How to update from Procedure to Process - ISO 9001:2000 to ISO 9001:2008

K

kwbang

#1
Hello All of Cove members,

I work for the small-sized company manufacturing kind of controllers for factory automation. (maybe you could know: PLC, Drive, IO) :D
Recently, We have changed ISO 9001: 2008 from ISO 9001: 2000. At this point, I need to update our QMS with more process concept saying process approach in ISO standard. In fact, I am confused how much level I am supposed to do for process build-up. In other way to speaking, I don't know exactly what is the right way in this small company where the management wants me to do easygoing, limited resource and no impact or changes as possible. Although I thought that I need to follow the basic rule of process improvement or making things, as of now, I am getting to move toward making process hierarchy first and just making or adding process map and tutle diagram at the major procedures that could be considered ad key processes in general. Of course, I am not feeling good way.. but no participations and no time as well, I do my self based on current procedures.

What do you think of this simple way of process build-up?
And, what is your recommendations for me?

- Thank you. And have a great day!!
 
Last edited by a moderator:
Elsmar Forum Sponsor
#2
Hello kwbang, and welcome to the Cove :bigwave:
I am confused how much level I am supposed to do for process build-up.
If I understand this right, I think you are on the right track when you plan to add process maps to the procedures for the major processes. Just don't forget an overall description (You can put it in your manual) of the interaction of those processes.

Fortunately this does not require any big changes in your written procedures. As for the level of detail, clause 4.2.1, note 2 in the standard allows you to determine how detailed you should make it due to:

a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.

In a small company you should be able to make it rather uncomplicated.

/Claes
 
R

Richard Pike

#3
Recently, We have changed ISO 9001: 2008 from ISO 9001: 2000. At this point, I need to update our QMS with more process concept saying process approach in ISO standard.
That change you mention is not as a requirement of ISO 9001 2008 changes from 2000 version.

For 2008 upgrade, simply do a word search for 2000 and replace with 2008 // oh and in doc control, ensure you now register the latest 2008 version.

Dont use 2008 as an excuse for extensive work on your system. If you want to improve your System, then that's great, but do so under the requirement for continuous improvement of 2000 & 2008 - because there is simply NO difference between the two that could result in any non-conformance.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Welcome to the Cove! :bigwave:

Based on my time doing internal auditing I can tell you the thing I have most sorely missed is flow charting - process maps are an even "higher elevation" look at what goes on.

It's just that I have noticed we can get so mired in details in our process documents that a person is left asking "But what do I do?" Procedures don't need to be exacting so much as they need to be accurate and adequate for doing the right thing, on time, hopefully every time. That doesn't usually need a whole lot of encyclopedic mass.
:2cents:
 
R

Richard Pike

#5
Welcome to the Cove! :bigwave:

Based on my time doing internal auditing I can tell you the thing I have most sorely missed is flow charting - process maps are an even "higher elevation" look at what goes on.

It's just that I have noticed we can get so mired in details in our process documents that a person is left asking "But what do I do?" Procedures don't need to be exacting so much as they need to be accurate and adequate for doing the right thing, on time, hopefully every time. That doesn't usually need a whole lot of encyclopedic mass.
:2cents:

Yep absolutely agree Jennifer -- but ISO 9001 / 2008 revision should not be used as an excuse for this ?
 
K

kwbang

#6
Hello Claes, Nice to meet you here!

You are right. Thank you for your comment in a kind manner.
Could you recomend me what could normally be major processes from ISO perspective? I think it can be Supplier Chain, Delvelopment and Problem Solving Process.
 
Last edited by a moderator:
K

kwbang

#7
Hello Rechard and Jennifer,

I totally agree with you. The flow chart is ok I think though, DNV is always asking me process map with KIPs and you know, more looks great documents visually..
Anyhow, it is right they say, my company seems weak on the process approching overally. That's way I am updating those things of process build-up. - Thanks!
 
#8
.
Could you recomend me what could normally be major processes from ISO perspective? I think it can be Supplier Chain, Delvelopment and Problem Solving Process.
I suppose all the processes you mentioned above may be regarded as sub processes to your over all process, which in your case would be something like manufacturing controllers for factory automation.

Basically you need to walk the route from Marketing, sales and order handling to whenever your responsibility ends, maybe when delivery is taken care of. Just remember not to complicate things unnecessarily.

/Claes
 
K

kwbang

#9
Claes, Thank you!

Based on your warmest mention, what I understand is that the key or major processes of my company can be made from organizations/functions basis which are divided as Sales, Business, Operation, Development, Customer Satisfaction and other supporting functions. And sub-processes should be considered connecting with that mega-process, not complicated as possible if not necessary. (At this point, I wonder two/three sub processes are OK or not for the each processes.)

Am I following on the right track?
 
#10
At this point, I wonder two/three sub processes are OK or not for the each processes.
That, I am afraid, is not for me to say: Your company as any other is unique, and you need to map your processes as they are in fact set up.

Am I following on the right track?
I believe so, but I also suggest a closer look at clause 0.2 Process approach in ISO 9001:2008, paying particular attention to figure 1 which can be used as a template for a process map. There is no actual requirement to use a process map at all, but most do as it is usually the best and simplest option to fulfil the requirements of clauses 4.1b and 4.2.2c.

/Claes
 
Thread starter Similar threads Forum Replies Date
L Revision of procedure - Can't update the procedure before the actual process change Document Control Systems, Procedures, Forms and Templates 13
J Rating Nonconformance's - Auditor said we should update our procedure (CAR/PAR) Preventive Action and Continuous Improvement 12
D GMDN code update - Canada - Do you know if there is guidance? Canada Medical Device Regulations 0
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 33
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 2
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational Update on ISO TC 210 JWG 1 activities Medical Device and FDA Regulations and Standards News 0
M Informational EU – October 2019 update – State-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 2
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization Medical Device and FDA Regulations and Standards News 0
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 7
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Digital Health Update: Mid-Year Update on Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Is it compulsory to update the obsolete GMDN codes in ARTG? Other Medical Device Regulations World-Wide 4
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Informational EU – Update on state-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 1
E Gamma Sterilization Product Update Manufacturing and Related Processes 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
B IEC 62304 - Update Checklist IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
C Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
Marc Software Update 23 November 2018 Forum News and General Information 1
M Medical Device News Joint Action On Market Surveillance Of Medical Devices (JAMS) Releases Progress Update EU Medical Device Regulations 0
Marc Attachment List Update - 2018-11-16 Forum News and General Information 0
K Medical Device Software Update in Field of AIMD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
M Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices Other Medical Device Regulations World-Wide 0
M Medical Device News TGA update 26-09-18 - Medical Devices Safety Update, Volume 6 September 2018 Other Medical Device Regulations World-Wide 0
M Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice Canada Medical Device Regulations 0
S How to enforce my colleagues to update SOPs? Document Control Systems, Procedures, Forms and Templates 4
M Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices Canada Medical Device Regulations 0
Marc 2018 Software update - Donations Appreciated Forum News and General Information 21
J Update Technical File for EU Class IIa Medical Software Products EU Medical Device Regulations 3
L Re-calibrate after software update? Calibration Frequency (Interval) 3
W EU GDPR General Data Protection Regulation - What we need to update for our QMS EU Medical Device Regulations 14
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26

Similar threads

Top Bottom