Is there a requirement for Management Review Meeting Minutes?

  • Thread starter Garfield_01 - 2011
  • Start date
G

Garfield_01 - 2011

#1
Hi all,

I have a question about the management review record. Recently, our MR refused to summarize and take management review minute of meeting. He said that the presentations ( from each section ) using during the review can be used as the review output / review record. However, the comment and recommendation from management team was not inclueded. He told me that the requirement was not mentioned about minute of meeting. As far as, the presentation is kept with the follow up activities, everything is ok.
Is this understanding correct? So confuse

Thanks in advance for reply.

Garfield_01
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Management review-the minute of meeting

Having and reviewing materials for a management review are one thing; however, the standard asks us for more. ISO 9001: 5.6.1 calls out for records of management review.

Showing we are reviewing the system's results, including audit results and process performance metrics such as scrap rates is easy with minutes. Other methods might work, such as dated lists of reviewed items and specifically responsive management actions or initiatives, resources allocated for plans to change some of those metrics like scrap rates, and projects to improve audit results. See 5.6.3.

Management review references are also found in 8.5.1, Continual improvement.

If there is a staunch refusal to make meeting minutes I wonder if it is because Management does not want to open itself up to legal scrutiny. I guess I have a suspicious mind.
 
J

Jan C

#3
Re: Management review-the minute of meeting

We use a form for Management Review that covers all things required by the standard and that is included with our minutes as our record. The minutes are for any discussion that is not covered on the form plus it covers all actions determined from the review. After all, action is the "output" of the review and without it, what is the point? We received kudos from our external auditors in both our preassessment and cert audits so it must be working.
 

SteelMaiden

Super Moderator
Super Moderator
#4
Minutes....well, each of us probably has different ideas of what minutes are, there is a requirement, (Jennifer stated it) that we keep a record of the review. In my mind, that means that you have to indicate which of the inputs were covered, and record the outputs. i.e. decisions made, action items to be followed up on, corrective or preventive actions to be done, etc.
 
Last edited:
G

Garfield_01 - 2011

#5
Got your points and thanks a lot for all replys. The story was the customer who performed the audit per TS req gave us the major N/C. The wrap up will be made this evening, and I don't think that suit for.
 
#6
ISO900:2000 Section 5.6.1 (last sentence) said:
...Records from management reviews shall be maintained (see 4.4.4).
Now read the whole of 5.6.1 General, 5.6.2 Review Input, and 5.6.3 Review Output. You SHALL have some kind of record of all of those items. For example, you SHALL RECORD that you reviewed the audit results since the last management review and you SHALL RECORD that the results were either acceptable or that you are doing something to make them acceptable.

You don't necessarily need MINUTES but you do need a RECORD. Try the attached Management Review Record. Fill in the data that you reviewed and be specific. For example, in Section 6 Status of Internal Audit Activity you would enter "Reviewed Internal Audits 2006-1 & 2006-2, covering the entire QMS. 5 Findings noted, see Corrective Actions 2006-1 through 2006-5. All CAs are closed.

During the actual review, assuming Management finds that Internal Audit Activity requires no further action, you simply record by hand, "Results acceptable". If further action is required (e.g., Closing Corrective Action 2006-5), you would fill in something like "See Item 1 in Section 14" (i.e. Improvement of effectiveness of the Quality Management System and its processes, by the way). In Section 14 you would record as Item 1 "Close Corrective Action 2006-5 by March 1st assigned to Garfield_01."
 

Attachments

V

vanputten

#7
Garfeild_01:

How does your organiztion provide evidence of any decision or actions related to 5.6.3, a, b and c?

What was presented in the meeting probably only provides the data to support whatever decision are made. My guess is that the presentation material does not include decisions and actions as a result of the Management Review.

Regards,

Dirk
 
G

Garfield_01 - 2011

#8
Icy Mountain:

Thanks a lot for the example. I'll try this to the MR and hope I won't explain him much detail.

Drik:

Your guess is correct. At least we fail Req.5.6.3 (a). So much of work to do before the coming survelliance audit! :(
 

Colin

Quite Involved in Discussions
#9
I think the template provided by Icy Mountain is excellent and some good advice also given by others.

Just a general thought on MR agenda's, why do we often have a separate topic for 'recommendations for improvement'? Should this not be attached to all topics on the MR agenda?
 
#10
Just a general thought on MR agenda's, why do we often have a separate topic for 'recommendations for improvement'? Should this not be attached to all topics on the MR agenda?
The template I provided is meant to incorporate the ISO9004 guidelines. 5.6.3, Review Output, begins: "By extending management review beyond verification of the quality management system..."
Each topic on the MR agenda can produce a recommendation for improvement and they are listed by topic in my review output "minutes". However, an effective MR can and will produce Recommendations for Improvement that are beyond the scope of the QMS. We capture these RFIs in a separate section for extra visibility AND to set them apart from QMS improvements. For example, the last statement under 5.6.3 in ISO9004 is: "...information for strategic planning for future needs of the organization."

I will not put strategic planning recommendations in front of a 3rd party auditor the same way I would put a recommendation that we reduce the Cost of Poor Quality on Product X coming from Production Team Y. <ducks, expecting return fire>
 
Thread starter Similar threads Forum Replies Date
A How to satisfy the "Interested Party" Management Review Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Is there a requirement for Management Review Meeting under BRC? Management Review Meetings and related Processes 6
M How to satisfy the Management Review requirement without a meeting? Management Review Meetings and related Processes 29
J What to be reported on "New or Revised Regulatory Requirement" at Management Review? Management Review Meetings and related Processes 8
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
R ISO 20000 requirement about the Change Management Policy IT (Information Technology) Service Management 3
J Will this fulfill the AS9100D Risk Management Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M The requirement for Communication via Top Management Quality Manager and Management Related Issues 4
P Requirement Development and Requirement Management - Which comes first? Software Quality Assurance 1
J ISO 9001/AS9100 Requirement for Management Responsibility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Is it a requirement of 9001:2008 to have Management Training Records? Training - Internal, External, Online and Distance Learning 6
B Configuration Management - Is Configuration Management a requirement of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
R Obsolescence Management - Airbus specific requirement - Help needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
G Requirement to inform a Notifying Body about changes in Top Management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F How do you calculate Overall Residual Risk - Requirement of 14971 Risk Management ISO 14971 - Medical Device Risk Management 7
M Planning requirement 5.4: How should the management prove compliance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Notifying Registrar of Management Changes - A TS 16949 requirement? Registrars and Notified Bodies 11
F Management Representative - Is there a requirement for a substitute management rep? ISO 13485:2016 - Medical Device Quality Management Systems 2
L Is there a requirement for Directors meetings as a supplement to management reviews? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
Marc ISO 9001 Management Responsibility Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
J When PPAPs are not a contractual requirement APQP and PPAP 9
I Overwhelmed with attribute MSA requirement for visual inspection IATF 16949 - Automotive Quality Systems Standard 8
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
A The requirement of the PMS plan--suitable indicators and threshold values EU Medical Device Regulations 0
S Battery powered device - electrical protection requirement IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0

Similar threads

Top Bottom