SBS - the best value in QMS software

How Can I Remember the ISO 9001 Clauses?

N

nln123

#1
Is there any easy methods/ways to remember the ISO 9001 clauses 4.1- 4.20 clauses .I get always confused .It will be useful particularly when doing Quality audits?

------------------
N.Lakshminarayana
 
Elsmar Forum Sponsor
J

John C

#2
N.Lakshminarayana,
I was working with ISO 9002 for quite a while before I discovered the convenient way the standard was put together with everything in ‘real time’ order. From that moment I developed a liking for the standard and admiration for the people who first designed it (BS or US Mil Std people before them?).
Suddenly, I could visualise the standard laid out on the system it was supposed to control instead of just as an arbitrary set of requirements. It is still useful for me but, unfortunately, ISO 9001:2000 will probably put an end to this.

I see the standard broken into 4 distinct areas and it is very easy to remember them this way;

Section 1. Management’s direct involvement; 4.1 and 4.2;
Considering a company setting up a quality (documented) system; It is senior management that must make the decision and take responsibility and the logical first thing they will do is decide their policy (4/1/1). Then they will consider what people should be involved (4.1.2.1) and what resources they need (4.1.2.2) - with the people they’ll include a Management representative (4.1.2.3) and, lastly, senior management remember that someone will have to review performance - they decide to do it themselves (4.1.3).
With everyone together and the objectives set (policy), the next thing is to put together the documented (quality) system (4.2.1)consisting of two parts - procedures first (4.2.2), of course and then quality planning (4.2.3).

Section 2; Getting down to business - dealing with the customer and the purchasing responsibilities;
We can’t do anything without a contract. (4.3)
And, if the contract is for a product we need to design, then we have to see to that. (4.4)
The output of design is documents and we have to control these and also our procedures and plans. (4.5) and changes of same (4.5.3).
Now we are going to build something so we need to purchase material (4.6.1), evaluate subcontractors (4.6.2) and give them the information about what we want to buy (4.6.3)
But if we are building with someone else’s material, then we have ways of looking after that (4.7)

Section 3. We are into the manufacturing (or business) area; It starts with controlling the flow of product (4.8) and the process (4.9), then inspection and test of what we build 4.10, which brings us to the need for control of test equipment (4.11) and indication of test status (4.12).
This leads to some rejects so they have to be controlled (4.13)
and we need to take some corrective action as a result (4.14)
and move the good and the bad product out (4.15)

Section 4. Reviewing and tidying up; Having contracted for a job and finally delivered the product, we now make sure our records are in place (4.16) and review our performance (4.17) before getting on with the next job. We probably find we need some extra training (4.18) and we may even get a call for some servicing (4.19) (whatever that means - I never figured this out - some people think it means repairing field returns but I think it means visiting your customer and maintaining or repairing equipment)
Oh, yes, Statistical Techniques! We forgot them, of course, so we’ll tag them on at the end. (4.20)
rgds, John C


[This message has been edited by John C (edited 25 October 2000).]
 
A

Al Dyer

#3
No easy method,

Read, Absorb, Understand, and only answer questions after you review the standards.

ASD...
 
S

Steven Truchon

#4
I dont try to remember, that requires use of valuable memory space <gr>. But I do keep a printed list in full view at my desk and one taped down securely on my clipboard for reference. Over time and through many audits and related activities the list has become embedded in my mind and I find I dont refer to the list nearly as often.
 

Randy

Super Moderator
#5
When asked for his phone number one time, Albert Einstein looked it up in a phone book. He said it was a waste to remember something that he could go to a reference for.

I feel the same way about clauses.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Originally posted by Steven Truchon:

I don't try to remember, that requires use of valuable memory space....
It took me a couple of years but after - well, I guess it's been 8 years or more - I pretty much know the old version by heart. The new version I will learn the old fashioned way - as I use it, sooner or later I'll remember it all. Probably. Hopefully. I'm getting old...
 
G

Greg Mack

#7
It is really like learning the words to a song. You never really get it all until you listen over and over.

The same with the Standard. It is easy to remember though if you think about it in an orderly manner.

For example, The way it is structured would be how the parts of the system should be strung together in order - at least it works that way for me.

I am very comfortable with the new Standard already, and know it pretty much off hand. I achieved this by reading not only ISO9001, but 9004 and HB 90.0 (which helped me relate new sections to the old)

After that, I completed an adequacy audit on our current system to the new Standard.

If you don't want to do that, then you could tape you own voice reading each clause and play the tape each night before you go to bed.
 
Thread starter Similar threads Forum Replies Date
E Preparing for the ASQ CPGP (GMP professional exam), how to revise and remember the vast syllabus? ASQ - American Society for Quality 2
S 100 Places to Remember Before They Disappear Coffee Break and Water Cooler Discussions 8
SteelMaiden Remember Mikey from Life Cereal Fame? Coffee Break and Water Cooler Discussions 2
ScottK Just remember this when you think you hate your job Funny Stuff - Jokes and Humour 3
ScottK Remember Auditors - It's all in how you ask the question! Coffee Break and Water Cooler Discussions 1
K Remember Hollywood Squares? Funny Stuff - Jokes and Humour 5
Marc Anyone Remember B. F. Skinner? The father of Reinforcement Theory Philosophy, Gurus, Innovation and Evolution 13
L I looking for a book, but cannot remember the name? . . . . HELP! Book, Video, Blog and Web Site Reviews and Recommendations 3
A Remember Ford/Firestone? Has anything really changed because of this? Philosophy, Gurus, Innovation and Evolution 5
Marc Remember DOS? After Work and Weekend Discussion Topics 5
C How to develop an Equipment / Machinery FMEA - Remember the key word: Predictive FMEA and Control Plans 7
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M ISO 14971 Determination of Competent Persons ISO 14971 - Medical Device Risk Management 4
R Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO Other Medical Device Related Standards 9
Q The scope of ISO 21534 Other Medical Device Related Standards 0
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 3
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
N Quality Compliance Officer - ISO 13485, London Job Openings, Consulting and Employment Opportunities 0
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
N ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
A Tips and Tricks to understand ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
K ISO 50001 Consultant wanted Paid Consulting, Training and Services 0
K Comparison wanted: ISO 15378:2018 vs. PS9000:2016 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
John C. Abnet ISO 45001:2018 (5.4 - Consultation and participation of workers) Occupational Health & Safety Management Standards 10
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
S ISO 15223-1:2020 Symbols Other Medical Device Related Standards 1
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
R ISO 10993-18 Medical Device and FDA Regulations and Standards News 1
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 4
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom