SBS - The best value in QMS software

Is Scope Validation required for ISO 9001?

H

hari_p

#1
Dear Cove cofriends,

We are one of the reputed companies in the middle east with interests in a wide range of the construction spectrum such as EPC( Engineering, Procurement, COnstruction), Infrastructure Project Development, Construction (Oil & Gas), Facilities Maintenance etc. Now, we had an external recertification audit conducted last month, and they successfully conducted the audit without any observations (thanks to the very sound and matured QMS we have :)), but the certification agency now have reported that the certificates could not be issued because we don't have live projects in some of the business line identified in the scope of the QMS. But how do you expect to have continued business in some domains where huge investment is involved particularly in this time of global recession. We have in the past and very recently (within a span of 1 or 2 years) succesfully completed projects in all of these domains. Is it really required to have continued live projects in all the areas identified in the scope of the QMS. Even there is no such requirement in ISO 9001. Please help.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Why not have a broader single scope that encompasses all your activities, which the CB will appreciate as well as your customers. The more you divide scope, the more specific examples the CB would look to audit to mention in the scope.
 

harry

Super Moderator
#3
............................ but the certification agency now have reported that the certificates could not be issued because we don't have live projects in some of the business line identified in the scope of the QMS. .............................
The question that you should ask yourself is whether you will issue others with a certificate to cover a scope where there are no on going projects and related documents to audit (unable to provide evidence). The answer is obvious.

Somashekar's suggestion is one possible way but why had these issues not being ironed out with your CB earlier? My CB agreed beforehand to expand my scope if we could provide auditable evidence in subsequent audits.
 

somashekar

Staff member
Super Moderator
#4
The question that you should ask yourself is whether you will issue others with a certificate to cover a scope where there are no on going projects and related documents to audit (unable to provide evidence). The answer is obvious.

Somashekar's suggestion is one possible way but why had these issues not being ironed out with your CB earlier? My CB agreed beforehand to expand my scope if we could provide auditable evidence in subsequent audits.
CB's (Lead auditor) take a lot of effort to detail the scope and get agreement beginning in the opening meeting and finalizing in the closing meeting in the presence of the Management, MR and all responsible managers, so that it is clear and to the proper benefit of the client.
 
H

hari_p

#5
The question that you should ask yourself is whether you will issue others with a certificate to cover a scope where there are no on going projects and related documents to audit (unable to provide evidence). The answer is obvious.

Somashekar's suggestion is one possible way but why had these issues not being ironed out with your CB earlier? My CB agreed beforehand to expand my scope if we could provide auditable evidence in subsequent audits.
Dear Harry,

Thanks for your informative reply. But the field we are talking about is very different from manufacturing, like manufacturing of electronic assemblies, automotive etc. When we say EPC, it would be interesting to note that only handful of EPC contracts get awarded per year globally. Therefore it is very unlikely that we get EPC contracts per year to demonstrate our compliance. Does that mean that we need to exclude such business lines from our scope? We already have demonstrated our capabilities in this field with some projects and we have the system in place to handle such works in the future. I had assumed the ISO 9001 certifies your system capability and not the product quality.
 

harry

Super Moderator
#6
I know because I carry out 'design and built' projects. I too, had plenty to show in the past but that is the past. For as long as I don't have a project in hand for my CB to audit, I don't expect to get a scope for it - otherwise it would be of no value (at least to me). And yes, because of the economic situation, I had not being able to land a new job in this field for the last few years.
 
Thread starter Similar threads Forum Replies Date
P Injection Molding Machine Validation Scope Capability, Accuracy and Stability - Processes, Machines, etc. 6
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R CB/Auditor Requiring a change in scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
H Implementing ISO22301 on a Limited Scope Business Continuity & Resiliency Planning (BCRP) 2
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
Q The scope of ISO 21534 Other Medical Device Related Standards 0
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 4
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
G APQP Scope and scale tool APQP and PPAP 2
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
C IATF 16949 - Scope or not? IATF 16949 - Automotive Quality Systems Standard 2
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
qualprod To raise a NC beyond the audit scope? Two signatures were missing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M ISO 27001 ISMS scope for companies with subsidiaries IEC 27001 - Information Security Management Systems (ISMS) 0
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
R Scope of ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 6
D Scope of Facility - Our auditor asked us last week for our "Scope of the Facility" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Scope of MRB (Material Review Board) Responsibilities Misc. Quality Assurance and Business Systems Related Topics 5
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
F API Spec Q1 Scope - Limiting the scope of certification Oil and Gas Industry Standards and Regulations 3
M How To Define ISMS (information Security Management System) Scope IEC 27001 - Information Security Management Systems (ISMS) 18
qualprod ISO 9001:2015 8.5.1 f - Scope with customer special process requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom