Has anybody done IMS - Management Review Meeting

Skilz

Involved In Discussions
#1
Hi All,

Have anybody carried out a Integrated management system (9001/14001) review meeting.

We are 9k & 14k certified, so are looking at combining the 2 std in one review. Anybody got a template of how they went about it.

thanking you
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2
Before the review issue a report on system performance including any upcoming changes to opportunities, risks and stakeholder concerns.

Give the participants two weeks to study the report, provide additional inputs and to seek clarifications.

Then hold the review to exchange the views and ideas of the participants while recording who promised to do what by when following the review.

Transfer these commitments to preventive action requests or corrective action requests (or improvement projects).

Then publish hard copy on your confidential notice board report for all employees:

  • A. What the system helps us to do well;
  • B. Where the system let’s us down.
  • C. What management is doing about B. above.
Illustrate the report on the review of system performance to the employees with cartoons, photos, anecdotes and anything else to keep it interesting.

And include the date of the next review (unless something dramatic happens meantime).
 

Randy

Super Moderator
#3
Yep,l trained on how to do it and audited a ton of the suckers (meaning IMS, not people) even more complicated. You've got a checklist in your hands right in the standards themselves. Just do your normal MR and add in the things that are different, you can do it by bits and pieces or all at once or more than once doesn't matter, nobody cares. The hard part is to make sure you include everything that's required and that you document the whole ball of wax.

9+14 is easy, wait until you do 9+14+45+RC, that's when it gets fun
 

junior1505

Starting to get Involved
#9
Greetings of the day, Skilz,
You need to define a template with about 35 rows understanding the standard requirements and shall requirements to address in the MRM.
if you refer the standard and its annexure, you can devise from it.
do recite, if you wish any additional inputs.
Regards.
 
Thread starter Similar threads Forum Replies Date
P Has anybody had any experience with GM4350M? Customer and Company Specific Requirements 2
Stuart Andrews Has anybody ever used the Powerway SPC software module? Quality Assurance and Compliance Software Tools and Solutions 1
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
L GRR for a tolerance that has changed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
D Partial FAI - AS9102 - One single drawing has 10 part numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 17
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
Sidney Vianna IAQG News IAQG has a new website - December 2019 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Richard Regalado ISO 22301:2019 has been published - Nov 2019 Business Continuity & Resiliency Planning (BCRP) 0
S FAIR - If we have not produced a part in over 2 years, but nothing has changed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Nicole Desouza Who has to be compliant with REACH Declarations? REACH and RoHS Conversations 11
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A Would an MRP system that has been in use for over 10 years require validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Informational VDI 2017 - Medical Grade Plastics - German VDI has published a "Richtlinie" Other Medical Device Related Standards 1
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
I Who has had to move from ISO 9001:2015 to ISO 13485 and what were the challenges? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Informational UTC ASQR Rev.11 has a mistake; certification of distributors to IATF 16949 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
lilybef FDA and Biocompatability Testing - Reviewer has requested implantation testing Other Medical Device Related Standards 11
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
C Has an amended version of IEC 60601-1-6 TRF been released for use in conjunction with IEC62366-1:2015? Human Factors and Ergonomics in Engineering 0
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
Q MHRA has released a new guidance document related to 'GXP' Data Integrity EU Medical Device Regulations 3
B FDA Philippines has no check or balance outside the health department Supplier Quality Assurance and other Supplier Issues 3
S Doubts about SPC taken in Machining - Part has +-0.01 Tolerance Statistical Analysis Tools, Techniques and SPC 5
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1
P NPR Metric - What if Customer has relaxed measure? TL 9000 Telecommunications Standard and QuEST 1
D EU Harmonized Standards to which a company has declared compliance EU Medical Device Regulations 13
N Customer Survey Question Has Me Stumped - Compliance with Laws and Regulations Customer and Company Specific Requirements 4
B Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Records Records and Data - Quality, Legal and Other Evidence 10
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
B Procedure Pack - KIT - Each has its own CE Mark CE Marking (Conformité Européene) / CB Scheme 6
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Who has had a Transition Audit from TS 16949 to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 120
M Has anyone done a Gage R&R for Spectrophotometer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10

Similar threads

Top Bottom