Where to begin to move our company towards ISO 9001 certification

J

JonLo

#1
Hello!

Let me start by saying it's really nice to find a website with so much interaction and help available.

I've been tasked to move our company towards 9001 certification. This company purchased another company that used the standard back in 2005 but most of the departments did not adapt to it.

We are a munufacturer of automotive parts.

A lot of the Documents are still available to use from back then. Do I need to do a gap anaylsis to see where I need to start?

Does anyone have a questionaire they can share with me to get me started? I didn't see anything in the forms area.

Your help is greatly appreciated!!

Jon
 
Elsmar Forum Sponsor
#2
Re: Where to begin???

Hello!

Let me start by saying it's really nice to find a website with so much interaction and help available.

I've been tasked to move our company towards 9001 certification. This company purchased another company that used the standard back in 2005 but most of the departments did not adapt to it.

We are a manufacturer of automotive parts.

A lot of the Documents are still available to use from back then. Do I need to do a gap analysis to see where I need to start?

Does anyone have a questionnaire they can share with me to get me started? I didn't see anything in the forms area.

Your help is greatly appreciated!!

Jon
Glad to have you here, Jon!

Before you start considering documents, one of the first things you should determine is if your top management are behind implementation - which normally means a level of comprehension of what their role is, what resources are needed and what it'll cost. A gap analysis might also be part of that to determine what you've got and if it's any good.

I'd suggest finding a good consultant to help you with the above. I can help as can others here.
 
I

isoalchemist

#3
Re: Where to begin???

Ask two questions: Why does your management want an ISO 9001 QMS? If you are an auto company why do you not want ISO 16949? (the auto version of 9001).

If you can't get good answers they don't understand what they are requesting, which turns your assignment into a nightmare.

Understand what the standard requires and determine your processes, then you have the gap analysis as your starting point. Remember the 9001 standard does not dictate how you must do things only that you have processes tou can defend meet the requirements. The auto standard is a bit more perscriptive, but its been too many years (revisions) since I spent any time with it.

Welcome to the Cove, its a great place for info and help.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#4
Re: Where to begin???

Do I need to do a gap anaylsis to see where I need to start?
Look at the numerous pieces of information at the ISO website page dealing specifically with ISO 9001 implementation. It is critical to emphasize from the early going that this is a MANAGEMENT system; if top management does not get involved from the implementation onset, and decide how business processes will be designed, maintained, improved and corrected to satisfy both the intent and requirements of the ISO 9001 Standard, the effort is doomed. You might even achieve certification, but you will never have a true QMS.

Good luck, and welcome to The Cove.
 
J

JonLo

#5
Yes Top Management is onboard and put me in the position to do whatever is necessary to reach the goal but will not be directly involved in setting up the system, assigning processes. ect...

As far as the type of certification..their was a previous division of the company that was purchased that was 9001 certified but kind of fell apart trying to integrate into a non ISO facility. I think thats why they want to keep the 9001 version.

We produce high performance aftermarket engine parts. Management is more concerned with a quality system in general than the type of certification we have.

Are we better off with the 16949 version even though alot of the 9001 work instructions and procedures are still being used to a certain extent?

Thanks again for all your help!
 
#6
Yes Top Management is onboard and put me in the position to do whatever is necessary to reach the goal but will not be directly involved in setting up the system, assigning processes. ect...
You may wish to revisit this with them! Are you sure they understand? "On-Board" sounds to me like they're happy for you to do it all, and tell them when the certificate arrives!

Part of an effective implementation is going to involve them, whether they like it or not! They need to know what they have to do, to be involved, to ask the right questions. I know you know them better than anyone, but this isn't sounding like a good start to me...
 

psyched1

Involved In Discussions
#7
I always start with a letter from the highest authority that states "My name is authorized to implement ISO 9001" and then have the individual expand on why its important to the company. This ensures their is an understanding between you and the powers that be.

This should be circulated to all management and posted through out the facility. I also keep one on my office wall.

The letter gives you something to point at when someone resists the change and they will. ISO 9001 is not easy. It requires a level of discipline in creating and following a structured path.
 

psyched1

Involved In Discussions
#8
TS 16949 is a requirement if you are a Tier 1 or 2 vendor if not you are adding paperwork and waste/cost to your system. For a specialty aftermarket supplier

I would suggest getting the disciplines of ISO 9001 down first.
 
H

HotRodHon

#9
A gap analysis is a good place to start. Once you see the costs associated with all the added systems, you can then get buy in from the top on paper in the form of a project budget. If they are not willing to give you a budget, it's all lip service.

Usually, I shy away from consultants, but in this case I would recommend one. Hard to perform a gap analysis without knowing the full requirements.
 
#10
You probably are not eligible for ISO/TS 16949. To be eligible you need to be currently producing parts for current use in production auto assembly. ISO 9001:2008 is where you belong.

I agree with Andy that you would be well served by using a consultant. My clients frequently tell me that they could have done it without, but it would have taken much longer and probably would not have turned out as good.

With consulting help or not, start learning all you can about the ISO 9001:2008 standard. Get a copy of the standard and read it. Take an internal auditing class to become more familiar. If they are willing to do so, get some of top management to take the class as well. The more they know and understand, the easier it will be for them to support you.
 
Thread starter Similar threads Forum Replies Date
G New to ISO 9001 - Where to begin? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
W Where to begin with an ISO 9001:2015 internal audit Internal Auditing 13
supadrai Forced into Regulatory Affairs Role - Where do I begin? Career and Occupation Discussions 4
F Where does Contact begin for Biocompatability? EU Medical Device Regulations 5
N Where to begin defining and monitoring Quality Metrics in a Machine Shop Manufacturing and Related Processes 9
J Risk Management - Where to begin? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
T Implementing a Kaizen Team - Where Should I begin? Lean in Manufacturing and Service Industries 7
R MSA (Measurement Systems Analysis) - Where to begin when setting up a system? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 14
GStough Where to begin - creating a Quality Plan for Class I Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
H Auditing Lean as a process - Where to begin? Internal Auditing 9
T Changing Existing Quality Culture/Program - Where to Begin? Misc. Quality Assurance and Business Systems Related Topics 5
M Quality program, where to begin? One man machine/mold shop Quality Management System (QMS) Manuals 13
C where 2 begin? Info Mgmt Blueprint for internal Communication & knowledge xchange Document Control Systems, Procedures, Forms and Templates 3
CarolX Where does Quality begin? Philosophy, Gurus, Innovation and Evolution 36
M Research and Development Process - Where does research end and development begin? Misc. Quality Assurance and Business Systems Related Topics 15
F Where do I begin for ISO 9K:2K? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Where did my Alignment go wrong? MCOSMOS Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
Q Where to place our Safety Program in our QMS? Occupational Health & Safety Management Standards 9
MaHoDie Where to show the Software version IEC 62304 - Medical Device Software Life Cycle Processes 2
E Where can i get latest toyota and honda Supplier Quality Assurance Manual (SQAM) Customer and Company Specific Requirements 3
I Where to find MDR compliance device? EU Medical Device Regulations 6
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
I ISO 9000 Where to Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 81
Ajit Basrur Where to find a pagination requirement as "Page x of y"? ISO 13485:2016 - Medical Device Quality Management Systems 7
T Assessing risk where harm is indirect - Generic devices / accessories / intermediates ISO 14971 - Medical Device Risk Management 8
J Incoming Stock QC, where to start? Manufacturing and Related Processes 6
J Stock Traceability Methods, where to start? Manufacturing and Related Processes 0
shimonv Where do you place Human Factors report in a 510(k) application? Other US Medical Device Regulations 3
B Where do the definitions of the types of processes come from? IATF 16949 - Automotive Quality Systems Standard 9
Awais Where to get started on DFM / DFMA Manufacturing and Related Processes 2
S Where to start for MDSAP for Canada? Canada Medical Device Regulations 5
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
M Testing criteria - where to place Design and Development of Products and Processes 2
J UDI - Where to document it? EU Medical Device Regulations 8
J Where to get a Black belt certification ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 13
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 2
J Where is the definition of a critical supplier? ISO 13485:2016 - Medical Device Quality Management Systems 5
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
B When Travel is allowed - Where are you going? Travel - Hotels, Motels, Planes and Trains 22
G Where to buy Template / sample SCSMS Manual, checklist Supply Chain Security Management Systems 1
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Where to acquire EN 868-5 required dye (Amaranth red)? Other Medical Device Related Standards 2
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
H Where to get EK MED 1927/16 Other Medical Device Regulations World-Wide 3
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1

Similar threads

Top Bottom