ISO 9001 Nonconformances an how to handle them

C

Candace.Dahlman

I've done some various searches on the forum and unable to find exactly what I'm looking for. Here is my situation:

I was hired about 6 weeks ago as the Quality Manager at a drilling company who has carried ISO certification for 3 years. The recertification audit is coming up very soon. One of the first things I did was an internal audit of the QMS just to get a baseline of understanding. I wrote 3 major corrective actions:

1) The organization does not have a procurement process in place that describes the criteria for selecting suppliers, so, suppliers are not evaluated, approved or reevaluated.

2) There is not a documented process for selecting employees based on their qualifications and the only training the org documents is the safety training.

3) Management Review of Corrective Action - The organization had Corrective Actions open all the way back to 2011 (47 of them). I felt that this could be a CA against the CA System, but felt that if management review were reviewing status of CA's then they should have made sure the corrective actions were taken care of...

So, here are my dilemmas and questions.

The Procurement Process is bigger than a breadbox. And I've created a Corrective Action plan to implement this process in a controlled manner. It's going to take me longer than the time I have before the audit to get the process in place, much less have any objective evidence or set up the infrastructure with the users of the process. Question is - If I have a corrective action, will the ISO Auditor still issue a nonconformance?

On the selection of employees, I've been putting together a roles and responsibilities matrix that describes each job role, the responsibilities and the required qualifications as well as any training. I think that bridges us to where we need to go for this. Can you think of anything else that I need besides documenting it?

On the bunches of Corrective Actions - Would it be acceptable for me to just close all the CA's as OBE - it's a safe guess that we're not going to go back and create any documents or meeting minutes or anything for a job that is over. And again - if I have the corrective action as I work through this, will the ISO auditor cite it as a nonconformance?

I really appreciate any and all advice/suggestions. My new boss, the Senior VP is very supportive of my efforts, but every time I bring up an issue, he doesn't feel like it's really an issue because the last auditor didn't have a problem with how they did it. Oh, did I mention they had the same ISO Auditor for the certification and two surveillances, but we have a new guy for the recertification?

Thanks again,

Candy
 

AndyN

Moved On
Looks like you have a really good grasp of the situation, Candy. I wouldn't worry about the next auditor. If anything is brought up, clearly state that their previous auditor had let the system languish in that non-compliant state for a number of years and, should the auditor care to make an issue, you will be taking it up with the CB as to why they permitted their auditor to allow it! You will, however, welcome them back, in a year's time, to see the improvements. Otherwise, both the (new) auditor and the CB will be finding themselves without a client!
 

Chennaiite

Never-say-die
Trusted Information Resource
......If anything is brought up, clearly state that their previous auditor had let the system languish in that non-compliant state for a number of years and, should the auditor care to make an issue, you will be taking it up with the CB as to why they permitted their auditor to allow it! ....

Sorry to say, I wouldn't resort to what sounds like armtwisting. Instead I will try to put up a show that gives the New Auditor a feeling of things under control. And then, yes, pray to have a real Auditor on board and not a guy who is hungry for writing NCs.
 

harry

Trusted Information Resource
........................a drilling company who has carried ISO certification for 3 years. ......................................

1) The organization does not have a procurement process in place that describes the criteria for selecting suppliers, so, suppliers are not evaluated, approved or reevaluated.

2) There is not a documented process for selecting employees based on their qualifications and the only training the org documents is the safety training. .................................

From what you had described, it would be interesting to find how how they managed to get through the initial audit!!

There is every possibility that the procurement process may reside elsewhere such as with finance and the employment or selection process be with HR, where you may not be given automatic or easy access. Have you check with them?
 

John Broomfield

Leader
Super Moderator
Candy,

Your third party auditor would be foolish duplicate your reporting of these nonconformities.

I would be concerned about the capability of the corrective action process and the past disengagement of top management in making sure their management system continued to be suitable, adequate and effective.

May I suggest you compile a report of the performance of the management system for top management to review its performance. Then have them report the State of the System back to the employees so they know what their management system:

A. Does well
B. Does less than well
C. And what TM is doing about B

John
 
Last edited:
Thread starter Similar threads Forum Replies Date
B Suspension of ISO 9001 Certificate - Major Nonconformances Identified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
D NCRs (Nonconformances) allowed during ISO 9001 Recertification Audit General Auditing Discussions 21
C Nonconformances - Recently Audited on Recertification of ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
G ISO 9001-2000 Registration Nonconformances - What are the most common ones? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C How to to become an ISO 9001:2015 consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A QMS Roll out with guidance from ISO 9001 Quality Management System (QMS) Manuals 8
C Computerized System Validation in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Experience Records - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A ISO 9001 & API Q1 Approved Supplier/Sole Agent ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Matrix to determine what's needed to create a QMS v ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Integrating ISO 9001:2015 audits with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 9001: 2015 MR Outputs - "any need for changes to the quality management system' Management Review Meetings and related Processes 13
L ISO 9001, 14001, 45001 Audit Questions for a Security & Corporate Affairs Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
giavannatabbs ISO 9001:2015 Control of Records - QMS Communications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
H ISO 9001:2015 - 8.5.1 - Routers not being signed Manufacturing and Related Processes 9
Q Documented information ISO 9001:14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Is there a mandatory requirement to notify customers of the complaint resolution in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J ISO 9001:2015 Document Revison History ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q KPI rules for ISO 9001 first certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Sidney Vianna Tesla Lacks Major Automotive Quality Certifications such as IATF 16949 and ISO 9001 IATF 16949 - Automotive Quality Systems Standard 15
Cats Clause ISO 9001 - verification of Tape Measures and Steel rules ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S ISO 9001 Quality Management System and its processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Preservation of Raw Materials in ISO 9001:2015 Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
L Assignment on the link between Quality Gurus & ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
jeancloude17 Advice for ISO 9001 for software Design and Development of Products and Processes 2
Ed Panek ISO 9001 Cert Scope Adjustment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Parallax_Error ISO 9001: Quality Management as a process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Iso 9001 Clause 7.1 - Advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K Applicable ISO 9001 clauses for Human Resources? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ISO 9001:2015 Registered Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
JDJohnson Micrometer & Caliper Calibration (ISO-9001) General Measurement Device and Calibration Topics 26
G Why do you guys think ISO 9001 doesn't ask specifically for preventive maintenance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
D ISO 9001:2015 Calibration Procedures Manufacturing and Related Processes 16
G Auditing Top management: 6.3 ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G IT being audited during ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Moncia Customer satisfaction monitoring - ISO 9001 and 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
Sidney Vianna ISO 9001 News ISO 9001 Design Specification to be developed - May 2022 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S ISO 9001:2015 Project Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Common items : which iso 9001 are common to all areas? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
G ISO 9001 - when implementing customer requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
V ISO 9001 or ISO 17065 required for an organization issuing 5 star rating certification of digital experience? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D ISO 9001:2015 Recertification Audit Timing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J ISO 9001:2015 Is a Project Evaluation form necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
malasuerte Performance of ISO 9001 certified vs. non-certified manufacturing companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11

Similar threads

Top Bottom