1. Unannounced Audits
according to Commission Recommendation
2013/473/EU of 24th September 2013
Klaus – Dieter Ziel
Managing Director
Präsentation Beiersdorf,
Qserve Conference, Amsterdam 18th November 2013
2010.06.14.

2. Agenda
 Summary
 Unannounced Audits:
What does it mean?
Cost estimate
What manufacturers have to do
Implementation
How does it „feel“?
 Video

3. Summary
 Drastic change in business culture between manufacturer
and Notified Body
 Several manufacturer will quit

4. What does it mean?
 Goal: verify the day-to-day compliance
 in addition to regular audits
 visit the manufacturer and/or critical subcontractor and/or crucial supplier
every third year (frequency may increase under specific circumstances…)
Minimum: 1 day with 2 auditors (for larger companies more time on-site….)

5. What does it mean?
Check for compliance against the documents and legal requirements:
Quality Management System
Product(s)
 class IIa and IIb: under annex II or annex V MDD
 class IIb and class III: certified according to annex III and annex II, section 4 MDD

6. What does it mean?
Check for compliance against the documents and legal requirements:
Quality Management System QMS
check implementation in general
audit at least 2 critical processes
Design Control
Establishment of material specifications
Purchasing
Control of incoming material or components
Assembling
Sterilisation
Batch-release
Packaging
Product quality control

7. What does it mean?
Check for compliance against the documents and legal requirements:
Product(s) (class IIa and IIb) under annex II or annex V MDD
Check recently produced adequat sample(s)
Against technical file/specifications of the manufacturer
Verify („Witness-Testing“) sample(s) against applicable test protocolls and
test results
„Witness-Testing“ done by manufacturer or by critical subcontractor or by
crucial supplier

8. What does it mean?
Check for compliance against the documents and legal requirements:
Product(s) (class IIb and III) under annex III or annex II(4) MDD
Check recently produced adequat sample(s)
Follow specific sampling requirements
Samples taken also from the market and/or at customer location
Against technical file/specifications of the manufacturer
Verify („Witness-Testing“) sample(s) against applicable test protocolls and
test results
„Witness-Testing“ done by manufacturer or by critical subcontractor or by
crucial supplier

9. Cost estimate
Audit preparation, audit on-site, reporting
4 t€ „plus“
Travelling expenses (tickets, hotel, time needed…)
0 – ca. 5t€
Buy samples from the market (only for annex III and annex II(4))
?? €
Testing (external) of samples (only if witness-testing is not possible) ?? €
TOTAL
min. 4 t€ up to ???

10. What manufacturers have to do
Identify critical subcontractors and crucial suppliers
Establish/modify contracts with critical subcontractors and crucial suppliers
Establish/modify SOP how/when to inform the Notified Body
Establish SOP on „Unannounced Audits

11. Implementation
On what legal basis?????
When?
Some Member States already asked their Notified Bodies to establish an
implementation plan
Germany: next meeting on 26th/27th November
Major Problem for Notified Bodies: Ressources !!

12. How does it „feel“?
Unannounced Audits: hope to avoid another PIP case!
Some manufacturers will stopp their business
Some manufacturers will give-up their MDD certification
Because of costs and new complexity/additional requirements
„Cultural“ change in the working relationship
Today: relationship at eye level, looking for compliance
Tomorrow: „Police-style“, identify the „black sheeps“

13. MEDCERT Video
MEDCERT Video

14. Thank you very much for your attention!
www.medcert.de
www.med-cert.com