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FAQ's - Quality Management
  Systems


Please Submit Questions Not Covered Here to: bernardt@mdqaconsultancy.co.uk

 

What Conformance Routes are available and how do I demonstrate compliance to a
particular Conformance Route?
Class
I devices do not require a Quality Management System (QMS), whilst Class
IIa require a QMS to ISO 9002:1994 + EN 46002:1996 + Annex VII for a
Technical File. Class IIb devices require a QMS to
ISO 9001:1994 + EN 46001:1996 + Annex II clause 3.2 (c ) for a Technical
File Whilst Class III require a QMS to ISO 9001:1994 + EN 46001:1996 + a
Design Dossier in accordance with Clause 4 of Annex II.
 
What happens to EN 46000 now that the "new" version of ISO 9001 was
published in December 2000?
EN 46001/2/3:1996 is still
valid and can be used to demonstrate compliance for Medical Devices until
December 2003. However, during the transition period, Companies are advised to
begin to convert their QMS's to replace EN 46001/2/3 with ISO 13485:1996. 
 
How does ISO 13485
fit into a Medical Device compliance picture now?
ISO
13485 is a much better standard than EN 46001/2/3:1996. ISO 13485 is widely
accepted Internationally, whereas EN 46001/2/3 is only recognized in Europe.
Canada, for example, have insisted on ISO 13485 in preference to EN 46000, for
some time now. 
 
What are the
differences between ISO 13485 and EN 46001/2/3?
At first
glance, the two standards might seem identical, as the clause numbers are the
same. But closer inspection reveals
subtle differences. The following is a non-exhaustive summary of 
ISO 13485's content;
 


  

    CLAUSE
    
      
CLAUSE TITLE

    
      
ISO 13485 ADDITIONAL
      REQUIREMENTS

  

  

     4.2.2
    Quality System
    The Product File (4.2.2)
      includes Installation & Servicing 
  

  

    4.4.1
    Design Control (General)
    Requires Risk Management to
      be conducted throughout the design process
  

  

    4.5
    Document & data Control
    identical to EN 46000
  

  

    4.6
    Purchasing Records
    identical to EN 46000
  

  

    4.8
    Identification &
      Traceability
    the term
      "refurbish" is replaced by "rework to specified
      requirements" 
  

  

    4.9
    Process Control
    almost identical but s/w
      validation included
  

  

    4.10
    Final Inspection & Test
    identical to EN 46000
  

  

    4.13
    Control of non-conforming
      product
    the impact of the rework on
      product  must be reviewed and documented 
  

  

    4.14
    Corrective & Preventive
      Action
    almost identical to EN 46000
  

  

    4.15
    Handling,
      Storage...etc....Delivery
    sterile requirements removed,
      but are covered in 4.9
  

  

    4.16
    Quality Records
    almost identical to EN 46000
  

  

    4.18
    Training
    requirements repositioned to
      clause 4.9 (A)
  

  

    4.20
    Statistical Techniques
    removed but still
      necessary
  

  

     
     
     
  




 
What are the future plans for ISO 9001:2000 and what should I be doing now, to
ensure that I comply in the longer term?
Within the
3 year transition (by December 2003) there will be a 'special' Medical Device
version of  ISO 9001:2000 which will incorporate the revised requirements
of ISO 13485. Companies are advised to start as soon as possible and
embrace the new requirements gradually, over say the next 12 months or so.
 

How do I comply with the "Process Approach" for ISO 9001:2000?

The requirements are contained in the first 
clause of the standard, which is reproduced here; 




4.1   General requirements



The 
organization shall establish, 
document, implement and maintain a quality management system and continually 
improve its effectiveness in accordance with the requirements of this 
International Standard.



 



The 
organization shall



 



a)  
identify the processes needed for 
the quality management system and their application throughout the organization 
(see 1.2),



 



b)  
determine the sequence and interaction
of these processes,



 



c)  
determine criteria and methods 
needed to ensure that both the operation 
and control of these processes are effective,



 



d)   ensure the
availability of resources and information 
necessary to support the 
operation and monitoring of these processes,



 



e)  
monitor, measure and analyse these 
processes, and



 



f)    implement 
actions necessary to achieve planned 
results and continual improvement 
of these processes.



 



These processes 
shall be managed by the organization in accordance with the requirements of this 
International Standard.



 



Where an 
organization chooses to outsource any 
process that affects product conformity with requirements, the 
organization shall ensure control over 
such processes. Control of such outsourced processes shall be identified
within the quality management system.



 




NOTE Processes 
needed for the quality management system referred to above should include 
processes for management activities, provision of resources, product realization 
and measurement.




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