Medical Device
& QA Consultancy
Quality Management Systems for the Medical Device Industry
ISO 9001:2000 is now published as an International
Standard.
(was published
in December 2000)
SUMMARY of the
CHANGES
The term "Quality
Management" is used instead of "Quality Assurance"
· The term "the
Company" is used instead of "the Supplier"
· The term "the
Supplier" is used instead of "the Subcontractor"
· Justified "Permissible
exclusions" are allowed (previously called "reduction in scope")
· The term “Customer” is
replaced with “Interested Parties”
· There is a requirement to
only have a “Documented Procedure” in 6 Instances
· There is a lesser requirement
for “Keeping Quality Records”.
· Top Management has replaced
the previous term Executive Management.
· Top Management is now required
to have “Vision” and to “Lead” the Company, through the Quality Policy and
Quality Objectives.
Top Management must sign up to the “Eight Management
Principles”, which are;
ö Customer focused organisation
ö Leadership
ö Involvement of People
ö Process approach
ö System approach to management
ö Continual improvement
ö Factual approach to decision making
ö Mutually beneficial Supplier arrangements
The
"Process Orientated" structure of the New Standard has four (4)
sections -
ö Management Responsibility
ö Resource Management
ö Product/Service Delivery Realisation
ö Measurement, Analysis and Improvement
Some Questions that you might have…….
|
Qö What about EN
46001:1996? Aö The above standard will be replaced by ISO 13485:1996. |
|
Qö The clauses
of ISO 13485 do not match those of ISO 9001:2000 Aö ISO 13485:1996 will be revised to align with ISO 9001:2000.. This is
scheduled to occur sometime during 2001, but the timescale might slip. |
|
Qö I have heard it said that if my current system is being
effectively Implemented, then I can comply with the new standard without much
effort. Is this correct? A ö Most definitely NOT! The new standard requires the
following; ·
Processes to be Mapped ·
Interrelationships between Processes to be Identified and Defined. ·
Inputs and Outputs to be identified for each Process. ·
Performance Indicators to be identified for each Process ·
Improvement of each Process to be planned and achieved. In reality, the majority of
Quality Management Systems meeting the requirements of the old 1994 standard
would not incorporate all of the above points, although a very few companies would come pretty
close….. |
OUR GAP ANALYSIS REPORT HELPS YOU TO IDENTIFY HOW MUCH effort you need to meet the new requirements
We are Offering a GAP ANALYSIS service, for a minimum fixed cost, to compare your current ISO 9000:1994 Quality Assurance System to the new requirements. The Service provides a written Report and also help if necessary to implement the changes.
To take advantage of this Service, please fill out the GAP
Analysis Information Form in complete confidence.
Let Medical Device & QA Consultancy partner you to accomplish a smooth and painless transition from the existing ISO 9000:1994 to the new........
ISO 9001:2000
Medical Device & QA Consultancy has a wealth of experience in helping Medical Device Manufacturers achieve compliance with current ISO 9000, EN 46000, ISO 13485 and FDA 21 CFR 820 QSR requirements. Currently we have over 2,400 hours actual auditing experience, on behalf of European Notified Bodies, in auditing Medical Device Manufacturers like yourself, for their compliance with the Medical Device Directive (93/42/EEC). As you will be already aware, Quality Management System (QMS) compliance is central to any Medical Device strategy. To start to plan ahead and find out how your QMS Documentation can be amended to incorporate the ISO 9001:2000 requirements into your QMS ahead of time, please follow
Follow this LINK to see the BASIC CONCEPT OF ISO 9000
Revision 2000
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If you require further information on any Medical Device compliance issue, or
if you have any suggestions to improve this Web Site, please feel free to
e-mail Bernard J. Tremaine at:
bernardt@mdqaconsultancy.co.uk
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