ISO 13485 Certification 6 Steps to - omtec

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Robert Packard, Consultant

www.MedicalDeviceAcademy.com

[email protected] June 12, 2013

ISO 13485 Certification

6 Steps to

http://www.medicaldeviceacademy.com/

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Raise Your hand

How to get what you want…

• If there is a , pay attention.

• If you have a question…


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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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Your Certification Goals

• Required by Customer

• Required for Canadian Licensing

• Recognized Standard for CE Marking

• Industry Best Practice


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DemingCycle

PLAN DO

CHECKACT

ContinualImprovement

Break it into Chunks

• What is excluded and not applicable?

• Use the Deming Cycle


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Resources Needed

• Equipment – None

• $ – Consultants, Standards and your Certification Body

• People – 1 FTE for 6 months


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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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21 CFR 820


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Canadian MDR & CMDCAS


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MDD


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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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Waterfall Diagram

User Needs

Design Input

Design

Process

Design

Output

Medical

Device

VALIDATION

VERIFICATION

REVIEW


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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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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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Documentation Hierarchy

copied from “13485 Plus”


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Your 1st Procedure

• Control of Documents

• “A documented procedure shall be established”

• “The organization shall establish documented requirements”


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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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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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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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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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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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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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Stage 1 Audit

• Typically 1 day

• Review all QMS Documentation

• Verify implementation of Management Processes – Internal Auditing

– CAPA

– Management Review


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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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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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Q & A


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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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Future Course Dates

October 2013

3 Thursday

October 2013

4 Friday

Supplier Qualification CAPA

San Diego Airport

Liberty Station

http://www.sandiegoairport.homewoodsuites.com/


http://www.sandiegoairport.homewoodsuites.com/

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