Looking to certify to ISO 9001 - Any advice?


Alex Hoffman

Good afternoon dear forum users. Faced the need to certify my company in accordance with ISO 9001. Advise a good specialist!
Elsmar Forum Sponsor


Hunkered Down for the Duration with a Mask on...
Staff member
My advice is to read through existing discussions here on implementing ISO 9001 in a company - There are a lot of existing discussions. After you do, ask more specific questions you come up with, and give people here more details such as what type of company, how many employees and things like that.

A read through Implementing A Quality Management System wouldn't hurt.


Staff member
Super Moderator
Marc is quite right, of course.

I would like to toss in a few general thoughts.

First, is upper management really on board? Will they commit time (including theirs) and resources to the successful implementation of a quality-centric business? I think the most frequent failure of quality system implementations is lack of commitment from management. If they're undermining efforts (overtly or covertly), there's little chance of success.

Second, while it's quite tempting, be wary of using "canned" quality management systems. These are often written to accommodate fortune 500 companies and may not be a fit for your organization. I saw one case where the canned QMS called for more committees than the company had employees. Your QMS needs to fit your company's culture and people. Trying to shoe-horn in one that doesn't is also a path that is unlikely to lead to success.

If you take Marc's suggestion and do the searches, I'm sure you'll see these themes but I wanted to get them up front.


Quality Manager
What kind of business is it, machining or otherwise? I also encourage finding out how honestly into it top management and ownership really are. I would purchase the current revision and read through it taking notes. During that time remember to put things into the context of your organization and watch for and understand the differences between "shalls", "as applicables", and such. Then take what you all do and go from there, rather than trying to start at the standard to force it into the shop.

That's all general and not exact, but it's a starting point. And it can help you keep from getting too far into templates or what some auditors claim you have to do.


Super Moderator
Good afternoon dear forum users. Faced the need to certify my company in accordance with ISO 9001. Advise a good specialist!
Hi Alex,

We found ISO 9001 for Small Enterprises - What to do very useful when we got started some years ago. The current edition covering the 2015 version of the standard is likely even better than the earlier one we had.

Read and understand this booklet. Get your managers to do the same. Then select a local consultant with experience and recommendations. A good one will help by answering questions, leading the first few periodic meetings, and keeping you away from common mistakes. The consultant won't write your documents; your team should do that.

ISO 9001 is a great standard. Implementing it is challenging, exciting and, done right, very rewarding. As you work on your implementation, pay particular attention to your continuous improvement process. An effective CI process will polish all others over time and deliver success to your business.

Good luck! Let us know how it works out for you.
Thread starter Similar threads Forum Replies Date
D 17025 - I am looking for someone to come in and certify our laboratory equipment ISO 17025 related Discussions 1
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
blackholequasar Looking into Nadcap for the first time AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 7
K Looking for a job as Quality Engineer Career and Occupation Discussions 2
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
mihzago Looking for an Australian/ NZ Sponsor Other Medical Device Regulations World-Wide 0
S New Foreign Exporter Looking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Looking to Impress - New Job - Advice, Thoughts, Comments Welcome Career and Occupation Discussions 23
J Looking for a training organization that can provide in house DFMEA training FMEA and Control Plans 4
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
N Looking for Gamma sterilization facility in China ISO 13485:2016 - Medical Device Quality Management Systems 4
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 5
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
A New to QC, looking for resources Problem Solving, Root Cause Fault and Failure Analysis 3
bryan willemot Looking for a certified test report for aerospace parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
K I’m looking for a square probe for my linear height gauge Manufacturing and Related Processes 1
C Looking for China Good manufacturing practice China Medical Device Regulations 1
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
A We're currently looking for any studies performed on various PPE materials Qualification and Validation (including 21 CFR Part 11) 1
C Looking for APQP Training recommendations preferably in the aerospace industry APQP and PPAP 2
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
H Looking for Tips on finding an IATF consultant Consultants and Consulting 6
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
bryan willemot Looking for a good CoC to put with my certification sheets when we send parts Document Control Systems, Procedures, Forms and Templates 1
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0
K Looking for a good Six Sigma book Six Sigma 7
G Looking to move to an electronic QMS software Software Quality Assurance 11
C Looking for source of silicone contamination in ISO Class 8 Cleanroom Other Medical Device Related Standards 2
F Looking for a Japan MAH recommendation that is not too expensive Japan Medical Device Regulations 5
P Looking for Risk Assessment Template - Not necessarily Asset based IEC 27001 - Information Security Management Systems (ISMS) 1
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Looking for FMEA plastic injection molding FMEA and Control Plans 8
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
N Looking for input on the attached Process / IATF 16949 Clause Matrix IATF 16949 - Automotive Quality Systems Standard 4
Ajit Basrur Looking for a Design Transfer Checklist 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N I am looking at two Registrars Registrars and Notified Bodies 18
P ISO 14001 - Looking for a Gap Analysis Template ISO 14001:2015 Specific Discussions 3
E Usability Process - Looking for a template (IEC 62366) IEC 62366 - Medical Device Usability Engineering 1
S What are you looking for in an automated quality management system? Quality Assurance and Compliance Software Tools and Solutions 8

Similar threads

Top Bottom