SBS - The best value in QMS software

Need assistance with ISO 9001 Certification Approach

G

Gray Warner

#11
#11
Chris - If you have management commitment, then you need to have some intense executive planning meetings to set the policies, get the internal customer/supplier relationships going between the departments, and start linking the systems together. If the departmental processes are not linking together, it seems to me that the commitment might be there now, but the departments are very territorial. Train as many internal auditors that you can from management, supervision and respected professionals from all of the departments to help write procedures, audit the processes, and change the system.
I remember years ago struggling through a pre-audit with our registrar when building most of our quality system from scratch. When the registrar's lead auditor expressed serious doubts, we pulled the auditors together and performed 28 man-days of audits to clean house, and followed through with literally dozens of noncompliances, performing root-cause analysis and verifying effectiveness of the corrective actions. Several of these auditors were from middle management from different departments, fully backed by the entire management team, so changes happened. When the same lead auditor returned for the registration audit, he was blown away by the difference that he saw in the quality culture, and registration went smoothly.
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Need Assistance for Implementing ISO 9001 in our organisation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S NADCAP approval for Conventional Machining and Chemical processes - need assistance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
S Need Assistance in Visual Inspection - Tiny electronic components AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
E Need assistance with Complaint Management Database Customer Complaints 3
S Need assistance on how to generate Change Notices for Vendors and tracking APQP and PPAP 0
O Need Assistance in understanding AS9100 Rev.B AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
S Need assistance in GD&T and Design of checking fixtures, gauges Design and Development of Products and Processes 3
K Need Assistance Interpreting Gage R&R Data - Stylus profilometer Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
J Furnace repaired - Do I need a new initial TUS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
J Need a contract monitoring Tool General Information Resources 0
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 3
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
K Do I need a "State of the art" plan? CE Marking (Conformité Européene) / CB Scheme 1
S Need advice for schooling Quality Manager and Management Related Issues 5
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Need guidance on project ISO 13485:2016 - Medical Device Quality Management Systems 2
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
N IPC-A-630 - Is this free or do i really need to pay for it? Manufacturing and Related Processes 4
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
silentmonkey How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom