What documented procedure in this case ...

somashekar

Staff member
Super Moderator
#1
When I have design and development in my process and the necessary documented procedure, and going along I decide to outsource the design and development process to an other ISO13485 company, what must I do with the documented procedure ?
1. Remove my documented procedure
2. Revise it to direct to the controls exercised over design and development outsourcing, which is documented elsewhere in QMS.
3. Any other opinions ?
 
Elsmar Forum Sponsor

Pancho

wikineer
Super Moderator
#2
Perhaps you can insert a first step, or a scope section, in the old procedure that reads:

"If design and development is done in-house, then this procedure applies. Else refer to 'D&D outsourcing procedure'."
 
M

MichelleN

#3
I believe you should insert in your procedure what controls you have in place in case you outsource this process (or parts of this process);
 

yodon

Staff member
Super Moderator
#4
I don't know that anything is necessary to add to your procedures. The outsourcing would fall under purchasing controls and you have to qualify your provider. Specify in the contract with them specific expectations to enable your product to remain compliant with applicable standards.
 

somashekar

Staff member
Super Moderator
#5
I don't know that anything is necessary to add to your procedures. The outsourcing would fall under purchasing controls and you have to qualify your provider. Specify in the contract with them specific expectations to enable your product to remain compliant with applicable standards.
Yes, a quality agreement is established that covers all the design and development stages, and how the responsibilities are owned and shared. This agreement further refers to project checklist, which are established for every project of a new design or design change. This also has the MDD requirements mapped.
I was tempted to remove my documented procedure. However since I finally own the design process and the ISO13485 asks for a documented procedure for design and development, I revised my procedure to direct to the outsourcing controls.
Wanted to know how other people handle such a situation.
 

sreenu927

Quite Involved in Discussions
#6
Hi Somasekhar,

Although you own the design, but you are outsourcing your D&D process to a Contract mfg. So from my view, you may obsolete your procedure in case if you decide not to perform ANY Design activities at your site or keep as it is in case if you plan to do some in near future!
When the auditor inspects you, he can verify your quality agreement between your firm and the contract manufacturer (CM) where by it lists down the roles and responsibilities or controls you impose on your CM and one among them may be to follow 13485 then by default design control procedures exists and if the CM is not ISO 13485, then you need to specify that the CM has to have established process to meet design control processes and you audit them at definite intervals and this report can be reviewed by your auditor!

Regards,:2cents:
Sreenu
 
Thread starter Similar threads Forum Replies Date
J ISO 17025 Documented Procedure for 6.2.5 - Determining competency ISO 17025 related Discussions 4
Q Risk Based Thinking - Is a Documented Procedure required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
M [Student] Documented Process vs Documented Procedure IATF 16949 - Automotive Quality Systems Standard 5
Ninja What is the most useless {real} documented procedure you've seen? Coffee Break and Water Cooler Discussions 4
Q "Documented Procedure" Health Canada Canada Medical Device Regulations 8
J Can the mandatory procedures of ISO 9001-2008 be documented within one procedure? Document Control Systems, Procedures, Forms and Templates 5
J Recycling Procedure (ISO9001) - Do I need a documented process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M HACCP vs. ISO 22000 Documented Procedure requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 1
A Should the FSMS have a Documented Generic Procedure for Verification and Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
Q Core Process without a Documented Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Establish a Documented Procedure (4.2.3) vs. Establish Process (7.6) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K ISO 9001 Clause 4.2.4 Control of Records - Documented Procedure help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R Documented Procedure for the Calibration of Pulse Current Monitors/Tranformers General Measurement Device and Calibration Topics 4
T ISO 13485 Documented Data Protection Procedure Requirement ISO 13485:2016 - Medical Device Quality Management Systems 3
P Production Process deviated from Documented Procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Is a Documented Procedure required for HR (Human Resources) Document Control Systems, Procedures, Forms and Templates 39
K Must every CCP (Critical Control Point) have a (documented) procedure? Food Safety - ISO 22000, HACCP (21 CFR 120) 4
Z Does this Process need an established Documented Procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
somashekar Is a Procedure generally understood as 'Documented Procedure' Document Control Systems, Procedures, Forms and Templates 49
M Documented Procedure for Control of Nonconforming Product - Electricity Generation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
somashekar Customer Feedback System including Customer Complaints - Documented Procedure ISO 13485:2016 - Medical Device Quality Management Systems 10
K ISO/TS 16949:2009 Required Processes and Documented Procedure Requirements IATF 16949 - Automotive Quality Systems Standard 11
L Audit of an Accounting Department - No Documented Procedure for Accounting General Auditing Discussions 19
Q Consultation and Communication - Documented Procedure Required? OHSAS 18001 4.4.3 Occupational Health & Safety Management Standards 2
somashekar Documented Rework Procedure - ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
A Documented Procedure in Quality Manual ISO 13485:2016 - Medical Device Quality Management Systems 3
R Procedure for Control of Data, Documented & Electronic needed Document Control Systems, Procedures, Forms and Templates 3
S How a "Service" Nonconformance can be Documented - Nonconformance Procedure Nonconformance and Corrective Action 18
J Documented Receiving Procedure where there was none Document Control Systems, Procedures, Forms and Templates 4
C Monitoring and measurement - 7.6 of ISO 13485 - Documented procedure required? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Documented procedure for handling Verbal Orders - 7.2 and Verbal Orders IATF 16949 - Automotive Quality Systems Standard 2
Q Feedback System (8.2.1) - Requirements for "..establishing a documented procedure..." ISO 13485:2016 - Medical Device Quality Management Systems 5
S NCR under MDD - No documented procedure for class I device registration mechanism ISO 13485:2016 - Medical Device Quality Management Systems 2
B ISO 13485 Calibration Requirements - Requiring a Documented Procedure for control? ISO 13485:2016 - Medical Device Quality Management Systems 8
Q ISO 9001 / ISO 13485 - What is considered a 'documented' procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
R Procedure Request for the six 'must have' documented procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D 14001 Documented Procedure Requirements ISO 14001:2015 Specific Discussions 2
Q Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Missing routers/documented information Nonconformance and Corrective Action 5
K AS9100D Clause 7.5.2.a) - What is considered to be "documented information"? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
Q AS9120 7.5.3.2 Control of Documented Information - Audit Nonconformance AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 20
L VDA 1 Documented Information and Retention (new revision 4, August 2018) VDA Standards - Germany's Automotive Standards 0
M Quality System Processes without Documented Procedures Document Control Systems, Procedures, Forms and Templates 39
C Significant Organizational Changes - Documented Responsibilities Document Control Systems, Procedures, Forms and Templates 4
B Documented process for type and extent of control IATF 16949 - Automotive Quality Systems Standard 6
K Documented problem solving and documented error-proofing - IATF 16949 10.2.3 & 10.2.4 Internal Auditing 7
Q Stage 1 audit observations - documented report? General Auditing Discussions 5
H Documented processes required by IATF 16949 section 4.4.1 IATF 16949 - Automotive Quality Systems Standard 1
H New IATF 16949 required Documented Processes IATF 16949 - Automotive Quality Systems Standard 5
P Retained Documented Information for Management Reviews ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Similar threads


















































Top Bottom