Are there ISO9001:2015 Requirements for Preventive Maintenance?

[indubioush]

Maintenance, one word, is required, if applicable. I don't really see much of a distinction between "maintenance" and "preventive maintenance."

 

[John Broomfield]

Preventive maintenance tends to be more analytical (of equipment performance data) than ordinary maintenance at prescribed intervals.

Where it doesn’t really matter (to customers or to the effectiveness of the system) if equipment occasionally breaks down then simple maintenance would probably suffice.

 

[Sidney Vianna]

Preventive maintenance tends to be more analytical (of equipment performance data) than ordinary maintenance at prescribed intervals.

Actually, condition-based maintenance is normally known as predicitve maintenance; interval-based maintenance is typically referred to as preventive maintenance.

 

[outdoorsNW]

Suppose demand for products made on a particular machine type declined. A company now has several more machines than needed to meet current demand. A failure of the machine will cause a hard, easily detected failure at a later point, such as not making a hole when a later step requires something to be put in the hole. Assume scrap and downtime cost is acceptable. In this case can the AS9100 company simply wait until the machine breaks to perform maintenance and not violate AS9100D?

 

[Marc]

Suppose demand for products made on a particular machine type declined. A company now has several more machines than needed to meet current demand. A failure of the machine will cause a hard, easily detected failure at a later point, such as not making a hole when a later step requires something to be put in the hole. Assume scrap and downtime cost is acceptable. In this case can the AS9100 company simply wait until the machine breaks to perform maintenance and not violate AS9100D?

Please do not take this personally - This discussion is related to ISO 9001 requirements. It would be more appropriate to start a new discussion (thread) in the appropriate AS9100 forum to avoid confusion.

 

[somashekar]

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

The ISO 9001 does not require the organization to have a preventive maintenance program. ISO standards do not prescribe any technique that has to be adopted, and so the ISO 13485 smartly uses the work "interval of performing the maintenance activities"
Where necessary, the NOTE in the end of the clause description will indicate towards the techniques that could be adopted by the organization.
It gives you the freedom and triggers the risk based approach.
Now it all boils down to your business, your industry and the risks that you can foresee to apply preventive maintenance program where necessary.

 

[John Broomfield]

Thank you Sidney. I was thinking prediction was part of preventive maintenance. Essential when your machine is delivering your service directly to your customers.

 

[spamman]

I agree with all folks stating that it is good to perform preventive maintenance and typically based on the equipment manufacturers recommendations and / or historical information/use. For custom equipment, this takes time to define. As putting into place an ISO9001 system, performing maintenance of equipment and infrastructure and recording those events should suffice until such time as to build a full PM system AND perform/maintain it. (To be honest I like 13485 much more as it is more prescriptive and allows for less interpretation.)

 

[tony s]

I am not looking for whether its "good" to have one but rather if it is required.

Not required by ISO 9001.

Although intended for the 2008 version (but also applicable to 2015, IMHO), the Approved Interpretation by ISO/TC 176 even clarified that:

 

[Marc]

Preventive maintenance tends to be more analytical (of equipment performance data) than ordinary maintenance at prescribed intervals.

I think of these this way:

Preventive: Change your car's engine (or transmission) oil every X miles driven. Generally the machine or assembly (the motor if it's a car) manufacturer determines an 'appropriate' interval in various ways.

Predictive: Using fluid analysis at X hours of use to determine what parts are wearing and the content expected over that time period. E.g.: Increasing and/or high levels of chromium indicates piston wear so Time to Overhaul may be reduced.

Also see: Definition - Preventive Maintenance vs. Predictive Maintenance - Distinction between