How to set quality objectives of R&D outsourcing - Examples please

P

Pauling

#1
Dear all,

Nice to meet you!:)
We got the ISO 13485 certificate including design and development, production and distribution.However we only play the role of distributor and R&D Outsourcing.We strongly want to keep the D&D scope of certificate,so we keep R&D Dept..
But how to set the quality objectives of R&D outsourcing to make it reasonable and implemented?
Forgive my poor english and pls help to comment!
Thanks in advance!
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: how to set quality objectives of R&D outsourcing

Dear all,

Nice to meet you!:)
We got the ISO 13485 certificate including design and development, production and distribution.However we only play the role of distributor and R&D Outsourcing.We strongly want to keep the D&D scope of certificate,so we keep R&D Dept..
But how to set the quality objectives of R&D outsourcing to make it reasonable and implemented?
Forgive my poor english and pls help to comment!
Thanks in advance!
Welcome to the Cove. ;)

I am not an expert on ISO 13485, but I would think that the objectives would need to be determined by the Organization. They also need to be measurable, in my opinion.

Look at the Objectives as a Goals for the Organization to accomplish and lines up with the Policy of the organization.
 
S

SteveK

#3
Re: How to set quality objectives of R&D outsourcing-Examples please

Hi Pauling,

One example could be (as used by our company):
“That all manufactured products meet the required customer specification and that they comply in accordance with the relevant Regulatory and/or International Standards.”
Measures of this can be any complaint feedback, customer questionnaires, auditing etc.

Even if you are 'just' a distributor you will be the contact point for (dis)satisfied customers.
 
D

Duke Okes

#4
Re: How to set quality objectives of R&D outsourcing-Examples please

Who are the customers of the R&D process and what would they measure about it? Who owns the R&D group and what measures of performance do they care about? What should the R&D group be doing in the future?

Once you know the performance measures that are applicable then you can better decide what objectives/targets would be useful.
 

Colin

Quite Involved in Discussions
#5
Re: How to set quality objectives of R&D outsourcing-Examples please

I think it is worth evaluating why objectives are required (other than because the standard says so) before deciding what they should be.

Objectives are often used to drive improvement (or at least conformance) so what do you want to improve? Is it time taken to fulfill a design, adherence to requirements, reduction in required design changes, etc. Once you have identified what needs improving you can set an objective.

The next step is to evaluate current performance, decide by how much you can/want to improve and attach a value to your objective. Then establish a strategy to achieve the objective. Continue to monitor and measure which will tell you if you are on track or not.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#6
Re: How to set quality objectives of R&D outsourcing-Examples please

Here is ISO9000 definition of Quality Objective:

ISO9000 said:
quality objective

something sought, or aimed for, related to quality (3.1.1)

NOTE 1 Quality objectives are generally based on the organization's quality policy (3.2.4).

NOTE 2 Quality objectives are generally specified for relevant functions and levels in the organization (3.3.1).
 
Thread starter Similar threads Forum Replies Date
S How to set Quality Objectives for Relevant Functions Misc. Quality Assurance and Business Systems Related Topics 7
B Activities to Realize Set Quality Objectives and Business Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
bio_subbu Re: How to set Quality Objectives for our Quality Management System? ISO 13485:2016 - Medical Device Quality Management Systems 11
A Quality Objectives is there a set number to have? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Training Employees about Quality - Philosophy / Mind set Misc. Quality Assurance and Business Systems Related Topics 1
4 Quality vs Production on CMM Set Up Requirements Manufacturing and Related Processes 1
F How to set-up a Dual Company QMS (Quality Management System) Quality Manager and Management Related Issues 2
C Has anyone here set up a Quality Clinic? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
A Quality Assurance Set up in Telco operator - Constraints Document Control Systems, Procedures, Forms and Templates 3
D How to set my quality dimension yearly target based on prior years data? Statistical Analysis Tools, Techniques and SPC 3
M Quality estimation of one and an entire set of elements Statistical Analysis Tools, Techniques and SPC 2
C What is the right method to set quality goal? Goal Setting 10X (68% improvement) Quality Tools, Improvement and Analysis 0
R Hired to set up a First Article Test Lab on base - 17025 Quality System? ISO 17025 related Discussions 3
Marc The Sub-Set of Quality Tools Quality Tools, Improvement and Analysis 4
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
G CE marking of MD and IVD set EU Medical Device Regulations 3
J How to Set Microbial Limits in Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 3
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
B Set RH spec from dewpoint spec General Measurement Device and Calibration Topics 2
S Is Optical Parallel Set required calibration? ISO 17025 related Discussions 1
R Gauge R&R on pre-set torque wrench Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A How to set up Continuous CpK monitoring of an injection mold process Reliability Analysis - Predictions, Testing and Standards 7
N Internal Audit Schedule – Who gets to set the schedule? Internal Auditing 16
G Comparing Gauge Blocks - Translating the calibration between the master set and the QA set General Measurement Device and Calibration Topics 2
L How to evaluate the process capability of a data set that is non-normal (cannot be transformed and does not fit any known distribution)? Capability, Accuracy and Stability - Processes, Machines, etc. 12
N When to record values if a spec for a mfg process is set Manufacturing and Related Processes 3
Marc Time Zone - Set your Time Zone Elsmar Xenforo Forum Software Instructions and Help 1
D As a newcomer to QMS, I really appreciate how ISO is set up. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C IATF 16949 Cl 8.5.1.3 - Verification of job set up IATF 16949 - Automotive Quality Systems Standard 4
D How to set equipment calibration/verification criteria General Measurement Device and Calibration Topics 1
S GRR on ID with set of pin gauges Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
G What to Check - Set Up vs. In Process Inspections Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
N The known set of all root causes Nonconformance and Corrective Action 11
G What degrees of freedom means in uncertainty budget and how do I set the value Measurement Uncertainty (MU) 2
D What is the exact Temperature Coefficient Value to be set on a Conductivity Meter? General Measurement Device and Calibration Topics 2
renenatasha MDD Classification for Pressure Monitoring Set CE Marking (Conformité Européene) / CB Scheme 1
U Are all manufacturers required to set up eMDR system? Other US Medical Device Regulations 4
S Gage Block Verification or buy a new set (cost aspect) General Measurement Device and Calibration Topics 1
E How to use the Standard Error and how to set the error limits? Reliability Analysis - Predictions, Testing and Standards 2
C Implementing a set of bore gages at a machine Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
S How to set up the Accupoint 2 ATP sanitation monitoring system Quality Assurance and Compliance Software Tools and Solutions 1
L How do I set a limits to cfu in an ISO class 7 Clean Room? ISO 13485:2016 - Medical Device Quality Management Systems 2
A What is the definition of Installation that requires Record Keeping vs Set-up 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
G AS9120 - What should we be expecting once we set forth into becoming certified? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C ISO 9001:2008 Audit Major Finding - Dial Calipers not set to zero ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A IEC 60601-2-24 Question: Free Flow Clamp on Set? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Lowest Acceptable Grade for Master Gage Set Calibration and Metrology Software and Hardware 1

Similar threads

Top Bottom