QMS monitoring, measurement, analysis and evaluation requirement - Template

#1
  • There is no objective evidence to show xyz has implemented its QMS monitoring, measurement, analysis and evaluation requirements. Action to monitor, measure, analyze and evaluate QMS process-based objectives exists but not yet implemented (9.1.1)
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
  • There is no objective evidence to show xyz has implemented its QMS monitoring, measurement, analysis and evaluation requirements. Action to monitor, measure, analyze and evaluate QMS process-based objectives exists but not yet implemented (9.1.1)
Presumably, this was a nonconformance you received?

You have an action to implement it, but its not yet done. So, what are you asking of this forum?
 

John Broomfield

Staff member
Super Moderator
#6
Are you saying your colleagues as supervisors were unable to describe how they made sure every member of every process team had all they needed to fulfill the objectives of each process?

Are they not ensuring these processes are monitored and corrected as necessary?

Bear in mind that evidence does not necessarily have to be documented unless and lack of documentation is causing the process to go wrong.
 
#8
Are you saying your colleagues as supervisors were unable to describe how they made sure every member of every process team had all they needed to fulfill the objectives of each process?

Are they not ensuring these processes are monitored and corrected as necessary?

Bear in mind that evidence does not necessarily have to be documented unless and lack of documentation is causing the process to go wrong.
Thanks, I was racking my brain on the kind of documentation, I will be asked during my external audit.
 

Jim Wynne

Staff member
Admin
#10
Yes, I need sample of completed documentation on this subject.
You still haven't provided enough information for anyone to help you. Your original post, which appears to be a nonconformity statement, says in part, "Action to monitor, measure, analyze and evaluate QMS process-based objectives exists but not yet implemented (9.1.1)." What does "Action to..." mean? What action is being referred to? What did the auditor say when asked about this?
 
Thread starter Similar threads Forum Replies Date
K ISO 13485:2016 Cl. 4.2.3 - Determine QMS Processes, Monitoring, Measuring, etc. ISO 13485:2016 - Medical Device Quality Management Systems 4
M Options when MSA acc. to VDA 5 is NOK (Qms > 30%) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D QMS Realignment after business splits into 2 different companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
G One-person QMS - possible? ISO 13485:2016 - Medical Device Quality Management Systems 18
A SaaS SaMD - Impact QMS ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO9001 QMS: Quality Manual Examples & Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
qualprod Can a consultant be audited instead of QMS responsible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
Ed Panek How to address a QMS Entry Error ISO 13485:2016 - Medical Device Quality Management Systems 8
D Digital Healthcare - QMS requirements Other US Medical Device Regulations 3
BeaBea QMS/ Training Management Software Service Industry Specific Topics 4
R QMS for Medical products & Pharmaceutical Drugs in one facility Medical Device and FDA Regulations and Standards News 3
C First Round of QMS Internal Audits - Ethical Dilemma Internal Auditing 10
N Handling B-Grade Products within the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
M Supplied Goods out of QMS / DtS? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Can outsourced processes be excluded from QMS scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 6
S Implementation of QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Correcting Electronic QMS Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Are We Ready for a QMS? Quality Management System (QMS) Manuals 8
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
J Quality Objective for QMS prior to Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
V Remote QMS Coordinator Position Job Openings, Consulting and Employment Opportunities 6
A How to prepare QMS manual for purchasing department Quality Management System (QMS) Manuals 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 1
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
A Electronic forms QMS Document Control Systems, Procedures, Forms and Templates 12
supadrai Remote Opportunity - Large Scale Glove Factory QMS / RA / Legal Job Openings, Consulting and Employment Opportunities 0
C Retention of QMS Plans and Reports ISO 13485:2016 - Medical Device Quality Management Systems 5
Q New QMS...Old Projects ISO 13485:2016 - Medical Device Quality Management Systems 5
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 8
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 0
S AS9120 Store QMS packages AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Disappointed in leadership buy-in to QMS Quality Manager and Management Related Issues 68
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T How you ensure that QMS is effective and efficient? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 10
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
SocalSurfer Can you recommend an enterprise QMS for new AS9100 startup AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
H Expanding our business and the implications to our QMS Manufacturing and Related Processes 2
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2

Similar threads

Top Bottom