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HOW CAN YOU ENSURE THE QUALITY & SAFETY OF YOUR MEDICAL DEVICE PRODUCTS?TRANSFORM YOUR MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM WITH ISO 13485

BE THE BENCHMARKBE THE BENCHMARK

BE THE BENCHMARKBE THE BENCHMARK

ISO 13485

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ABOUT ISO 13485ISO 13485 is a quality management system standard that allows an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. It is applicable for any organization involved in medical device manufacturing: design and development, production, storage and distribution, installation, or servicing of medical devices and associated activities regardless of size or business type.

ISO 13485 supports medical device manufacturers by providing a framework necessary to demonstrate compliance to regulatory requirements in the following areas:

• Management responsibility

• Resource management

Certification can help businesses improve their overall performance, mitigate risk, enhance efficiency, show clients and customers a commitment to maintaining a high standard and meet government and regulatory requirements.

BENEFITS OF ISO 13485• Mitigate risks

• Reduce operating costs

• Improve stakeholder relationships

• Legal compliance

• Customer satisfaction

• System approach to management

THE ISO 13485 QUALITY MANAGEMENT SYSTEM

• Product realization

• Measurement, analysis and improvement

PROCESS AND PRODUCTION CONTROL

• Design Change Management

• QMS Change Management

• Risk Review

DESIGN CONTROL

• Risk Management

• Inputs/Outputs

• Verification/Validation

PRODUCT SURVEILLANCE

• Complaint Handling

• Risk Monitoring

• Vigilance

RESOURCES

• Personnel Competency

• Infrastructure

• Work Environment

CHANGE MANAGEMENT

• Design Change Management

• QMS Change Management

• Risk Review

CORRECTIVE AND PREVENTIVE ACTION

• Eliminate Noncomformities

• QMS Improvement

• Verify Effectiveness

MANAGEMENT RESPONSIBILITY

• Management Review

• Inspection Readiness

• Internet Audit

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To gain a holistic understanding of the potential risks within the Medical Device industry, SGS has developed a methodology that utilizes our compliance data to identify the standards’s top pain points and business impact events. This analysis was based on the data collected from ISO 13485, the top standard for medical devices.

The graphic on the right highlights this process by identifying:

1. Top industry pain points2. Impact events most likely to occur3. Impact areas with the highest business risk

KEY INDUSTRY FINDINGS

Our analysis indicates that the events with the highest risk revolved around Product Nonconformity and Quality Failure. The top impact events are:

• Product Nonconformity• Quality Failure• Product Recall• Unscheduled Downtime• Noncompliance and Fines

LINKING ISO 13485 PAIN POINTS TO BUSINESS IMPACT

ISO 13485 DATA SPECIFICATIONS

2900 CERTIFICATES ISSUED9400 DATA POINTS

PAIN POINT IMPACT EVENT IMPACT AREA

1 2 3

HIGH LIKELIHOOD

MEDIUM LIKELIHOOD

LOW LIKELIHOOD

PRODUCT RECALL

BrandReputation

Employee Morale

Legal

Complications

Financial

Impact

Brand

ReputationEm

ployee M

oraleLegal

Complications

Financial

Impact

Brand

Reputation

Employee

MoraleLegal

ComplicationsFi

nancial Imp

act

Brand

Reput

ation

Emplo

yee

Mor

ale

Lega

l

Com

plica

tions

Finan

cial

Impa

ctBr

and

Repu

tatio

n

Em

ployee

Mora

le

Legal

Complica

tions

Financial

Impact

1

2

3

PRODUCT NONCONFORMITY

NONC

OM

PLIAN

CE AN

D FINES

UNSC

HEDU

LED

DOW

NTI

ME

LACK

OF D

EFIN

ED TIM

ELINES

LACK

OF A

DEQU

ATE

DEFI

NED

RES

OURC

ES A

ND

MAT

ERIA

LS

QUALITY FAILURE

SUPPLIER CONTROL

LACK OF CONTROLLED, DEFINED PROCESSES

UNALIGNED USER REQUIREMENTS AND DESIGN

OUTPUT

S

ISO 13485

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WHAT ARE THE MOST COMMON ISO 13485 PAIN POINTS?With our ISO 13485 analysis, SGS is able to find trends in our client’s data points and detect threats and areas of improvement. Each standard clause and their corresponding data points were reviewed, allowing us to discover the top pain point areas for the standard. Our methodology identifies the top five industry pain points based on the number of occurrences within our data set. Our technical and industry experts then map each pain point to the most likely event that can negatively affect operations, which we refer to as impact events. These events allow us to identify the risk level of the four main impact areas of an organization. The graphic below showcases this process for our ISO 13485 data and identifies Legal Complications as the highest risk factor.

IATF 16949 DATA SPECIFICATIONS

x DATA POINTS

x CERTIFICATES ISSUED

ISO 13485 DATA SPECIFICATIONS

2900 CERTIFICATES ISSUED

9400 DATA POINTS

Lack Of Core Tools Knowledge

* data points

Problem Solving & Root Cause

Lack Of Adequate Resources

Verification Of Contingency Plans

Management Commitment

Logistics Delays& Failures

Product NonconformityProduct Recall

Cost IncreaseCustomer Complaints

Employee Morale

Legal Complications

Financial Impact

Brand Reputation21%

14%

14%

12%

11%

IMPACT AREA RISK LEVEL

HIGH MEDIUM LOW

1. PAIN POINTS 2. BUSINESS IMPACT EVENTS 3. IMPACT AREAS

* data points

Employee Morale

Financial Impact

Brand Reputation

IMPACT AREA RISK LEVEL

HIGH MEDIUM LOW

1. PAIN POINTS 2. BUSINESS IMPACT EVENTS 3. IMPACT AREAS

Product Recall

Lack of Controlled, Defined Processes40%

21%

18%

13%

7%

Unaligned User Requirements And Design Outputs

Lack Of Adequate Defined Resources And Materials

Lack of defined timelines

Quality FailureUnscheduled Downtime

Noncompliance and Fines

Supplier Control

Product Nonconformity

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UNETHICALCONDUCT

WORKPLACESAFETY

INCIDENTOPERATIONALINEFFICIENCY

QUALITYFAILURE

NON-COMPLIANCE

ANDFINES

SHIPMENTDAMAGES

SUPPLIERNON-

COMPLIANCEPRODUCT

RECALLHUMANERROR

BRAND REPUTATION

EMPLOYEEMORAL

FINANCIALIMPACT

LEGALCOMPLICATIONS

CUSTOMERCOMPLAINTS

DATALOSS

UNSCHEDULEDDOWNTIME

COSTINCREASE

LOGISTICSDELAYS

& FAILURES

SUPPLYCHAINISSUES

PRODUCTNONCONFORMITY

HIGH MEDIUM LOW

BY LIKELIHOOD OF OCCURRENCE

PROUDCT NONCONFORMITY

IMPA

CT A

REA

IMPACT EVENTSRISK AREAS

CUSTOMER COMPLAINTS LOGISTICS DELAYS & FAILURES

IMPACT EVENTS MOST LIKELY TO OCCUR

Understand the industry landscape by seeing how key areas of your business are impacted by the identified events.

Identify the top three events based on # of occurrences and see how they rate (low, medium, high) against the 4 impact areas.

The dark orange boxes showcase the area most likely to be affected by these events.

LINKING IMPACT EVENTS TO BUSINESS RISKOur analysis has identified Supplier Compliance, Cost Increase, and Supply Chain Issues as the impact events most likely to occur. The heat map below highlights these three events and allows us to see how they all impact each of the four impact areas. Legal Complications is the impact area most likely at risk if these events were to occur.

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SGS ACADEMY TRAINING COURSESSGS has the capabilities in place to deliver consistent, effective and high-quality training for the Medical Device industry.

PLEASE VIEW THE WORLDWIDE COURSE SCHEDULE AT WWW.SGS.COM/TRAINING

ISO 13485:2016 MEDICAL DEVICES QMS LEAD AUDITOR TRAINING

Build your knowledge, skills, and practical tool-kit to effectively lead Medical Device quality management system audit teams to perform audits of ISO 13485:2016, in accordance with ISO 19011:2011 auditing guidance.

COURSE DETAILS / Duration: 4 days

ISO 13485:2016 MEDICAL DEVICE QMS INTERNAL AUDITOR TRAINING

Build your knowledge, skills, and practical tool-kit to perform internal audits of an ISO 13485:2016 medical device quality management system.

COURSE DETAILS / Duration: 3 days

ISO 13485:2016 DOCUMENTION AND IMPLEMENTATIONThis course provides knowledge and skills to create and maintain Quality Management System documentation that meets the requirements of ISO 13485:2016

COURSE DETAILS / Duration: 2 days

LEARNING MANAGEMENT SYSTEM SGS Academy has a customized Learning Management System (LMS), fully integrated with our global training schedule. It provides management and employees with direct online access to relevant training programs and continuous professional development. SGS Academy LMS makes learning easier to organize, record and undertake. It has several advantages for learners and management.

FOR LEARNERS

• Intuitive: uses recognizable online methods to enhance the training experience

• Effective: uses client data to target relevant courses, promoting continuous professional development

• Transparency: all training is recorded and can be accessed at any time

FOR MANAGERS

• Reports: has a relevant number of reports available. Managers can access the data they need in a suitable format

• Invoicing: complete control over invoicing, allowing budget supervision

• Resource management: provides complete command over all aspects of staff training

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SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Enhancing products, processes, systems and skills is fundamental to your ongoing success and sustained growth. We enable you to continuously improve, transforming your products, services and value chain by increasing performance, managing risks, better meeting stakeholder requirements, and managing sustainability.

With a global presence, we have a history of successfully executing large scale, complex international projects. Our people speak the language, understand the culture of the local market and operate globally in a consistent, reliable and effective manner.

YOUR STEPS TO CERTIFICATION

DOCUMENTATION AUDITS REVIEW AUDIT

ON-SITE AUDIT CLOSING THE GAP CERTIFICATION ISSUANCE

SURVEILLANCE AUDITS

HOW SGS CAN HELP

TRAINING PRE AUDIT CERTIFICATION AUDIT

REFERENCE MATERIALS

SGS BUSINESS PRINCIPLES

WHY SGS?

Integrity

Quality and Professionalism

Corporate Sustainability

Health, Safety, & Environment

Respect

Leadership

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