SBS - The Best Value in QMS software

Is a letter of intent on file good enough for audit considerations?

R

Ron Dooley

#1
#1
Since out side labs have until Jan 2001 to meet either A2LA, ISO Guide 25 or equivalent is a letter of intent on file good enough for audit considerations?

I not what is the criteria?
 
Elsmar Forum Sponsor
R

Ron Dooley

#3
#3
Sorry about tthe lanquage I was asking what is the criteria?

Apparently the letter of intent was suggested by our Auditor and I was told to comply.

I have called the service agencies I do business with and have notified them that I will require the letter of intent.

All of the service companies have responded stating that they intend to meet the standard by the deadline of Jan. 2001.

This apparently doesn't satisfy my boss he has instructed me to inform them that he requires a letter from the registrar they plan on using before our audit in mid April.

Again thanks for your help on this issue..
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
#4
This apparently doesn't satisfy my boss he has instructed me to inform them that he requires a letter from the registrar they plan on using before our audit in mid April.
Click to expand...
Your boss is asking for more than the registrar. Does your boss have pointy hair? Oh, well, that's why, in large part, I'm independent. Sorry I can't help with pointy haired bosses.
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
#6
The bottom line is the requirement is being interpreted by the registrar's auditor - the spec is too vague. If I was auditing, I would take ISO9002 registration as sufficient evidence.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P Letter to file or special 510k or traditional 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
E Covering letter to CDSCO Other Medical Device Regulations World-Wide 2
G Rework, Reprocess, or Correction - A simple blurred letter on the legible etching ISO 13485:2016 - Medical Device Quality Management Systems 4
D FDA De Novo Cover Letter - What is expected US Food and Drug Administration (FDA) 3
M Informational US FDA – Programmable CSF Shunts and Magnetic Field Interference with Implanted Hearing Devices – Letter to Health Care Providers Medical Device and FDA Regulations and Standards News 0
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
M Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR) Medical Device and FDA Regulations and Standards News 0
T Change to the FDA cleared device (ours) - Submission or Letter to file? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M FDA News USFDA – Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) – Letter to Health Care Providers Medical Device and FDA Regulations and Standards News 0
R IATF Exemption Request Letter IATF 16949 - Automotive Quality Systems Standard 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
P Notify Registrar of Escalation letter IATF 16949 - Automotive Quality Systems Standard 1
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
K Letter to file vs Special 510 for additional accessory in orthopaedic kit Other US Medical Device Regulations 1
E What is the general time line to prepare for IATF Letter of Conformance? IATF 16949 - Automotive Quality Systems Standard 1
J Do I need a letter to file? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Sample of an end-use-letter for drugs according to FDA requirements US Food and Drug Administration (FDA) 2
R Sterilization Adoption - Design House - Adoption Letter from Contract Manufacturer EU Medical Device Regulations 3
E Customer Letter/Notification - Is it a field action? Other US Medical Device Regulations 4
L When FDA receives an MDR from user and sends a letter to the manufacturer Other Medical Device and Orthopedic Related Topics 3
H Most Poorly Written FDA Warning Letter Ever? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
J FDA 483 Warning Letter for use of Calipers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
T FDA Form 483 Warning Letter - What next? US Food and Drug Administration (FDA) 7
S FDA Warning Letter Remediation - Enforcement Resolution & Remediation Process US Food and Drug Administration (FDA) 3
L Warning Letter adressed to owner/operator or facility? US Food and Drug Administration (FDA) 1
J How I should format a SCAR Cover Letter? SQE asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
P Questions on CLIA (Clinical Laboratory Improvement Amendments) waived letter Other US Medical Device Regulations 4
AnaMariaVR2 Agila Specialties Private Limited Warning Letter US Food and Drug Administration (FDA) 0
J Help I need your opinion on a News Letter Misc. Quality Assurance and Business Systems Related Topics 15
S FDA Warning Letter on Medical Device Reporting Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Z AS9100 Clause 7.4.2.d Revision Letter Flow Down to Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
B Does anyone have a Type II DMF Example of a LOA (Letter of Authorization)? US Food and Drug Administration (FDA) 4
AnaMariaVR2 Jubilant HollisterStier General Partnership [warning letter] US Food and Drug Administration (FDA) 1
M FDA Warning Letter - Product Association with Search Engine Results - Problems Ahead? US Food and Drug Administration (FDA) 10
R FDA 510(k) Cover Letter Contents US Food and Drug Administration (FDA) 2
Wes Bucey Value of a good cover letter Career and Occupation Discussions 0
S Similar Medical Devices - 510k versus Letter to File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A 483 Response Letter - Are there any Special Formal or Content related Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
AnaMariaVR2 Warning Letter to Fercy Personal Care Products - company kicked out FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
insect warfare Letter to Tech Support Funny Stuff - Jokes and Humour 5
A FDA 483 Warning Letter Response Time Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
AnaMariaVR2 FDA writes up Warning Letter to British Homeopathic Drugmaker US Food and Drug Administration (FDA) 0
R Dealing with Device/Design changes by a "Letter to File" vs. 60601 Retesting IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
F Haz-Mat Letter example wanted Federal Aviation Administration (FAA) Standards and Requirements 1
F FAA Letter of Need to establish Continuing Need Federal Aviation Administration (FAA) Standards and Requirements 1
Y Siemens Healthcare - FDA Warning Letter Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom