Level 1, Level 2 Very Confused

K

KRAPO

#1
I HAVE RECENTLY TAKEN OVER AS QUALITY DIRECTOR. I HIRED A CONSULTANT TO REWRITE OUR QUALITY MANUAL, WHICH HE DID, BUT LEFT OUR LEVEL 2 ALONE, I.E. WITH 20 ELEMENTS. I HAVE BEEN TRYING TO REWRITE THE LEVEL 2 BUT I'M NOT SURE WHAT I NEED TO DO FOR THIS DOCUMENT. CAN ANYONE SHED SOME LIGHT ON WHAT I SHOULD BE DOING WITH LEVEL 2. ARE THERE TEMPLATES TO HELP?:frust:
 
Elsmar Forum Sponsor
K

KRAPO

#3
:confused: MAYBE THAT IS THE QUESTION I SHOULD BE ASKING. DO I TAKE THE LEVEL 2, 20 ELEMENTS AND REDO THEM TO CONFORM INTO THE 5 CLAUSES PER 9001:2000?
 
#4
Do you need to change them? The standard does not require your procedures to align numerically with the standard. I've worked with several companies that decided to keep their existing procedures and use them as is (only updating them where they absolutely need to).

Another option would be to just re-number them to match the new standard. Also, look very closely to determine if you really need them. If not, now is your opportunity to dump them. BTW, you might find you need additional procedures. It is your program and it is mostly up to you.
 

Randy

Super Moderator
#5
You hired someone to write your (actually his by the way) quality manual? Why didn't you just send me 50% of what your paying that person so I could send you one of the ones that have been posted here in Word format and I could do the cut & paste. Apparently this indivual took the money and ran if your still operating under the infamous "20 elements".

As for your Tier 2's (I hate that classification along with other tripe and trivia....buzzword bingo anyone?) .....just take account of what you do or need to do, and put it in writing...Who, what, where, when, how, why. Implement it. Then see if it works. If it doesn't...fix it. If it does...move on to more important stuff. There is a ton of stuff here in the Forums that can give you the help you need. Seek and ye shall find!!
 
K

KRAPO

#6
:eek: UNFORTUNATELY I JUST FOUND THIS GREAT SITE OR I WOULD HAVE SENT YOU THE $$$. THANX FOR THE INPUT.

NOT SO CONFUSED NOW,

KRAPO
 

apestate

Quite Involved in Discussions
#7
hahahaha.

Come on. If you wanted to do everything yourself, you wouldn't have to pay anyone.

em, Krapo, what you have now is what lots of registrars are suggesting. Basically, the 20 element quality system is revamped and updated to include the new requirements of ISO 9001:2000. To do this, a new Level 1 quality manual is written, and it references the old QOP procedures since they really cover most of the requirements of ISO 9001:2000. I think I've seen this called a "bridge manual."

This is what has been suggested by the registrar that will audit our company. As you can see, there is much debate over the spirit of the standard among the quality professionals here on this website. I don't know if anyone here would accept a bridge manual as a serious attempt at the new standard. However, the registrar is who suggested such a thing to me in the first place.

As you can see, you must consider what the registrar wants and what you want. If you have the time and interest, I suggest you work with your procedures. You can really make those documents worth having.

As far as templates and help in that task, I suggest premium files access on this website. The cost is minimal for the amount of information you get.

However, a real set of templates for ISO 9001:2000 procedures may not exist. Not in any reasonable quality, anyway. If you look through the standard, I could name you seventeen, twenty, or twenty-five possible procedures. Six are required, you know, and four of those six can be combined into two. So a complete fill in the blanks set of procedures is not really natural. So much must be original and unique, or at least suited to your business.

I've been new to quality management for a while, and this website has been my greatest aid. When I first came into this, I purchased a complete documentation package for almost a thousand dollars. I have completely abandoned its documentation, at this point, preferring my documents be created from scratch. The internet site I bought it from referred me here for some of my questions, however, so I guess I owe them that.
 

apestate

Quite Involved in Discussions
#8
re-read db's reply, KRAPO.

If you choose to go with what you have, you're still going to need to review the updates to the standard. You may want to add to your existing procedures, in some cases, and you may want to create new ones to address some new requirements.

Some procedures may no longer have a place in documentation.

You're going to have to do some work to the system, just to be reasonably assured registration.
 

Randy

Super Moderator
#10
Whatever you do, don't be afraid to ask for advice here. What you get may not be perfect, but it will definitely start the old thought juices flowing. Some pretty good folks have supplied many fine examples of material that you or anyone else can use for their system development.

Good luck:bigwave:
 
Thread starter Similar threads Forum Replies Date
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
Y What are different Special Inspection Level 1-4 and General spesification 1-3 ? AQL - Acceptable Quality Level 0
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 7
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Level 3 KPI Excel Template Manufacturing and Related Processes 1
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
R Bottom up approach versus system level ISO 14971 - Medical Device Risk Management 2
C Failure nets - Same level effects FMEA and Control Plans 0
H Graphical analysis of results - Confidence level bands nomenclature Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Level of Clinical Evidence - MDR EU Medical Device Regulations 3
D GM BIQS level 5 requirements Customer and Company Specific Requirements 5
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
I What level of change in documentation requires re-training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Level 3 PPAP submission of intentional defective parts APQP and PPAP 4
eule del ayre List of Level 3 PPAP requirements for automotive suppliers APQP and PPAP 20
I Document levels and approval requirements for lower level documents like work instructions, forms etc. Document Control Systems, Procedures, Forms and Templates 18
B AS9102 FAI & Lower Level Drawings - How should we perform the FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Rameshwar25 What is a Control Plan at "Material Level"? IATF 16949 - Automotive Quality Systems Standard 4
N How to resolve discrepancies in Level 3 PPAP supplier dimensional reports? APQP and PPAP 11
M Creating a Plant Level Value Stream Map Process Maps, Process Mapping and Turtle Diagrams 1
khotchandrakant Defining Acceptance Quality Level, I need clarity on AQL 1.5, 2.5, 4.0 AQL - Acceptable Quality Level 5
P GM BIQS level 5 training? Training - Internal, External, Online and Distance Learning 2
Ron Rompen Dual level holes - Measurement method suggestions wanted General Measurement Device and Calibration Topics 9
A Level of details required for Class IIb Product Verification and Validation CE Marking (Conformité Européene) / CB Scheme 1
D System Level FMEA example wanted FMEA and Control Plans 2
samer Do we have to determine Educational level for all Staff as pr 7.2 b clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J What level PPAP for 5 critical parts? APQP and PPAP 8
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
E High level structure - Planning and operation control Occupational Health & Safety Management Standards 2
rob73 Worldwide device regulatory authorities at country level Other Medical Device Regulations World-Wide 6
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
C Example Work Instruction/Procedure for AQL (Acceptable Quality Level) AQL - Acceptable Quality Level 4
W Level of V&V in Class II Medical Device (Dialysis Machine) IEC 62304 - Medical Device Software Life Cycle Processes 10
K FDA Premarket Submissions for Embedded Software - Level of Concern Other US Medical Device Regulations 4
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
A What KPI's do you use at Shop Floor Level and Team Boards? Quality Tools, Improvement and Analysis 4
T Struggling with ISO 13485:2016 Clause 6.2 - Level of Risk Associated with Work ISO 13485:2016 - Medical Device Quality Management Systems 3
J Multi-level QMR Process Management Review Meetings and related Processes 6
ncwalker Definition Needed: High Level Acronym Buzzword Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
A How to rollout Security Awarness at Project Level in the Organisation IEC 27001 - Information Security Management Systems (ISMS) 1
M What level of control should be exercised on distributors? Supplier Quality Assurance and other Supplier Issues 10
M ISO 13485 and the High Level Structure (HLS) ISO 13485:2016 - Medical Device Quality Management Systems 0
P Automotive Supplier PPAP Level Requirements Supplier Quality Assurance and other Supplier Issues 6
P Is the next revision of ISO 15378 following the High Level Structure? Other ISO and International Standards and European Regulations 5
M Medical Device Software "Level of Concern" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Marc Definition RQL = Rejectable Quality Level Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
J Can a Surge test fail to a test level and still considered as Compliant? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom