When should the OHSMS certification audit be performed?

dpdelgado

Lust for learning
#1
This is my first time to post; so, forgive me if I'm in the wrong forum.

When should the OHSMS certification audit be performed? I know it should not be conducted during plant shutdown. Should it be when the organization is at its "normal operating mode"? If so, how does one define "normal operating mode"? Thoughts?
 
Elsmar Forum Sponsor
#2
Welcome to the Cove :bigwave:

I have moved your question to this section as it relates to Occupational Health & Safety.

Just to clarify on your question - are you referring to the OHSAS 18001 – Occupational Health and Safety Management Systems certification?
 

dpdelgado

Lust for learning
#4
Welcome to the Cove :bigwave:

I have moved your question to this section as it relates to Occupational Health & Safety.

Just to clarify on your question - are you referring to the OHSAS 18001 – Occupational Health and Safety Management Systems certification?
Thanks, Ajit.
Yes, I was referring to OHSAS 18001 certification.
 

dpdelgado

Lust for learning
#5
Under normal operating conditions
Thanks, Randy.

What is the definition of "under normal operating conditions"? How about if the organization has two normal operating modes. For example, a company that operates a ski resort in winter, and, then, operates the resort as a mountain bike trail in summer. Will the company need to be audited in winter for its ski resort operation, and in summer for its mountain bike trail operation?
 
Last edited:
#6
Thanks, Randy.

What is the definition of "under normal operating conditions"? How about if the organization has two normal operating modes. For example, a company that operates a ski resort in winter, and, then, operates the resort as a mountain bike trail in summer. Will the company need to be audited in winter for its ski resort operation, and in summer for its mountain bike trail operation?
Explain in your scope, as well as talk with your CB customer support., and leave it to the CB. Conduct your internal audit under both conditions. Certification process involves survelliance audits and the CB will decide if they have to cover both your normal operating conditions going further.
This is something unlike shift operations where the certification audit is scheduled across all shifts.
 

Randy

Super Moderator
#8
You're over complicating a simple process. The answer is quite simple, when are you doing stuff with people working, that makes the company money, during what could be considered a normal business workday for your business?

Winter, Summer, day or night

Have you picked a certification body yet? If you have they will tell you, if you haven't then when you do they will tell you.

Focus on the important stuff and in this case it's the effective management of health & safety risk.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#9
Have you picked a certification body yet?
It looks like a CB picked him instead, as he wrote
I am writing guidelines for the CB on "normal operating conditions" that is why I am asking the questions.
As for the underlying question, normal operating conditions is when the organization is delivering it's "normal" intended output, and there are no unusual/unexpected extraordinary circumstances affecting it's ability to produce it's products or deliver it's services.

There will always be organizations that are affected by seasonal issues. The example you gave is one. A farm where harvesting only happens ever so often is another.

A CB must use common sense to determine when the to schedule an audit so the assessment is done during a time when the system is operational and the risks and processes put in place to manage such risks can be demonstrated effectively.

In the example you cited, if the first stage 2 audit is done during the winter, the scope of certification could be limited to winter related activities and, in the summer, the scope of certification could be expanded to include summer related activities.

Good luck.
 

dpdelgado

Lust for learning
#10
It looks like a CB picked him instead, as he wrote


As for the underlying question, normal operating conditions is when the organization is delivering it's "normal" intended output, and there are no unusual/unexpected extraordinary circumstances affecting it's ability to produce it's products or deliver it's services.

There will always be organizations that are affected by seasonal issues. The example you gave is one. A farm where harvesting only happens ever so often is another.

A CB must use common sense to determine when the to schedule an audit so the assessment is done during a time when the system is operational and the risks and processes put in place to manage such risks can be demonstrated effectively.

In the example you cited, if the first stage 2 audit is done during the winter, the scope of certification could be limited to winter related activities and, in the summer, the scope of certification could be expanded to include summer related activities.

Good luck.
Thanks for the insights, Sidney!
 
Thread starter Similar threads Forum Replies Date
B Should I buy IEC 62304:2006, IEC 62304:2006/AMD 1:2015 or both? EU Medical Device Regulations 1
W "Accurate to ±2%" means "64% of measurements should be within 2% of the actual value"? US Medical Device Regulations 4
H Should we stop inspecting a part if its never been rejected? Reliability Analysis - Predictions, Testing and Standards 3
D What distributor requirement should we (manufacturer) require from the Distributor? EU Medical Device Regulations 0
M Should there be another column in the Optimization section (step 6) of AIAG-VDA DFMEA form? FMEA and Control Plans 0
C By when should harmonized standards be complied with? EU Medical Device Regulations 5
W Strategy for determining which components from a system should be "ME EQUIPMENT" -- home healthcare environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
B Documented information - Should be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Is engineering a process and should it have its own process turtle? IATF 16949 - Automotive Quality Systems Standard 7
P Which MDCG Document should I use for PMS Plan and PSUR? EU Medical Device Regulations 2
M Who should quality representative report to? ISO 13485:2016 - Medical Device Quality Management Systems 5
H When should the first PSUR be issued? EU Medical Device Regulations 5
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
C When should you quit programming? Job Openings, Consulting and Employment Opportunities 9
C Should resolution be included in uncertainty budget for digital caliper or micrometer calibration? Measurement Uncertainty (MU) 5
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
T How should I approach REACH, CM, etc. as a job shop? RoHS, REACH, ELV, IMDS and Restricted Substances 18
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 7
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5

Similar threads

Top Bottom