SBS - The Best Value in QMS software

8.7.1.4 Control of Reworked Product & 8.7.1.5 Control of Repaired Product

Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Do you have a copy of ISO 9000:2015? Definitions and explanations have been moved into that separate standard. From ISO 9000:2015:
3.12.8
rework
action on a nonconforming (3.6.9) product (3.7.6) or service (3.7.7) to make it conform to the requirements (3.6.4)

3.12.9
repair
action on a nonconforming (3.6.9) product (3.7.6) or service (3.7.7) to make it acceptable for the intended use
Intended use is what happens at point of use, or delivery to the customer. Rework is what happens in production, prior to delivery.
 
Thread starter Similar threads Forum Replies Date
T IATF16949:2016 8.7.1.4 Control of non-applicable reworked product IATF 16949 - Automotive Quality Systems Standard 3
I IATF 16949 Cl. 8.7.1.4 Control of reworked product IATF 16949 - Automotive Quality Systems Standard 2
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
D GAMP CAT 5 Change Control Qualification and Validation (including 21 CFR Part 11) 9
D Use Error Risk Controls and Control Verification ISO 14971 - Medical Device Risk Management 6
S Maintenence related action in Control plan FMEA and Control Plans 3
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
R Control Methods in Control Plan FMEA and Control Plans 4
M Design Control - Management of Electronic CAD files Design and Development of Products and Processes 11
S TSCA (Toxic Substances Control Act) PIP 3:1 RoHS, REACH, ELV, IMDS and Restricted Substances 0
S Use of Attributes Control Charts Statistical Analysis Tools, Techniques and SPC 1
U Appraiser Out of Control Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
Z AS9100 Control of Nonconforming Outputs - Rework Dispositions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 5
K Quality Control/Assurance in the Metal Industry Quality Tools, Improvement and Analysis 10
K Defining risk control measures IEC 62304 - Medical Device Software Life Cycle Processes 14
J Warehouse temperature and humidity control EU Medical Device Regulations 7
Jimmy123 IATF16949 Control Plan FMEA and Control Plans 1
D Control Number for Class III and IV devices Canada Medical Device Regulations 1
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C UDI Questions on Control Units Other US Medical Device Regulations 6
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Control-self assessment Internal Auditing 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 1
A Prototype control plan FMEA and Control Plans 2
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 4
W FMEA - Current control and occurrence rating FMEA and Control Plans 3
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 8
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
A Fabric roll inspection - What type of Control Chart to use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Monitoring and Control Instruments RoHS, REACH, ELV, IMDS and Restricted Substances 3
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
T Risks arising from control measures vs. ineffective control measures ISO 14971 - Medical Device Risk Management 11
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
T Linking Control Plans and PFMEA's FMEA and Control Plans 3
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 12

Similar threads

Top Bottom