ISO 9001 Cert Scope Adjustment

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#1
We are a company that has two products. One is a battery we make using thin film under our 9001 QMS. The other is a wearable temperature patch under 21 CFR and ISO 13485 as a medical device. Our battery is a critical supplier to our medical device.

We had our 9001 surv audit today and the auditor wanted to adjust our cert scope from "Design and manufacture of thin film batteries" to "Design and manufacture of thin film batteries excluding medical devices" They stated it was to prevent liability and confusion.

Myself and our CEO refused the change as it would be confusing to customers who wanted to use our battery in their medical devices. My perspective is the QMS is being audited; not the specific products we make and to add that exclusion in our scope if unfair as its only added because we also manufacture medical devices. I also stated that scopes should positively define the certificate; not exclude items from certification.

Comments?
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Leader
Admin
#2
This is a discussion to be had with the CB Technical Manager, not the auditor. In principle, I don’t see any problems for the scope of certification to be left unchanged or refined to something such as D&M of thin film batteries for medical device applications.
For the auditor to propose the exclusion when he knows the batteries are used in medical devices is preposterous and fraudulent. Apparently in his mind there is a derrière to be covered.
 

Randy

Super Moderator
#5
For the auditor to propose the exclusion when he knows the batteries are used in medical devices is preposterous and fraudulent. Apparently in his mind there is a derrière to be covered.
Or it might be part of a corrective action related to an AB nonconformity over scope specificity
 

Tagin

Trusted Information Resource
#6
They stated it was to prevent liability and confusion.
1) An 9001 QMS auditor's scope does not include legal determinations and so should not be providing guidance on what causes 'liability'. They are also presumably not a licensed lawyer, and so are on that basis also unqualified to make such arguments.
2) The auditor needs to cite a specific violation or inadequate coverage of a 9001:2015 clause. They cannot simply claim possible 'confusion'. Your scope currently adheres to clause 4.3 as far as I can see.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#7
Or it might be part of a corrective action related to an AB nonconformity over scope specificity
Even worse. Scope statements cannot be deceiving. If the batteries ARE used in medical devices, for the auditor to propose something that is contrary to that, is a fraud in my estimation. Very likely there is a concern over the ISO 9001 auditor competence to audit NACE Code 39(?) and someone is engaged in an attempt to cover their you know what.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#9
He also stated that our quality objectives cannot mention by name our only customer and that we need to keep the two QMS completely separated. For example from "Achieve less than 5% reject on (customer named product) in their production line" to "Achieve less than 5% on _ANY_ customer usage of battery."

We only have one customer; OURSELVES.
 

malasuerte

Quite Involved in Discussions
#10
He also stated that our quality objectives cannot mention by name our only customer and that we need to keep the two QMS completely separated. For example from "Achieve less than 5% reject on (customer named product) in their production line" to "Achieve less than 5% on _ANY_ customer usage of battery."

We only have one customer; OURSELVES.
Pretty bad on both takes. Your scope statement is yours alone; and fine imo. Quality objectives can most certainly have the customer named. This is the whole premise of a Foundry - multiple customers all with different requirements/quality objectives.
 
Thread starter Similar threads Forum Replies Date
E AS9100 / ISO 9001 Cert Suspended AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 28
Al Rosen American Global Standards Virtual Cert Program for ISO 9001 Registrars and Notified Bodies 12
B Does a distributor have to have an ISO 9001 cert to sell to a TS 16949 company? IATF 16949 - Automotive Quality Systems Standard 26
L ISO 9001, 14001, 45001 Audit Questions for a Security & Corporate Affairs Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
giavannatabbs ISO 9001:2015 Control of Records - QMS Communications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
H ISO 9001:2015 - 8.5.1 - Routers not being signed Manufacturing and Related Processes 5
Q Documented information ISO 9001:14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Is there a mandatory requirement to notify customers of the complaint resolution in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J ISO 9001:2015 Document Revison History ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q KPI rules for ISO 9001 first certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Sidney Vianna Tesla Lacks Major Automotive Quality Certifications such as IATF 16949 and ISO 9001 IATF 16949 - Automotive Quality Systems Standard 15
Cats Clause ISO 9001 - verification of Tape Measures and Steel rules ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S ISO 9001 Quality Management System and its processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Preservation of Raw Materials in ISO 9001:2015 Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
L Assignment on the link between Quality Gurus & ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
jeancloude17 Advice for ISO 9001 for software Design and Development of Products and Processes 2
P ISO 9001: Quality Management as a process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Iso 9001 Clause 7.1 - Advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K Applicable ISO 9001 clauses for Human Resources? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ISO 9001:2015 Registered Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
JDJohnson Micrometer & Caliper Calibration (ISO-9001) General Measurement Device and Calibration Topics 26
G Why do you guys think ISO 9001 doesn't ask specifically for preventive maintenance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
D ISO 9001:2015 Calibration Procedures Manufacturing and Related Processes 16
G Auditing Top management: 6.3 ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G IT being audited during ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Moncia Customer satisfaction monitoring - ISO 9001 and 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
Sidney Vianna ISO 9001 News ISO 9001 Design Specification to be developed - May 2022 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S ISO 9001:2015 Project Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Common items : which iso 9001 are common to all areas? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
G ISO 9001 - when implementing customer requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
V ISO 9001 or ISO 17065 required for an organization issuing 5 star rating certification of digital experience? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D ISO 9001:2015 Recertification Audit Timing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J ISO 9001:2015 Is a Project Evaluation form necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
malasuerte Performance of ISO 9001 certified vs. non-certified manufacturing companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Filling totes and pails - when is a calibrated scale / flowmeter required in ISO 9001 General Measurement Device and Calibration Topics 4
Moncia ISO 9001 calibration question please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 9001 Clause advice Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Sidney Vianna ISO 9001 News ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Management Review ISO 9001-2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
J Process capability analysis in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Use an iso 9001/2015 form for api q1 systeme Oil and Gas Industry Standards and Regulations 5
Q Which Kapt standard assignment ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Quality Awareness 7.3 ISO 9001-2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Cats Clause ISO 9001:2015 7.1.5 Monitoring and measuring resources: Application to training providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10

Similar threads

Top Bottom