ISO 9001 Certification - Successful First Registration Audit? (Poll)

Did your company obtain certification after...

  • 1 audit

    Votes: 36 97.3%
  • 2 audits

    Votes: 1 2.7%
  • 3 audits

    Votes: 0 0.0%
  • 4 audits

    Votes: 0 0.0%

  • Total voters
    37
Elsmar Forum Sponsor
#3
It would also be a neat learning thing if you let us know what kind of nonconformances were found (if any), and what the auditors focused on.
 
S

SuRiVs

#4
Not certified yet

db said:
It would also be a neat learning thing if you let us know what kind of nonconformances were found (if any), and what the auditors focused on.
I'm working in a small company that haven't been certified yet, so I will agree that knowing the nonconformances and the auditor's focus will be very interesting.
 

RoxaneB

Super Moderator
Super Moderator
#5
Doing it right the fist time....ahh...I used that line on my resume a long time ago. Sent out 500 resumes before noticing the error....first time...not fist time. :) But, yeah, my location attained registration to ISO 9001:2000 (and ISO 9002:1994 way back when) on the first attempt.

Long audit for us...

- July 1 = US Sales office
- July 3 = Canadian Sales office
- July 8 & 9 = Actual location

Nonconformances

  1. (US Sales) 6.2.2 Competency, Awareness and Training : Training was not complete for processing a New Product Inquiry.
  2. (CDN Sales) 4.2.4 Control of Records : Record retention period was not identified for all key records.
  3. (Site) 7.4 Purchasing : The continuing qualification method identified for XYZ is not the method currently employed. The method used is the "Supplier Performance Evaluation" whereas the method stated is an Audit by ABC.

Opportunities for Improvement

  1. (US Sales) 4.2.4 Control of Records : You may wish to review the retention times of some key records to ensure they meet all legal requirements.
  2. (CDN Sales) 8.2.1 Customer Satisfaction, 8.4 Analysis of Data, 8.5.1 Continual Improvement : You may wish to consider having feedback from the mill on delivery performance. Both from a "ready to ship" and "ship" status.
  3. (Site) 4.2.4 Control of Records : You may wish to consider identifying the disposition/disposal requiremnts for archived records on tape.
  4. (Site) 6.3 Infrastructure : The telephone communication system between the *** and the @@@ has the potential to allow misunderstanding of requirements. You may wish to consider replacing the verbal system with a documented system.
  5. (Site) 7.6 Control of Monitoring and Measuring Devices : Consider applying monitoring and measuring principles to manufacturing processes (e.g., Maintenance).
 
#6
"We" (former co.) registered 2 sites, 125 souls each, to 9k94, in 9 months, in 1998, 1st 3rd party audit. Secrets:
Good, strike that, excellent steering committee (1 non-managment rep. from each dept.) at each site.
1 knowledgable and intelligent CQE/CQA at each site (besides me, the QMgr.)
Good consultant, knew the standard, keen on process maps, death on overwriting/overdocumenting (they were 9k94 registered).
Near fanatical support from the Pres & CEO (just don't let him talk too the registrar too lon).
Fair and reasonable auditor(s) from NQA-USA (select a registrar that fits you).
We had a couple of minors each site, related to not doing what we said (due mostly to the speed and abbreviation of training and internal auditing required to implement the system that quickly).
 

RoxaneB

Super Moderator
Super Moderator
#7
Audit Plan

Day 1 - US Sales

  • 7.2 Customer related processes
  • 4.2.3 Documentation requirements
  • 6.2.2 Competency, awareness and training
  • 7.1 Planning product realization
  • 7.5.1 Control of production
  • 8.2.1 Customer satisfaction
  • 8.5.2 Corrective action
  • 8.5.3 Preventive action
  • 8.5.1 Continual improvement

Day 2 - CDN Sales

Same as above

Day 3 - Site

  • 5.0 Management responsibility
  • 6.1 Provision of resources
  • 6.3 Infrastructure
  • 8.2.1 Customer satisfaction
  • 8.5.1 Continual improvement
  • 4.0 Quality management system
  • 6.0 Resource management
  • 8.2.2 Internal audit
  • 8.5.2 Corrective action
  • 8.5.3 Preventive action
  • 7.4 Purchasing
  • 7.5 Customer property - verify exclusion
  • 4.2 Documentation requirements

Day 4 - Site

  • 7.1 Planning of product realization - verify exclusions 7.3, 7.5.2, 7.5.4
  • 7.5.1 Control of production
  • 8.2.3 Monitoring and measurement of process
  • 7.5.3 Identification and traceability
  • 7.5.5 Preservation of product
  • 8.3 Control of nonconforming product
  • 8.2.4 Monitoring and measurement of product
  • 7.6 Control of monitoring and measuring devices
  • 7.4.3 Verification of purchased rpoduct
  • 8.4 Analysis of data
 
C

Christi Day

#8
We just passed the certification audit to 9001:2000 (first try). I must admit my ideallist attitude towards the entire process has been shattered. Our auditors did not seem to know the standard or understand the spirit of the standard (which reminds me to find that other thread about registrars to vent my frustration). Our findings were:

Rulers in the office were not calibrated (they are used for straight edges in non-engineering areas).
Training records did not indicate re-evaluation dates.
Three quality systems notices were not processed in a timely manner.
Three bottles of chemicals in the Test Lab were expired.
Each record does not specify owner, retention time, disposal method.
 

gpainter

Quite Involved in Discussions
#9
I do not believe that are many companies that took more than 2 times. Most on the first for ISO. However it took a local company 3. Do the Preassessment and correct the findings and you should make it. Good Luck and help is here when needed.
 

gpainter

Quite Involved in Discussions
#10
Christi Day said:
We just passed the certification audit to 9001:2000 (first try). I must admit my ideallist attitude towards the entire process has been shattered. Our auditors did not seem to know the standard or understand the spirit of the standard (which reminds me to find that other thread about registrars to vent my frustration). Our findings were:

Rulers in the office were not calibrated (they are used for straight edges in non-engineering areas).
Training records did not indicate re-evaluation dates.
Three quality systems notices were not processed in a timely manner.
Three bottles of chemicals in the Test Lab were expired.
Each record does not specify owner, retention time, disposal method.
Just wondering, who is your registrar.
 
Thread starter Similar threads Forum Replies Date
G USAS ISO 9001 Certification, online is it worth it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O ISO 9001 new certification advice request - Develop a QMS from scratch ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
J ISO 9001 - How to decide if a company needs or will benefit from certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Implications of Dropping ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S ISO 9001:2015 & ISO 14001 Re-Certification Audit Preparation ISO 14001:2015 Specific Discussions 8
somashekar ISO 9001 Certification, School context - Students are...? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P ISO 9001:2015 Supplier Certification Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
I ISO 9001 and VWAD (Verified-Accredited Wholesale Distributors certification) Coffee Break and Water Cooler Discussions 1
S Responsibilities between government owner and private subcontractor of a power plant seeking ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
E ISO 9001 certification of the new plant before start of production ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
N ISO 9001 certification with limited scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Heavy Civil Construction Company Implementing ISO 9001:2015 for Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
QSM_Rick Advice on selecting an ISO 9001:2015 Lead Auditor Certification Course ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
A Combined ISO 13485 Certification with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 23
G Discontinuing ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
S What to expect in an ISO 9001:2015 Lead Auditor Certification Course Training - Internal, External, Online and Distance Learning 9
S ISO 9001:2008 Certification Scope does not mention "manufacturing" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A How soon can I apply for ISO 9001:2015 certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S ISO 9001 Certification Renewal until 2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M ISO 9001 Certification of the QMS of a Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Need assistance with ISO 9001 Certification Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
U ISO 9001 Certification for Highly Distributed International Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Can we exclude our subsidiary company from our ISO 9001 certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
N Passed ISO 9001:2008 Certification Audit Covegratulations 9
M Joint ISO TS 29001 and ISO 9001 Certification - One or two certificates? Oil and Gas Industry Standards and Regulations 5
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4
G Does AS9100 Certificate include ISO 9001 Certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
J TS 16949 Certification for 20 out of 70 ISO 9001 Certified Lines IATF 16949 - Automotive Quality Systems Standard 4
H RABQSA ISO 9001:2008 Lead Auditor or ASQ CQA - Which certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Steps to Preserve ISO 9001 Certification during Corporate Acquisition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
F Setting up a New QMS for Certification when ISO 9001 is about to Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
U Compliance with CFR 21 Part 11 vs. ISO 9001 Certification Qualification and Validation (including 21 CFR Part 11) 9
Q Planning Activities After ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Complete Company Restructuring & Impact on ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J What is the most common industry requesting ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
E Letting go of ISO 9001:2008 certification...What other framework to use? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Query about ISO 9001 Certification Documentation for a Service company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T What happens in an ISO 9001:2008 Re-Certification Audit? General Auditing Discussions 11
T ISO 9001:2011 Certification - Is that legit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M Adding AS9100C Lead Auditor Certification to an IRCA ISO 9001 LA Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R ISO 9001 Certification - School/University Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Multi-Site Certification to ISO 9001, 14001 and OHSAS 18001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
F Moving our Distribution Company - ISO 9001 Certification Impact ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Reduced Insurance Premium with ISO 14001 or ISO 9001 Certification ISO 14001:2015 Specific Discussions 3
M ISO 9001 Registration Process - Timeline for obtaining ISO 9001 certification Registrars and Notified Bodies 3
K Which Certification - ISO 13485 vs. ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 8
T If a company becomes TS 16949 certified does it still need ISO 9001 certification? IATF 16949 - Automotive Quality Systems Standard 12
J Where to begin to move our company towards ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom