What is acceptable quality manual content? How much detail to put in here?

C

cleverfox

#1
What is acceptable quality manual content?

I am writing the transition quality manual and am unsure how much detail to put in here. Is the quality manual just the shalls redressed? Or is it a declaration of how the organization plans on meeting those requirements.

Take this requirement, "5.5.3 Internal communication - Top managament shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the" QMS.

Example1 - Top management at XYZ Corp. ensures that appropriate communication processes are established and that communication takes place regarding the effectiveness of its QMS.

Example2 - Top management reports on the effectiveness of the QMS through team briefings, notification boards, and other management led discussions.

We all know that some processes are too varied to detail in a quality manual, so is it better to just say that the organization will do it and let the auditor ask how we do it and show them, or say how it intends to do it more specifically?

What are your thoughts? :bonk:
 
Elsmar Forum Sponsor
N

noboxwine

#2
Waste of Time IMHO

In my many moons of doing this, I have always just copied the standard, added a company logo and controlled it. Never before have I seen a use or value for a Quality Manual in house----it's just a waste of time used for registrstion compliance purposes only. If you see some value, structure it the way you'd like and go for it----but dont set yourself up for audit findings. Let us know and good luck ! :bigwave:
 
#3
Hullo fox,

I suggest you begin by taking a look in ISO 9001:2000 clause 4.2.2 and then proceed to the thread Help - Tips on updating Manual (1994 - 2000) .

4.2.2:

The organization shall establish and maintain a quality manual that includes
a) the scope of the qualityman agement system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
If you already have the have the system up and running all you have to do in order to comply with b) is to put in a reference to your system. If so, the manual can be very brief indeed.​
/Claes​
 
#4
cleverfox said:
I am writing the transition quality manual and am unsure how much detail to put in here. Is the quality manual just the shalls redressed? Or is it a declaration of how the organization plans on meeting those requirements.

Take this requirement, "5.5.3 Internal communication - Top managament shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the" QMS.

Example1 - Top management at XYZ Corp. ensures that appropriate communication processes are established and that communication takes place regarding the effectiveness of its QMS.

Example2 - Top management reports on the effectiveness of the QMS through team briefings, notification boards, and other management led discussions.

We all know that some processes are too varied to detail in a quality manual, so is it better to just say that the organization will do it and let the auditor ask how we do it and show them, or say how it intends to do it more specifically?

What are your thoughts? :bonk:
I like example 2 better. It shows that you have read, understand and are applying the standard. Also, there is no requirement for Level 1 docs anyway. All you have to do for your QM is just what Claes suggests. Remember, if you need to document things for control, then document them. Other than that, you only need to document what absolutely aligns with a "shall". Make the system work for you and don't build a monster you can't feed.
 
C

cleverfox

#5
Thank you NOBOXWINE, Claes and Dave B. I think I will go both ways. I will restate the shalls and when it is not too constricting I will try to add some value and show the auditor that we (I) have read and understand the standard.

I really enjoy getting feedback from my peers so quickly. I think that we all usually know what needs to be done, but need re-iteration from others who have been through this. Kind of like sticking our toe in the water before jumping in completely. :lick:

Thanks guys,
fox
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#7
Myself, I started out rehashing the standard and adding more text to make the document useful, then completely changed my mind later. I posted my rough draft @ "Is your company registered to ISO9001:2000" and received a lot of feedback from the forum (thanks everyone!).

I also searched these forums and did an internet search and looked at dozens of examples. I just searched for "Quality Policy Manual".
 
#8
cleverfox said:
---X---I really enjoy getting feedback from my peers so quickly. I think that we all usually know what needs to be done, but need re-iteration from others who have been through this. Kind of like sticking our toe in the water before jumping in completely. :lick:

Thanks guys,
fox
Exactly... If the Cove is good for anything, that must be it... Being able to discuss your work with others in the same situation really is a tremendeous help. A real confidence builder if you ask me.

/Claes
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#9
Claes

In the thread that you referenced above, you described how you created the policy manual after your system was in place and kept it to the minimum.

This was one of the trains of thought that changed my mind about my manual in progress. I was determined not to rehash the standard, but in writing our manual IAW the standard, I ended up doing just that in the end anyway.

Your comment got me thinking - if I write IAW our system, then the manual will be truly useful. I'm following your advice and keeping it very simple and ensuring that the requirements in 4.2.2 are included. I'll post my completed manual in (hopefully) the next couple of weeks.

Thanks!
 
R

Rick Goodson

#10
Cari Spears said:
Claes

In the thread that you referenced above, you described how you created the policy manual after your system was in place and kept it to the minimum.

This was one of the trains of thought that changed my mind about my manual in progress. I was determined not to rehash the standard, but in writing our manual IAW the standard, I ended up doing just that in the end anyway.

Your comment got me thinking - if I write IAW our system, then the manual will be truly useful. I'm following your advice and keeping it very simple and ensuring that the requirements in 4.2.2 are included. I'll post my completed manual in (hopefully) the next couple of weeks.

Thanks!
Just another thought. I have been writing Q manuals under 1994 and 2000 that are basically the same. In 1994 I usually had to rehash the shalls, but that was in addition to the basic concept. The manual starts with a description of the business and the markets it services. Then we add the Q policy and Q objectives. Next we add a statement saying we meet all of the requirements of the standard, or what we exclude, and any other standards we adher to. The balance of the manual is divided into the business functions such as Sales, Purchasing, Engineering, Human Resources, etc. Under each section we add how that department/function works and how it meets the ISO9001 requirements. For example, if HR is responsible for internal communication and has a news letter, bulletin boards, quarterly meetings; we state that. Under purchasing we describe how we select and control suppliers. Finally we include a matrix in the appendix that crosses the ISO 9001 elements to pages in the manual where we address them and the procedures, flowcharts, etc that support individual requirements. The manual (without the appendix) is a useful sale/marketing tool and with the appendix passes muster with the registrar.

One of the nice things about this style of manual is you do not rewrite when the standard changes. You simply aadd the new requirements references and redo the appendix matrix.

Rick
 
Thread starter Similar threads Forum Replies Date
J Acceptable Wording in the Quality Manual - Design and Development Exclusion Quality Management System (QMS) Manuals 12
C Example Work Instruction/Procedure for AQL (Acceptable Quality Level) AQL - Acceptable Quality Level 4
M Quality Objectives - Acceptable Levels and Functions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
S Is this Quality Policy acceptable in the context of ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 24
S What are typical Acceptable Quality Levels (AQL) adopted in Food industry? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
W Application of AQL (Acceptable Quality Level) Concept AQL - Acceptable Quality Level 15
M AQL (Acceptable Quality Level) for Mixed Part Defect IATF 16949 - Automotive Quality Systems Standard 1
S AQL (Acceptable Quality Level) Report Form example wanted AQL - Acceptable Quality Level 1
Q AQL - How do I determine Acceptable Quality Level (AQL) for In-Process Inspection? AQL - Acceptable Quality Level 2
A What is the purpose of using AQL (Acceptable Quality Level) for Sampling? AQL - Acceptable Quality Level 3
K So confused with AQL - How does AQL (Acceptable Quality Level) fit with my company AQL - Acceptable Quality Level 7
Y Advice on this real case on AQL (Acceptable Quality Level)? AQL - Acceptable Quality Level 3
L AQL (Acceptable Quality Level) Question Quality Manager and Management Related Issues 7
D Who uses AQLs (Acceptable Quality Level)? AQL - Acceptable Quality Level 8
M Is it acceptable or advisable to have a "Quality Systems Glossary"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
H Need help with AQL (Acceptable Quality Level) for a QC inspection AQL - Acceptable Quality Level 8
S AQL (Acceptable Quality Level) for Safety Critical Parts AQL - Acceptable Quality Level 13
N AQL (Acceptable Quality Level) Sampling Plan for Small Lots AQL - Acceptable Quality Level 8
M AQL (Acceptable Quality Level) for Zero Defects AQL - Acceptable Quality Level 13
H AQL (Acceptable Quality Level) for Medical Devices AQL - Acceptable Quality Level 14
Q AQL - How do I find Acceptable Quality Level? AQL - Acceptable Quality Level 75
D Problem with AQL (Acceptable Quality Level) AQL - Acceptable Quality Level 9
J Can "Compliance to ALL Requirements" be an Acceptable Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Sanity Check on AQLs (Acceptable Quality Level) AQL - Acceptable Quality Level 3
M Failure Rates and Standard Acceptable Quality Level for Incoming Components Supplier Quality Assurance and other Supplier Issues 5
C ISO 9001:2000 In Textile Industries - AQL (Acceptable Quality Level) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Marc AQL - Acceptable (Assured) Quality Level AQL - Acceptable Quality Level 0
C Linking Acceptable Quality Levels (AQL) and Average Output Quality AQL - Acceptable Quality Level 7
apestate Custom hardware product - What acceptable quality level (AQL) is expected in the US? AQL - Acceptable Quality Level 4
R Acceptable Outgoing Quality Level (AOQL) aka Acceptable Outgoing Quality (AOQ) Statistical Analysis Tools, Techniques and SPC 6
J LTPD (Lot Tolerance Percent Defective) vs. AQL (Acceptable Quality Level) Definitions AQL - Acceptable Quality Level 5
N Setting AQL (Acceptable Quality Level) on C=Zero inspections AQL - Acceptable Quality Level 16
K AQL (Acceptable Quality Level) vs. IRR (Initial Reliability Requirement) AQL - Acceptable Quality Level 6
W Acceptable Quality Levels (AQL) - What is the usage of AQL 100 to 1000? AQL - Acceptable Quality Level 10
Marc AQL (Acceptable Quality Level) vs. PPM (Parts per Million) - Equivalences? AQL - Acceptable Quality Level 16
L AQL (Acceptable Quality Level) vs. LTPD (Lot Tolerance Percent Defective) AQL - Acceptable Quality Level 12
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
M Measurement Error - How to determine what is acceptable? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
M Are Fungal counts acceptable in class 1000 clean rooms? Other ISO and International Standards and European Regulations 2
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
samer Acceptable limits for Spills - Tracking Hydraulic Spills ISO 14001:2015 Specific Discussions 3
V Acceptable maximum RSD (relative standard deviation) for an sample size Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B Gage R&R Acceptable (10-30%), deduct Total Variation from Tolerance Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Q Acceptable calibration accuracy of a 60" linear measuring device General Measurement Device and Calibration Topics 16
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
Q Is it acceptable to mix components from two different lots into an assembly? ISO 13485:2016 - Medical Device Quality Management Systems 1
C Acceptable NDC for %GR&R part inspection to Tolerance (%Tolerance) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Operator Checks - How to show that they were completed on a checklist as acceptable IATF 16949 - Automotive Quality Systems Standard 2

Similar threads

Top Bottom