SBS - The best value in QMS software

Change Management System - Does ISO 9001 specify you need a process flow?

J

Jameson4

#1
Looking for some help. I have recently joined a company and have been given the task of handling the ISO 9001 system and have a question regarding change management. Does ISO 9001 specify you need a process flow on how you manage changes in the way you produce your product. If so how detailed does it have to be.
 
Elsmar Forum Sponsor
D

Duke Okes

#2
Re: Change Management System

It is not necessary but if it is a complex process it might be useful as a way to summarize the related procedure.
 

antoine.dias

Quite Involved in Discussions
#3
Re: Change Management System - ISO 9001

Hello and welcome to the Cove.

In 9001, several locations are found with reference to changes :

4.2.3.c
5.4.2.b
5.6.1
5.6.2
7.2.2 ( x3 )
7.3.7 ( x5 )

Although it is not directly required in the standard it is best that you manage the way changes are incorporated in you company.
If you have this documented is up to you.

Best regards,

Antoine
 

Kales Veggie

People: The Vital Few
#4
Re: Change Management System

The ISO 9000 standard requires only a handful of documented procedures and a quality manual.

I agree with other Covers here. It would be in your best interest to document/flow chart your process. The complexity of your documentation would depend on the complexity of your product and potential impact on your company and your customer (making a change to a complex engine is different from making a change to a bolt).

Do it for the good of your company and customer, not for the standard.
 
C

CliffK

#5
Looking for some help. I have recently joined a company and have been given the task of handling the ISO 9001 system and have a question regarding change management. Does ISO 9001 specify you need a process flow on how you manage changes in the way you produce your product.
No, as others have said.
If so how detailed does it have to be.
Here's the right answer to whether you need one (or a procedure), and how detailed it has to be: it depends.

Here are a few of the variables:
- How complex is the product?
- How complex is the process?
- How many people are involved?
- How strong is the need for standardization?
- How experienced/well trained are the people involved?
- What are the consequences of doing it wrong?

A common strategy is to capture the high level flow and, sometimes, responsibilities in a flow chart; then, fill in any salient details with procedures/work instructions. If you can count on people to execute most of the steps in the flow chart, write documents to cover the tricky bits.
 
A

AngLow

#8
Does anyone have an example flowchart of procedure for management of change that i could reference?

thanks
 
J

JaneB

#9
Does anyone have an example flowchart of procedure for management of change that i could reference?

thanks

How about you tell us more about:
1. What kind of product/s you produce now
2. What kind of workflow /processes are involved ?
3. Do you have any flowcharts that show this?

Without better information, it's slow guessing to try and figure out what you might be after.

Alternatively, try searching the Posts Attachments List (see green button at screen top).
 

somashekar

Staff member
Super Moderator
#10
Hi Jameson ...
Take a look at the Note 1 of 7.1
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract can be referred to as a quality plan.
and then ISO 10005:2005, Quality management systems — Guidelines for quality plans.
Does ISO 9001 specify you need a process flow on how you manage changes in the way you produce your product. If so how detailed does it have to be.
It can be as detailed as you wish to have and maintain. All that it has got to be is really really useful to you. Any change can be first addressed from the quality plan document which will drive down further to the areas requiring changes.
 
Thread starter Similar threads Forum Replies Date
M How to implement the 4M Change Management System Lean in Manufacturing and Service Industries 3
L The Perfect Engineering Change and Concessions Management System Document Control Systems, Procedures, Forms and Templates 8
M GM Quality System Basic - Banking & Bypass Procedure in Change Management Manufacturing and Related Processes 6
C Management Of Change System or Software - Recommendations and Ideas wanted After Work and Weekend Discussion Topics 2
A Complete change of the ISO 9001 Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Chennaiite Change Management System - Development vs. Production Changes IATF 16949 - Automotive Quality Systems Standard 5
A Enterprise change management control system software - Medical Devices Quality Assurance and Compliance Software Tools and Solutions 0
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M EMS change management ISO 14001:2015 Specific Discussions 2
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
R Change Management vs Opportunity for Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
U Change Management vs Change Control? Design and Development of Products and Processes 4
D Customer and Company Specific Requirements for notification of Customers of a change in Management or Key Personnel Customer and Company Specific Requirements 3
J Change management with CFDA approved devices China Medical Device Regulations 1
R Linking the Processes of Continual Improvement, Change Management, Risk Management, Action Planning, etc? Preventive Action and Continuous Improvement 5
R 8.1.3 Management of change - Evidence of HIRA and related things Occupational Health & Safety Management Standards 3
T Change control and configuration management - When to create a new model/part number? Other Medical Device and Orthopedic Related Topics 0
R ISO 20000 requirement about the Change Management Policy IT (Information Technology) Service Management 3
J South Korea, MFDS - Medical Device Change Management Other Medical Device Regulations World-Wide 5
Q Top Management Change Prior to Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Y Change Management in a very complex Research Organization Misc. Quality Assurance and Business Systems Related Topics 3
M ISO 13485:2016 Cl. 5.1 - Management commitment verbiage change ISO 13485:2016 - Medical Device Quality Management Systems 2
P Change Management & New Hires ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Are we an outlier for so many variations of Change Management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Who can Change goals and kpi of top management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Software Application for Management of Change (API 5.11) Other ISO and International Standards and European Regulations 3
G Management of Change Procedure Quality Manager and Management Related Issues 7
somashekar 5.4.2 b) Integrity of QMS in Change Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T Engineering Change Management Systems Document Control Systems, Procedures, Forms and Templates 3
M Engineering Change Management Generic Procedure Manufacturing and Related Processes 3
K How do I change management culture in regards to product? Supplier Quality Assurance and other Supplier Issues 4
N Change Management, Configuration Management or Other Process? Manufacturing and Related Processes 9
N New to Management: Culture Change Advice Quality Manager and Management Related Issues 20
C Change Management Toolkit Template Document Control Systems, Procedures, Forms and Templates 5
E Does anyone have a Change Management database? Document Control Systems, Procedures, Forms and Templates 7
T TS 16949 compliant Change Control Management Process IATF 16949 - Automotive Quality Systems Standard 3
T When is a Change Management Process required? Document Control Systems, Procedures, Forms and Templates 12
J Backsliding QMS - My office has gone through major management change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Process Change in a Laboratory - Start Date for new Procedure - Management Opinions Misc. Quality Assurance and Business Systems Related Topics 4
D Management of Change - MOC Procedure and Forms - Engineering, Project, Safety Systems Manufacturing and Related Processes 1
R Change in Direction - Management decides to Outsource Manufacturing Operations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Management Notice of Change - Sample Wanted AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Change Control Review Management Success or Effectiveness Metric Quality Manager and Management Related Issues 3
M ITIL vs. ISO 20000 Change Management Requirements IT (Information Technology) Service Management 3
D ECO (Engineering Change Order) Risk Management Criteria and QA Document Control Systems, Procedures, Forms and Templates 19
D Specifications - All the same type of document? Change Management part of our QMS Document Control Systems, Procedures, Forms and Templates 4
S Change Management - From basic level to implement it succesfully ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Change Management Process Mapping Process Maps, Process Mapping and Turtle Diagrams 7
A Management of Change? What does that mean? Misc. Quality Assurance and Business Systems Related Topics 8
G Management of Change Process (OHSAS) - What would an Auditor expect to see? Occupational Health & Safety Management Standards 6

Similar threads

Top Bottom