Section 4.10 - Inspection & Testing: Applicability to an R&D Company?

S

Steph

#1
Good Day Everyone,

The company I work for is strictly R&D, meaning the OEM's send us product to run and we send it back, or perform lab tests. My question is, do we have to include Section 4.10 in our quality system. At this point and time our only inspection/testing of incoming product is that the lot number on the packing slip matches the gaylord lot #.

Thanks,
Steph
 
Elsmar Forum Sponsor

barb butrym

Quite Involved in Discussions
#2
you need to cover it somewhere, as it is critical....is it under customer supplied stuff? Typically 4.7 is where I would put it, and save receiving inspection for stuff you buy....even if it just ID and stock. Don't you buy test support stuff and supplies, ESD equipment, packaging stuff?

Do you do a test report? Is it reviewed (ie inspected?) before shipment back to the customer?

Step out of the box, and look in to answer this question. Inspection is many things to many people.
[This message has been edited by barb butrym (edited 06 July 1999).]

[This message has been edited by barb butrym (edited 06 July 1999).]
 
B

Brenda Mundroff

#3
Our registrar is imposing inspection and testing on us, also. As a DP-shop, we don't code the programs or test them. We just run what is given to us. If it doesn't work, we contact those who support it. Where is the in-process inspection there?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Does you registrar have other clienys which do what you do? Ask for 'references' from such a company they have registered. Call up the quality person and ask them how they dealt with it.
At this point and time our only inspection/testing of incoming product is that the lot number on the packing slip matches the gaylord lot #
If that's all you do, then that's all you address in your documentation.

[This message has been edited by Marc Smith (edited 06 July 1999).]
 
Thread starter Similar threads Forum Replies Date
A TS 16949 Section 8.2.4.1 - Layout inspection vs. QS-9000 Section 4.10.4.1 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K What to include in SOP Definitions section Document Control Systems, Procedures, Forms and Templates 3
K Why 'FD&C act section number' and 'section number' in the title of the act are different? US Food and Drug Administration (FDA) 1
M API Spec. Q1, 8th Ed. Section 7.5.2 vs. Q1, 9th Ed. Section 5.7.1.5 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
K IPC-610 Section 10.4.2.2 clarification - Distance to be measured Various Other Specifications, Standards, and related Requirements 0
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
I ISO 9001:2015 Section 9.3.2 C1 "customer satisfaction and feedback from relevant interested parties" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 section 5.3 Quality Policy - No framework for establishing and reviewing quality objectives ISO 13485:2016 - Medical Device Quality Management Systems 2
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
dgrainger MHRA - Creation of new UK Responsible Person section with added content. Medical Device and FDA Regulations and Standards News 0
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
B ISO 50001 Interpretation of section 3.3.9 (Outsourcing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C IATF 16949:2016 Section 8.5.1.2 item d) accessible for use at the designated work area(s) IATF 16949 - Automotive Quality Systems Standard 5
W Tying the need for Demand Planning to a section of AS9100/9110 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L AS9102 Form 1 Section 13 Detail or Assembly Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
eternal_atlas Section 7.8.4 Specific requirements for calibration certificates ISO 17025 related Discussions 2
T MDR on Good Laboratory Practice (GLP) - Pg 110, section 6.1 (b) EU Medical Device Regulations 1
M ASTM A6 Material Standard - Section Nominal Sizes Manufacturing and Related Processes 1
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
T Relevant internal and external communication - ISO 9001:2015 section 7.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y IEC 62304 Section 4.3(a) - 100% probability of failure IEC 62304 - Medical Device Software Life Cycle Processes 3
C AIAG's IATF 16949 section 7.1.5.1.1 - Torque MSA Requirement Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
C Applicability of ISO 9001:2015 Section 8.5 - Engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Documented processes required by IATF 16949 section 4.4.1 IATF 16949 - Automotive Quality Systems Standard 1
L AS9100D Requirements vis-a-vis Section 8.5.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Q ISO 9001, section 4.3 Determining the scope of our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Ajit Basrur Looking for examples of "User Training" - ISO 13485 section 7.2.1 d) ISO 13485:2016 - Medical Device Quality Management Systems 6
J NADCAP NDT (specifically RT) - Checklist AC7114 Rev. K, section 8.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Medical Device Accessories - Health Canada - CMDR Section 21 Canada Medical Device Regulations 1
R Background of Annex X section 1.1d of MDD 93/42/EEC EU Medical Device Regulations 74
WCHorn Rendering Scrap Unusable before Disposal (AS9100D, Section 8.7) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Sam Lazzara Preferred Location for Revision History Section in Documents Document Control Systems, Procedures, Forms and Templates 16
O CQE Handbook - Missing Section VII - Risk Management Misc. Quality Assurance and Business Systems Related Topics 1
T ISO 17025 Section 5.9.1 - Assuring Quality of Tests - Requirements ISO 17025 related Discussions 4
B IATF 16949 Section Clause 8.3.4.1 - Monitoring - Design and Development Input(s) IATF 16949 - Automotive Quality Systems Standard 3
J Bill of Materials required according to MDD93/42/EC Annex II Section 3.2 ISO 13485:2016 - Medical Device Quality Management Systems 5
B IATF 16949 Section 8.5.1.5 (Total Productive Maintenance) IATF 16949 - Automotive Quality Systems Standard 19
B Calibration/Verification Records - IATF 16949 section 7.1.5.2.1 f) IATF 16949 - Automotive Quality Systems Standard 6
B TS16949 Section 8.2.2.3 Product Audit - Requirements for various Customers IATF 16949 - Automotive Quality Systems Standard 10
M Complying with AS9100 D Section 8.4.3 m. Ensuring that persons are Aware of... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
S ISO9001:2015 Section 4.4.1 - Support Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q ISO 9001 Section 7.6 - Computer Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R OHSAS 18001:2007 Section 3 - Controlling Work Place Risks Occupational Health & Safety Management Standards 3
K ISO 9001:2015 Section 8.5.3 - Property belonging to customers or external providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Salt Bath Probe Style SAT requirement Waiver per AMS 2750 Rev E Section 3.4.7 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1

Similar threads

Top Bottom