This document discusses standards related to quality management systems for medical devices and laboratories. It provides an agenda for a webinar that will address ISO 13485, ISO 14971, ISO 15189, and ISO 17025. The webinar will discuss the importance of quality management system standards and risk management programs in ensuring patient well-being for medical devices and laboratories. It will also cover updates to standard revisions and considerations for implementation programs.

1. The challenges of medical and labs quality systems
– new or old paths and requirements
– ISO 13485, ISO 14971, ISO 15189,
ISO 17025

2. Agenda
Entering notes
The objectives and goals of
Webinar
• ISO 13485, ISO 14971, ISO
15189 and ISO 17025 all have
one thing in common: the
wellbeing of patients.
• Attend this free webinar to
learn and understand the
importance of QMS and RM
improvements programs in
medical devices and
laboratory environments and
standards implementations.
What we will address
• What are standards to take
care
• Why to implement
standards
• What are news in standards
revision
• What to consider in
implementation programs

3. Part One
Basic of Medical and labs QMS – Standards need to be addressed
• 15% of patients in a 5
country study receive
either incorrect or
delayed reports on
abnormal results.
• Boone DJ, IQLM, 2005
• Seventy percent of clinical
medicine decision making
is predicated upon, or
confirmed by, or
documented by medical
laboratory test results.
• Dighe, A. S.,
Medicolegal liability in
laboratory medicine,
Semin Diagn Pathol, 2007

4. Why …?
Manufacturer benefit
Laboratories benefit
Health care benefits
Patients benefits
Government benefits
Public - community benefits

5. Standards for accreditation (1)
ISO/IEC 17011Accreditation Bodies
Laboratories Inspection Bodies
Testing and Calibration Inspection
ISO/IEC 17025
ISO/IEC 15189
ISO/IEC 17020

6. Standards for accreditation (2)
ISO/IEC 17011Accreditation Bodies
Certification Bodies
EMAS Verifiers Council
Regulation 1221/2010
Eco-Management
and Audit Scheme
ISO/IEC 17021
Environmental
Management
Systems
ISO/IEC 17021
Quality
Management
Systems
ISO/IEC 17024
Persons
ISO Guide 65
(EN45011)
Products

7. Medical devices (ISO)
Slide 7 of 57
 ISO13485:2003, Medical devices - Quality
management systems - Requirements for
regulatory purposes
 ISO/TR 14969, Medical devices - Quality
management systems - Guidance on the
application of ISO13485:2003

8. Medical Devices product certification
Notified Body certified products under the Medical
Devices Directives:
• The Medical Devices Directive (MDD) - all products
• The Active Implantable Medical Devices Directive
(AIMDD) - all products
• The In Vitro Diagnostics Directive (IVDD)
• This means whatever type of device a manufacturer
wishes to market in Europe, where CE marking is now a
legal requirement, certified (accredited) need to have
the technical expertise to assist and
provide appropriate conformity assessment services.

9. Specifically Developed for quality improvements
Medical
Laboratories
ISO 9001
QUALITY
MANAGEMENT
SYSTEM
ISO 17025
QUALITY
MANAGEMENT
SYSTEM
Technical
requirements
ISO 15189
QUALITY
MANAGEMENT
SYSTEM
Technical
requirements
Medical
requirement

10. Main Risk management - Risk
Analysis and Management
Standards
• More then
50 IEC
60601
Medical
Electrical
Equipment
Standards
EN ISO 14971
Medical devices Application of risk
rnanagement to medical devides
EN/IEC 60601-1-4
General requirements for safety
Collateral Standard:
Programmable electrical medical
systerns
IEC 60812
Analysis techniques for system
reliability
Procedure for failure mode and
effects analysis (FMEA)

11. MEDICAL
DEVICES
STANDARDS
DEFINITION
ISO 14971 Establishes the requirements of risk management for ensuring the
safety and reliability of medical devices
IEC 60601 Identifies required safety standards for electro medical
equipment
ISO/TR 80002 Applies the risk management requirements
of ISO 14971 to medical device software
Defines lifecycle requirements for medical
device software to establish a framework for
software development and maintenance
IEC 62304 Requires that any software used to develop
and manufacturer medical devices meet
certain standards for data security and
integrity
21 CFR Part Il
Defines testing procedures to ensure
medical device software specifications meet
functional needs and software fulfills its
design specifications
INTERESTINGSTANDARDS
Also…..

12. Some additional parties ….

13. Important info

14. Part two-
• Why to implements QMS standards in medical
devices and lab business environmental?

15. Why those busineses need Quality Management
Medical device and Labs
• — Highly complex operations
• Individuals doing complex tasks
• — Absolute need for Accuracy
• — Absolute need for Confidentiality
• — Absolute need for Time Effectiveness
• — Absolute need for Cost Effectiveness

16. What are the benefits of being
certified to ISO 13485?
• Whether you are looking to operate internationally or expand locally,
ISO 13485 Certification can help you improve overall performance,
eliminate uncertainty, and widen market opportunities.
• Companies with this certification communicate a commitment to
quality to both customers and regulators.
• Increase access to more markets worldwide with certification
• Outline how to review and improve processes across your
organization
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that you produce safer and more effective medical
devices
• Meet regulatory requirements and customer expectations

17. Increased Regulator Acceptance
Source: ILAC

18. UKAS announced (as a sample….)
• ISO 13485 – Medical Device Certification ISO 13485 is the
world’s most recognised medical device standard and ensures
excellence in the provision of medical devices.
• The primary objective of this standard is to facilitate
harmonised medical device regulatory requirements by
providing an effective solution to meet the comprehensive
requirements for a quality management system (QMS).
• ISO 13485 provides a practical foundation for manufacturers
to address regulations and responsibilities, as well as
demonstrating a commitment to the safety and quality of
medical devices. Accredited certification is used to assess
conformity of medical devices against this standard.

19. Does ISO 13485 apply to ALL medical
device manufacturers?
• No, most manufacturers of Class I medical
devices that are not provided sterile or do not
have a measuring function do not need to
implement ISO 13485. See page which shows
exactly which medical device companies need ISO
13485. Also, Standards are voluntary and many
international markets (Europe, Australia, Japan)
offer other alternatives for meeting their national
quality management system requirements. One
exception is Canada which requires Class II, III and
IV manufacturers to meet the ISO 13485
standard.

20. Is a CE Marking certificate the same as
an ISO 13485 certificate?
• No. CE Marking certificates are intended to
demonstrate compliance of a device with
applicable European Directives.
• ISO 13485 certificates prove compliance of a
company’s quality management system with the
ISO 13485 standard.
• CE Marking certificates are sometimes accepted
as proof of compliance with the national medical
device regulations of some countries.

21. Please do understand…..

22. Why was the change made?
• The European standard EN ISO 13485:2012 Medical Devices, Quality Management Systems,
Requirements for Regulatory Purposes, has been published, after approval by CEN on 24
January 2012. This replaces EN ISO 13485: 2003. The change was made as a number of
European countries objected to the inference that ISO 13485 inferred compliance to the
Medical Device Directive (MDD). To solve this problem, annexes at the beginning of the new
standard have now been expanded to link the clauses of ISO 13485 to the Medical Device
Directive.
• It is important to note that the text of the global standard ISO 13485:2003 is unchanged. Only
the foreword and annexes in the European version have been revised.
• During 2011, the European Commission raised an objection to the harmonization status and
the implied Presumption of Conformity of a number of European standards including EN ISO
13485. Sweden also raised a formal objection to the European Commission in February 2011
on the link between adhering to the standard and compliance to the Medical Device
Directives (MDD).
• To restore confidence and bring back the presumption of compliance indicated by the
harmonized status of the standard, Annexes ZA, ZB and ZC were revised and add further
details on the link between standards and the three Medical Device Directives 90/385/EEC,
93/42/EEC and 98/79/EC.

23. The UKAS Approach to Transition of Certification Body
Accreditation to the 2012 version of ISO 13485
• The 2012 standard does not make any changes to the
normative requirements of the standard.
• The changes include revisions to the foreword plus annexes
made to provide greater clarity on applicability & alignment of
ISO 13485 clauses with the QMS requirements of the
medical device directives, MDD, AIMD & IVDD.
• Therefore there is no requirement for transition assessment
for UKAS accreditation, accreditation schedules for existing
accredited Certification Bodies will be automatically updated
to reflect the 2012 standard and, at your next UKAS
scheduled assessment, UKAS will check that the 2012
standard has been adopted by the Certification Body.

24. Joint
certifications

25. What we can find on the market?

26. 26
Medical Product Development Process
*Time line approximately 10-20 yrs
Discovery
Non-clinical/
Pre-clinical trial
Clinical
TrialPhase I
CT Phase II
CT Phase III
(Multi-centre)
Marketing
CT Phase IV
Post-marketing
Safety of
personnel &
facilities
Safety & toxicology
in in vitro and
animal studies
Efficacy in
patients
Continuous monitoring of adverse effects
Safety in human
(normal subjects)
Importants of Labs acreditations and ISO 15189

27. 27
Scope of ISO 17025
Does not cover compliance with regulatory and safety requirements for
laboratory operations
General
requirements
for competence
testing /
calibration
laboratories
quality
administrative
technical systems
tests
calibrations
sampling
to confirm or
recognize
competence

28. 28
Scope of ISO 15189
Medical
Laboratory
Particular
requirements
for quality & competence
Laboratory QM
technical
processes
Quality
administrative
technical systems
Based on ISO
17025
&
ISO 9001
to confirm or
recognize
competence

29. ISO 15189:2007: Content
Management Requirement
• Organization
• Quality management system
• Document control
• Contract review
• Referral laboratories
• Supplier review
• Advisory services
• Complaint resolution
• Identification and control of
nonconformities
• Corrective actions
• Preventive actions
• Continual Improvement
• Quality and technical records
• Internal audits
• Management review
Technical Requirements
• Personnel authorities and
responsibilities
• Accommodation and
environmental conditions
• Laboratory equipment
• Pre-examination procedures
• Examination procedures
• Assuring quality of examination
procedures
• Post-Examination procedures
• Reporting of results
Annexes

30. Types of clinical investigations
Type of study
Design of a clinical investigation
Open non-randomized clinical investigation
Safety and performance validation
Randomized
To confirm safety and effectiveness endpoints
Blinded
Single
Double
Used to eliminate
the subjectivity of
data.
Difficult to set-up.
ISO 14155:2011
Clinical
investigation of
medical devices
for human
subjects -- Good
clinical practice

31. Labs QMS
Laboratories not implementing a
quality management system
guarantees UNDETECTED
ERRORS

32. Part three
• - The What, Why, When, And How of Risk
Management For Medical Device and Labs

33. Dimensions of medical device risk
• Medical devices–which may be defined as any equipment
used to diagnose, treat, or monitor patient health–are
subject to a variety of complex quality and safety analyses
due to the potential significant impact on human lives.
• Numerous standards throughout the medical device
industry require the use of a documented process to
identify, analyze, and eliminate or control the risks
associated with medical device hard-ware, software, and
electronics.
• This process, known as risk management, must address
potential risks throughout the entire product lifecycle of
medical device products, including development,
manufacture, maintenance, and disposal or
decommissioning

34. • ISO/IEC Guide 73: 2002 - Risk Management -
Vocabulary - Guidelines for use in Standards
• ISO/IEC Guide 51:1999 - Safety Aspects -
Guideline for their inclusion in standards
• WHO Technical Report Series No 908, 2003 Annex
7 Application of Hazard Analysis and Critical
Control Point (HACCP) methodology to
pharmaceuticals
• GAMP Good Practice Guide ISPE, 2005
A risk-based approach to compliant electronic
records and signatures
• ISO 14971:2000 - Application of Risk Management
to Medical Devices

35. Main Risk management - Risk
Analysis and Management
Standards
EN ISO 14971
Medical devices Application of risk
rnanagement to medical devides
EN/IEC 60601-1-4
General requirements for safety
Collateral Standard:
Programmable electrical medical
systems
IEC 60812
Analysis techniques for system
reliability
Procedure for failure mode and
effects analysis (FMEA)
ISO/TC 210
ISO/TR 16142:2006
Medical devices -- Guidance on the selection
of standards in support of recognized essential
principles of safety and performance of
medical devices

36. What is Risk Management?
Risk Management is a process to:
• Identify the hazards associated with devices;
• Estimate and evaluate the associated risks;
• Control these risks and monitor the effectiveness
of that control throughout the devices life cycle.
It is more than a Risk Analysis – It is a process of managing risks

37. Risk Management Process (ISO 14971)
Risk Analysis
• Intended use/purpose
• Hazard Identification
• Risk estimation
Risk Evaluation
• Risk acceptability decisions
Risk Control
• Option analysis
• Implementation
• Residual Risk evaluation
• Overall Risk Acceptance
Production data
• Validation data
• Review of risk management experience
Post-Production data
•After release data
• Review of risk management experience
Lessons Learned
• Feedback for next generation products
and upgrades.
Risk
Assessment
Risk
Management

38. Critical Components ISO 14971
• Management responsibility
– Risk acceptance
policies/periodic reviews
• Qualification of personnel
– Record of qualifications
• Risk management plan
– Roadmap of RM (criteria for risk
acceptance- before the analysis occurs)
• Risk management file
– Where is the documentation
• Risk Evaluation
– Risk acceptability decisions
• Risk Control
– Risk reduction (eliminate, protect
against, warn about)
• Options analysis
– Inherent safety by design
– Protective measures in the product
or in the process
– Safety information (warning)
• Risk/benefit analysis
– If the risk is greater than would be
generally acceptable, the benefit
must outweigh this risk-
• Overall residual risk
– Combined impact of all risk for the
product
• Risk Management Report
– A summary of what was done-
pointers to portions of the file
– High level document/overview
• Post Production Information
– Unanticipated risks
– Under-anticipated risks

39. ISO 14971 – Overview of Annexes
• Annex A (informative) Rationale
for requirements
• Annex B (informative) Overview
of the risk management process
for medical devices
• Annex C (informative) Questions
that can be used to identify
medical device characteristics
that could impact on safety
• Annex D (informative) Risk
concepts applied to medical
devices
• Annex E (informative) Examples
of hazards, foreseeable
sequences of events and
hazardous situations
• Annex F (informative) Risk
management plan
• Annex G (informative)
Information on risk management
techniques
• Annex H (informative) Guidance
on risk management for in vitro
diagnostic (IVD) medical devices
• Annex I (informative) Guidance
on risk analysis process for
biological hazards
• Annex J (informative)
Information for safety and
information about residual risk

40. Product
Development
Phases
(MEDICAL DEVICES)
Product Risk Management- On-goingPrelim. Risk Assessment
Feasibility Design Pilot
Base
Business
Concept

42. Same samples

43. Risk controls

44. Good samples
Hazard Foreseeable
sequence ot events
Hazardous
situation
Harm
Electromagnetic
energy
(Line voltage)
Electrode cable
unintentionally
plugged
into power line
receptacle
Line voltage
appears on
electrodes
Serious bums
Heart fibrillation
Death
Electromagnetic
energy (ESD)
1 Electrostatically
charged patient
touches infusion
pump
2 ESD causes pump
and pump alarms to
consciousness
3 Insulin not
delivered to patient
Failure to deliver
insulin
unknown to patient
with
elevated blood
glucose level
Minor organ
damage
Coma,
Death

45. Part four
• - Quality, competences and risk management
– the main pillars of future development

46. Why?
Medical devices
and Laboratories
not implementing
a
quality
management
system guarantees
UNDETECTED
ERRORS
Competency is
the consistent
application of
knowledge and
skill to the
standard
performances
required in the
workplace.
Process, known as
risk management,
must address
potential risks
throughout the
entire product
lifecycle of medical
device products,
including
development,
manufacture,
maintenance, and
disposal or
decommissioning

47. ISO 15189:2012
• 5.1 Personnel
• 5.1.1 General
• 5.1.2 Personnel qualifications
• 5.1.3 Job descriptions
• 5.1.4 Personnel introduction to the organizational
environment
• 5.1.5 Training
• 5.1.6 Competence assessment
• 5.1.7 Reviews of staff performance
• 5.1.8 Continuing education and professional development
• 5.1.9 Personnel records

48. ISO 14971
Qualification of personnel
• Persons performing risk management tasks shall have the
knowledge and experience appropriate to the tasks
assigned to them. These shall include, where appropriate,
knowledge and experience of the particular medical device
(or similar medical devices) and its use, the technologies
involved or risk management techniques.
• Appropriate qualification records shall be maintained.
• NOTE Risk management tasks can be performed by
representatives of several functions, each contributing their
specialist knowledge.
• Compliance is checked by inspection of the appropriate
records.

49. KNOWLEDGE IS ESSENTIAL

50. 50
50
Competency Assessment
Job Description
Task-specific Training
Competency Recognition
Retraining

51. Why Online Learning?
Efficiency E-learning allows learners to cover the same
material in half the time of instructor-led training
Velocity Training can be deployed on-demand within
minutes — not weeks or even months
Timeliness Learners receive what they need — when they
need it
Consistency Quality of training delivered is consistent and
continuously updated

52. Personnel Records
52
Performance
Appraisal
Competency Assessmen
CONFIDENTIAL
Training Records
Competency Assessment

53. Closing notes
• The presence and the future of medical
devices and labs accreditations and
certifications.

54. What is Accreditation/certification?
Plan
Check
DoAct
Accreditation or
certification
(Evaluative Tool)
Mandatory Requirements (legal, standards,
clients, interesting parties, etc.
Opps For Improvement
4.1
5.4
7.1
8.2.3
8.4
8.5.1
ISO 13485
General for
Accreditations-
certification
schemas

55. Development of European accreditation
EA Development Strategy 2010-2015
Strengthening use of accreditation and the EA
MLA as a basis for notification
Reinforce the peer evaluation system
Reconsider, improve organisation and structure
Increase resources
Reinforce relations with all stakeholders
Reinforce cooperation with AB’s of the European
Neighbouring Policy (ENP)
Reinforce influence in the international
accreditation organisations

56. BS EN ISO 13485:2012
Medical devices. Quality management systems. Requirements for regulatory
purposes
• In 2011 the European Commission raised a
concern around the legal text supporting
presumption of conformity to the Medical
Device Directives (Annexes ZA, ZB, ZC) in EN ISO
13485:2003. The outcome was that CEN decided
to publish a new edition of the standard (EN ISO
13485:2012). This standard has a revised
Foreword and Annexes ZA, ZB and ZC, but the
core text remains unchanged.

57. BSI begins to talk about…..

58. Result of WG1 meeting in 2014
• During the last WG1 meeting held in july, the published draft
version of ISO 13485 (the one called ISO DIS 13485:201X, you've
probably heard about or had a copy of the draft) was submitted to
the vote of the WG members.
Result:
• the draft was not approved.
• Consequence:
• there will be a new round of comments / changes / approval, which
makes the objective of publishing the final version in 2015 very
unlikely.
• A new draft (DIS) may be released by the end of the year or the
beginning of next year. If it were approved, a final draft (FDIS)
would be released in 2015 and the new official version in 2016.

59. BSI announced …..

60. Why implement an ISO 13485 QMS?
• Contract
tendering
qualification
• Reduce operating
overheads
• Protect customers
• Protect from legal
action

61. News are expecting….

62. In CONCLUSION, the Future is...
• 'It is in the interests of patients, of society, and
of governments
– that medical devices and laboratories operate at
high standards of professional and technical
competence...
• and it is in interests that their competence
– is verified through a process of inspection and
assessment comparison against appropriate
standards, as a confirmation of their good
standing

64. EA Accreditations - 2010
Calibration Laboratories 2,565
Testing Laboratories 12,201
Medical (ISO 15189) Laboratories 871
Greenhouse Gas Verifiers 78
Inspection Bodies 4,691
Product CBs 993
Management System CBs 1,029
Persons CBs 323
Organic Farming CBs 133
Occupational H&S Management
CBs
174
Information Security Management
System CBs
92
Food Safety Management System
CBs
174
PT Providers 80
Accredited CABs: 23,404

65. Change in
behaviour
Sharing information
The Only People Who Like Change are Wet
Babies–Mark Twain

66. Change in behaviour
• From tick-box
approach for compliance
towards
systematic
risk-based thinking

67. Change in behaviour
•Doing things,
that do not matter
for the patient - client

68. EUROQUALITY GROUP
FROM 1990
CQI, IRCA, PECB