Preventive Maintenance Requirements - ISO 9001

[Stijloor]

Re: Seek advice on preventive maintenance under ISO 9001

ISO 9001:2008, 4.2.4 states, "Records established to provide evidence of conformity to requirements . . . shall be controlled." Conformity to requirements is not limited to requirements of the standard, but includes management's own requirements. However, if management has established requirements for maintenance, it is possible that no records of maintenance were established. (In some cases, it might be obvious that maintenance was performed, thus no records are required.) In this case, maintenance records are not required of the standard. Certainly in most cases, if maintenance is required, some record of maintenance is generated. If management needs these records to ensure maintenance is being performed as required, these records have been established as records to provide evidence of conformity to requirements and the standard requires them to be controlled accordingly.

Your interpretation. I'll stick with mine.

Stijloor.

 

[ISO 9001 Guy]

Re: Seek advice on preventive maintenance under ISO 9001

8.2.2 requires internal audits to determine whether the QMS "a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization."
If management has required anything beyond the standard to control its processes, including requirements for maintenance records, these records must be maintained (per 4.2.4) so conformity to requirements can be assessed. At least, that's my take on it.

 

[Stijloor]

Re: Seek advice on preventive maintenance under ISO 9001

8.2.2 requires internal audits to determine whether the QMS "a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization."
If management has required anything beyond the standard to control its processes, including requirements for maintenance records, these records must be maintained (per 4.2.4) so conformity to requirements can be assessed. At least, that's my take on it.

I agree that IF a decision is made to establish and maintain records, then they must be controlled per 4.2.4.

However, not all processes established by the organization require records.
We spoke about maintenance. IF management decides to implement a (preventive) maintenance process; that in itself does not mandate the establishment of records (even though this is a good practice). My point is that not all processes established beyond the requirements of ISO 9001:2008 require records to be established and maintained.

Stijloor.

 

[ISO 9001 Guy]

Re: Seek advice on preventive maintenance under ISO 9001

Yep, I think we agree.

 

[Stijloor]

Re: Seek advice on preventive maintenance under ISO 9001

Yep, I think we agree.

Stijloor.

 

[Helmut Jilling]

Re: Seek advice on preventive maintenance under ISO 9001

I agree that IF a decision is made to establish and maintain records, then they must be controlled per 4.2.4.

However, not all processes established by the organization require records.
We spoke about maintenance. IF management decides to implement a (preventive) maintenance process; that in itself does not mandate the establishment of records (even though this is a good practice). My point is that not all processes established beyond the requirements of ISO 9001:2008 require records to be established and maintained.

Stijloor.

I generally agree, but remember, there is also a requirement to provide objective evidence that the requirements are met. That often would be records, or other forms of objective evidence.

 

[dtr18c]

Re: Preventive Maintenance requirements under ISO 9001

Although records of maintenance may not be required as some have already pointed out why. I would like to add that having maintenance records helps determine the adequacy of preventive maintenance tasks and frequencies.

 

[Stijloor]

Re: Preventive Maintenance requirements under ISO 9001

Although records of maintenance may not be required as some have already pointed out why. I would like to add that having maintenance records helps determine the adequacy of preventive maintenance tasks and frequencies.

Adequacy of maintenance tasks can only be determined by maintenance process performance results (measurements), not the records stating that the maintenance was actually performed.

Stijloor.

 

[dtr18c]

Re: Preventive Maintenance requirements under ISO 9001

Adequacy of maintenance tasks can only be determined by maintenance process performance results (measurements), not the records stating that the maintenance was actually performed.

I was thinking that if the occurrence of a particular maintenance task (let's say reactive maintenance in this case) becomes greater overtime (which can be identified by reviewing maintenance records). It can be determined to increase the frequency of preventive maintenance and/or identify additional preventive tasks needed. (This is geared more towards software to track maintenance as it would be more difficult to identify trends sifting through paper records)

Thinking about it, the maintenance process performance results which I believe you are talking about "downtime" is a better measure. (Especially since the main purpose of pm is to reduce downtime) Was I wrong to refer to downtime as the only metric in this case? Doesn't some sort of record need to be created in order to create the maintenance process performance metrics?

 

[Big Jim]

Re: Seek advice on preventive maintenance under ISO 9001

Correct, there is no requirement for records in 6.3. But that doesn't mean that records of maintenance are not required. Record requirements reside in 4.2.4. If an organization has requirements to perform maintenance, 4.2.4 requires records are maintained to demonstrate conformity to these maintenance requirements. If an organization has no requirements for maintenance, then records are not required.

Amazing. Even with the TC 176 ruling in your face, you are still trying to make up your own rules. TC 176 WROTE THE STANDARD!

Also, you may or may not have noticed that there is no reference to 4.2.4 in element 6.3.