ISO 9001 Management Responsibility Requirement

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
4.1 Management Responsibility


I liked some of Charlies responses here. He clarifies a few issues quite well IMHO.

-----snippo-----

Subject: Re: Q: Mgmt. Responsibility & Design Control/Pfrang/Scalies
Date: Fri, 18 Dec 1998 11:52:48 -0600
From: ISO Standards Discussion <[email protected]>

From: Charley Scalies <scalies[email protected]>
Subject: Re: Q: Mgmt. Responsibility & Design Control/.../Pfrang/Scalies

> From: [email protected] (Doug Pfrang)
>
> Charley, thank you for your reply and the good questions you raise. I'll
> respond to your questions in the same order you asked them, and hopefully
> clarify my dilemma.
>
> To your first paragraph, I realize my interpretation might be somewhat
> novel, but the language of the Standard seems broad -- section 4.1.2.3
> states that the Mgmt. Rep. "shall have defined authority for...REPORTING on
> the performance of the QUALITY SYSTEM...as a basis for improvement of the
> QUALITY SYSTEM," and section 4.1.3 similarly requires "management with
> executive responsibility [to] REVIEW the QUALITY SYSTEM..." (emphasis mine).
> To me, "quality system" suggests ALL elements of the Standard that are
> applicable to the organization, including design control if the firm is
> registered to ISO-9001. Because section 4.1 applies to the entire QUALITY
> SYSTEM, I am wondering how other companies apply section 4.1 to the DESIGN
> CONTROL component of their QUALITY SYSTEM; i.e., what do others do to
> address the formal REPORTING and REVIEW requirements that I have emphasized
> in the language above?

Those companies for whom I have consulted have done two things.1. The design process owner will review his/her own system annually to ensure it continues to remain suitable and effective. He/she verifies that the review was conducted and summarizes any changes or improvements that were or will be made. 2. The internal audit function independently verifies and reports on the effectiveness and suitabilty of the design control system based upon the applicable procedures and the desired outcome of those procedures. They, too, report on any improvement opportunities.

Both these "reports" make their way to the Management Rep who in turn provides the data or summaries therof to executive management for management review.

> If, as you mention, no other company interprets the
> Standard to mean that section 4.1 applies to all components of the quality
> system, then I would be curious what the reasoning is to exclude from the
> management review something as important as design control if the company is
> registered to 9001.

That's not what I meant. 4.1 does apply to the entire standard. However the management review portion does not directed that it be done paragraph by paragraph. The "common" (my customers) practice is for executive management to review performance of the system against the quality objectives and policy. In other words, if the system is achieving the objectives and leads to realization of the quality policy, it's good. If not, it needs corrective action. Those who are interested in doing more than meeting objectives will look more deeply.

> To your second paragraph, I did not mean to suggest we were not auditing
> design control. We do -- just as we audit all other activities. My
> question is not about the extent to which Internal Audits (section 4.17)
> apply to design control; it is about the extent to which Mgmt.
> Responsibility (section 4.1) applies to design control. Specifically, how
> do the Mgmt. Reps. in other companies "report on the performance of the
> quality system" (section 4.1.2.3(b)) as regards design control, and what
> sort of issues does the "supplier's management with executive
> responsibility" evaluate when it "reviews the quality system" (section
> 4.1.3) as regards design control?

Based upon the reviews and audits of others (process owner and auditors) the executive management person or group will look at individual elements on an exception basis only. Remember, meeting ISO9000 is not the purpose of the quality system. The purpose is to achieve the policy and objectives. The ISO9000 system is one vehicle by which that can be done.

> To your third paragraph, our design process seeks, of course, various
> improvements such as time-to-market, cost-of-goods, etc. What is unclear to
> me is the extent to which this must be formally addressed, formally
> reported, formally reviewed, formally recorded, etc., as set forth in
> section 4.1. In fact, the same questions could be asked about Servicing
> (section 4.19), but Design Control (section 4.4) has such a huge number of
> requirements that I am wondering to what extent companies address them as
> formally as section 4.1 seems to require. As you point out, there is a risk
> of too much bureaucracy. On the other hand, because good design control is
> critical to good product quality, some level of formal review of the design
> control process by executive management does seem appropriate. Plus,
> section 4.1 seems to require it. Accordingly, I am wondering what other
> companies do to strike a balance.

Executive management can delve into as much detail as it wishes. If you think it's important that they examine the particular activities of improvement efforts, that's what they should do. If you think they should receive only summary reports of improvement activities, then that's what they should do. ISO9000 only requires that the results of Preventive Actions be reported and considered at management reviews. Of course, executive management should be as interested in improving the end performance of the quality system (results) as they are in improving cash flow, profits, ROI, share value, etc since one tends to impact the other. One of my accounts has, as a key element of its quality policy, "maintaining our competitive edge". Their management group has to identify how they measure this and then review to determine if it is being met. In their case, review of improvement activities, in some detail, is a must.

Hope this gives you some help.
Charley
--
Charles J. Scalies/2000+
http://pobox.com/~scalies
 
Elsmar Forum Sponsor
D

Don Winton

#2
Marc,

Agreed. I particularly like the distinctions he draws between the varying sections and their applicability.

Regards,
Don
 
D
#3
I have established monthly Mgmt. Review meetings until we become QS certified. From there, it will go to quarterly. Scrap costs, machine downtime, etc. are included in my repoort for the meeting.
Also included are pitfalls, needed resources, and internal audits achieved since the last meeting. You can also review corrective and preventive action. You cna also swithch these items at different meetings so they don't become boring?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
I would look at it as an issue of priorities, not simply 'switching' to keep people from being bored... In your meeting you should (prior to adjournment) determine the base agenda for the next meeting based upon what comes up/came up during the meeting. The agenda can be added to or in other ways 'reprioritized, if neccessary, prior to the next meeting.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
Maybe I was a bit abrupt with this. In the pdf files directory there is a simple template for a small (I have used a derivitive for larger companies) a management review (ISO9001). It includes all the basics they want - have you taken a look at it?

I guess what I'm saying is there should be a 'master' schedule which is what you are referring to by 'switching' parts of. With consideration of the basic minimums scheduled for that specific meeting, then:
In your meeting you should (prior to adjournment) determine the base agenda for the next meeting based upon what comes up/came up during the meeting. The agenda can be added to or in other ways 'reprioritized, if neccessary, prior to the next meeting.
in addition to basics scheduled for the next meeting.

Have I confused you yet?
 
Thread starter Similar threads Forum Replies Date
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Casana ISO 9001 - 9.3.1 Management Review - Attendees in a flat organization Management Review Meetings and related Processes 6
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
W ISO 9001:2015 Management Review Input Template wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G ISO 9001 - 9.3.1 Management Review - Content and Frequency Management Review Meetings and related Processes 12
qualprod ISO 9001 vs PMBOK (project management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S ISO 9001:2015 Clause 9.3.2 - MR (Management Review) - Adequacy of resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Can we integrate both ISO 9001:2015 and API Q1 Management System Standards Quality Management System (QMS) Manuals 11
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
R ISO 9001:2015 9.3 - Required inputs to the management review - Audit Nonconformance Manufacturing and Related Processes 14
J 3 Questions about Management Review - ISO 9001 and IATF 16949 Management Review Meetings and related Processes 4
A ISO 9001 Help - New Quality Manager - Upper Management Support Issues ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
F ISO 9001:2015 4.3 - Determining the scope of the quality management system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
H ISO 9001:2015 Cl. 9.3.1 - General Director doesn't participate in Management Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q No Financial Management (ISO 9001:2015) - Your Opinions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G ISO 9001:2015 - Management Review 9.3.2 c) 5) - Monitoring and Measurement Results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Top Executive Management ISO 9001:2015 and IATF 16949 Overview IATF 16949 - Automotive Quality Systems Standard 4
Z MRM (Management Review Meeting) Template for ISO 9001:2015 Management Review Meetings and related Processes 3
T ISO 9001:2015 Training for Management Team in NM - Seeking Suggestions and Providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Risk Management - Additional Process in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO 9001:2015 Clause 9.3.2 - Management Review Inputs must be Documented? Management Review Meetings and related Processes 15
A Integrated Management Systems - ISO 50001 and ISO 9001 possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Leadership Responsibility in an ISO 9001:2015 Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Global / Local Management Review - ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D What should be included in Management Review Meeting for ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Informational Risk Management Implementation for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 60
S ISO 9001 and a safety management system based to ISM code ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Marc 15 minute Top Management presentation on ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
A Informational Risk Management (and Risk Based Thinking) in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 54
H ISO 9001-2008 Management Review Management Review Meetings and related Processes 3
K The differences between ISO 9001 vs a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S ISO 9001 Clauses which reference the 8 Principles of Quality Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T ISO 9001:2008 Management Representative and other Management Staff ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
D Integration of ISO 9001 and OHSAS 18001 - Management Manual Occupational Health & Safety Management Standards 5
V ISO 9001 Clause 5.6.2(f) Management Review Input in a Small Company Management Review Meetings and related Processes 7
R First ISO 9001 Management Review....HELP Management Review Meetings and related Processes 7
D Auditing Management Support - ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
L What exactly does Configuration Management in ISO 9001, Clause 7.5.3 means? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C CRMs (Customer Relationship Management) to help achieve ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Documentation for ISO 9001:2008 - 6. Resource Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Why is ISO 9001 an Overarching Management System Quality Manager and Management Related Issues 3
D ISO 9001, OHSAS 18001, ISO 14001 Management Review Template Document Control Systems, Procedures, Forms and Templates 5
B ISM Code (International Safety Management Code) Requirements and ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Free Webinar ISO 9001 Clause 5 "Management Responsibility" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
eternal_atlas Audit of Management Representative Functions (ISO 9001 & OHSAS 18001) Occupational Health & Safety Management Standards 9
F ISO 9001 Quality Management System for Printing Press ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
J ISO 9001/AS9100 Requirement for Management Responsibility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Management Review that covers ISO 9001, ISO 13485, and Directive 93/42/EEC wanted Management Review Meetings and related Processes 10
D ISO 9001:2008 and Environmental Management System (EMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N ISO 9001 and the HR Function - Developing a Total Quality Management System for HR ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16

Similar threads

Top Bottom