Beruflich Dokumente
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New requirements
Transition Timing
Questions
Structure
Structure
Structure
Structure
Regulatory requirements
Regulatory requirements
Risk Management
Regulatory requirements
Risk Management
Supplier controls
Regulatory requirements
Risk Management
Supplier controls
Feedback
Regulatory requirements
Risk Management
Supplier controls
Feedback
Regulatory requirements
Risk Management
Supplier controls
Feedback
Clarifications
0.1 General
2003 2016
• Requirements for QMS that can be used by an • Requirements for QMS that can be used by an
organization for: organization involved in one or more stages of the life-
• design and development cycle of a medical device:
• production • design and development
• installation and servicing of medical devices • production
• design, development, and provision of related services. • storage and distribution
• installation
• Can also be used by internal and external parties, • servicing
including certification bodies, to assess the organization’s • final decommissioning and disposal of medical devices
ability to meet customer and regulatory requirements. • and design and development, or provision of associated
activities (e.g. technical support).
2016
2016
2016
2016
1 Scope
2016
• Applicability to organizations that are involved in
one or more stages of the life-cycle of a medical
device.
• Use by suppliers or external parties that provide
product, including quality management system-
related services to medical device organizations.
• Identifies responsibilities for monitoring,
maintaining, and controlling outsourced processes.
• Allows for clauses 6, 7 and 8 to be not applicable.
• Clarifies that the term “regulatory requirements”
3 Terms and Definitions Several new definitions added and some existing
definitions refined
• Customer complaint - complaint
• Distributor
• Importer
• Labeling – redefined
• Life-cycle
• Manufacturer
• Medical Device Family
• Performance Evaluation
• Post-market surveillance
• Product
• Purchased Product
• Risk
• Risk management
• Sterile Barrier System
© DQS Group April 6, 2016 19
ISO 13485:2003 vs ISO 13485:2016
5 Management Responsibility
6.3 Infrastucture
• 7.2.3 Communication
• Communication with customers shall be planned and
documented
• Shall communicate with regulatory agencies
7.4 Purchasing
7.4 Purchasing
7.4 Purchasing
• Software validations
• Approach proportionate to risk in use of software
• Effect on product conformity to specifications
• 7.5.8 Identification
• 7.5.9 Traceability
• No changes
• 8.3.4 Rework
• No changes
• 8.5 Improvement
• 8.5.1 General
• No changes
TC Recommendation
TC Recommendation
Recommending that:
2 years after publication (1 March 2018), all
accredited certificates be to ISO 13485:2016
TC Recommendation
Recommending that:
2 years after publication (1 March 2018), all
accredited certificates be to ISO 13485:2016
DQS Inc
1-800-285-4476
customerservice@dqsus.com
www.dqsus.com
Medical Program
Rick Burgess
Medical Program Manager
Richard.Burgess@dqsus.com
763-229-9833