Comprehensive Compliance - Obligations, Actions, Audits Streamline your Quality and EHS compliance program with integrated regulatory data and easy to use software. By Nimonik ISO 9001:2015 Free Checklist Internal Quality Management System Audit. Sep 03, 2020 Internal audit checklists are great tools to help implement a QMS and prepare for a third party ISO 9001:2015 certification audit. Learn more about ISO 9001 and QMS in our beginner’s guide. Get started with this ISO 9001:2015 Gap Analysis and Internal Audit Checklist built using iAuditor – the world’s number #1 inspection software platform.
What is an ISO 9001 audit?
An ISO 9001 audit is a documented, systematic, and objective process for gathering facts.
What is an ISO 9001 Audit Checklist?
An ISO 9001 audit checklist is a key element in planning for and carrying out a process audit, which is a requirement of the ISO 9001 standard. The checklist for any internal quality audit is composed of a set of questions derived from the quality management system standard requirements and any process documentation prepared by the company. The checklist is created in step two and used in step three of the Five main steps in ISO 9001 Internal Audit.
ISO 9001 Audit Checklist Preparation
As part of the internal quality audit preparation, the ISO 9001 auditor will review the ISO 9001 requirements and process documentation defined by the company for the process to be audited. While it may be beneficial to use an audit checklist template when preparing for an audit, it is important to ensure that the checklist be adapted to the process of the organization, and that it is not a generic process. So, the steps of creating an audit checklist would be reviewing the ISO 9001 standard, and then creating questions to ask when reviewing records and personnel of the process. The goal is to find evidence that the process is meeting its own requirements.
As an example, the ISO 9001 clause for management review inputs requires that management review include:
- information on results of audits,
- customer feedback,
- process performance and product conformity,
- status of corrective and preventive actions,
- follow-up actions from previous management reviews,
- changes that could affect the quality management system, and
- recommendations for improvement.
If the company process requires that management reviews produce minutes of meeting as a record, then the internal audit checklist could request that the auditor review the minutes of meetings and question that each piece of input information was presented to the management review meeting for assessment.
As this would only be one question on a checklist for reviewing the management review process, the ISO 9001 audit checklist would contain the many questions required to assess the process.
Using the ISO 9001 Audit Checklist
To audit ISO 9001 the auditors will use the checklists created and look for evidence that the process being audited meets the requirements of the defined process. Where process documentation is not present, it is often relevant to use the requirements of the ISO 9001 standard, focusing on reviewing the process suppliers, process inputs, process steps, process outputs and process customers to ensure that they are consistently understood by the employees using the process. The idea is to review for the effectiveness of the process, and to ensure that non-conformances could not be caused because the process does not have a written document describing it. Again, the goal of using the internal audit checklist for ISO 9001 is to review the process and to confirm that the process records provide evidence that the process meets its requirements. Only secondly does the auditor raise a corrective action to have the process owner correct instances when the process does not meet requirements.
For a better understanding of the ISO 9001:2015 internal audit process, see this free online training:ISO 9001:2015 Internal Auditor Course.
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I am working with an automotive industry.I want to maintain my HR Department/documents according to ISO 9001,14001,18001 for audit purpose. Kindly provide guidelines/checklists for the same urgently.
regds,
xyz
From India, Pune
As an internal and lead auditor of my company for ISO 14001, OHSAS 18001 & TS 16949, following are the documents required:
ISO 14001
1) Water Testing certificates
2) Water Meter readings
3) Pollution Control Board License
4) Sewage water license and readings
5) Certificate for handling of Hazardous wastes / Chemicals
6) LPG usage license.
7) State Electricity board certificate
OHSAS 18001
1) Safety audits NCR Reports
2) Accident register
3) Accident details monitoring
4) Near Miss Investigation Analysis
5) LPG water sprinkler working
6) Safety of machines and workers / staff
7) Assembly point to be recognized
8) Mock drills reports
9) Identifcation of machines
10) Fire safety training documents
11) Fire Extinguishers maintenance and adit report
12) Safety Committee meeting reports
TS 16949 / ISO 9001
1) Competency Mapping documents
2) Training records (no. of trainings conducted, manhours & periodical
review)
3) Factory License
4) ESI & PF returns challan
5) Regular maintenance of canteen and office building (form to be
maintained)
6) Other Statutory requirements
7) Linkage of training needs identified from PMS and Comeptency Mapping
and Training conducted.
8) Training feedback forms and its analysis......
Hope this must ahve cleared your doubts....
Regards
Ankit
09869851356
From India, Mumbai
As per Ankit, at ISO TS/16949 he mentioned 8 points. To my knowledge and belief, point No.3 ~ 6 are not required here.
For ISO TS/16949 the following is required :
1) Training Calendar (Yearwise Plan with Budget etc./Inhouse/External training plan)
2) Training Need Identification Form
3) Training Attendance
4) Training Matrix (Planned Vs. Actual)
5) Training Reports
6) Training (Induction & Orientation) - for New joined employees
7) Training Feed Back Form
8) Training (OJT forms)
9) Training Effectiveness & Evaluation Form
10) Skill Matrix of Shop Floor employees & other Staff
11) Competency Mapping (Matrix)
Of course, for ISO 14001 the following are required:
Factory's Licence,
Pollution Control Board Consent,
Pollution (Air, Water & Soil Test certificates from PCB Laboratory (or) PCB authorized agency
Pollution (Harzardous Wastage Handling, Storage, Disposal, Transportation Consent form PCB - its regular follow up register
ETP / STP analytical test reports (monthwise) - fees paid proof (from PCB authorities)
A separate space (room) - for storing Hazardous Wastes (approval to get from PCB)
Other licences like Explosive Licence(if any hazardous chemicals used in company), Methanol Usage Licence (if used in company),
Company and Contract Vehicle Pollution Test Certificates,
Fire Licence from Local Divisional Fire Officer(District HQ),
Health Department Licence from Local District Authorities, etc. is needed.
Hope the above is in order.
K. Gopalakrishnan
Sriperumbudur
90940 16863
From India, Bangalore
Thanks for your useful link. Pls keep posting like this.
Best rgs
Jenny
--------
All infos about ISO 9001 can be found at ISO 9001. It's quite useful.
From Vietnam, Hai Phong
From India, Mumbai
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From India, Mumbai
From India, Pune
From India, Pune
From India, Mumbai
Iso 9001 Audit Checklist
Hello Friend,As far as Human Resources is concerned ,I would recommend you to maintain evidentory records for following documents as part of Quality,Health and safety management (QHSE) system requirements,
1.Training needs and identification analysis
2.Training records
3.Job description of employees
4.Evaluation of training and feedback reports
5.Employee database and files
6.Health reports of employees
7.Applicable Legal requirements related to that particular geography and industry
8.Fire fighting and first aid trainers list
9.Records of fire drill and any such trainings held in past
10.Roles and responsibilities documents related to HSE system
11.Operational procedures pertaining to HR if any
12.KPIS and performance measures related to HSE systems for HR department
13.Records related to evaluation of compliance and leagal requirements
14.Non confromacne and corrective and preventive action records if raised by auditor to HR dept in past.
15.Policy document for HSE system (this is not mandatory but employees in HR should be aware of thier role related to policy)
As far as logistics is concerned you can maintain all these documents in electronic format on server or in personal computer files.
All the best.Kindly feel free to get in touch with me for any assistance further.
Best regards,
Raju Prasad
rajuprasad12@yahoo.com
From India, Mumbai
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