ISO 13485 5.5.2 - Can a consultant be our Management Representative

#1
A small device manufacturing company which is ISO13485 certified is seeking a consultant to maintain and continuously improve their QMS. Can this consultant also be their management representative and attend their ISO audits?
 
Elsmar Forum Sponsor
#3
Thanks to Sidney for your response! I have a follow-up question. The ISO13485 5.5.2 states that the management representative is " a member of management who, irrespective of other responsivities, has responsibility and authority that includes: ......". Does this mean the consultant has to be a member of management? What is the evidence to show the compliance in this case?
 

JoshuaFroud

Involved In Discussions
#4
Management Representative must be "management" in that they must have the authority and responsbility to make changes to the Quality Management System.

I have acted as Management Rep, while having the job title of Quality Specialist.

As long as you can demonstrate that person has the relevant authorities to furfil the requirements of the role as defined in the standard they are "management".
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
This issue has been discussed numerous times in the past for ISO 9001. The major challenge for a "consultant" or a low level employee acting as management representative is to have REAL AUTHORITY over senior people of the organization. The reporting aspect is doable, but real authority is hard to attain.
 

racglobal

Involved In Discussions
#6
Hello
Now you are outsourcing an important QMS process to an external party. Make sure this person is properly qualified just as you would qualify any other supplier.
 
Thread starter Similar threads Forum Replies Date
M Internal audit consultant ISO 13485 (English speaker) Consultants and Consulting 3
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
L Mock Audit by External Consultant (ISO 13485) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 5
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 31
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom