ISO92k Procedures - Has anyone kept the level II structure from ISO9002 1994

Jim Green

Involved In Discussions
#1
It has been covered in numerous threads regarding the structure of the ISO 92k manual. Just repeat the standard!!!. Seems easy enough. Should be a 1 day job.
Now what about the exsisting procedures from 9002 1994. Will they not have to get a whole new facelift? This does not seem as easy as the Quality Manual re-run.
Has anyone kept the level II structure from 9002 1994 and implemented the new standard within those procedures. Where were the dificult elements. What pitfalls should I be aware of.
It is often quoted in this forum not to over complicate things and that is my main goal. It just gets so frustrating trying to interpert this stuff.

Signed Quality Rookie
 
Elsmar Forum Sponsor
M

M Greenaway

#2
Jim

According to ISO9001:2000 you no longer have to 'repeat' the standard in your quality manual as the requirement to 'address the requirements of this international standard' has gone - thank god.

As for your procedures you dont (and shouldnt) bin them if they served a useful purpose under your 1994 certification. But you need to define your processes - written text can adequately do this, and if your procedures are well written they may cover it - but look very closely.

If they dont then you could map your processes using a simple flow diagram technique, and reference your procedures from this.
 

gpainter

Quite Involved in Discussions
#3
Our registrar is suggesting to keep the SPs you have and just add to them. Originally I was going to redo everything but have since changed my mind, unless someone can change my mind back.
 
E

energy

#4
I tried that

Originally posted by gpainter
Our registrar is suggesting to keep the SPs you have and just add to them. Originally I was going to redo everything but have since changed my mind, unless someone can change my mind back.
I suspect that most auditors are comfortable with the SP's created under the 1994 version. Me too. It was suggested by our Consultant, one registrar in an interview and myself that we just use the matrix in the back of the new standard. Our GM shot it down. They wanted the manual and SP's to reflect the various sections of the standard so that they could take the procedure and find the section and make sure that I wasn't selling them a pig in a polk. I fought it, but lost. They said, "Sure, you know the relevant elements, but we don't." Try as I might to explain that they can use the cross reference list as well as I, they felt that we were not doing what the new standard wants. Kind of like building a new car with old hardware. Duh! :bonk: But now, as I try to match up the procedures we have, some procedures are proving difficult to develop. For example, Element 9 Process Control is now 4 sections of the new standard. 6.3, 6.4, 7.5.1 and 7.5.2. Not to mention all of section 4 and 5, that used to be Elements1 and 2 and Contract Review is now in 4 sections. Cut and paste. Cut and paste. The procedures that they submit saying that they are product realization are really mesurement and monitoring, and so on. It really bites the big one. So, if you have the green light to use a matrix as reference, stay with it! If I had any, I'd be pulling my hair out! :ko: :smokin:
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
I restate my position that they seriously screwed things up when they rearranged the standard. Before everything was grouped and made sense. Now it's a pain in the :ca: because everything is all spread out.

In the 3 upgrades I've done all we did was rewrite the systems (quality) manual and did two new flow charts. Procedures were not changed and they retained the same grouping / 'numbering' (identification) system as the old 20 elements grouping (ie: identification didn't change).
 
E

energy

#6
I'm curious!

Originally posted by Marc
In the 3 upgrades I've done all we did was rewrite the systems (quality) manual and did two new flow charts.
Without compromising your recipe for success, may I be so bold as to ask the title of those flowcharts? If for nothing else, it would set my mind at ease knowing the areas they address. I have reasonable expectations of being able to address all the required areas. Might they be Customer Satisfactionand/or Customer Communication? Can we expect to see something similar in the Premium files someday soon? ;) :ko: :smokin:
 

barb butrym

Quite Involved in Discussions
#7
it has always been my contention that if you did ISO 9001.1994 well, the changes/additions are minor....and a cross reference and some procedural adjustments and/or flow charts (the customer and CI stuff..and a baseline if i didn't already do that, most cases I had it covered) are all that is needed to tie it up. The variation comes with how much "wiggle words' you incorporated. i.e. if you did bare minimum, meeting the standard just to meet it, you had some catching up to do. If you were using the system to add value to the company you were already measuring CS and CI at management review.

I stopped using the standard numbering system soon after I started it. except for the QM. I used department/responsibility acronyms as the prefix.

I agree..... the restructure of the standard has some good points for new implementations, but for current systems it really does a disservice.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
8.5.3 Preventive Action (to keep any auditors from bitching and to make it clear / distinct within the company (as opposed to corrective action) but using the corrective action system to initiate and track.

The other was a high level flow chart of the 'quality systems process'.

No magic.

I've always used the 20 element segregation 'system' because I've seen that as a good way to categorize procedures but I haven't always linked them through a numbering system that follows the old categories. I always saw the decision as to whether to name procedures (or otherwise identify them) in alignment to the ISO numbering as a customer/client decision.
 

Jim Green

Involved In Discussions
#9
Energy
I may be seeing the Quality Light. Just briefly explain how the matrix. Should be constructed.

Area of confusion; Mark is saying that all he did was re-write the quality manual and add some flow charts.

Don't we have to show in our SP's who is responsible etc.
Example:
6.2.2 a) determine the necessary competence for personnel performing work effecting product quality.

This statement is new to the standard. We repeat the statement in the manual. Under training 4.18 Good to go.

Now the auditor is going to check the Sp's to see if that catch word "competence" is noted and who is responsible? Am I right here or totally of base. Do we not have to describe in our SP's just like in 1994 version the who's what's and why's of all the new clauses in 2000???
 
E

energy

#10
Jmho!

Originally posted by Jim Green
Energy
1. I may be seeing the Quality Light. Just briefly explain how the matrix. Should be constructed.

2. Don't we have to show in our SP's who is responsible etc.
Example:
6.2.2 a) determine the necessary competence for personnel performing work effecting product quality.

This statement is new to the standard. We repeat the statement in the manual. Under training 4.18 Good to go.

3.Now the auditor is going to check the Sp's to see if that catch word "competence" is noted and who is responsible? Am I right here or totally of base. Do we not have to describe in our SP's just like in 1994 version the who's what's and why's of all the new clauses in 2000???
1. This one is easy, I think. You have Table B.2 in the back of the standard ANSI/ASQ/ISO 9001:2000. I had intended to list my procedures in the right column where the 1994 element references are. But, that's not an option at my place, now.

2. I do show responsibility in all our procedures as well as reference procedures that are related and records and retentivity /location.

3. I wouldn't know that. He/she may ask how we determine competency. I have a problem with anybody asking me about my competence. I know that I'm not, so I've been told!
HR is tasked with that procedure and will probably insert the word somewhere. As for putting words in your procedures that mimic the standard in some form, I would throw some of them in to avoid what Marc has alluded to as an Auditor saying "I know you are doing it to the standard, but you don't exactly say that", or something to that affect. Like you, I'll eventually find out when we go for our pre-assessment. And, always keep your eyes on the Quality Light.
 
Thread starter Similar threads Forum Replies Date
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
R Scientific Operating Procedures For Sterilization Practices in India PSA/2012/1 Other Medical Device Regulations World-Wide 0
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
DuncanGibbons Are the IQ OQ & PQ procedures applicable to the aerospace industry? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 7
A Recall/Adverse event report procedures in Kuwait/Qatar/Kenya Other Medical Device and Orthopedic Related Topics 3
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 21
F Recommended practice for furnishing Technical Procedures ISO 17025 related Discussions 1
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
F ISO 17025:2017 Clause 7.4.1 - Requirements for Procedures ISO 17025 related Discussions 4
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N ISO 9001: 2015 - Example standards policies, procedures, acknowledgements and checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Quality System Processes without Documented Procedures Document Control Systems, Procedures, Forms and Templates 39
L IATF 16949 requirements for Product Safety Procedures IATF 16949 - Automotive Quality Systems Standard 14
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
K Assigning the Correct Procedures Applicable to Job Titles General Auditing Discussions 15
M Medical Device News FDA's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices Other US Medical Device Regulations 0
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2
M Translate Procedures into Spanish Other Medical Device Regulations World-Wide 5
J Nonconforming product procedures SOP help :) Nonconformance and Corrective Action 2
P How to have employees buy-in of quality procedures. Best practices? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M IATF Clause 8.4.2.2 - What procedures does this apply to? IATF 16949 - Automotive Quality Systems Standard 1
S Which ISO 9001 Clause applies to "Procedures are outdated"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
K Proto 6106 and 6106A Adjustment procedures General Measurement Device and Calibration Topics 0
M ISO13485 Documentation packs (manual, procedures, forms etc) ISO 13485:2016 - Medical Device Quality Management Systems 3
S How many QMS processes and procedures? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Job Titles referenced in Procedures IATF 16949 - Automotive Quality Systems Standard 18
Q Management control Procedures & Operational Control Procedures ISO 14001:2015 Specific Discussions 1
S Risk based approach - Procedures already take a risk-based approach to QMS processes ISO 13485:2016 - Medical Device Quality Management Systems 3
G ISO 17025 Calibration Laboratory Assessor's Common Questions and Procedures ISO 17025 related Discussions 11
S Are 2 Hard Copies of Procedures and Instructions Required? ISO 13485:2016 - Medical Device Quality Management Systems 6
I Procedures from recognized standards or specifications ISO 17025 related Discussions 3
I Concerning procedures within Quality Manual ISO 17025 related Discussions 10
S Language of procedures when operating in multiple countries ISO 13485:2016 - Medical Device Quality Management Systems 4
A AS9100 Rev D - List of Required Procedures Document Control Systems, Procedures, Forms and Templates 5
A AS9100D Quality Manual & Procedures needed Quality Management System (QMS) Manuals 4
K AS9100:2016 (Rev. D) Required Procedures AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 19
A Special Procedures for Non Aerospace Customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Importance of Written Procedures in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Is KPI in Process Valid if not supported by Procedures? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
N International / Traceable Standards - Procedures for Calipers, Micrometers, Etc. ISO 17025 related Discussions 2
M Retiring documents in Document Control Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R How to Control Videos as part of the QMS Documented Procedures and Instructions Document Control Systems, Procedures, Forms and Templates 2
L Procedure Change Request Form - "ISO Procedures" Document Changes Document Control Systems, Procedures, Forms and Templates 5
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
D Referencing Standards in Procedures - Current version or actual? Document Control Systems, Procedures, Forms and Templates 6
Moncia Complaint / Non-Conforming Product / CAPA Procedures - Please share your experience ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom