Requirement for manufacturing process validation in IATF 16949

morteza

Trusted Information Resource
#1
Hello all,

I am searching a requirement for manufacturing process validation in IATF 16949 standard.

Based on “design and development” definition in ISO 9000:2015 (clause 3.4.8), it seems that the scope of clause 8.3.4.2 (Design and development validation) includes manufacturing process validation.

Is it right?

Thanks
 
Elsmar Forum Sponsor

morteza

Trusted Information Resource
#3
Do you mean ISO 9001?
Hi Marc,

I mean the definition of the term "Design and development" in ISO 9000:2015.
In clause 3.4.8 of ISO 9000:2015, it has been stated:

design and development
set of processes(3.4.1) that transform requirements(3.6.4) for an object(3.6.1) into more detailed requirements for that object.

Note 1 to entry: The requirements forming input to design and development are often the result of research and
can be expressed in a broader, more general sense than the requirements forming the output(3.7. 5) of design
and development. The requirements are generally defined in terms of characteristics(3.10.1). In a project(3.4.2)
there can be several design and development stages.

Note 2 to entry: In English the words “design” and “development” and the term “design and development” are
sometimes used synonymously and sometimes used to define different stages of the overall design and development.
In French the words “conception” and “développement” and the term “conception et développement” are sometimes
used synonymously and sometimes used to define different stages of the overall design and development.

Note 3 to entry: A qualifier can be applied to indicate the nature of what is being designed and developed
(e.g. product(3.7.6) design and development, service(3.7.7) design and development or process design and
development
).
 

Howard Atkins

Forum Administrator
Staff member
Admin
#4
The standard specifically states

4.3.1 Determining the scope of the quality management system - supplemental
The only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001, Section 8.3. The exclusion shall be justified and maintained as documented information (see ISO 9001; Section 7.5).
Permitted exclusions do not include manufacturing process design.

Following this the only clauses excluded are in fact
8.3.2.2 Product design skills ....
8.3.3.1 Product design input ...
8.3.5.1 Design and development outputs - supplemental

8.3.4.2 Design and development validation
Design and development validation shall be performed in accordance with customer requirements; including any applicable industry and governmental agency-issued regulatory standards. The timing of design and development validation shall be planned in alignment with customer-specified timing; as applicable.
Applies to all for both product (if not excluded) and process for all
 

AMIT BALLAL

Super Moderator
#5
Hello all,

I am searching a requirement for manufacturing process validation in IATF 16949 standard.

Based on “design and development” definition in ISO 9000:2015 (clause 3.4.8), it seems that the scope of clause 8.3.4.2 (Design and development validation) includes manufacturing process validation.

Is it right?

Thanks
The requirement of Process validation is addressed in 8.5.1(f) clause of IATF16949:2016 standard.

8.3.4.2 is for validation of design and development (Such as simulation).
 

Howard Atkins

Forum Administrator
Staff member
Admin
#7
There are 2 separate issues here

As there is a requirement for PRODUCT and PROCESS design both of these design functions MUST be validated as defined in 8.3
There is another requirement

8.5.1 Control of production and service provision
here there is a requirement
f ) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;

In TS the requirement included all manufacturing

7.5.2.1 Validation of processes for production and service provision — Supplemental
The requirements of 7.5.2 shall apply to all processes for production and service provision.


There is no longer a distinction between the standards due to the change in the manner that the requirement is written and the requirements is
8.5.1 Control of production and service provision NOT Validation of processes for production and service provision
 
Thread starter Similar threads Forum Replies Date
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
I Room Identification within Manufacturing Facility - Is there a Requirement? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L What is the TS 16949 requirement for Back-Up Manufacturing plant? Supplier Quality Assurance and other Supplier Issues 5
Q Elements Of Manufacturing - New Chysler Requirement IATF 16949 - Automotive Quality Systems Standard 1
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
H FAI Requirement After Moving CNC Machine? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Biocompatibility requirement for electrode adapters Other Medical Device Related Standards 1
briteme4 AS9102 FAIR Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Put on escalation by customer? is there a requirement to notify registrar? IATF 16949 - Automotive Quality Systems Standard 6
E Translation requirement labels EU Medical Device Regulations 4
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K ROHs compliance requirement REACH and RoHS Conversations 1
E Language requirement DoC EU Medical Device Regulations 3
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 13
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 8
J When PPAPs are not a contractual requirement APQP and PPAP 9
I Overwhelmed with attribute MSA requirement for visual inspection IATF 16949 - Automotive Quality Systems Standard 8
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
A The requirement of the PMS plan--suitable indicators and threshold values EU Medical Device Regulations 0
S Battery powered device - electrical protection requirement IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1

Similar threads

Top Bottom