Can somebody help me to identify the 27 ISO 13485:2003 procedures?

P

Paul22

I have been informed that to obtain ISO 13485:2003 certificate, I have to document 27 procedures.
Can somebody help me to identify the 27 procedure's!
Thanks in advance.
Paul
 
A

Aaron Lupo

Paul22 said:
I have been informed that to obtain ISO 13485:2003 certificate, I have to document 27 procedures.
Can somebody help me to identify the 27 procedure's!
Thanks in advance.
Paul
Click to expand...
Attached Files 13485 asq
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Can somebody help me to show a 'delta-FMEA' example? FMEA and Control Plans 10
E Definition QUALITY 4.0 - Somebody here could explain the meaning of Quality 4.0? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
M Taguchi versus fractional factorial: Can somebody check the results? Quality Tools, Improvement and Analysis 3
Wes Bucey Did somebody drop the ball at Boeing? Quality Manager and Management Related Issues 38
A Customer Demands (MSA=Bias + GRR/2). Can somebody explain what it means? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
C QMS Related Interview - Profiling Somebody in Newsletter Preventive Action and Continuous Improvement 14
R ISO 9001 and ISO 9004 - Can somebody briefly explain their difference? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Referencing somebody else?s CE Mark and NB Number on an Instruction Leaflet? CE Marking (Conformité Européene) / CB Scheme 7
B Can somebody tell me about Lithium Ion Battery pack related standards Other Medical Device Related Standards 4
B RoHS (Restriction of Hazardous Substances) - Can somebody guide me? RoHS, REACH, ELV, IMDS and Restricted Substances 7
Ajit Basrur Can somebody share training material for ISO 17025 ? ISO 17025 related Discussions 2
B Can somebody share the latest 'Drug Dossier Format'. Document Control Systems, Procedures, Forms and Templates 1
Jim Wynne I'm Somebody Now!! Funny Stuff - Jokes and Humour 45
I TS 16949 - 6.2.2.4 Employee motivation & empowerment. Can somebody provide me example IATF 16949 - Automotive Quality Systems Standard 8
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
A Help in rolling out a Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
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

Similar threads

Top Bottom