ISO 13485 Certification RVP 6-12-2013

Slide 1 of 30
6 Steps
to
ISO 13485
Certification
Robert Packard, Consultant
June 12, 2013 www.MedicalDeviceAcademy.com

rob@13485cert.com
Slide 2 of 30
How to get what you want
If there is a , pay attention.
If you have a question
Raise
Your
hand

rob@13485cert.com
Slide 3 of 30
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

rob@13485cert.com
Slide 4 of 30
Your Certification Goals

Required by Customer
Required for Canadian Licensing
Recognized Standard for CE Marking
Industry Best Practice

rob@13485cert.com
Slide 5 of 30
Break it into Chunks

What is excluded and not applicable?
Use the Deming Cycle PLAN DO

Continual
Improvement
Deming
Cycle
ACT CHECK

rob@13485cert.com
Slide 6 of 30
Resources Needed
Equipment None
$ Consultants, Standards and your

Certification Body
People 1 FTE for 6 months

rob@13485cert.com
Slide 7 of 30
Additional Regulations
US FDA 21 CFR 820 (QSR)
Canada Canadian MDR & CMDCAS
Europe MDD, IVD, AIMD
JPAL, TGA, SFDA, Brazil, India, Etc.

rob@13485cert.com
Slide 8 of 30
21 CFR 820

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Slide 9 of 30
Canadian MDR & CMDCAS

rob@13485cert.com
Slide 10 of 30
MDD

rob@13485cert.com
Slide 11 of 30
Design ControlsWhen?
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


rob@13485cert.com
Slide 12 of 30
Waterfall Diagram
User Needs REVIEW
Design Input
Design
Process
Design
VERIFICATION
Output
Medical
Device
VALIDATION

rob@13485cert.com
Slide 13 of 30
Two Hump Diagram

Identify Failure Estimate Probability
Modes of Occurrence
Hazard
Identification
Product
Launch
Concept Feasibility Development Pilot Release 510(k)
Phase Phase Phase Phase Phase
DHF Design Transfer

Begins

rob@13485cert.com
Slide 14 of 30
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

rob@13485cert.com
Slide 15 of 30
Min. Design Requirements

Design Control Procedure & Forms
Training Records including Risk Management
At least one design plan?
At least one design review?

rob@13485cert.com
Slide 16 of 30
Documentation Hierarchy
copied from
13485 Plus

rob@13485cert.com
Slide 17 of 30
Your 1 st Procedure
Control of Documents
A documented procedure shall be established
The organization shall establish documented

requirements

rob@13485cert.com
Slide 18 of 30
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?


rob@13485cert.com
Slide 19 of 30
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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Slide 20 of 30
Process Interaction Diagram

Management Processes
Risk Management Post-Market Surveillance Internal Auditing Data Analysis CAPA

(7.1) (8.2.1) (8.2.2) (8.4) (8.5.2 & 8.5.3)
Management Review
(5.6)
Core Processes
Product Realization Process
Incoming Final
Planning Purchasing Production Shipping
Inspection Inspection
(7.1) (7.4.1) (7.5.1) (7.5.5)
(7.4.3) (8.2.4)
Support Processes
Document Control Record Control Training Validation Calibration Monitoring

(4.2.3) (4.2.4) (6.2.2) (7.5.2) (7.6) (8.2.3)

rob@13485cert.com
Slide 21 of 30
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

rob@13485cert.com
Slide 22 of 30
CAPA
CAPAs are the heart of a Quality Management
System (QMS) and tell auditors how effective the
QMS is
NCMRs
VOC Surveys
Complaints
Internal Audits
Mngt. Review
Effectiveness CAPAs
MAUDE
Clinicals Service
Validation Risk Analysis

rob@13485cert.com
Slide 23 of 30
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

rob@13485cert.com
Slide 24 of 30
Stage 1 Audit
Typically 1 day
Review all QMS Documentation
Verify implementation of Management

Processes
Internal Auditing
CAPA
Management Review

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Slide 25 of 30
Stage 2
Duration Determined by IAF MD9 Guidance
Review 100% of Clauses in the Standard
May involve more than one auditor

rob@13485cert.com
Slide 26 of 30
IAF MD9 Table

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Slide 27 of 30
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

rob@13485cert.com
Slide 28 of 30
Q & A

rob@13485cert.com
Slide 29 of 30
Future Course Dates

CAPA Supplier Qualification
September 2013 September 2013
9
Monday
10Tuesday
Orlando Airport
http://embassysuites3.hilton.com/en/hotels/florida/embass
y-suites-orlando-airport-MCOATES/about/index.html

rob@13485cert.com
Slide 30 of 30
Future Course Dates

CAPA Supplier Qualification
October 2013 October 2013
3
Thursday
4
Friday
San Diego Airport
Liberty Station
http://www.sandiegoairport.homewoodsuites.com/

rob@13485cert.com

ISO 13485 Certification RVP 6-12-2013

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Slide 1 of 30

June 12, 2013 www.MedicalDeviceAcademy.com

How to get what you want

If there is a , pay attention.

If you have a question

June 12, 2013 www.MedicalDeviceAcademy.com

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Your Certification Goals

Required for Canadian Licensing

Recognized Standard for CE Marking

Industry Best Practice

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Break it into Chunks

Use the Deming Cycle PLAN DO

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

$ Consultants, Standards and your

People 1 FTE for 6 months

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Canada Canadian MDR & CMDCAS

Europe MDD, IVD, AIMD

JPAL, TGA, SFDA, Brazil, India, Etc.

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Canadian MDR & CMDCAS

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Develop and Start Using Draft Forms prior to

Should be your 1st process

Retroactive implementation is not uncommon

June 12, 2013 www.MedicalDeviceAcademy.com

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Two Hump Diagram

DHF Design Transfer

June 12, 2013 www.MedicalDeviceAcademy.com

Also called a Design Requirements Matrix

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Min. Design Requirements

Training Records including Risk Management

At least one design plan?

At least one design review?

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

A documented procedure shall be established

The organization shall establish documented

Robert Packard, Consultant

June 12, 2013 www.MedicalDeviceAcademy.com

Records needed for objective evidence.

How do you demonstrate effectiveness?

How do you demonstrate competency?

June 12, 2013 www.MedicalDeviceAcademy.com

Trigger for Retention Period Start