ISO13485 - Clause 1 Scope

Clause 1 Scope

1.1 General

• Demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory

requirements applicable to medical devices and related services. 1.2 Application

• Possible exclusion of clause 7.3 (design & development)
• Possible non applicable of parts of clause 7
• Both must be justified in quality manual
• Examples: 7.5.1.2.1 (cleanliness), 7.5.1.3 & 7.5.2.2 (sterile); 7.5.3.2.2 (implant)
• Question: what about section 8.2.4.2 (implant)?

“Appropriate” Term