ISO Elements

M
#1
We are working on becoming ISO 9000 compliant. We're using the ISO 9001:1994 standards. We're a software consulting group. We provide a service to our customers; we do not create products (our contractors are our product). We find contractors/consultants for our customers. Our full-time staff consists of 6 employees. Currently, we have approx. 10 contractors.
Now my question:
After reading and reading the standards, I have concluded that only 9 of the 20 elements really apply to our business. Is this o.k? Can we say that the other elements just don't apply to us and still become ISO 9000 certified?
 
Elsmar Forum Sponsor
A
#2
I am quite sure that most of the 20 elements do apply.

Management needs to review the system; Contracts with customers need to be established and reviewed; Documentation and Data needs to be controlled; You purchase the services of the contractors and consultants, and any product used for the outcome of the service quality you provide; Identification and Traceability of the service (tracking contractors, consultants and their projects; the service processes, outlining what is indicated in the standard;.
4.10 could be addressed in a number of ways, for instance: inspection and verification of the consultants and contractors (how do you determine the criteria for using a contractor or consultant, verifying their references, application, portfolios,etc.)Keep in mind this element ties in with 4.6.
Element 4.10 can be tied in with Test Status, Verification Status, etc. Nonconformance for service problems requiring a disposition; Corrective Action for systemic problems requiring a Corrective Action Plan; 4.15 take into consideration how your company delivers the services you provide to your customers, etc.; records need to be kept, Internal Quality Audits need to be conducted; training will need to be established for the owners/management and other full time personnel of the
company; servicing if you guarantee any aspect of your work.
Statistical Techniques could be the trends and analysis you identify from tracking nonconformances, corrective actions, customer complaints, etc.

If you are just starting outwith your ISO Project, I suggest you identify your processes and sub-processes, then when you have a true picture of your business as it is take and line the processes against the ISO elements and go from that point to fill in any deficient areas.

You may also want to consider ISO 9001:2000, which is due out December,28,2000.

Service areas can actually be great fun in both documenting and implementing, especially if you are creative.

awk
 
J

Jim Triller

#3
A product is the output of a process. Your product is the service you provide to your customers - to find them contractors/consultants that meet their needs.

I have implemented an ISO 9002 registered system for a service company that has one employee and uses several subcontractors. Only one element, Control of Inspection, Measuring and Test Equipment, did not apply. I suspect that if you want your company to be fully compliant the same might hold true for your organization.

Please feel free to contact me via email if you have specific questions on how the elements may apply to your situation.
 
R

Rick Goodson

#4
In a word, no.

Assuming you are looking at ISO 9000 registration, you will need to register under the new revision ISO 9000: 2000 (standard to be issued December 15, 2000). There is an exclusion allowance, but only for items in clause seven, Product Realization. Even within clause seven there are sub clauses I believe will apply to your organization. By the way, I believe that your product is not your contractors but the service of determining customer needs, contractor capability and linking the two. Depending on the contractual arrangements with both your contractors and your customers, the software that is provided may be part of the product you supply under ISO.

Shifting back to ISO 9001: 1994, at a minimum I see 13 elements that apply without spending to much time thinking about it:

4.1 Management responsibility
4.2 Quality System
4.3 Contract review
4.4 N/A
4.5 Document and data control
4.6 Purchasing (maybe, need to understand your business, could be qualification of the contractors under the concept of a approved supplier list)
4.7 Control of Customer Supplied Product (this can be interpreted to include intellectual property your customers provide so you can source the software contractors)
4.8 N/A
4.9 Process Control
4.10 Inspection and Testing (Could be interpreted to be qualification of the contractors)
4.11 N/A
4.12 N/A (could apply depending on the definition of your product)
4.13 N/A (could apply depending on the definition of your product)
4.14 Correctine & Preventive Action
4.15 N/A (could apply depending on the definition of your product)
4.16 Control of Quality records
4.17 Internal Quality Audits
4.18 Training
4.19 N/A
4.20 Statistical techniques

I am sure some of the other forum contributors will have comments as well.

Hope this helps.
 

Marc

Fully vaccinated are you?
Leader
#5
Originally posted by MRW:

After reading and reading the standards, I have concluded that only 9 of the 20 elements really apply to our business. Is this o.k?
What elements do you believe do not apply? Why? That's what the auditor is going to ask.
 
Thread starter Similar threads Forum Replies Date
T Should the Internal audit for ISO 9001 cover all elements of the standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
E Auditing to ISO 9001:2008 Elements Internal Auditing 3
A ISO 13485 Internal Audits Must Cover All Elements of QMS? Internal Auditing 13
L What are the seven elements of the "DO" section of ISO 14001:2004 ISO 14001:2015 Specific Discussions 15
G Does ISO 17025 and Z540-3 cover all the elements of ISO 10012? ISO 17025 related Discussions 2
G Does ISO 17025 Cover the elements in MIL-STD-45662A? ISO 17025 related Discussions 5
R ISO 14001 Clause 4.4.4c - Interaction of Main Elements: How to Demonstrate? ISO 14001:2015 Specific Discussions 4
S Control of Non-Conforming Product - Report to do about ISO elements Nonconformance and Corrective Action 2
Raffy Statistical Process Control - ISO 11462-2:2001 Key elements of an SPC System Statistical Analysis Tools, Techniques and SPC 1
C Does anyone have a flowchart relating all the QS (ISO) elements? QS-9000 - American Automotive Manufacturers Standard 2
Q KPI rules for ISO 9001 first certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Ed Panek Auditor Feedback ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
K Help with ISO 14971: Benefit-Risk Analysis ISO 14971 - Medical Device Risk Management 1
A ISO 80601-2-30 - the rated range of cuff pressure in the IFU Other Medical Device Related Standards 0
V ISO 17025 Accreditation Consulting Needed ISO 17025 related Discussions 1
S ISO 13485 certification training Training - Internal, External, Online and Distance Learning 1
B New to ISO 14971. Comparing to MIL-STD-882 ISO 14971 - Medical Device Risk Management 7
Sidney Vianna Informational ISO Net Zero Guidelines - Free Download Sustainability, Green Initiatives and Ecology 4
Sidney Vianna Tesla Lacks Major Automotive Quality Certifications such as IATF 16949 and ISO 9001 IATF 16949 - Automotive Quality Systems Standard 15
D Is Good Laboratory Practice (GLP) Required in ISO 17025? ISO 17025 related Discussions 4
Ed Panek ISO 13485 Reporting Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
Cats Clause ISO 9001 - verification of Tape Measures and Steel rules ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
W Looking for IATF 16949 (and ISO 17025) QMS software Suggestions Quality Tools, Improvement and Analysis 8
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
B Multisite Certification Requirements for ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 8
D ISO 27001:2022 Harmonisation Timeline IEC 27001 - Information Security Management Systems (ISMS) 3
R Process Maps for ISO 17025 ISO 17025 related Discussions 2
S ISO 9001 Quality Management System and its processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
K Becoming a Trainer for ISO/AS Lead Auditor and AATT Courses Professional Certifications and Degrees 2
M Preservation of Raw Materials in ISO 9001:2015 Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
B ISO 13485 Qualification of R&D Equipment Qualification and Validation (including 21 CFR Part 11) 1
J Recognised/reputable courses for ISO 13485 Section 7.3 (Design & Development)? Other ISO and International Standards and European Regulations 1
S ISO 14001 Operational Planning and Control - Proving evidence of communicating environmental requirements to suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
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
J Properly referencing ISO standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
Q ISO 13485 certificate needed if I go for MDSAP certification? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Informational ISO/TS 10020:2022 Quality management systems — Organizational change management — Processes Other ISO and International Standards and European Regulations 0
Ed Panek ISO 9001 Cert Scope Adjustment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P ISO 9001: Quality Management as a process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
K ISO 2859-5 (single run production) control plan issues FMEA and Control Plans 2
K ISO 17025 Method Validation and Verification for Test Lab ISO 17025 related Discussions 4
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 11
P Registrar Cancelled ISO 13485 Auditors multiple times? Registrars and Notified Bodies 1
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 17025 Lead Assessor Training ISO 17025 related Discussions 0
H Active Implantable Medical Devices - ISO 14708 and EN 45502 Other Medical Device Related Standards 0
L ISO 10993-18 vs ISO 18562-4 Other Medical Device Regulations World-Wide 4
J Iso 9001 Clause 7.1 - Advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21

Similar threads

Top Bottom