Quality Plan for ISO 9001 and ISO 13485 - Template or Example Needed

Z

zkoulou

#21
ISO 13485 - Template SOP and Forms needed

Hi all,

Can anybody help with the following.
I am looking for templates of standard operating procedures and forms.
Can anyone share those templates with me.
Many thanks
Zak
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#22
Re: ISO 13485 - Template SOP and Forms needed

Hi all,

Can anybody help with the following.
I am looking for templates of standard operating procedures and forms.
Can anyone share those templates with me.
Many thanks
Zak
Look here:

Procedure.

Form.

Look and pick the ones that you can use/modify....

Stijloor.
 
A

Albert dupont - 2010

#23
Hi all,

I am searching for a good example how an ISO 3834 plan is made. Can someone help me? Thank you in advance.
 
Last edited by a moderator:
D

DrM2u

#24
Hi all,

I searched through the Cove for a good Quality Plan but could not find one. Can some one share ?
Have you looked at the sample QP provided in the AIAG APQP guide manual? It is a good example that you can build on. I think it is also referenced in the PPAP manual and I think it was included in the old QS9000 manual.
 
D

Doctor D.

#26
Please refer to ISO 10005 for guidance and example of template. The standard satisfies the requirements of both ISO 9001 and ISO 13485.
Typically a Quality Plan is scaled to the entitie's quality system arrangements, resources, infrastructure, products and type of interactions, thus not one template would fit all. Good luck!
 

harry

Super Moderator
#27
Please refer to ISO 10005 for guidance and example of template. The standard satisfies the requirements of both ISO 9001 and ISO 13485.
Typically a Quality Plan is scaled to the entitie's quality system arrangements, resources, infrastructure, products and type of interactions, thus not one template would fit all. Good luck!
ISO 10005: 2005 Quality management systems -- Guidelines for quality plans

ISO 10005:2005 provides guidelines for the development, review, acceptance, application and revision of quality plans. It is applicable whether or not the organization has a management system in conformity with ISO 9001.

ISO 10005:2005 is applicable to quality plans for a process, product, project or contract, any product category (hardware, software, processed materials and services) and any industry. It is focused primarily on product realization and is not a guide to organizational quality management system planning.

ISO 10005:2005 is a guidance document and is not intended to be used for certification or registration purposes.
 
L

leonardo.m

#28
Re: Quality Plan template

You will need to be more specific on your request. Quality Plan is pretty general.
Hello Sir,
I really need your help. Our client is requiring us to submit a Quality Plan which be based from ISO 9001:2008. Our Project is to supply and install San storage to them. would you please give me an example of a quality plan. Please help.thanks in advance.
 

Jim Wynne

Staff member
Admin
#29
Re: Quality Plan template

Hello Sir,
I really need your help. Our client is requiring us to submit a Quality Plan which be based from ISO 9001:2008. Our Project is to supply and install San storage to them. would you please give me an example of a quality plan. Please help.thanks in advance.
Welcome to the Cove. :bigwave:

If you go further up this thread to this post you'll find an attachment that people seem to have found useful. You can also go to the top of the screen and click on Post Attachments List and then search for quality plans.
 
J

Julie O

#30
Re: Quality Plan Template or Example Needed

As best I can determine, ISO 13485 does not require a quality plan. However, under 7 Product Realization, there is a Note 1 that states, " A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan."

FDA's Quality System Regulation requires a quality plan "which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured." According to the FDA's Quality System Inspection Manual:
"The firm must have a written quality plan that defines the quality practices, resources and activities relevant to the devices that are being designed and manufactured at that facility. The manufacturer needs to have written procedures that describe how they intend to meet their quality requirements. For firms that manufacture devices as well as other products, there must be a quality plan that is specifically relevant to devices. Much of what is required to be part of the plan may be found in the firm's quality system documentation, such as, the Quality Manual, Device Master Record(s), production procedures, etc. Therefore, the plan itself may be a roadmap of the firm's quality system. The plan in this case would need to include reference to applicable quality system documents and how those documents apply to the device(s) that is the subject of the plan. Quality plans may be specific to one device or be generic to all devices manufactured at the firm. Quality plans can also be specific to processes or overall systems."
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
M Large Construction Project Quality Plan - ISO 9001-2008 using ISO 10006 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
A Quality Plan for Plastic Industry for ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K ISO 9001 Compliant Project Quality Plan Requirements Misc. Quality Assurance and Business Systems Related Topics 4
R ISO 17025 sufficient enough to drop ISO 10005 Quality Plan? ISO 17025 related Discussions 1
S Quality Auditing System - Audit Plan per guidance from ISO 19011 Internal Auditing 8
N Template for a Quality Plan upgrading to ISO 13485 from ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 2
J Internal Audit NC ISO 9001 Clause Mapping - Quality Objective Achievement Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P ISO 9001 in construction organization: Your thoughts (quality control plan, etc) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P Looking for Quality Plan Examples - Medical Devices - ISO 13485 Misc. Quality Assurance and Business Systems Related Topics 3
B Quality Plan for ISO 9001-2000 - Assembly and Custom Build process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Quality Objectives ISO 9001:2000 - Is an action plan required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
G What is an ISO 9000 Quality Assurance Plan? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO 9001 Quality Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M ISO 9001:2000 Process Based Internal Quality Audit Plan General Auditing Discussions 11
C Example ISO 9001 Quality Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 41
D Quality plan for moving locations ISO 13485:2016 - Medical Device Quality Management Systems 3
R Electrical contractor Project Quality Management Plan Quality Manager and Management Related Issues 1
qualprod Annual SWOT for 4.1? I plan to revise quality objectives and strategic route ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Need help on Quality Improvement Plan (QIP) Quality Tools, Improvement and Analysis 5
L Quality Manual for a Quality Plan (Manufacturing secrets?) Request Misc. Quality Assurance and Business Systems Related Topics 1
S Quality Plan at a small Medical Device Company - Is the quality plan a DMR document ISO 13485:2016 - Medical Device Quality Management Systems 6
D API 5CT Compliant Quality Plan for Manufacturing Manufacturing and Related Processes 0
Q What is a Quality Charter and how does it differ from a Quality Plan? Quality Manager and Management Related Issues 4
shimonv 21 CFR 820.20(d) says: Each manufacturer shall establish a Quality Plan 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L Quality Plan to decommission a Medical Device Facility Decommissioning and Transfer Quality Manager and Management Related Issues 1
S Quality Assurance Plan template for CNC Milling Industry AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Does a process map satisfy 21 CFR 820.20(d) (Quality Plan)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Need suggestion on Software or App for Tracking Quality Plan Status Software Quality Assurance 1
A Quality Plan - Inspection method, equipment list for inspection of a Spur Gear Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
K NPI (New Product Introduction) Quality Plan Outsourced Manufacturer/Supplier APQP and PPAP 3
L Difference between a Quality Plan and Inspection & Test Plan (ITP) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P What should a Quality Plan Include and Examples Misc. Quality Assurance and Business Systems Related Topics 3
G QMS Quality Plan Documents Software Document Control Systems, Procedures, Forms and Templates 4
M Business Plan vs Quality Plan in the TS16949 standard Benchmarking 5
I Contingency Plan that meets requirements of API Q1 Quality Management System Other ISO and International Standards and European Regulations 3
M Requirements of a TS 16949 Quality Plan IATF 16949 - Automotive Quality Systems Standard 2
R Quality Plan for Cookies and Crackers - Baking Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Quality Plan Template for producing a New Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 8
5 MDD Quality Plan Templated Wanted Document Control Systems, Procedures, Forms and Templates 2
L Electrical Cable Harness Quality Control - Sampling Plan for Pull Test Manufacturing and Related Processes 4
Z Quality Assurance Plan for Engineering Service Industry Quality Manager and Management Related Issues 1
V Improvement Plan for existing QUALITY TEAM Quality Manager and Management Related Issues 6
Q PQP (Project Quality Plan) and QCP (Quality Control Plan) Differences ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Quality Plan Revisions and Numbering ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
I Quality Assurance Business Plan & Strategy Quality Tools, Improvement and Analysis 3
C Quality Management Plan example wanted AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R Quality Manual and Quality Plan for Customer Experience ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B QCP (Quality Control Plan) from client with EN 10204 type 3.1 Material Certificates Various Other Specifications, Standards, and related Requirements 2
M What is a Quality Assurance Plan? Help with Content for a Sea Port QA Plan Misc. Quality Assurance and Business Systems Related Topics 8
somashekar Can Documents of External Origin be a Quality Plan? ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom