ISO 9001 vs. CE Mark European directives

A

Aida Petrescu

#1
Please help me to clarify the following issue: if a company has the CE mark for thei products and don't has the ISO certificates for the company, the product is OK. I know that the CE mark includes the ISO approvals (is it true or false?).
 
Elsmar Forum Sponsor
A

AJPaton

#2
CE Mark is based on a set of European directives taht deal with product categories. It's much like UL labelling for your product.

I was involved a few years ago with the EMC, electromagnetic compatability directive for the company I was working with. I also got the pleasure of reading the Low Voltage Directive. We would not be allowed to sell in the EU after the directives were enacted without meeting the specs. However, we were able to self-declare.

ISO is also apparently required to sell in the EU now, but registration cannot be self-declared, and it does not call out product specifications as the CE Mark directives do.

Hope this clears some of the confusion up.

AJP
 
A

Alf Gulford

#3
Aida-
I hope I'm addressing your question correctly. I'm not an expert, but I've rubbed shoulders with this issue. At least with medical devices, it depends on the risk-based classification of the equipment.

Per the Medical Device Directive, Class 1 non-sterile/non-measuring devices can be 'self-declared' (see Annex VII)and the CE mark applied without witnessed testing or quality system registration. You do need to have documented testing, technical files, etc. available upon request.

For Class 2a or higher, you need both a Declaration of Conformity and either registration to a recognized quality system (read ISO 900x) or witnessed (and expensive) testing.

This is a narrowly focused response to a very big question and all I can offer based on experience.

This is an area where a good consultant would be worth their weight in platinum!

Best of luck with this one.

Alf
 
J

James Gutherson

#4
I have to agree with Alf's answer, 'It depends'.

My experience is with the CE Recreational Craft (boats) directive. There are 6 different classes of certificate issued depending on the level of inspection and registration to a Quality system, ranging from no inspection/no registration through to 3rd party independant inspection/ISO9001 registration.
 
Thread starter Similar threads Forum Replies Date
V Class III Device CE Mark with ISO 9001 Registration? EU Medical Device Regulations 4
B Registration Mark Controls - 'ISO 9001:2000 Certified and CB/AB Logo' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
giavannatabbs ISO 9001:2015 Control of Records - QMS Communications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
H ISO 9001:2015 - 8.5.1 - Routers not being signed Manufacturing and Related Processes 5
Q Documented information ISO 9001:14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Is there a mandatory requirement to notify customers of the complaint resolution in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J ISO 9001:2015 Document Revison History ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q KPI rules for ISO 9001 first certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Sidney Vianna Tesla Lacks Major Automotive Quality Certifications such as IATF 16949 and ISO 9001 IATF 16949 - Automotive Quality Systems Standard 15
Cats Clause ISO 9001 - verification of Tape Measures and Steel rules ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S ISO 9001 Quality Management System and its processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Preservation of Raw Materials in ISO 9001:2015 Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
L Assignment on the link between Quality Gurus & ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
jeancloude17 Advice for ISO 9001 for software Design and Development of Products and Processes 2
Ed Panek ISO 9001 Cert Scope Adjustment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P ISO 9001: Quality Management as a process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Iso 9001 Clause 7.1 - Advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K Applicable ISO 9001 clauses for Human Resources? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ISO 9001:2015 Registered Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
JDJohnson Micrometer & Caliper Calibration (ISO-9001) General Measurement Device and Calibration Topics 26
G Why do you guys think ISO 9001 doesn't ask specifically for preventive maintenance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
D ISO 9001:2015 Calibration Procedures Manufacturing and Related Processes 16
G Auditing Top management: 6.3 ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G IT being audited during ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Moncia Customer satisfaction monitoring - ISO 9001 and 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
Sidney Vianna ISO 9001 News ISO 9001 Design Specification to be developed - May 2022 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S ISO 9001:2015 Project Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Common items : which iso 9001 are common to all areas? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
G ISO 9001 - when implementing customer requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
V ISO 9001 or ISO 17065 required for an organization issuing 5 star rating certification of digital experience? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D ISO 9001:2015 Recertification Audit Timing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J ISO 9001:2015 Is a Project Evaluation form necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
malasuerte Performance of ISO 9001 certified vs. non-certified manufacturing companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Filling totes and pails - when is a calibrated scale / flowmeter required in ISO 9001 General Measurement Device and Calibration Topics 4
Moncia ISO 9001 calibration question please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 9001 Clause advice Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Sidney Vianna ISO 9001 News ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Management Review ISO 9001-2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
J Process capability analysis in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Use an iso 9001/2015 form for api q1 systeme Oil and Gas Industry Standards and Regulations 5
Q Which Kapt standard assignment ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Quality Awareness 7.3 ISO 9001-2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Cats Clause ISO 9001:2015 7.1.5 Monitoring and measuring resources: Application to training providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Quality Management-ISO 9001:2015 General Auditing Discussions 1

Similar threads

Top Bottom