Records required for ISO 9001 clause 7.1.5.1 - Fitness for purpose of the monitoring and measurement resources

[tony s]

Since the standard is applicable to all types of organization, the term "fitness for their purpose" of the various "monitoring and measuring resources" can be demonstrated on the following examples:

• for measuring equipment (e.g. calipers, micrometers, etc.) - the appropriate discrimination, bias, number of distinct categories, etc. should be ensured;
• for medical devices - the safety of the material, design, ease of use, ergonomic requirements, FDA approval, etc. should be ensured;
• for examination or evaluation tools (e.g. on schools/universities) - the relevance, clarity of the set of questions, currentness, approval of education body, etc. should be ensured....

 

[Heydar Mojahed]

I am consultant in a food supply co. Customer requirement for weight of food is 300 gr. +- 10 gr. We use 500 gr. digital scale with accuracy 1 gr. for weighing the food, we do not use 50 k g. big scale for this purpose.
We maintain the specifications file for these kind of resources and retain the records of data of measurements to prove the conformity. And also our scale has calibration label and certification and not expired date yet.
So we can meet the req. 7.1.5.1 and 7.1.5.2. Are we in the right way?

1. Your measuring instrument calibration records.

It is evidence for 7.1.5.2 not 7.1.5.1

 

[GSpoto]

I am consultant in a food supply co. Customer requirement for weight of food is 300 gr. +- 10 gr. We use 500 gr. digital scale with accuracy 1 gr. for weighing the food, we do not use 50 k g. big scale for this purpose.
We maintain the specifications file for these kind of resources and retain the records of data of measurements to prove the conformity. And also our scale has calibration label and certification and not expired date yet.
So we can meet the req. 7.1.5.1 and 7.1.5.2. Are we in the right way?

It is evidence for 7.1.5.2 not 7.1.5.1

You are doing fine considering your statements. Cannot comment with anything else since I haven't deep knowledge of your processes or on the actual customer requirements.

 

[Heydar Mojahed]

Briefly, monitoring and measurement resources shall be suitable, precise, accurate, reliable, calibrated and surely clean.

 

[Big Jim]

I am consultant in a food supply co. Customer requirement for weight of food is 300 gr. +- 10 gr. We use 500 gr. digital scale with accuracy 1 gr. for weighing the food, we do not use 50 k g. big scale for this purpose.
We maintain the specifications file for these kind of resources and retain the records of data of measurements to prove the conformity. And also our scale has calibration label and certification and not expired date yet.
So we can meet the req. 7.1.5.1 and 7.1.5.2. Are we in the right way?

It is evidence for 7.1.5.2 not 7.1.5.1

I believe that calibration records are for both 7.1.5.1 and 7.1.5.2. If you look closely nothing is said about the need for records (retained documented information) in 7.1.5.2 so there is no reason to believe there is a need for something different or additional. Records for fitness of purpose applies equally to both.