Procedure Numbering Change? Still the need for maintaining Level 1, 2, 3, documents?

E

energy

#1
I have tried to get an answer on this by posting to "Documentation", but to no avail.
So let me try it here.
With the decline of the number of written procedures in the new version of the standard, is there still the need for maintaining Level 1, 2, 3, documents. If so, please tell me where this is justified..In the old standard or the new one. Is this just accepted practice or is there a guideline that addresses this?
 
Elsmar Forum Sponsor
G

gutieg

#2
The clause 4.2.1 (Documentation requirements - General) from the ISO 9001:2000 international standard reads :

"The quality management system documentation shall include

a) Documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this international standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and,
e) records required by this International Standard (see 4.2.4)"

So, yes, the hierarchy of documentation needs to be followed, but the content and volume of each level may be shorter or different.If you read the ISO 9000:2000 Standard (Fundamentals and vocabulary) the point 2.7.2 Types of document used in quality management systems, it says : "Each organization determines the extent of documentation required and the media to be used. This depends on fators such as the type and size of the organization, the complexity and interaction of processes, the complexity of products, customer requirements,the applicable regulatory requirements,the demonstrated ability of personnel,and the extent to which is necessary to demonstrate fulfillment of quality management system requirements". Now, the vocabulary standard is a guide, it allows you to determine the size of the cake, but the general structure of it , is a "shall" on the new ISO 9001.

Regards

Gus Gutierrez
 
E

energy

#3
Gus,

I think I understand the hierarchy as you so aptly pointed out, but, the Level 1,2,3, etc. continues to allude me. All courses and training directs themselves to the terms Level 1, etc., like they are something mandatory. Why not call them A,B,C or something equivalent. Maybe, I'm making too much of a thing out of it. Thank you for the response.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
By convention the document 'layers' in a 'typical' documentation structure are called levels or tiers. Instructors use the terms most associated which what they're discussing. Nope - I do not know when or who started the convention.

Why levels or tiers? Why numbers instead of letters? Why not? And why change now. Some companies use dates as revision levels for documents. Some use letters (rev A) while some use numbers (Rev 2).

Why call a car a car. We could just as easily call it a wombattlement. And if, in the mid- to late-1800's someone HAD called automobiles wombattlements and the name caught on, we'd probably be calling them that today.

See this old thread Document Levels
 
E

energy

#5
Thanks Marc. You pretty much said what I thinking. Somehow, when you hear it from those in the business, it assures you that your're not missing something. Guess it was a good idea to change the topic forum. Shoot for the high profile topics and the response is guaranteed. By the way, this is the best ISO Forum out there. Believe me, I tried them all. Keep on truckin!
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
It's not always the forum topic. You posted on 26 Dec - and it was sorta lost in the holiday fray. A few questions here go unanswered, but most are responded to. Actually the documentation forum was the best place for the question - but no big deal.
 
I

isodog

#7
There is still the three levels, manual, procedures, instructions, and documents. It is traditonal and nothing in the ISO 9000:2000 standard would indicate otherwise.

However, if you include the manual with the procedures, as suggested in the new revisions, you only have one book (manual and procedures). you still have two levels,i guess.

In many small (> $1,000,000 sales)companies procedures and instructions get confused as managers wear many hats and it's difficult to compartmentalise topics.

But, conceptually, the four levels do exist, if only for us geeks that want to put everything in a catagory.

This has NOTHING to do with the success of your system. If it works and you can tell where the information to run the business is located, YOU HAVE A SYSTEM!!!!

My advice is make your system serve your customers and challenge your auditor to find out where it doesn't. That is what you really want from an auditor. That's what it's all about.

Dave
 

barb butrym

Quite Involved in Discussions
#8
LOL...one of my favorite arguments is 'what makes sense to your company (ergo adds value???????)

I actually had an auditor tell my client one of his level 3 work instructions SHOULD BE a level 2 procedure.... WOW did I have fun wrestling in the mud with that one!!!!!! levels are just a way to break off a type of control or maybe a drop in formality perhaps...as some people need that seperation formally defined....most companies do it cause they think they should????? DAH....if it deoesn't add value don't do it
 
E

energy

#9
Barb, That is a concern, as you state, that there is a thin line between designating a "Level 2" or a "Level 3" document. If in the "Level 2" document there are a couple of HOW TO's, one may say that we should create a "Level 3" document to cover this. As we are going forward in our ISO effort, I have not had the opportunity to be audited by an outside party. Just trying to get a feel, from those already certified, what to expect.
Energy
 
D

David Mullins

#10
If the level thing worries you that much, just think of there being two types of documents:

A. those that apply across the company/business/etc.

B. Those that only apply to a sub-group of the company, e.g. department/team/etc.

The workers and the CEO don't care about levels - only you do!

------------------
 
Thread starter Similar threads Forum Replies Date
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
J ECR to ECO to ECN Procedure and numbering system Document Control Systems, Procedures, Forms and Templates 4
S Numbering of Pages in a Revised Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
W Procedure Clause ?Level? Numbering System explanation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Procedure Numbering System suggestions Document Control Systems, Procedures, Forms and Templates 54
MarilynJ6354 Procedure Numbering - Is there any reason we HAVE to number our procedures? Document Control Systems, Procedures, Forms and Templates 30
N Quality Procedure numbering - Transitioning Document Control Systems, Procedures, Forms and Templates 6
G RoHS Procedure REACH and RoHS Conversations 1
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 3
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Article 22 Procedure Pack Labelling EU Medical Device Regulations 4
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
R Procedure, Frequency and Acceptance Criteria for Replicate, Recalibration, Before-After and Intermediate Checks ISO 17025 related Discussions 8
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
Moncia Production Planning procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
L Purchasing procedure and workload ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Roles and accountabilities procedure? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Procedure equals a process? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
M EU MDR - RA procedure for EU EU Medical Device Regulations 5
F Procedure for Device End of Life/Obsolescence Other Medical Device and Orthopedic Related Topics 3
A MAH license transfer (medical device registrant) procedure in Indonesia Other US Medical Device Regulations 0
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 2
U Product Lifecycle Procedure Guidance Design and Development of Products and Processes 7
V Datron 4707 or 4708 33K, NAVAIR or TB cal procedure General Measurement Device and Calibration Topics 1
R MDR Article 22: Systems and procedure packs Other Medical Device Regulations World-Wide 12
I Containment procedure for parts after a power outage. IATF 16949 - Automotive Quality Systems Standard 1
F ISO 17025:2017 Format for Procedure and Records Document Control Systems, Procedures, Forms and Templates 3
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4
E AS9100 installtion procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Procedure on Privacy Policy in the ISO 13485 quality management system ISO 13485:2016 - Medical Device Quality Management Systems 3
K 820.200 Servicing Procedure - Our system (because there is an API involved) is classified as Class 3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Substance of concern (SOC) management procedure wanted Reliability Analysis - Predictions, Testing and Standards 2
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Different procedure templates for different standards - We have two different management systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Validation procedure, Major NC CAP - Equipment Validation process is not effective ISO 13485:2016 - Medical Device Quality Management Systems 5
T Something between a manual and a procedure? Document Control Systems, Procedures, Forms and Templates 9
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0

Similar threads

Top Bottom