SBS - The best value in QMS software

How to write a Project Plan to Overhaul our QMS

TPMB4

Quite Involved in Discussions
#11
Well I reckon that approach would see me out the door here. They are very much quality focussed and it wouldn't take that much to tip the balance to the dole queue!!! I offer a ROI with that approach and that is my salary at the very least!!

Funny thing is, I'd still like to see it happen!! Even if it means me out of a job. Perverse that.

Anyone seen it happen? quality function being fully integrated or embedded into the organization that no separate quality function is needed??
 
Elsmar Forum Sponsor
Q

qpled

#12
That is why I am taking a slow approach to revamping our quality manual - only necessary and small changes/updates until Sept. 2015 (I hope the 9001:2015 standard will be ready then!).
 

Wes Bucey

Prophet of Profit
#13
Among all the suggestions, I lean toward Sidney's. I've written about Change Management numerous times here in the Cove and it's one of my "go to" presentations.

I also talk about incorporating Deming's SoPK (System of Profound Knowledge), but the kickstart to Change has to be a consensus of dissatisfaction with the status quo before outlining a remedy.

Some of the best and most successful changes I have witnessed have followed Sidney's suggestion of reinventing the organization, eliminating the silos of departments, and creating a culture of mutual help and support versus the "that's not my job" mentality found in so many organizations.

The one thing I caution is that Change is never a one person job. Regardless of the ultimate plan or who devised it, successful Change still requires getting buy in from the entire organization and overcoming pockets of resistance, preferably with logical or emotional persuasion, but sometimes with surgical excision.
 
#14
That is why I am taking a slow approach to revamping our quality manual - only necessary and small changes/updates until Sept. 2015 (I hope the 9001:2015 standard will be ready then!).
As a matter of fact you may be able to chuck the manual in the shredder at that time, as there is no mention of a manual in the Comittee Draft for ISO 9001:2015.

/Claes
 

TPMB4

Quite Involved in Discussions
#15
As a matter of fact you may be able to chuck the manual in the shredder at that time, as there is no mention of a manual in the Comittee Draft for ISO 9001:2015.

/Claes
I should ask this elsewhere or read the relevant threads but if they go without a manual what is required either in its place or as the QMS documentation? I've not read up enough on the ISO 9001:2015 situation I know or I would know the answer but if anyone can let me know...
 

Stijloor

Staff member
Super Moderator
#16
I should ask this elsewhere or read the relevant threads but if they go without a manual what is required either in its place or as the QMS documentation? I've not read up enough on the ISO 9001:2015 situation I know or I would know the answer but if anyone can let me know...
It is not a requirement to include the QMS documented procedures in the Quality Manual. The option is include or reference to them.

So if the Quality Manual goes away, documents can be maintained regardless of the QM.

I will miss the QM though....;)
 
Last edited:
#17
I should ask this elsewhere or read the relevant threads but if they go without a manual what is required either in its place or as the QMS documentation? I've not read up enough on the ISO 9001:2015 situation I know or I would know the answer but if anyone can let me know...
Well... We will know for certain in 2015, but right now 4.2.1b and 4.2.2 from the current version appears to have gone missing, while the rest of 4.2 remains. Speaking for myself I'd just as well be rid of that particular piece of ballast, as it serves no useful purpose. On the other hand there is nothing to prevent those so inclined from keeping it.

/Claes
 
Thread starter Similar threads Forum Replies Date
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
L How to write a proper defect description in a NCR Nonconformance and Corrective Action 4
qualprod When to write up a nonconformance and require a NCR - We produce labels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Validation of existing equipment - I have been asked to write a quality assessment for equipment ISO 13485:2016 - Medical Device Quality Management Systems 13
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
qualprod Write down same nonconformity in several processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
GStough Have You Had to Write a NC Against a Quality Manual in a Supplier Audit? General Auditing Discussions 12
D What is the appropriate way to write a conclusion from a % contribution result? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Who should write Departmental Work Instructions Document Control Systems, Procedures, Forms and Templates 6
L Requirement to write a Detailed Inspection Plan (DIP) APQP and PPAP 5
E How to write requirements for Medical App Validation and Verification IEC 62366 - Medical Device Usability Engineering 7
Z What to write on A3 Methodology Recognition Certificates? Six Sigma 2
T SOP for How to Write a Specification for Raw Materials and Finished Good ISO 13485:2016 - Medical Device Quality Management Systems 3
alonFAI Update an existing QMS manual or write a new one for AS9100C Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C How to write a Post Market Surveillance REPORT (not procedure) EU Medical Device Regulations 4
E How to write an Aseptic Media Fill Validation Document Other US Medical Device Regulations 2
Q Who must write Quality Manual as per ISO 9001 Clause 5.5.2? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
J Can An External Auditor Also Write The Same Non-Conformance As An Internal Auditor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C How to Write Procedures without too many Details ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B How do I tell my boss to write neatly without offending her? Career and Occupation Discussions 8
W How to write an EASA 145 Quality Manual EASA and JAA Aviation Standards and Requirements 3
N Do I Need to Write a CAR for..... (All Opinions Wanted :) ) ISO 13485:2016 - Medical Device Quality Management Systems 7
B I'm trying to write detailed Customer Service Work Instructions Customer Complaints 10
T How do I control web-based asp forms/rpts that write to and pull from an Access DB Document Control Systems, Procedures, Forms and Templates 4
P Internal Audit Corrective Actions - Can a CB write an NC on an in-process CA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 27
J How to Write the Planned Interval to Conduct Internal Audit, Management Review, etc.. ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to write a US FDA proof MDR procedure? Other US Medical Device Regulations 5
Y New Guidance for the Industry - How to write a Request for Designation (RFD) US Food and Drug Administration (FDA) 0
Q How to write Statement of Purpose for a Law School Admission Career and Occupation Discussions 9
K How to Write a User's Manual for Peachtree - Seeking help Document Control Systems, Procedures, Forms and Templates 4
K ISO 22000 requirement to write a Food Safety Manual Food Safety - ISO 22000, HACCP (21 CFR 120) 2
E How to write a Validation Risk Management Plan for Equipment ISO 14971 - Medical Device Risk Management 5
A How to write Quality Manual? Point to consider Quality Management System (QMS) Manuals 2
M How to write a Nonconformance Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
S How to write a Prerequisite Program (PRP) for food industry ? Food Safety - ISO 22000, HACCP (21 CFR 120) 11
B How to write a SOP for a Medical Device Document Control Systems, Procedures, Forms and Templates 4
E Software to Write and Control Work Instructions? Document Control Systems, Procedures, Forms and Templates 7
A How to write quality policy? Basics of Quality policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Is it required to write a formal corrective action on any nonconformance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 29
M How to write the Essential Requirements EU Medical Device Regulations 14
R How to write a Capacity Plan Quality Manager and Management Related Issues 2
N Four CMMs and would like to write programs for intermediate checks General Measurement Device and Calibration Topics 5
A How to write a Quality Policy Statement Quality Manager and Management Related Issues 11
Jen Kirley How does a Demingite write a good self evaluation? Career and Occupation Discussions 5
E Starting to write a Quality System Manual - Import/export medical devices - Need help ISO 13485:2016 - Medical Device Quality Management Systems 1
L How to write Executive Summary for Health Canada medical device applications Canada Medical Device Regulations 4

Similar threads

Top Bottom