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Are there ISO9001:2015 Requirements for Preventive Maintenance?

#1
Can I hear some folks weigh in on ISO9001 requiring a Preventive Maintenance Program (whether documented or not...)? I fail to see where it is called out as required (like 13485). I am not looking for whether its "good" to have one but rather if it is required.

Thanks folks: Ed
 

indubioush

Quite Involved in Discussions
#2
7.1.5.1 clause b
Basically, monitoring and measuring resources shall be maintained. An then it says you need to maintain documented information that shows the monitoring resources are fit for use.
 

John Broomfield

Staff member
Super Moderator
#3
Preventive action is required but you’d have to show that failure to take preventive action would likely (see risk assessment) result in customer dissatisfaction, failure to fulfill objectives (aka ineffectiveness) or nonconformity.

Auditors though may be slow to recognize this so you may get away with no preventive maintenance unless equipment failure was stopping your organization from fulfilling a contract.
 
#4
7.1.5.1 clause b
Basically, monitoring and measuring resources shall be maintained. An then it says you need to maintain documented information that shows the monitoring resources are fit for use.
Yes, I see where the requirement for a "calibration" process is needed and has been created to satisfy the monitoring and measuring resources. I am looking at if a preventive maintenance system is required. I only see reference to "maintaining" equipment etc.....
 
#5
Preventive action is required but you’d have to show that failure to take preventive action would likely (see risk assessment) result in customer dissatisfaction, failure to fulfill objectives (aka ineffectiveness) or nonconformity.

Auditors though may be slow to recognize this so you may get away with no preventive maintenance unless equipment failure was stopping your organization from fulfilling a contract.
I can separate preventive action from preventive maintenance. There will processes to "maintain" equipment but I do not see a "compliance" need to have a preventive maintenance process unless like you state, there is a measurable impact to customer satisfaction or meeting requirements etc WITHOUT a PM system.
 

indubioush

Quite Involved in Discussions
#6
Maybe I'm not understanding what you mean by "preventative maintenance." Do you mean to have a system in which you perform routine actions on your equipment to ensure it always functions optimally. An example would be to do an oil change. Is this what you mean?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
I am not looking for whether its "good" to have one but rather if it is required.
7.1.3 provide and MAINTAIN infrastructure.
It does not state predictive, preventive or corrective maintenance. Most industrial settings would manage the risks of equipment downtime, by performing preventive/predictive maintenance. But, on a literal sense, the standard does not say preventive.
 

indubioush

Quite Involved in Discussions
#8
I'm going to go ahead and assume you do mean preventative maintenance of equipment. The requirement is that you maintain the equipment. Let's say the equipment manual requires the equipment to have an oil change every six months. You would have to do this. You would have to maintain documented information showing that this had been done. Yes, the requirement as it is written, is a lot less descriptive than ISO 13485, but if you have equipment that requires maintenance, how else are you going to track your equipment maintenance activities without a system to do so? On the other hand, if you do not have equipment that requires maintenance, no system is required. And in addition, having a system does not mean you need to have a preventative maintenance SOP.
 

John C. Abnet

Teacher,Sensei,Kennari
#9
The OP simply asked if ISO 9001:2015 has a requirement for preventive maintenance. The OP is not asking about preventive action .

The simply answer is no.
 

John Broomfield

Staff member
Super Moderator
#10
Preventive maintenance is one aspect of preventive action. It may or may not be necessary to satisfy customers.

For example, as with transport services, fairground rides, cloud data storage services or any service where its failure would dissatisfy customers.
 
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