Old Internal Assessments vs New

S

shane

#1
#1
We will be finishing up our internal assessments for this fiscal year this month. We are also working the upgrade to the new standard. To comply with the internal assessments clause, do I need to complete one more round of internal assessments using the new standard before our upgrade audit?

Thanks in advance for your help,

Shane
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
apestate

apestate

Quite Involved in Discussions
#3
#3
Our registrar, Orion Registrar of Arvada, Colorado, says they would like to see three months' use of the completed system and a complete round of internal audits. They would also want to see that the corrective action process is in use and that there has been at least one management meeting according to Management Responsibility.

I think most registrars use this as a sort of standard. As I look at my board right now, I don't see anything else that won't be used on a weekly basis. I think that's probably what they mean by requiring those things. Some companies might go three months without a corrective action, for example, but they want to see one anyway.

However, I would certainly talk to a registrar soon and explain your situation. Our registrar has scheduled document review for a date three months before our registration audit, and that might be an issue as far as scheduling to meet the deadline. Also, I'm sure registrars all take a different approach and want to see certain different things.
 
L

Lisa

#4
#4
Hi Shane,

We use NQA and were required to complete a full round of internal audits to ISO 9001:2000 before our certification could be upgraded. From what I've heard this is standard.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
I Old Time Scatter diagrams for defect type and location- software Quality Tools, Improvement and Analysis 3
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
Q Old products new class - Dental Devices - Choosing tests EU Medical Device Regulations 2
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
M Interesting Discussion Curious old drawings about electrical shock and safety IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Marc Interesting Discussion The periodic table is 150 years old - March 2019 Coffee Break and Water Cooler Discussions 3
Marc Old Registered Visitors "Pruned" from the Database - 20180916 Forum News and General Information 0
Marc 200-year-old museum in Rio de Janeiro Destroyed by Fire - 2 SEPT 2018 World News 2
C Document Control - old revision vs new revision Document Control Systems, Procedures, Forms and Templates 22
Marc Adventures in Design Quality Assurance - Two-week-old Pixel 2 XL displays World News 0
A Training Program Help - Old docs, new docs, so many docs... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Canada License Amendment - Old Product to New Product Canada Medical Device Regulations 2
B Old GD&T Symbol "~" Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
L Sources for Searching Old Electronic Parts Specs (Counterfeit Inspection) Quality Manager and Management Related Issues 3
Q Modifying an old printed record? ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
G Customer wants PPAP on Old Parts to New Standards APQP and PPAP 8
A Technical File Maintenance - Old generation product EU Medical Device Regulations 4
A PUWER (Provision and Use of Work Equipment Regulations) and old machines (UK rules) Occupational Health & Safety Management Standards 4
E I'm looking for old publications of European Quality in pdf Book, Video, Blog and Web Site Reviews and Recommendations 2
J How to Retrofit an old, manual CMM Calibration and Metrology Software and Hardware 5
C Upgrading an old Supermicrometer General Measurement Device and Calibration Topics 3
S Old Medical Device Software Submission Guidance from 1998 Other US Medical Device Regulations 8
G Not quite old news: Statement of Applicability IEC 27001 - Information Security Management Systems (ISMS) 3
R IMDS time frame submission for a very old product APQP and PPAP 1
M Old software and EN 62304 - ECG software for the display of ECG IEC 62304 - Medical Device Software Life Cycle Processes 2
W Where to find the Daimler DBL 6992 10 new (old) standard Customer and Company Specific Requirements 1
P Performance Qualification of old Rapid Mixer Granulator Qualification and Validation (including 21 CFR Part 11) 2
Q IQ Requirements for Old (10 yrs) Commissioned Equipment Qualification and Validation (including 21 CFR Part 11) 2
R Covegratulations to The Cove: 18 years old! Covegratulations 3
N FDA Aspects - No Improvements to 12 Year Old Software ISO 13485:2016 - Medical Device Quality Management Systems 4
T Software that will overlay Old Revision and New Revision Print and Compare Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
M Old MSDS Sheets vs new HCS Standard - Format Requirements Manufacturing and Related Processes 18
H Digging Up Bones - Inspector Retrieving Very Old Inspection Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
V Old 510(k) with no Indication Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K Retrospective DHF for an old non-registered device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
F Receiving a new Gage Block Set with an old Certificate Calibration Frequency (Interval) 3
Randy Looky here - Check out my 9-month old Great-Grandson Hayden Coffee Break and Water Cooler Discussions 4
G Help with an old Spectrum 1000BX FTIR unit - User Manual wanted Manufacturing and Related Processes 2
M AS9100A (old revision) - Required C=0 sampling plans if sampling was used? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Using Curve Fits and Predictions in place of good old Measurements General Measurement Device and Calibration Topics 3
N What to do about very old MSDS Sheets Occupational Health & Safety Management Standards 24
C Hazards of Old Electronics Quality Manager and Management Related Issues 9
D Registrar Requesting Copies of Old Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
V We put Old plating spec on supplier prints and need to PPAP to Customer. APQP and PPAP 1
G Old Medical Device Equipment - Compliance with New or Old Standard - What to do? Other Medical Device Related Standards 3
R PPAP requests for old parts that pre-date your PPAP Process APQP and PPAP 2
N Company Name Change - Existing Inventory with Old Company Name Other US Medical Device Regulations 9
Antonio Vieira Do you still keep old numbers of Quality Progress in paper format? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 9
Roberticus Customer Returned "Old" Non-Medical Parts ISO 13485:2016 - Medical Device Quality Management Systems 1
P What do you do when a family pet is dying from old age? Coffee Break and Water Cooler Discussions 19

Similar threads

Top Bottom