Informational Required Documents/Records in ISO 9001:2015

Big Jim

Trusted Information Resource
#41
It should be the result of a risk based determination; complexity of the activity, competence level of the people doing it, degree of automation, need for knowledge preservation and management, etc... Not easy, because you can never account for all possible scenarios and it will stifle process improvements. Hundreds of procedures, forms, etc it consumes a lot of time, effort, energy, money, etc. to be sustained.
That's another mistake; it has to work FOR THE ORGANIZATION and the workforce. Never make decisions on system design based on what (external) auditors would like or want to see.
However, it is to your advantage to make your documentation auditor friendly, particularly when doing so also makes it more organization friendly as well. Properly done, it will.
 
Elsmar Forum Sponsor

L.Soad

Involved In Discussions
#42
First of all, thanks for the feedback.
Not easy, because you can never account for all possible scenarios and it will stifle process improvements. Hundreds of procedures, forms, etc it consumes a lot of time, effort, energy, money, etc. to be sustained.
My company is a «niche» company. Pollution sampling (with A LOT of methods depending on the pollutants), every project is very specific. I went with «administrative» or «general» documentation (approx 20 procedures), and «technical» documentation (few procedures, like 3 or 4, such as «prepping for a project on the client site», «samples management», «writing of the report», and a shitload of records forms (for each method), and a methodological guide that keeps all the methods in 1 place, that can be brought on field).

That was «easy», but that sounds like a lot, and took me a lot of time indeed, but these methods are how the company earns some money ! and its the place where a mistake could cause the analysis (our prime product) to be off.

That's another mistake; it has to work FOR THE ORGANIZATION and the workforce. Never make decisions on system design based on what (external) auditors would like or want to see.
I know I should be thinking like that, but when you are alone vs 50 ppl who don’t give a crap about ISO 9001 (because of many reasons, the most important is: they have no time, always running, I’ll be happy if I can have a 2hours meeting with all the directors, they are always out at clients sites), it’s all that matters in the end. I think I could do a 2 hours presentation on why this company is not made for the 9001 and the 9001 is not made for us.

But... we need the ISO9001 to comply with the ministry, as it’s a prerequisite for an official countrywide accreditation. The fact is, they don’t care about ISO9001, I don’t have that much time to do it, that much support, and as usual, I’m the annoying guy even though I try to explain how it could help them.

I’m just a guy trying to get the ISO for the time I’ll be in the company, get paid, find another job, so sad to say that but they are not ready.

Sorry for the long post and the off topic discussion.

Soad
 

L.Soad

Involved In Discussions
#43
Soad,

So, second guessing the auditors?

Here, perhaps, we see the value of becoming a competent (or at least well-trained) auditor before documenting a management system.

As a rule, if you can show that “it works” for your company and it’s customers the auditor will be happy.

John
I hope it will, i have no idea :/

Sadly the ones creating a QMS seems to often be rookies like me, i've been reading you all for months now, thank you for your help

Soad
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#44
I know I should be thinking like that, but when you are alone vs 50 ppl who don’t give a crap about ISO 9001 (because of many reasons, the most important is: they have no time, always running, I’ll be happy if I can have a 2hours meeting with all the directors, they are always out at clients sites), it’s all that matters in the end. I think I could do a 2 hours presentation on why this company is not made for the 9001 and the 9001 is not made for us.

But... we need the ISO9001 to comply with the ministry, as it’s a prerequisite for an official countrywide accreditation. The fact is, they don’t care about ISO9001, I don’t have that much time to do it, that much support, and as usual, I’m the annoying guy even though I try to explain how it could help them.

I’m just a guy trying to get the ISO for the time I’ll be in the company, get paid, find another job, so sad to say that but they are not ready.

Sorry for the long post and the off topic discussion.

Soad
I don't think you need to apologize and your situation is not that uncommon. You've been tasked with "getting us that ISO 9001 thing". In most cases, situations like this one are extremely frustrating because you are not expected to mess with the way the company really operates and still, attain certification. However, the only smart and sustainable way to comply with ISO 9001 is to intelligently embed it in the organization business processes; (check ISO 9001:2015 5.1.1.c)).

Good luck to you and I hope you find some fulfillment in the current assignment.
 

L.Soad

Involved In Discussions
#45
I don't think you need to apologize and your situation is not that uncommon. You've been tasked with "getting us that ISO 9001 thing". In most cases, situations like this one are extremely frustrating because you are not expected to mess with the way the company really operates and still, attain certification. However, the only smart and sustainable way to comply with ISO 9001 is to intelligently embed it in the organization business processes; (check ISO 9001:2015 5.1.1.c)).

Good luck to you and I hope you find some fulfillment in the current assignment.
Thanks ! In fact i do find some fullfillment. hard to express why but i do. its hard, i can do alomost whatever i want to achieve the goal i have, i can speak about ISO9001 to all of the employees (its so easy to find the people i need to rely on (mostly young ing. and Msc.) and the ones going full break (more experienced with less studies), voluntary or not).

I'm trying to only change 3 things and all the rest is stuff already done (more or less) just going on paper, and some rigor in recording evidences , formalizing actions, etc. I think for the 15 years this company existed, it never had any formal action plan. its like a 5 person small business but with 50 employees.

I still don't know yet how i'm going to achieve my goal with regards to 5.1.1 a), f), i), j) ,etc ! but i'll keep you informed

Soad
 
#47
Sydney,
I apologize for hijacking this thread. I've been unable to post an original thread. We are about be nonresponsive to an AS9100 NCL based on the auditor having found a non-current SDS for a metal stamping ink. This is the second year that she has written us up for being out of compliance with OSHA regulations. I have copied every section of the standard referring to regulatory compliance, and it all except two relate to PRODUCTS meeting regulatory requirements. However, I am looking for other sources that support what you and I both believe to be accurate. Failure to keep the SDS binder up to OSHA standards is outside the scope of the QMS. Please help. We're a fantastic company with a successful and robust QMS, and we're about to get hammered for having an MSDS sheet instead of an SDS sheet.
 

Big Jim

Trusted Information Resource
#49
Sydney,
I apologize for hijacking this thread. I've been unable to post an original thread. We are about be nonresponsive to an AS9100 NCL based on the auditor having found a non-current SDS for a metal stamping ink. This is the second year that she has written us up for being out of compliance with OSHA regulations. I have copied every section of the standard referring to regulatory compliance, and it all except two relate to PRODUCTS meeting regulatory requirements. However, I am looking for other sources that support what you and I both believe to be accurate. Failure to keep the SDS binder up to OSHA standards is outside the scope of the QMS. Please help. We're a fantastic company with a successful and robust QMS, and we're about to get hammered for having an MSDS sheet instead of an SDS sheet.
This is inexcusable. Call your certification body and ask to talk to a member of their executive committee and tell them about this bogus nonconformity. Let them straighten up their auditor.
 
Thread starter Similar threads Forum Replies Date
H Is "Master Documents and Records list" required per ISO 9001 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
O What are typical records of different documents required by ISO9001? Records and Data - Quality, Legal and Other Evidence 2
L ISO 14001 4.4.4 d) - What exactly are the documents and records required by ISO 14001 ISO 14001:2015 Specific Discussions 3
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
Marc IAF Mandatory Documents (MD Series) - Required to be used by certification bodies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F The depth of the required Design Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Which documents are required for a class I medical device listing US Food and Drug Administration (FDA) 4
S Clarification in organizing required documents for ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 6
X Documents required by the quality management system shall be controlled ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Minimum documents required by AS9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
N What Documents are Required for each ISO 9001 Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
G Rookie to the ISO 9001:2008 World - Required Procedures and Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Controlled AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
T Control of Safety Documents Required? ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R What Documents are required for Application of Brazilian INMETRO IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
K Documents required to display/keep during ISO 9000 Audit in EPCC firm ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
W Electronic Distribution of Controlled Documents: Validation required? Qualification and Validation (including 21 CFR Part 11) 5
J ISO 9001:2008 Clause 4.2.3 - What are the required documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
C ISO 3834-2 references ISO 3834-5 for the list of documents required for conformity Other ISO and International Standards and European Regulations 1
M All Internally Generated Documents ? Required to be Controlled or Not All? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
C Control of Documents - Is a unique format required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Required documents for Class III Medical Device in Yemen Other Medical Device Regulations World-Wide 3
M List of documents required for engineering service project (CAD/CAM) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
V What documents are required for Education and Training in AS9100 Internal Auditing 3
A Documents required for ISO 17020 vs. ISO 9001? General Measurement Device and Calibration Topics 10
P Required Documents and Document Control in Human Resources for ISO 9001:2000 Document Control Systems, Procedures, Forms and Templates 5
P New product Design & Development for automotive requirements - Documents required Design and Development of Products and Processes 4
T Using References - Required in Quality Documents? Document Control Systems, Procedures, Forms and Templates 2
R Documents required for certification process - AS/EN/JISQ9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
E New and revised documents - Acknowledgement of distribution required? Document Control Systems, Procedures, Forms and Templates 3
E Level 3 PPAP with only a few of the required documents? APQP and PPAP 3
R TS16949 Grandfather documents - Control Plans - Required or not based upon date FMEA and Control Plans 4
Howard Atkins TS 16949 Clause 4.2.1 - Required Documents IATF 16949 - Automotive Quality Systems Standard 15
G Control of External Documents - Which documents are required to be controlled? IATF 16949 - Automotive Quality Systems Standard 10
C How long we're required to keep supplier and our PPAP documents? Supplier Quality Assurance and other Supplier Issues 1
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 10
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 3
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
A When there is a 2 year lapse in production, is a full FAI required? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
C Is it required to put"Rx only" on the home page of an app? Medical Device and FDA Regulations and Standards News 4
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Is Optical Parallel Set required calibration? ISO 17025 related Discussions 1
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
Similar threads


















































Top Bottom