Outsource Management Representative?

E

eureka

#1
Mr

Does Management representative may be outsourcing or have to be employee of the company?
Robert
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
The MR should be an employee because this person is auditable. Have you tried using the SEARCH mode in the forum?
 
#3
Although the standard does not specify, it does (in my opinion) imply that the Mgmt Rep must be a member of the management team with the necessary responsibility AND authority to affect change with regard to the EMS.
 
R

Rachel

#4
Okay, fellas and ladies, I got one for ya...

Here's the thing: I am technically the QMS auditor for our company. I've been given the task of implementing 9K:2K. I have been with the company for *4* big months. I'm also 23 and fresh out of school last April. As such, yep, I am nowhere *near* top management. My boss reports to the CEO, but I...do not.

So, 9K:2K, 5.5.2 states that the management rep must be a "member of management...[and must have] responsibility and authority that includes...reporting to top management on the performance of the QMS...<blahblahblah>."

My responsibilities are basically that of the management rep (5.5.2a), but I'm not at the right level in the company org chart to actually *be* the management rep.

Who wants to shed some light for me? Any takers?? :bonk:

Cheers,
-R.
 
Last edited by a moderator:

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#5
Hi Rachel:
It's easy. The short answer is, your boss is the MR and you do all the work.:biglaugh:
 
#6
Rachel said:
My boss reports to the CEO, but I...do not.

Who wants to shed some light for me? Any takers?? :bonk:
Ok, I'll bite. Assuming that your boss is the management rep, there is nothing that prevents him from delegating tasks to you. He is still reponsible for them of course...

/Claes

Added later: Simultaneous posting again? Hullo Al..:agree:
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#7
Claes Gefvenberg said:
Ok, I'll bite. Assuming that your boss is the management rep, there is nothing that prevents him from delegating tasks to you. He is still reponsible for them of course...

/Claes

Added later: Simultaneous posting again? Hullo Al..:agree:
Hi Claes:
Great minds think alike.
 
G

Greg B

#8
Sorry Rachel,

I have to agree with Al and Claes. My last Four Managers have all been the MR but as Al & Claes have stated I have done ALL of the work. I have suggested the audit scopes and schedules, Performed the audits, written all the quality reports, managed the MR meetings (secretary) etc etc. You see, at the bottom of my Job Description is a little phrase that says something like:
'...and other duties as delegated by the Manager'.
I think we have all had to bear the brunt of 'Delegation' as usually the MR does not know what the h*ll is going on.JMHO.:soap:

Eureka,
I would love the opportunity to be a contract MR (if there was such a thing). Walk into companies tell them what is wrong and leave them to fix it. Easy money. (Actually I think we call them registrars) :biglaugh:

Greg B
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
That is an easy one

I am not saying that I necessarily agree with the TC 176 OFFICIAL interpretation, but just check http://www.tc176.org/pdf/rfi027_final.pdf

The Management Rep does NOT have to be a full time employee of the organization. It can be someone that works on a part time basis. Not sure if that is what you meant by "outsorcing".
 

Randy

Super Moderator
#10
"Outsourcing" would be hiring someone from thoe outside Sid, like me or Marc, or Kevin L or any of the other free lancers here being the MR.
 
Thread starter Similar threads Forum Replies Date
R Change in Direction - Management decides to Outsource Manufacturing Operations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Could an organisation outsource all Part M activities? EASA and JAA Aviation Standards and Requirements 0
F Is it good to outsource the Internal Audits? Quality Manager and Management Related Issues 16
B Outsource Production Line need ISO13485 Certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
J Scope of Registration ? Design Responsible ? Outsource Design??? IATF 16949 - Automotive Quality Systems Standard 2
D How to Audit Outsource process (New Trainee Auditor) ISO 13485:2016 - Medical Device Quality Management Systems 2
L Question: outsource medical device electric safety test to OEM supplier ISO 13485:2016 - Medical Device Quality Management Systems 3
D Does waste water equipment need calibration if we also outsource testing? Miscellaneous Environmental Standards and EMS Related Discussions 12
S Definition Outsource - Outsourcing - Subcontracting - Definition - TS 16949 and ISO 9001 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14
Howard Atkins If you outsource production can you register to ISO/TS 16949? IATF 16949 - Automotive Quality Systems Standard 2
D Medical Device Directive manufacturer - Wanting to outsource some proceses ISO 13485:2016 - Medical Device Quality Management Systems 27
M Outsource of Internal Quality Audits and Incentive for Auditor General Auditing Discussions 23
G Does Outsource of Processes refer to things like heat treat of the product? Preventive Action and Continuous Improvement 5
S Management Review (9.3) - Management Review Minutes/Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 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
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
M Management is about people? Human Factors and Ergonomics in Engineering 1
R Electrical contractor Project Quality Management Plan Quality Manager and Management Related Issues 1
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P How to develop executable quality management system for rookies? IATF 16949 - Automotive Quality Systems Standard 10
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
G Supplier management when the supplier is your headquarter IATF 16949 - Automotive Quality Systems Standard 3
G IMS (Integrated Management System) 9001, 14001 & 45001- Request Assistance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
A Building up a global quality management system ISO 13485:2016 - Medical Device Quality Management Systems 2
A Building up a global quality management system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
R Change Management vs Opportunity for Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L SAE AS9145 vs. SAE AS6500 (Manufacturing Management Program) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
John Broomfield Informational Terms used in quality management [Deleted] Misc. Quality Assurance and Business Systems Related Topics 6
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
T Management review meeting workflow ISO 13485:2016 - Medical Device Quality Management Systems 9
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 4
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Starting an ISO 41001:2018 Facility management system Other ISO and International Standards and European Regulations 3
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
V Gage Management and Gage R&R Software General Measurement Device and Calibration Topics 1

Similar threads

Top Bottom