Help in rolling out a Quality Management System

Adehanks

Starting to get Involved
Hi Everyone,

I'm abut to start rolling out a Quality Management System at my current company and I'm starting with Document Management and Control. Does anyone have any advice, strategy or material that will help me off the bat? I really appreciate any support.

Thank you all.

Adeanx
 

Golfman25

Trusted Information Resource
I am going to assume you're looking at ISO and that you have the standard. I would start with mapping the standard to your current processes to see if you have any gaps. Then work from there. Doc management and control will develop has you create and/or remove docs from you system.
 

Kronos147

Trusted Information Resource
I'm abut to start rolling out a Quality Management System at my current company and I'm starting with Document Management and Control. Does anyone have any advice, strategy or material that will help me off the bat?

I would start by cataloging what you have, and controlling it. Identify the gaps, fill the holes.

A concept I believe is that most successful companies actually meet many of the requirements of ISO9001, as the requirements tend to be good business practices. The gap is usually in retaining effective documentation to demonstrate conformance to requirements (a.k.a. records).

That being said, my advice is to embrace your strengths, and shore up your weaknesses. Don't re-invent the wheel.

Cheers.
 

John Broomfield

Leader
Super Moderator
Hi Everyone,

I'm abut to start rolling out a Quality Management System at my current company and I'm starting with Document Management and Control. Does anyone have any advice, strategy or material that will help me off the bat? I really appreciate any support.

Thank you all.

Adeanx

Study the way in which your organization already seeks to understand and fulfil customer requirements and you’ll see evidence of its management system that is already up and running.

By capturing or documenting this system you and your colleagues should be able to use it and improve it to provide confidence that customer requirements will be fulfilled.

I would not start with the control of documented information unless that currently is the most pressing problem. It can however be extremely useful to adopt/design the organization’s document coding scheme to ease the linking of system docs as you work with your colleagues to develop the organization’s management system for delivering quality services and products.

Search the Cove for document coding or numbering and to ease your development of this management system.

John
 

mattador78

Quite Involved in Discussions
As above make sure anything new you write up is done with the people who actually do that job. If the jobs already working you dont need to add anymore steps in than what they are already doing.
 

ScottK

Not out of the crisis
Leader
Super Moderator
Are you planning on some sort of registration or just doing this because there is too much chaos in the current org?
If you are going for a registration start with senior management because if they don't support it you're dead in water.
If you are just trying bring order there are thing you can gradually do in line with recognized standards.. document control, record control, training and competence, an NCR and/or CAR process, etc.

If you're going down the ISO9001 path I recommend this book: https://a.co/d/dm2Cf3H
 

Big Jim

Admin
Are you planning on some sort of registration or just doing this because there is too much chaos in the current org?
If you are going for a registration start with senior management because if they don't support it you're dead in water.
If you are just trying bring order there are thing you can gradually do in line with recognized standards.. document control, record control, training and competence, an NCR and/or CAR process, etc.

If you're going down the ISO9001 path I recommend this book: https://a.co/d/dm2Cf3H

That's a great book because it cuts through the inane jargon associated with how the standard is written.

May I also suggest you get a copy of ISO 9002:2016? It was written by the same group that wrote the standard and it both helps explain the standard, but also gives example of how to accomplish each of the requirements.
 
Thread starter Similar threads Forum Replies Date
B 8D Evaluation Help? Rolling Out 8D Evaluation Training to a Team Nonconformance and Corrective Action 5
K Need Help With IATF 16949 Audit NC IATF 16949 - Automotive Quality Systems Standard 5
M Looking for kindly help... If there is any prohibits from contract manufacturing in US? About SR medical devices US Medical Device Regulations 0
Ed Panek Looking for help... FDA Pre Sub, IVD, Investigational level experience US Medical Device Regulations 0
T 5 Why's Help Needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 32
M Lead Auditor Log book Help. General Information Resources 1
J Help Needed Customer and Company Specific Requirements 1
P True position with bonus Excel help Manufacturing and Related Processes 8
G Help Needed: Quality Control / Assurance process Quality Manager and Management Related Issues 3
D Little Help with "Tooling Change Program" for perishable tooling (8.5.1.6) IATF 16949 - Automotive Quality Systems Standard 4
D Seeking help in validating a cleaning process. Manufacturing and Related Processes 5
A Help required in establishing Laboratory Information Management System as per ISO 17025, Cl.7.11.2 ISO 17025 related Discussions 0
R Help Understanding Current Role; Distributor, Manufacturer, or Importer EU Medical Device Regulations 4
D HELP gage card not popping up Using GAGEpack Software 2
bryan willemot Wanted: in need of start up Lock out Tag out program in Excel or Word, your help is much appreciated Occupational Health & Safety Management Standards 3
L Quality Manual Help for Service Sector/Service Organization (Government Contractor/IT Services) Quality Management System (QMS) Manuals 5
K Help with ISO 14971: Benefit-Risk Analysis ISO 14971 - Medical Device Risk Management 3
E Please help! ! I AM FRASTRATED SO MUCH! Should inactive ingredient be included in the unit formula if it is removed during the manufacturing process? US Food and Drug Administration (FDA) 0
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 4
T Need 5 why’s help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
T Minitab Coding Help Using Minitab Software 0
G Help:Risk Management - Accessories US Food and Drug Administration (FDA) 1
T Containment help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
Kevin Walters IAQG Required Audit Days Needed (Please help) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T Need help understanding AS6174 clause 3.1.5. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R First Time Managing Calibration and Measurement System. Need Help. General Measurement Device and Calibration Topics 19
M Can someone help me with this CMM programming question? Manufacturing and Related Processes 2
C Need help in determining applicable clause for an audit finding (based on AS9120B) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Attempting to Poke Yoke a wire crimping process...need help Design and Development of Products and Processes 3
marmotte Help with Surgical Class I + 510(k) exemption US Food and Drug Administration (FDA) 0
T Help with updating procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
P Looking for help with an Ansys Workbench problem Manufacturing and Related Processes 0
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
O New metal detector, ccp -help! Food Safety - ISO 22000, HACCP (21 CFR 120) 2
J PFMEA/control plan question- PLEASE HELP ! IATF 16949 - Automotive Quality Systems Standard 8
J Help needed on clauses identification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S HELP in setting-up QMS Quality Tools, Improvement and Analysis 4
R Need help on calibration result analysis Measurement Uncertainty (MU) 17
S Help in SMART goals AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Vader22 IATF 16949 extended manufacturing site help IATF 16949 - Automotive Quality Systems Standard 4
G Need Help with Run @ Rate for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 0
F Need help in IMS management review Management Review Meetings and related Processes 3
A Please Help With EOQ Calculation Manufacturing and Related Processes 2
S Help needed in choosing the method of calculating the minimum sample size Internal Auditing 12
D IATF 16949 Certification and Letter of Conformance expiry (Help!!!) IATF 16949 - Automotive Quality Systems Standard 8
S I need help in corrective action plan Nonconformance and Corrective Action 15
S Help in document control procedure Document Control Systems, Procedures, Forms and Templates 14
D Weird spec sheet - need help Measurement Uncertainty (MU) 3
Edward Reesor ISO 19223 Discussion (Help) Other Medical Device Related Standards 1
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17

Similar threads

Top Bottom