Implementing ISO 13485 with an ISO 9001:2008 QMS

L

Light1

#1
We are a very small company, we have ISO 9001:9008 and we need to implement ISO 13485 Medical Devices. I have a certificate from a 12 hrs course on ISO 13485, but I am stumped on how to go about combining ISO 13485 into our current Quality Program.

:frust: Does anyone have a example format I could follow.


Any sugestions or examples on how to start?
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: ISO 9001:2008 IMPLEMENTING ISO 13485

Does anyone have a example format I could follow
Welcome to The Cove, Light1.

When you say an example format, what exactly do you mean? Conformance with ISO 9001 and 13485 requires organizations to adequate their (unique) business processes to include and satisfy the requirements of the standards. Business processes tend to be specific to each organization and there is no one-size-fits-all template.

Meaningful and value added conformance to the standards does require custom processes that lead to singular systems. So, I am not sure what you mean by example format. Sure you can get canned templates and documents, but I doubt they will really describe how your organization conducts it's processes.
 

SteveK

Trusted Information Resource
#3
We are a very small company, we have ISO 9001:9008 and we need to implement ISO 13485 Medical Devices. I have a certificate from a 12 hrs course on ISO 13485, but I am stumped on how to go about combining ISO 13485 into our current Quality Program.

:frust: Does anyone have a example format I could follow.


Any sugestions or examples on how to start?
As a start and from a documentation standpoint you will require more procedures in your QMS (look at the extra 'Shalls' in ISO 13485 over and above those in ISO 9001). I would also suggest you contact your NB for advice as well as searching the cove for info on this subject.:2cents:

Steve
 
P

phloQS

#4
Hi Light1,

The scope of ISO 13485 is a quality management system to fullfill regulatory purposes regarding medical devices (for EU: MDD 93/42). As above posters already mentioned there are more requirements in this standard always customized a bit more on medical devices. In ISO 9001 there are at least 6 procedures which must be documented. In ISo 13485 tehere are at least 17 procedures which must be documented, if they are applicable (for example sterilisation process is not a requirement for every company, but if you have one, you have to document it) Be carefull with "templates". The better way is, identify your processes, read the standard what MUST be documented and then write your procedures. Some of the things which are demanded by both standards are slightly different (for example MUST input for management review, Documentation of design and developement). In the following thread there is a list with a comparison: Comparison ISO 9001 to ISO 13485

regards

phloQS
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
T Is there any requirement to be compliant with IEC 62304 while implementing ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
E Implementing ISO 13485 in a facility that serves other industries as well ISO 13485:2016 - Medical Device Quality Management Systems 4
M Problems implementing ISO 13485 for Software-Only Medical Device Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Implementing Risk Management for Contract Manufacturers - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
R Help for implementing ISO 13485 (provision of software to Hospitals) ISO 13485:2016 - Medical Device Quality Management Systems 4
V Implementing Dock-to-Stock when regulated by ISO 13485 and 21CFR820 ISO 13485:2016 - Medical Device Quality Management Systems 12
Q How to find definitions from ISO 9001 when implementing ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 8
P Process Approach - Implementing ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 11
D Implementing ISO 13485:2003 - 8.5.1 - Advisory Notices - Recall Procedure ISO 13485:2016 - Medical Device Quality Management Systems 12
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
B Lessons Learned Implementing ISO 50001 (Chemical Engineering Progress) Other ISO and International Standards and European Regulations 0
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
G Heavy Civil Construction Company Implementing ISO 9001:2015 for Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Easy Way of "Implementing" Risk in ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N Implementing ISO 17025 in a Calibration Laboratory ISO 17025 related Discussions 8
L Implementing ISO 9001 in small Trading Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
F Implementing ISO 9001:2008 in a new Food Processing company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 22301 - Implementing a Business Continuity Management System Business Continuity & Resiliency Planning (BCRP) 15
M Implementing ISO 9001 in an Assembly Plant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
Q Implementing ISO 9001 and ISO 22000 systems at the same time Document Control Systems, Procedures, Forms and Templates 2
L Implementing ISO 27001 A12.1.1 Security Requirements Analysis and Specification IEC 27001 - Information Security Management Systems (ISMS) 2
C Implementing ISO 9001 - Getting whole team buy-in? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
M ISO 9001 - Implementing 7.3.2 - 7.3.7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Starting a Quality Department from Scratch and Implementing ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
E Implementing ISO 14298:2013 in a Company Other ISO and International Standards and European Regulations 9
S Implementing ISO 14001 in a Construction company ISO 14001:2015 Specific Discussions 3
S Implementing ISO 9001 and ISO 17025 separately or together ISO 17025 related Discussions 6
C Implementing ISO 9001:2008 in a small Sales and Service company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
C Implementing ISO 3834-2 - Keeping the organization informed Other ISO and International Standards and European Regulations 3
R EN ISO 14971:2012 - Implementing Annex Z content deviations ISO 14971 - Medical Device Risk Management 1
L How to start implementing a QMS according to ISO 17025 ISO 17025 related Discussions 5
S Implementing ISO 9001 for a small fabrication company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Implementing ISO 9001: 2008 in a Dietary Supplement Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Implementing ISO 14001 into an existing ISO/TS 16949 Quality Management System IATF 16949 - Automotive Quality Systems Standard 6
T Implementing ISO 9001 in a Home Business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Is an Initial Environmental Review a must while implementing ISO 14001 ISO 14001:2015 Specific Discussions 5
G Implementing Dual Standards in a Company - ISO 9001 & AS9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
H Implementing ISO 14001 versus Implementing ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Suggestion for Implementing ISO 9001 in a Start-Up Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Implementing ISO 9001 at our company for the first time ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R Implementing ISO 14001 - How do you Communicate to All the other Staff? ISO 14001:2015 Specific Discussions 2
R Quality Manager Training Methods - Learning and Implementing ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
A Major Software System Changes - Implementing TS 16949 and ISO 14001 IATF 16949 - Automotive Quality Systems Standard 2
B Understanding and Implementing ISO 9001 in a Small Manufacturing Business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Implementing ISO 9001 - One Department at a Time - Internal Provision Only ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
M Where to Start when Implementing ISO Standards in Rotational Molding ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Similar threads


















































Top Bottom