SBS - The best value in QMS software

Companies that offer to help you get certification only give you the bare minimum

Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#21
#21
Andymo said:
Thanks to all who replied. The comments were not implied as criticism of all consultants.

While I was not part of the implementation, I now have been handed the management of our QM system.

Please understand my frustration at what appears to be 'extra work' just to satisfy our customer requirements. If we simply stretch our documentation to simply document the existing working processes - then by my thinking we are just creating more toil for ourselves.

Will definitely purchase 'ISO in Plain English'

There are a couple of international courses here in SA on the ISO 9001, will look into attending them.
Click to expand...
Ah yes. A familiar story. But stories like yours can have happy endings, though you may become tired because they can feel pretty epic.

Enough of the metaphors. Andy has given good advice, as always. So has Helmut - look at ISO 9004 for more in-depth explanations.

The great thing you bring to this effort is your doubt. You are right to question "Why are we doing this?" if it doesn't make sense. The QMS is not supposed to be a complex, bureaucratic enigma. It is not ISO's intention to just make a bunch of demands for non-value-added bureaucracy. It is okay to ask "What the blazes does this thing mean and why is it important??"

The Cove is a great place for info, you have come to the right place. You have been advised to look at ISO 9001 in Plain English by Craig Cochran. I second that advice - his material looks very good, and I think the free excerpt will answer some of your questions here, today.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P Services (Management Systems Strategy) that we can offer to other companies Misc. Quality Assurance and Business Systems Related Topics 1
C In-process inspection - Tooling and assembly lines for automotive companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
D Big companies suffer from quality management system? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
R Customer Satisfaction importance in companies with Government/Public Administration as main customer? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Submission of MDR File - Partner Companies - Computed Tomography (CT) CE Marking (Conformité Européene) / CB Scheme 10
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M ISO 13485 extended Site (Two companies) ISO 13485:2016 - Medical Device Quality Management Systems 2
D 3 Companies - Medical device parts and substances - Responsibilities EU Medical Device Regulations 4
F ISO Certified companies - Is there a list of certified companies that I can access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
Q How is Medical Device Number (MDL) assigned to companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Nicole Desouza Are Shipping Companies Suppliers? Manufacturing and Related Processes 4
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
D Why are pharma companies automating QMS systems? Quality Management System (QMS) Manuals 2
M ISO 27001 ISMS scope for companies with subsidiaries IEC 27001 - Information Security Management Systems (ISMS) 0
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
R ISO 9001 versus ISO 13485 for Suppliers to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 2
R Qualification of Distributors such as McMaster-Carr and Digikey to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 3
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
T Why do most companies have Quality reporting to Engineering or Operations and not to CEO? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 45
T Series A ready company - Term for medical devices companies? Other Medical Device Regulations World-Wide 2
R How to keep track of all FDA rules and regulations for medical device companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Design Transfer between two companies with different QMS CE Marking (Conformité Européene) / CB Scheme 3
T QMS/MDD scope - Two companies located in different places work together Human Factors and Ergonomics in Engineering 10
J What my companies RoHS declaration should say 2011/65/EU, 2015/863, or 2017/2102 REACH and RoHS Conversations 3
K Outsourced Major Processes - Working for Two Sister Companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Y FDA PreCert Program for Software (Companies) - 2017 Other US Medical Device Regulations 1
A ISO 9001:2015 Implementation for Marketing and Sales Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Recommendation for US Agent Services for Medical Device Companies EU Medical Device Regulations 6
T Register of TS 16949 Certified Companies IATF 16949 - Automotive Quality Systems Standard 2
H How Calibration Precision checks are implemented in medical device companies General Measurement Device and Calibration Topics 2
M Using a Complaint Management Software (Medical Device companies) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Transfer of AS9110 Certification between Companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I FDA Medical Device Registration - Scenario - Two Companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Where to start to helping other companies to get ISO IEC 27000? Consultants and Consulting 1
S Elisa kits for poultry disease check up companies US Food and Drug Administration (FDA) 3
Marc What companies think climate change will have a material impact on their business? Sustainability, Green Initiatives and Ecology 11
E Should companies that perform calibration services be ISO 17025 accredited? ISO 17025 related Discussions 13
E CAPA Management Software Tool Recommendations for Small Companies Quality Assurance and Compliance Software Tools and Solutions 3
O List of ANVISA Registered Companies Other Medical Device Regulations World-Wide 1
Ajit Basrur FDA Loosens Pharmaceutical Regulations on 13 Companies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
I Auditing Transport Service Companies Service Industry Specific Topics 5
T What type of industries or companies that should implement PAS 55? Other ISO and International Standards and European Regulations 2
D Documentation Control Software for small companies on a Budget Quality Assurance and Compliance Software Tools and Solutions 10
T ISO 9001 for a Holding Company which owns several Food Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Three Sub-Companies - Is One Quality Manual Enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 9001 Certified Company and acquisition of non-ISO 9001 Certified Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom