SBS - The Best Value in QMS software

How to Write and Compile a Technical File for CE Marking

N

NLW

#1
#1
I am looking for information on how to write a technical file for CE marking. I have alot of info here but nothing seems to make sense as I have no idea what the compliance actions should be. It is for a machine that my company manufactures.
 
Free Trial of DISCUS Desktop
Elsmar Forum Sponsor
CharlieUK

CharlieUK

Quite Involved in Discussions
#3
#3
You probably have 2 options:
- read guidance such as the Blue Guide, the text of the Directives and associated guidance documents and try and work it out yourself
- hire a consultant to create a template for you that can be tailored to your company processed including items such as change control (ongoing compliance), purchasing and specifying (RoHS), Quality Assurance (compliance of ongoing manufactured products), identification of applicable standards.
Some more information can be found by clicking on the various Directives listed at https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

(Full disclosure - I'm a CE marking consultant....)
Charlie
 
I

Ian Southworth

Registered
#4
#4
CharlieUK said:
You probably have 2 options:
- read guidance such as the Blue Guide, the text of the Directives and associated guidance documents and try and work it out yourself
- hire a consultant to create a template for you that can be tailored to your company processed including items such as change control (ongoing compliance), purchasing and specifying (RoHS), Quality Assurance (compliance of ongoing manufactured products), identification of applicable standards.
Some more information can be found by clicking on the various Directives listed at Harmonised Standards - Internal Market, Industry, Entrepreneurship and SMEs - European Commission

(Full disclosure - I'm a CE marking consultant....)
Charlie
Click to expand...
Hi Charlie

Can you help Kan Ltd with PPE CE Complience

Regards
Ian
[email protected]
02380 456611
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
L How to write a proper defect description in a NCR Nonconformance and Corrective Action 4
qualprod When to write up a nonconformance and require a NCR - We produce labels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Validation of existing equipment - I have been asked to write a quality assessment for equipment ISO 13485:2016 - Medical Device Quality Management Systems 13
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
qualprod Write down same nonconformity in several processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
GStough Have You Had to Write a NC Against a Quality Manual in a Supplier Audit? General Auditing Discussions 12
D What is the appropriate way to write a conclusion from a % contribution result? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Who should write Departmental Work Instructions Document Control Systems, Procedures, Forms and Templates 6
L Requirement to write a Detailed Inspection Plan (DIP) APQP and PPAP 5
E How to write requirements for Medical App Validation and Verification IEC 62366 - Medical Device Usability Engineering 7
Z What to write on A3 Methodology Recognition Certificates? Six Sigma 2
T SOP for How to Write a Specification for Raw Materials and Finished Good ISO 13485:2016 - Medical Device Quality Management Systems 3
alonFAI Update an existing QMS manual or write a new one for AS9100C Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E How to write a Project Plan to Overhaul our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
C How to write a Post Market Surveillance REPORT (not procedure) EU Medical Device Regulations 4
E How to write an Aseptic Media Fill Validation Document Other US Medical Device Regulations 2
Q Who must write Quality Manual as per ISO 9001 Clause 5.5.2? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
J Can An External Auditor Also Write The Same Non-Conformance As An Internal Auditor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C How to Write Procedures without too many Details ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B How do I tell my boss to write neatly without offending her? Career and Occupation Discussions 8
W How to write an EASA 145 Quality Manual EASA and JAA Aviation Standards and Requirements 3
N Do I Need to Write a CAR for..... (All Opinions Wanted :) ) ISO 13485:2016 - Medical Device Quality Management Systems 7
B I'm trying to write detailed Customer Service Work Instructions Customer Complaints 10
T How do I control web-based asp forms/rpts that write to and pull from an Access DB Document Control Systems, Procedures, Forms and Templates 4
P Internal Audit Corrective Actions - Can a CB write an NC on an in-process CA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 27
J How to Write the Planned Interval to Conduct Internal Audit, Management Review, etc.. ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to write a US FDA proof MDR procedure? Other US Medical Device Regulations 5
Y New Guidance for the Industry - How to write a Request for Designation (RFD) US Food and Drug Administration (FDA) 0
Q How to write Statement of Purpose for a Law School Admission Career and Occupation Discussions 9
K How to Write a User's Manual for Peachtree - Seeking help Document Control Systems, Procedures, Forms and Templates 4
K ISO 22000 requirement to write a Food Safety Manual Food Safety - ISO 22000, HACCP (21 CFR 120) 2
E How to write a Validation Risk Management Plan for Equipment ISO 14971 - Medical Device Risk Management 5
A How to write Quality Manual? Point to consider Quality Management System (QMS) Manuals 2
M How to write a Nonconformance Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
S How to write a Prerequisite Program (PRP) for food industry ? Food Safety - ISO 22000, HACCP (21 CFR 120) 11
B How to write a SOP for a Medical Device Document Control Systems, Procedures, Forms and Templates 4
E Software to Write and Control Work Instructions? Document Control Systems, Procedures, Forms and Templates 7
A How to write quality policy? Basics of Quality policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Is it required to write a formal corrective action on any nonconformance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 29
M How to write the Essential Requirements EU Medical Device Regulations 14
R How to write a Capacity Plan Quality Manager and Management Related Issues 2
N Four CMMs and would like to write programs for intermediate checks General Measurement Device and Calibration Topics 5
A How to write a Quality Policy Statement Quality Manager and Management Related Issues 11
Jen Kirley How does a Demingite write a good self evaluation? Career and Occupation Discussions 5
E Starting to write a Quality System Manual - Import/export medical devices - Need help ISO 13485:2016 - Medical Device Quality Management Systems 1
L How to write Executive Summary for Health Canada medical device applications Canada Medical Device Regulations 4

Similar threads

Top Bottom