What is required in a combined ISO 9001, ISO 14001 and OHSAS 18001 Audit?

D

Davidb54

I am due an audit in April. 900.1400.1800. I am not sure what is involved. Could you give me an idea of whats in front of me.Thanks
 
H

harry

Trusted Information Resource
Davidb54 said:
I am due an audit in April. 900.1400.1800. I am not sure what is involved. Could you give me an idea of whats in front of me.Thanks
Click to expand...

Welcome to the Cove.

Are you that unprepared? Is your system running? Are you a QMR or just a person-in-charge of a certain process or department? And did you have the necessary training and perhaps involvement in Internal audits?

More information is needed - we don't want to speculate and jump on you.

Meanwhile have a look at some of the attachments

Audit preparation

Prepare for audit
 
Last edited:
Q

qusys

Trusted Information Resource
Davidb54 said:
I am due an audit in April. 900.1400.1800. I am not sure what is involved. Could you give me an idea of whats in front of me.Thanks
Click to expand...

Be more specific. What is your role in QMS? Are you talking of Registrar audit? Is this the first time for your organization or is it a surveillance audit?

A consideration from my side: why don't you check or consult first inside your organization to have news/info as well as awareness about this upcoming and important event?:bigwave:
 
H

Helmut Jilling

Auditor / Consultant
harry said:
Welcome to the Cove.

Are you that unprepared? Is your system running? Are you a QMR or just a person-in-charge of a certain process or department? And did you have the necessary training and perhaps involvement in Internal audits?

More information is needed - we don't want to speculate and jump on you.

Meanwhile have a look at some of the attachments

Audit preparation

Prepare for audit
Click to expand...

I have scheduled a training class for Jan. 28-31, 2013 that will give a very good teaching on much of what you would liek to learn. If you are interested, let me know. The class will address ISO and TS-16949, and is held in the Akron / Cleveland area.
 
Last edited:
D

Davidb54

Harry, thanks for your reply. I am just in charge of the process. I have had no formal training. What I have done is all the risk assessments and created training records for each employee (40 in total) I understand we need to have a management meeting. Apart from that I have'nt a clue. To be totally frank, feeling uptight about the whole thing. David
 
Randy

Randy

Super Moderator
It's exactly the same as any other audit to a single standard except everything is combined and it takes a bit longer, I'm doing (2) 9-14-18 audits in Feb and another in March...No biggy
 
H

harry

Trusted Information Resource
Davidb54 said:
.................. I am just in charge of the process. I have had no formal training. What I have done is all the risk assessments and created training records for each employee (40 in total) I understand we need to have a management meeting. Apart from that I have'nt a clue. To be totally frank, feeling uptight about the whole thing. David
Click to expand...

Don't worry. Every body faces this the first time - only thing is, I think your organization ought to provide you with better guidance or training. Sometime soon, there should be an internal audit or a series of it. You will gain more knowledge and experience from there.

The links I provided earlier pertains to preparation for audits - they should be useful for you to prepare for what's coming. Come back and ask questions whenever you have doubts.
 
D

Davidb54

Thanks again Harry, to help you understand the owner of the business is my lifetime friend. It used to be a small business but has grown substantially over the last few years.
I only work for him Wed/Thurs. Any advice would be welcome. I am finished now until next Wed.
David
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T New process capability analysis required when changing a product on the same line? IATF 16949 - Automotive Quality Systems Standard 6
G Clause 7.5.3 and Required Work Instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 41
K Equipment IQ/OQ/PQ required when you have 100% product inspection? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Help required in establishing Laboratory Information Management System as per ISO 17025, Cl.7.11.2 ISO 17025 related Discussions 0
Z AS9102B Form 1, line 19 question. Is a printed name and signature both required or is only a signature sufficient? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
D Is it required to have the operator initial their work in the IATF 16949:2016 standard? IATF 16949 - Automotive Quality Systems Standard 3
B Are forms and templates required? Document Control Systems, Procedures, Forms and Templates 10
A Why is Protective Earth Resistance required <0.1ohm or 0.2ohm in 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
D Is Good Laboratory Practice (GLP) Required in ISO 17025? ISO 17025 related Discussions 4
K What are the differences between the certificates required for home and medical medical equipment? US Food and Drug Administration (FDA) 1
I MOPP required for SIP when considering Single Fault Condition (SFC) in 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
B AS9100:D - Purchase Order required if ordering paint on supplier portal? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
V Is it required to recalibrate reference- standard instruments after equipment qualification General Measurement Device and Calibration Topics 0
B Supplier Evaluation report - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 3
H Registration for REACH required for Non-EU Down Stream Manufacturer? REACH and RoHS Conversations 5
P AS9100D clause 8.6 - Documentation required to show evidence of conformity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Is IATF certification required when customer doesn't require it? IATF 16949 - Automotive Quality Systems Standard 19
Kevin Walters IAQG Required Audit Days Needed (Please help) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Is MDSAP Audit Required? ISO 13485:2016 - Medical Device Quality Management Systems 3
H Required explanation of sub clause 7.2.101.2 (Exception) of IEC 61010-2-020:2006 CE Marking (Conformité Européene) / CB Scheme 5
Ashland78 PPAP required for repair of machine? IATF 16949 - Automotive Quality Systems Standard 5
Y Is preventive action required for each CAPA initiated? ISO 13485:2016 - Medical Device Quality Management Systems 24
B Spreadsheet - Used for complaint investigation - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 9
N 8.3.3.3 Special characteristics - Auditor said we are required to create our own, if no customer char. exist. IATF 16949 - Automotive Quality Systems Standard 10
P 9.2.2.2 & 9.2.2.3 Audit Cycle alignment required? IATF 16949 - Automotive Quality Systems Standard 1
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 5
I Are suppliers required to hand over process validation reports? ISO 13485:2016 - Medical Device Quality Management Systems 20
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
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
D Is calibration really required? IATF 16949 - Automotive Quality Systems Standard 6
D Filling totes and pails - when is a calibrated scale / flowmeter required in ISO 9001 General Measurement Device and Calibration Topics 4
S Supplier performance required to be reported to supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Is the Design Service Provider required to be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 13
B What are "appropriate drawings" required for a MDR in 21CFR820? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Record approval- Signatures required ISO 13485:2016 - Medical Device Quality Management Systems 9
M MDSAP required for Device Initial Importer/Distributor into Canada? Other Medical Device Regulations World-Wide 11
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
O New GTIN (DI) required? Other US Medical Device Regulations 0
P Is the second factor authentication (2FA) required for external users? Qualification and Validation (including 21 CFR Part 11) 1
validationspec EN 868-5 pdf required. Medical Device and FDA Regulations and Standards News 1
F Uncertainty not Required Measurement Uncertainty (MU) 3
I How to find required testing for a specific device? Other US Medical Device Regulations 3
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
S Is it required to complete Internal Audits within one year? ISO 13485:2016 - Medical Device Quality Management Systems 29
D "certified" in ISO 19011, as well as IATF required? IATF 16949 - Automotive Quality Systems Standard 6
M Is validation required when consumables are changed Qualification and Validation (including 21 CFR Part 11) 7
B Is labeling on the device itself required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Scrap Material Scale Calibration Required? IATF 16949 - Automotive Quality Systems Standard 21
K Is Calibration Required for Non-Adjustable Commercial Inspection Devices? General Measurement Device and Calibration Topics 11

Similar threads

Top Bottom