Scope and Exclusion of 7.3 - No Product Design - 7.3.1.1 Multidisciplinary Approach

L

lday38

#1
My company does not design product, am I correct in the assumption that we can exclude 7.3.1 from TS16949 but not the the 7.3.1.1 mutidisciplinary approach,and more in particular 7.3.2. design and development inputs? Would 7.3.2 design than refer to the tools and machines to make the product?
 
Elsmar Forum Sponsor
J

Jimmy Olson

#2
If your company does not design product than you can exclude all of 7.3 instead of limiting yourself to portions of it. Just put something in your manual that indicates you are excluding 7.3 and the reason and justification why.
 
L

lday38

#3
no inputs or ouputs -manufacturing process

Well that is good news. Thank you I thought I would at least have to document those requiremnts for the manufacturing process. It seems to be that the tool design and the station in which they are put in the press would have to be part of the design concept.
Would I have to document these requirments at another section?
 
D

Don Wood - 2011

#4
Permissible Exlcusions - Clause 7.3

Iday, take a good look at clause 1.2 of TS 16949:2002 (TS2) and the "IATF Guidance to ISO/TS 16949:2002", clause 7.3. The only clauses that can be excluded in their entirety is 7.3.2.1 (Product design input) and 7.3.3.1 (Product design output). All the other requirements of clause 7.3 are applicable to the design and development of an organization's manufacturing process. This includes 7.3.2 (Design and development inputs) and 7.3.3 (Design and development outputs), where the expectation is that one should substitute "Process" for "Product" in the ISO clauses.

Manufacturing process design CANNOT be excluded. This is clearly spelled out in clause 1.2 of TS2, and emphasized in the note under clause 7.3. Tool design cannot be excluded either, as tooling design clearly has a significant impact on the manufacturing process.

Take heart though - documented procedures are NOT required, but you are expected to comply with your customer's requirements for quality planning and product approval.

Hope this helps, and good luck on your transition efforts!
Don Wood
Deosil Management
Licensed Plexus Trainer/ ISO/TS 16949:2002 CB Auditor Examiner
 
Thread starter Similar threads Forum Replies Date
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
I ISO 9001 Scope - Exclusion of Design in an engineered solutions company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
P ISO9001 Scope Exclusion Verification in a Design Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
H New Multiple Sites - Scope Change or Exclusion(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Casana Exclusion of 8.3 for Design only scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
I Restricting scope to one part number for one customer IATF 16949 - Automotive Quality Systems Standard 6
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
S F-108 Request for Expansion of Scope of Accreditation ISO 17025 related Discussions 2
S Scope of management review ISO 13485:2016 - Medical Device Quality Management Systems 5
D Do all products fall under scope of AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
M AS 9100 Scope for Repair Station with PMA approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
Stefan Mundt Split Scope = Separate Audits ??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Kap.4.3 Determining the scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
G Why are 17025 scope angle measurements limited to 5 to 85 degrees? ISO 17025 related Discussions 2
3 Scope question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Internal Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 10
T How to handle out-of-scope activities. ISO 13485:2016 - Medical Device Quality Management Systems 7
Enghabashy Supply chain main policies ,scope, risk assessments & relavant KPI Supply Chain Security Management Systems 2
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Can outsourced processes be excluded from QMS scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D IATF 16949 M&TE Laboratory scope IATF 16949 - Automotive Quality Systems Standard 7
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
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 4
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 19
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 13485 Scope ISO 13485:2016 - Medical Device Quality Management Systems 7
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 3

Similar threads

Top Bottom