Implications of Dropping ISO 9001 Certification

B

blah01

Involved In Discussions
#1
#1
Our company is considering dropping its ISO 9001 certification while we are in the middle of a 3-year cycle; we just had our re-certification audit a couple of months ago. Since we've met our obligations for the audit this year I'm assuming our certificate is still good until the registrar calls us for the next audit next year, when I plan to let them know we no longer require ISO 9001 certification upon which they'll revoke our certificate.

Are there any implications from the perspective of our registrar we should be aware of? Could there be any penalties of any kind we should consider?

I would appreciate any insights/advice on this.

Thanks.
 
Paper to QMS ad
Elsmar Forum Sponsor
G

GunLake

Involved In Discussions
#2
#2
If it's in the middle of the 3 year cycle they may try to fight you for the money, every registrar is probably different but we dropped a 17025 cert and they wouldn't let go about the money, We just paid them and asked to not renew after the cycle.
 
JoshuaFroud

JoshuaFroud

Involved In Discussions
#3
#3
There is no real impact regulationwise dropping it mid cycle. You will probably want to review the contact you signed with you registrar as that is highly likley to have a clause covering early terminiation and detail any penalties within.
 
T

try2makeit

Quite Involved in Discussions
#4
#4
Also look at your Customers. How many are requiring at a minimum ISO certification and need to be notified once you drop the ISO cert.
 
B

Big Jim

Trusted Information Resource
#5
#5
On the side of the coin of not having a certificate, I recently helped a company gain AS9100D certification after their prime customer cut them off until they got certified. Loosing the lion's share of business was driving them toward bankruptcy. They thought they didn't have much competition.
 
B

blah01

Involved In Discussions
#6
#6
Thanks for the feedback.

We have no customer requirements driving the need for certification. We thought a couple of years ago we needed the certification to enter the EU market but having learned from this, we don't actually need the certificate given that the regulation allow our class of product to simply self-declare compliance.

Our registrar's rules don't mention anything about early termination from us so we are probably OK.

Thanks again.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
H Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Informational TGA – European implementation of Medical Device and IVD Regulations – Implications for Australia Medical Device and FDA Regulations and Standards News 0
M Automatic Data Gathering Requirements and Privacy Implications Medical Information Technology, Medical Software and Health Informatics 0
B Manufacturing Company Address Change - implications for FDA Other US Medical Device Regulations 1
M Informational TGA – Brexit – Implications for therapeutic goods in Australia Medical Device and FDA Regulations and Standards News 0
M "Minor" Address Change Implications on Product Labeling Requirements Misc. Quality Assurance and Business Systems Related Topics 2
M New Canadian Safety Standard? SPE 3000 - What are the implications? Canada Medical Device Regulations 1
M Implications of an import detention Other US Medical Device Regulations 3
S Change of Medical Device Company Registered Address - Implications Quality Manager and Management Related Issues 3
M CE Mark outside of Europe - Implications EU Medical Device Regulations 4
M What the FDA considers a Prescription Device - Decisions and Implications Other US Medical Device Regulations 18
S What are the implications of a major NC during a TS 16949 surveillance audit? IATF 16949 - Automotive Quality Systems Standard 3
K Business Impact Analysis Questionnaire - Financial Implications Business Continuity & Resiliency Planning (BCRP) 1
K Implications of References in Documentation Document Control Systems, Procedures, Forms and Templates 4
Hershal ILAC P14 and its implications General Measurement Device and Calibration Topics 0
B Implications for CE Marking due to Device Modifications by the Purchaser CE Marking (Conformité Européene) / CB Scheme 1
bobdoering Myth or Mythunderstanding: Implications of the Economic Design of Control Charts Statistical Analysis Tools, Techniques and SPC 1
T Implications on the Legal Status of the "Declaration of Conformity" EU Medical Device Regulations 6
M TS 16949 and its HR Implications - Job Descriptions? Competencies? IATF 16949 - Automotive Quality Systems Standard 2
M QS9000 element 4.1.6.1 implications QS-9000 - American Automotive Manufacturers Standard 4
K ISO 9001 2000 - Implications for a small company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J The Implications of ISO9001 - Quality Improvements vs. Customer Pressure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Anyone Dropping IATF and going back to ISO ? IATF 16949 - Automotive Quality Systems Standard 18
D Having got ISO 13485:2016 are you dropping ISO 9001? ISO 13485:2016 - Medical Device Quality Management Systems 8
R What does dropping ANSI Z540 Calibration Standard mean to my program? General Measurement Device and Calibration Topics 16
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
A Refusal to discuss ISO 9001 obligations... what to do? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
B Can we be ISO 9001 certified without a physical office? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
J Informational ISO 24971:2020 Released ISO 14971 - Medical Device Risk Management 0
S ISO 45001 and outsourcing the transporation of products Occupational Health & Safety Management Standards 3
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
Sidney Vianna Informational New edition of ISO 29001 released (June 2020) Oil and Gas Industry Standards and Regulations 0
R Who is the customer in the ISO/IEC 17025:2017? ISO 17025 related Discussions 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
L Combining 3 ISO 9001 registrations into 1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 7
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
N EN ISO 13640:2002 vs EN ISO 23640:2011 Other Medical Device Related Standards 1
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 0
K ISO 15223-1 Do Not Reuse and Do Not Resterilize Other Medical Device Related Standards 5
A ISO 10002:2018 Checklist Needed (Complaints Handling) Customer Complaints 5
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
Similar threads
Top Bottom