Changes  to  ISO  13485:2016

Presented  by:   Mark  Swanson  Owner/Lead  Consultant,  H&M  Consulting  Group  &  Associate  Director,  Medical  Technology  Quality  Graduate  Program,  St.  Cloud  State  University  

In  the  following  slides,  the  ISO  13485  Standard  is  paraphrased  for  instructional  purposes.  Refer  to  the  standard  for  the  actual  text.  

Comments  on  changes  are  based  on  FDIS  ISO  13485:2015.  Be  aware  that  additional  changes  are  likely  to  occur.  

Today’s  Agenda

Introduction   2  min.                                          

What  is  ISO  13485?   3  min.                                                      

Why  is  ISO  13485  changing?   15  min.                                                                        

How  is  ISO  13485  changing?     45  min.                                                                        

Questions   20  min.                                      

About  the  Presenter

Mark  Swanson  (CMQ/OE,  CQE,  CBA)  

is  the  President  and  lead  consultant  of  

H&M  Consulting  Group;  a  group  

focused  on  helping  small  to  mid-­‐sized  

companies  have  the  same  regulatory  

and  quality  systems  knowledge  as  the  

large  medical  device  companies.

In  addition  to  this,  Mark  is  currently  the  Director  of  the  Medical  

Technology  Quality  Graduate  program  at  St.  Cloud  State  University’s  

Twin  Cities  Graduate  Center  in  Maple  Grove,  Minnesota.  This  

innovative  program  was  started  in  2012  to  provide  quality  

professionals  with  graduate  level  learning  in  the  application  of  quality  

management  principles,  particularly  for  those  in  the  key  Minnesota  

industry  of  medical  devices.  

Mark  has  spent  close  to  4  years  being  an  active  member  of  ISO  

Technical  Committee  210  (TC210),  Working  Group  1  (WG1)  working  

on  the  revision  of  ISO  13485:2003  that  is  on  track  to  be  released  in  

February  2016  and  has  also  participated  with  ISO  TC176,  WG24  on  

ISO  9001:2015.  This  work  includes  discussions  regarding  the  impact  

of  changes  on  the  ISO  quality  management  system  standards,  the  

integration  of  different  management  standards  and  how  to  

effectively  integrate  the  different  ISO  standards  and  other  

regulations  into  a  single  quality  management  system.

Introduction

Questions  we  will  cover  today:  

• What  is  ISO  13485?  

• Why  is  ISO  13485  changing?  

• How  is  ISO  13485  changing?  

• What  is  the  planned  timeline  for  these  changes?  

• Other  considerations?

What  is  ISO  13485?Who  uses  ISO  13485?

What  is  ISO  13485?

• The  world-­‐wide  sector  Quality  Management  System  (QMS)  

standard  for  medical  device  organizations.  

• Takes  general  quality  system  requirements  for  all  organizations  

intending  to  provide  products  or  services  to  customers  and  

modifies  it  for  application  within  the  highly  regulated  medical  

device  industry.  

• An  internationally  agreed  way  to  implement  common  regulatory  

concepts  (presumption  of  conformity)  that  support  maximizing  

the  potential  benefits  of  making  the  strategic  decision  to  

implement  a  quality  management  system.

?

Potential  benefits  of  ISO  13485

• Enhances  the  ability  of  the  organization  to  meet  customer  

and  regulatory  requirements.  

• Helps  the  organization’s  capability  to  address  product  

safety  and  effectiveness.  

• Allows  the  organization  to  obtain  external  recognition  of  

conformity  of  the  quality  management  system  to  

accepted  requirements  (certification).

+

What  ISO  13485  is  NOT.

• It  is  not  a  required  structure  for  your  Quality  

Management  System.  

• It  does  not  define  requirements  for  the  products  

and  services  provided  by  the  organization.  

• It  does  not  define  other  business  requirements  or  

initiatives  (e.g.  financial  or  environmental  

requirements).

+

Why  is  ISO  13485  Changing?Why  is  13485  changing  now  and  what  are  

the  key  perspectives  for  the  change?

Why  does  ISO  13485  need  to  change?

• The  standard  was  due  for  revision  based  on  the  regular  5-­‐year  cycle  (second  edition  

released  in  2003)  

• First  review  (2008)  determined  no  change  needed.  

• This  review  (2012/13)  there  were  a  couple  of  drivers.    • Requests  from  GHTF  and  AHWP  

• User  survey—generally  pointed  out  the  need  for  clarifications  (implicit  requirements)  

• European  Union  lost  faith  in  ISO  13485  as  a  way  to  obtain  presumption  of  conformity  

with  the  EU  Medical  Device  Directive  (issuance  of  EN  ISO  13485:2012)  

User  Input—Clarity

• Enhance  Clarity  for  Users  –  Manufacturer’s  voice  • Survey  of  users  found  a  desire  for  the  standard  to  provide  more  clarity  (implicit  

requirement)  

• Guidance  exists  in  ISO  TR  14969  but  few  individuals  know  this  document  exists  (auditor  

interpretation)  

• Auditing    (ambiguity)  –  Certification  body’s  voice  • Some  clauses  difficult  to  audit  against  

• Nonconformities  could  be  written  against  different  clauses  

• MDSAP—Medical  Device  Single  Audit  Program

User  Input—Global  Harmonization

• Further  Harmonization  –  Global  voice  • GHTF  Study  Group  3  had  published  several  guidance  documents  with  additional  

concepts-­‐-­‐can  these  be  incorporated  and  used  with  changes  to  the  standard?  

• More  countries  developing  medical  device  regulations  did  not  believe  ISO  13485  could  

meet  their  needs  

• Prevalence  of  importers  &  distributors  in  a  few  geographies  

• Outsourcing  of  both  manufacturing  (contract  manufacturing)  and  design  (contract  design)  

• Organizations  that  only  do  part  of  the  overall  process  

• Enhance  compatibility  with  latest  regulations  and  expectations

User  Input—EU  Challenges

• Standard  not  Robust  Enough  –  EU  Regulator  Voice  • Due  to  scandals  in  EU  with  breast  and  hip  implants  the  entire  regulatory  framework  was  

being  challenged  

• Determined  that  ISO  13485  alone  and  as  written  could  NOT  assure  presumption  of  

conformity  to  the  MDD’s  “appropriate  quality  system”  requirement  

• More  prescriptive  requirements  need  to  be  included  in  the  standard  

How  is  ISO  13485  Changing?What  are  the  main  changes?

Overview

• New  Design  Specification  (ISO  Guide  72)  

• Move  toward  harmonization  with  US  CFR,  Brazilian  law  (ANVISA),  CMDR  (Canada),  

and  other  law  (MDD,  JPAL,  TGA)—MDSAP  

• Integrates  risk  throughout  the  QMS  and  product  life-­‐cycle—risk-­‐based  decision-­‐

making

Overview  (cont.)

• Additional  linkage  to  documentation  required  for  regulatory  purposes  

• Integration  of  QMS  software  

• Emphasis  on  appropriate  infrastructure  

• New  references  to  other  standards  (usability,  sterile  barrier,  etc.)

Overview  (cont.)

• New  sections  on  complaint  handling  and  reporting  to  regulatory  authorities  

• Clarity  for  auditing  

• Planning  and  documenting  corrective  action  (without  undue  delay)  and  preventive  

action  

• Maintains  current  format  (aligned  with  ISO  9001:2008,  not  2015)—see  next  slide

Impact  of  Annex  SL—Problems

• The  change  in  structure  is  not  the  concern  but  the  primary  issue  is  the  text  included  

in  the  mandated  TMB  required  format  could  lead  to  a  more  generic  standard  

• Many  regulators  have  the  current  ISO  13485  as  their  regulatory  model  (not  enough  

time  to  change)  

• Users  want  a  standard  that  is  more  detailed  and  clear  for  regulatory  purposes

Additional  Detail  of  ChangesWhat  potential  gaps  exist?

What’s  Changing?

• Introduction  &  scope  statement  clarifications  

• New/modified  Definitions  

• General  Requirements  clarifications—risk

What’s  Changing  (cont.)

• Updates  to  Management  Review  

• Competency/Training  effectiveness  

• Work  Environment  (health  &  cleanliness)

What’s  Changing  (cont.)

• Product  Realization  • Risk  Management  

• Resources  and  requirements  

• Design  stages—additional  detail  

• Verification  

• Validation  (use  of  pre-­‐clinical  and  clinical  evaluations)

What’s  Changing  (cont.)

• Purchasing—risk-­‐based  controls  and  define  communication  

• Production  and  Service—cleanliness/inclusion  of  service  activities  in  feedback/

process  and  software  validation  

• Identification  &  traceability  

• Preservation  of  product—storage  conditions  and  packaging  validation

What’s  Changing  (cont.)

• Feedback/Customer  communication—new  complaint  handling  &  reporting  sections  

• Non-­‐conforming  product  • Before  delivery  

• After  delivery  

• Improvement—Simplified  and  strengthened

Annexes  &  Bibliography

• Annex  A—comparison  between  2003  &  2016  versions  

• Annex  B—correspondence  of  sections  between  ISO  9001:2015  and  ISO  

13485:2016  

• Bibliography—the  information  provided  helps  locate  documents  referenced  in  the  

definitions  and  in  the  informational  notes

Timeline,  Other  Considerations  and  SummaryWhat  is  the  timeline  and    

things  we  should  keep  in  mind?

Current  (probable)  Timeline

• The  Working  Group  has  completed  the  first  stages  (WD,  CD,  DIS,  FDIS)  

• Document  is  currently  in  final  review  for  publication  (target  date  is  March  1,  2016).  

• WG1  has  started  work  on  a  guidance  handbook  (approx.  1  year)  

• The  recommended  3  year  transition  accepted  by  TC  210  and  IAF—no  new  

certifications/re-­‐certifications  after  year  2  

• Periodic  review  has  been  accelerated  to  March  2019

Summary—Why  did  I  come?

• Focus  of  this  change  is  clarifications  for  use  of  the  standard  (implicit  is  now  explicit)  

• Basic  changes  to  incorporate  risk-­‐based  decision  making  

• Set  up  to  align  documentation,  clinical  and  other  requirements  with  EU  (MDD)  

• Expansion  of  supplier  controls  and  post-­‐market  requirements  in  feedback  

• Drive  to  Medical  Device  Single  Audit  Program  (MDSAP)  (FDA  set  to  implement  in  

2017)

What  to  do  now?

• Determine  gaps  

• Ask  questions  of  experts

Free  Detailed  Deck  of  Specific  Changes:    http://greenlight.guru/iso-­‐13485-­‐webinar-­‐offer

Where  to  Get  More  Information

• ISO  13485  

http://www.iso.org  

• ISO  web  site  for  TC210    

http://isotc.iso.org/livelink/livelink/open/tc210    

• ISO  web  site  for  TC176/SC2  (ISO  9001)  

http://www.iso.org/tc176/sc02/public    

• IMDRF  website  (includes  GHTF  documents)  

http://www.imdrf.org    

• IMDRF  website  (includes  GHTF  documents)  

http://www.imdrf.org    

• Notified  Bodies/Certification  Bodies  

• Local  experts

Free  Detailed  Deck  of  Specific  Changes:    http://greenlight.guru/iso-­‐13485-­‐webinar-­‐offer

Thanks  for  Attending!  -­‐  Questions?

• Mark  Swanson,  President,  H&M  Consulting  Group  

• https://www.linkedin.com/in/markswansoncmq/  

• mark@hmcg.biz  

• 763-­‐234-­‐0727

• Jon  Speer,  Founder  &  VP  QA/RA,  greenlight.guru  

• www.greenlight.guru  

• jon.speer@greenlight.guru  

• 317-­‐762-­‐5311

Free  Detailed  Deck  of  Specific  Changes:    http://greenlight.guru/iso-­‐13485-­‐webinar-­‐offer