ISO 13485 Certification 6 Steps to - omtec
Transcript of ISO 13485 Certification 6 Steps to - omtec
Slide 1 of 30
Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
ISO 13485 Certification
6 Steps to
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Raise Your hand
How to get what you want…
• If there is a , pay attention.
• If you have a question…
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
6 Steps
1. Planning the Quality System
2. Additional Regulatory Requirements
3. Implementing Design Controls
4. Documents, Records & Training
5. Management Processes
6. The Certification Audits
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Your Certification Goals
• Required by Customer
• Required for Canadian Licensing
• Recognized Standard for CE Marking
• Industry Best Practice
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
DemingCycle
PLAN DO
CHECKACT
ContinualImprovement
Break it into Chunks
• What is excluded and not applicable?
• Use the Deming Cycle
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Resources Needed
• Equipment – None
• $ – Consultants, Standards and your Certification Body
• People – 1 FTE for 6 months
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Additional Regulations
• US FDA – 21 CFR 820 (QSR)
• Canada – Canadian MDR & CMDCAS
• Europe – MDD, IVD, AIMD
• JPAL, TGA, SFDA, Brazil, India, Etc.
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Robert Packard, Consultant
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21 CFR 820
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Canadian MDR & CMDCAS
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MDD
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Robert Packard, Consultant
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Design Controls…When?
• Excluded for contract manufacturers
• Develop and Start Using Draft Forms prior to implementation of Document Control
• Should be your 1st process
• Retroactive implementation is not uncommon
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Waterfall Diagram
User Needs
Design Input
Design
Process
Design
Output
Medical
Device
VALIDATION
VERIFICATION
REVIEW
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Two Hump Diagram
DHF
Begins
Product
Launch
510(k)
Design Transfer
Concept Phase
Feasibility Phase
Development Phase
Pilot Phase
Release Phase
Identify Failure Modes
Estimate Probability of Occurrence
Hazard Identification
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Input Output Verification Validation
item User Needs Design Inputs Design Outputs Verification Test Method Validation Test Method
1
2
3
4
5
6
7
8
9
10
Also called a Design Requirements Matrix
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Robert Packard, Consultant
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Min. Design Requirements
• Design Control Procedure & Forms
• Training Records – including Risk Management
• At least one design plan?
• At least one design review?
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Documentation Hierarchy
copied from “13485 Plus”
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Robert Packard, Consultant
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[email protected] June 12, 2013
Your 1st Procedure
• Control of Documents
• “A documented procedure shall be established”
• “The organization shall establish documented requirements”
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Integrating Training
• Think of document control and training as part of that change plan.
• Records needed for objective evidence.
• How do you demonstrate effectiveness?
• How do you demonstrate competency?
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Robert Packard, Consultant
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Control of Records
• Record Retention Table
• Trigger for Retention Period Start
• Electronic Records – 21 CFR Part 11
– Electronic back-up
– Unique electronic signature
– Audit trails
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Robert Packard, Consultant
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[email protected] June 12, 2013
Planning(7.1)
Production (7.5.1)
Final Inspection
(8.2.4)
Shipping(7.5.5)
Core Processes
Product Realization Process
Support Processes
Document Control(4.2.3)
Record Control(4.2.4)
Training(6.2.2)
Calibration(7.6)
Validation(7.5.2)
Monitoring(8.2.3)
Management Processes
CAPA(8.5.2 & 8.5.3)
Internal Auditing(8.2.2)
Data Analysis(8.4)
Purchasing(7.4.1)
IncomingInspection
(7.4.3)
Post-Market Surveillance(8.2.1)
Management Review(5.6)
Risk Management(7.1)
Process Interaction Diagram
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Robert Packard, Consultant
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Internal Auditing
• A full quality system audit is required to be completed prior to initial certification
• Recommended duration is equal to duration of Stage 1 & Stage 2 Certification Audit Combined
• May be conducted by a consultant, in-house auditors, or both
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
CAPA
CAPA’s
Risk Analysis
MAUDE
Clinicals
Effectiveness
Service
Mngt. Review
Internal Audits
VOC Surveys NCMR’s
Complaints
Validation
CAPA’s are the heart of a Quality Management System (QMS) and tell auditors how effective the QMS is
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Management Review
• 8 Required Inputs
• 3 Required Outputs
• Summary Statement in Minutes
– The QMS is Effective with the exception of…
– The Quality Policy remains appropriate
– The following Quality Objectives were established
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Stage 1 Audit
• Typically 1 day
• Review all QMS Documentation
• Verify implementation of Management Processes – Internal Auditing
– CAPA
– Management Review
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
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Stage 2
• Duration Determined by IAF MD9 Guidance
• Review 100% of Clauses in the Standard
• May involve more than one auditor
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IAF MD9 Table
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Robert Packard, Consultant
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Responses to Findings
• Corrective Action plans must be accepted by the auditor prior to certification recommendation
• Plans to do not need to be completed
• Progress on Stage 1 findings should be significant prior to Stage 2
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Q & A
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Future Course Dates
September 2013
9 Monday
September 2013
10 Tuesday
Supplier Qualification CAPA
http://embassysuites3.hilton.com/en/hotels/florida/embassy-suites-orlando-airport-MCOATES/about/index.html
Orlando Airport
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Robert Packard, Consultant
www.MedicalDeviceAcademy.com
[email protected] June 12, 2013
Future Course Dates
October 2013
3 Thursday
October 2013
4 Friday
Supplier Qualification CAPA
San Diego Airport
Liberty Station
http://www.sandiegoairport.homewoodsuites.com/