer satisfaction measurement
ISO9001-16Cl. 10 Improvement - continual improvement methodology for the quality management system
ISO9001-17Corrective and preventive actions
ISO9001-CL7.1.2Cl. 7.1.2 People - determining and providing persons necessary for effective QMS operation
ISO9001-CL7.1.3Cl. 7.1.3 Infrastructure - determining, providing, and maintaining infrastructure for quality processes
ISO9001-CL7.1.6Cl. 7.1.6 Organizational knowledge - determining knowledge necessary for QMS operation and process performance
ISO9001-CL7.2Cl. 7.2 Competence - ensuring competence of persons doing work under QMS control
ISO9001-CL7.4Cl. 7.4 Communication - determining internal and external communications relevant to the QMS
Show the 4 you already have
ISO9001-11Monitoring, measurement, and analysis
ISO9001-13Management review process
ISO9001-15Nonconformity and corrective action
ISO9001-18Cl. 6.3 Planning of changes - innovation and change management for the quality management system
How this is calculated
Already covered means a mapping runs from a control in ISO 13485 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.
Try another pair ยท
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