SBS - The best value in QMS software

When do you say that you are ready for Third-Party Certification?

S

samsung

#21
Ah... that puts a different complexion on it. In that case, it doesn't sound as though you are ready yet. A good review by management (by which I mean an effective one) should have recognised this - perhaps they don't really understand what they're supposed to be reviewing? (I'm being kind here).
Excellent point. This is a bitter truth & many managements fail to understand "what they're supposed to be reviewing". As a matter of fact:

1. 'ISO' is looked upon as a highly 'formal' system thrust upon from the heavens and hence extra cautiousness is often maintained for being too formal through 'generating' documents & even records. And thus it ceases to be a natural business system.

2. Lack of basic understanding about the term 'review' itself - it's just to see if something is done or simply an action has been taken rather than taking pain to see if it worked or not, was it the most appropriate action and the likes.

Sorry state of affairs.
 
Elsmar Forum Sponsor
D

Drew G

#22
I agree; it sounds to me that top management wants to have a quality system but are not willing to practice it, due to time constraints. Have you addressed that with them? What specifically is not affording them the time they need? Perhaps they need to improve their processes so they are more efficient, or you may need to go back to the basics of ISO 9000 and communicate the importance of it to top management again. Maybe hold a "wake up call" meeting to get Top Management on board and practising what they preach (instead of making you preach, and then take the fall when they are causing the system to fail by their inaction).

If you cannot get support from Top Management, and they are not willing to get on the same page as you (you are the quality systems manager right?) then you're SOL.
 
#23
I agree with you 100%...you see our Internal Audit was very "raw" since the Operational Procedures are not in place yet...and the Management Review was also "very raw" since there were really "nothing" to discuss. I agree that July is a very impossible sched for the CB Audit. However, our Management believes that this is possible. Being the QA Manager and Deputy QMR, I strongly disagree with this. Its like asking ask to do some magic. We are an Engineering Consulting firm by the way.

Can you please advice me on the proper approach given our situation. Many thanks to all! :thanks:
If you have a stage 1 audit scheduled, let it happen. My guess is that, if the auditor is competent, they will determine that you're not ready from past audit results etc.
 
O

Onayt

#24
I agree; it sounds to me that top management wants to have a quality system but are not willing to practice it, due to time constraints. Have you addressed that with them? What specifically is not affording them the time they need? Perhaps they need to improve their processes so they are more efficient, or you may need to go back to the basics of ISO 9000 and communicate the importance of it to top management again. Maybe hold a "wake up call" meeting to get Top Management on board and practising what they preach (instead of making you preach, and then take the fall when they are causing the system to fail by their inaction).

If you cannot get support from Top Management, and they are not willing to get on the same page as you (you are the quality systems manager right?) then you're SOL.
Actually, our Top Management is very supportive. The problem is that some Managers (VPs) find it hard to commit on agreed deadlines (i.e., drafting of procedures and forms; addressing Corrective Actions; monitoring of OTPs). I agree with the "wake up call" meeting. Can you give me some tips on how to go about this? I wud appreciate if you will give me some. :agree:
 
J

JaneB

#25
If you have a stage 1 audit scheduled, let it happen. My guess is that, if the auditor is competent, they will determine that you're not ready from past audit results etc.
Yes, I'd agree. They may need to hear it from the CB rather than you.

I would probably attempt to give your management a 'heads up' beforehand, by setting out what the current shortfalls are, why they are shortfalls (ie, which part/s of the Standards aren't being addressed), and what the likely result will be at the Stage 1 if not addressed. And yes, I would definitely summarise this in writing - eg, a summary agenda/briefing for a review meeting, at which you discuss status.

Then it's really up to top management to make their own decision on what to do. It's their responsibility (not yours). You'll just have to remember bite your tongue not to say 'told you so' at the Stage 1, and they may well be more inclined to listen to you in future. Sometimes people have to discover things for themselves, and a good external auditor can help them with this.
 
O

Onayt

#26
Yes, I'd agree. They may need to hear it from the CB rather than you.

I would probably attempt to give your management a 'heads up' beforehand, by setting out what the current shortfalls are, why they are shortfalls (ie, which part/s of the Standards aren't being addressed), and what the likely result will be at the Stage 1 if not addressed. And yes, I would definitely summarise this in writing - eg, a summary agenda/briefing for a review meeting, at which you discuss status.

Then it's really up to top management to make their own decision on what to do. It's their responsibility (not yours). You'll just have to remember bite your tongue not to say 'told you so' at the Stage 1, and they may well be more inclined to listen to you in future. Sometimes people have to discover things for themselves, and a good external auditor can help them with this.
Wow! What a very good advice from you Ms. Jane. I will do the draft right away and discuss this with our QMR.

Very helpful indeed. I'll let you know what happens next...=)
 
D

Drew G

#27
Dear Onayt,

My suggestion for a wake up call is to begin the process by sending a meeting invite, sending any supporting documents for the meeting, and then having the meeting. Beyond what I recommend procedurally, I definitely recommend that you never once falter in your speech or discussion about the seriousness of the QMS, and the importance of EVERYONE complying with it, or else your company is not engaging in best management practices. You should also not be robotic or create sterile environments during your meetings - while you want to maintain a very serious and focused tone, you also want to be light, jovial, and humurous if you can, and when appropriate. People don't like robotic meetings, and if that is what they are getting then that should be addressed by you immediately. Your biggest asset in getting everyone on board again at a "wake up call" meeting is your drive, and whether or not your VP's can see your (almost fanatical) passion towards your QMS. Also, discuss with top management (this includes VP's) in a very serious way that you are not going to stand for inconsistencies, non-compliances, and the company cannot cut corners for the sake of quality, ever! Someone famous once said (I'm paraphrasing here): when in tough times, the last thing you want to do is sacrifice your principles. Your company needs to stay on course, and they are likely relying on you for total guidance. You may relay this to them as if this is your mission and you will not be deterred, or made to perform at a lower level because of anyone else in the company. If it is company principle to do their best to maintain and continuously improve the QMS (as opposed to a QMS for the sake of marketing purposes), then point out that there is never a good time to cut corners in quality.

Sorry for the long post and if I said anything you already know!

G
 
O

Onayt

#29
Dear Onayt,

My suggestion for a wake up call is to begin the process by sending a meeting invite, sending any supporting documents for the meeting, and then having the meeting. Beyond what I recommend procedurally, I definitely recommend that you never once falter in your speech or discussion about the seriousness of the QMS, and the importance of EVERYONE complying with it, or else your company is not engaging in best management practices. You should also not be robotic or create sterile environments during your meetings - while you want to maintain a very serious and focused tone, you also want to be light, jovial, and humurous if you can, and when appropriate. People don't like robotic meetings, and if that is what they are getting then that should be addressed by you immediately. Your biggest asset in getting everyone on board again at a "wake up call" meeting is your drive, and whether or not your VP's can see your (almost fanatical) passion towards your QMS. Also, discuss with top management (this includes VP's) in a very serious way that you are not going to stand for inconsistencies, non-compliances, and the company cannot cut corners for the sake of quality, ever! Someone famous once said (I'm paraphrasing here): when in tough times, the last thing you want to do is sacrifice your principles. Your company needs to stay on course, and they are likely relying on you for total guidance. You may relay this to them as if this is your mission and you will not be deterred, or made to perform at a lower level because of anyone else in the company. If it is company principle to do their best to maintain and continuously improve the QMS (as opposed to a QMS for the sake of marketing purposes), then point out that there is never a good time to cut corners in quality.

Sorry for the long post and if I said anything you already know!

G
Hey Drew,

I really appreciate your advice...every word of it...it really boosted my morale and gave me the needed lift to move forward...to tell you honestly, im thinking of giving up lately...but with advices like yours, it gave me hope and courage...i will do this...i believe i can...i agree that i need to show to them my passion for "quality"...although im new on this, i believe its good to point out that this is my mission.

Many thanks Drew G!!! :applause:

All the best,
Onayt
 
J

JaneB

#30
I would advise against taking this kind of tone:
discuss with top management (this includes VP's) in a very serious way that you are not going to stand for inconsistencies, non-compliances, and the company cannot cut corners for the sake of quality, ever!
To adopt the attitude that you are 'not going to stand for' whatever, is inappropriate, except perhaps for the owner/MD. In anyone else, if you want to adopt that kind of 'do it my way or the highway' tone, you're highly unlikely to get people on side - indeed, y ou're more likely to offend them.

I'd advise the consultative approach: 'WE have a problem, this is what the problem is, now how can WE address this' approach. It is far more effective in my experience than the high-handed 'I won't stand for this' one.
 
Thread starter Similar threads Forum Replies Date
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
Ajit Basrur How do I label this commercial product ready for clinical study? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Series A ready company - Term for medical devices companies? Other Medical Device Regulations World-Wide 2
K Everybody ready for round 2? Our next audit is in late January IATF 16949 - Automotive Quality Systems Standard 9
S When will notified bodies be ready to perform audit to the MDR? EU Medical Device Regulations 1
P Getting ready for Boeing's AC7130 requirement for suppliers using a CMM AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Printing Machine Make Ready Rapid Changeover Case Study Lean in Manufacturing and Service Industries 2
A 6S 5 Minute Audit Sheet to guage if a Workspace is Safe and Ready to Go Misc. Quality Assurance and Business Systems Related Topics 4
M So you want an internet ready car? Coffee Break and Water Cooler Discussions 3
Marc Sunday Morning Cartoon - Ready, Woolen and Able Funny Stuff - Jokes and Humour 1
T If we are not meeting our Quality Objectives are we ready for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
P Am I ready to call auditor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
L AS9100 Rev C. - Not ready yet (January 2010) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
V Identification of Operational Prerequisite Programs (oPRP) for ready to eat products Food Safety - ISO 22000, HACCP (21 CFR 120) 4
T Time to get ready... Imported Legacy Blogs 2
J Getting Employees Ready for TS 16949 Registration Audit - Training Materials IATF 16949 - Automotive Quality Systems Standard 4
C RC14001 - Are we ready for a Baseline (Pre-Assessment) Audit? Miscellaneous Environmental Standards and EMS Related Discussions 11
Jim Wynne London is ready for some (American) football Coffee Break and Water Cooler Discussions 23
Wes Bucey Ready to send your donation? Coffee Break and Water Cooler Discussions 0
B Deployment of an "ISO9000-ready" QMS - Multi-facility site ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Survey - What is the demand of Pre-written/ready-to-use calibration procedures? General Measurement Device and Calibration Topics 14
A Seeking advice about what I have to do before we're ready for a certification audit IATF 16949 - Automotive Quality Systems Standard 3
H Gage manufacturer is not ready to give guarantee for 10% R&R for the new gages Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
J External third party audits Registrars and Notified Bodies 1
S Would this be a second site for the purposes of internal and third party audits? General Auditing Discussions 4
C Importer shell game - Using a third party logistics provider (3PL) in the EU EU Medical Device Regulations 5
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
F Firmware as SOUP - Sensor with third party produced firmware IEC 62304 - Medical Device Software Life Cycle Processes 2
Marc Medical device vulnerability highlights problem of third-party code in IoT devices Other Medical Device and Orthopedic Related Topics 1
R UDI for US - Third Party device Repackager Other US Medical Device Regulations 9
S QUALITY OBJECTIVEs for third party garments factory inspection ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2
S Regulatory strategy for Third party plugin in a PACS EU Medical Device Regulations 1
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
G Third party auditor mentions no grace period for calibration Calibration Frequency (Interval) 22
M Informational EU – DEKRA Certification GmbH is the third Notified Body designated under the MDR Medical Device and FDA Regulations and Standards News 0
M Informational Updated US FDA Resources for Third Party Review Organizations Medical Device and FDA Regulations and Standards News 0
Rameshwar25 Min working experience for IATF 16949 third party auditor IATF 16949 - Automotive Quality Systems Standard 5
M Medical Device News FDA - Eliminating Routine FDA news 14-09-18 - Re-Review of Third Party 510(k) Reviews Other US Medical Device Regulations 0
Anerol C Becoming an IATF 16949 Third Party Auditor Career and Occupation Discussions 12
K Tips for dealing with third party auditors General Auditing Discussions 11
M Forced NOT to meet End Customer Expectations - Corrupt Third World Country ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M AS9102 Training - Seeking third party agency that provides online AS9102 training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J One third of the total audit days on manufacturing (TS 16949) General Auditing Discussions 2
A Creating a policy to evaluate the Third Party Security IEC 27001 - Information Security Management Systems (ISMS) 4
R (OOT) Measurement Equipment after the calibration at a third Party lab General Measurement Device and Calibration Topics 3
R Medical Device Cyber Security Third Party Review Other US Medical Device Regulations 6
L Medical Device Installation Records from Third Party Installer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Temporary Facility Used For Production - Use of existing Third Party Logos ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Third Party Service Provider Risk Rating Spreadsheet Risk Management Principles and Generic Guidelines 1

Similar threads

Top Bottom