You can manage only what you measure: Monitoring and measuring resources in ISO 9001:2015

 Question:

We are doing internal audit (Gap analysis) for ISO 9001:2015 Certification (transition from 2008 to 2015 version).

What Processes and Systems should we have in place to ensure that Monitoring and Measuring Resources (cl.7.1.5) is covered by our Management system?

Section 7.1.5 Monitoring and measuring resources The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided: a) are suitable for the specific type of monitoring and measurement activities being undertaken; b) are maintained to ensure their continuing fitness for their purpose. The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

Answer:

1. It is important to clearly define that the monitoring and measuring resources include:
 

- measuring equipment (ME)

- approved measuring techniques;

- trained personnel.

2. The requirement ‘a) are suitable for the specific type of monitoring and measurement activities being undertaken’ is ensured via the following.

2.1 In the ‘Design and development and products and services’ Process the following is regulated:

a) the characteristics of products and processes (all figures in the design and technological documentation are the subject of measuring and monitoring),

b) tolerance (+/-allowable variations) or limit values.

2.2 The ‘Control of monitoring and measuring equipment’ Process (in ISO 9001:2008) or a similar ‘Monitoring and measuring resources’ process (in ISO 9001:2015) regulates:

a) methods and ME - based on cl.2.1.a;

b) the class of ME, which provides the necessary accuracy of measurements - based on cl.2.1.b

c) measurement techniques - based on cl.2.2.a

d) requirements for personnel

2.3 In the ‘Control of external processes, products and services’ Process (‘Purchases’ in ISO 9001:2008):

а) ME is being purchased - based cl.2.2.a and cl.2.2.b

2.4 In ‘Monitoring and measuring resources’ Process

а) the acquired ME (cl. 2.3.а) are received, marked and recorded in the Registry, a schedule of calibration is adopted.

2.5 In ‘Production’ Process:

а) calibrated ME (cl.2.4.а) and measuring techniques (cl.2.2.c) are established;

б) the personnel who carries out monitoring and measuring is allocated.

                                     

2.6 In ‘Control of personnel’ Process:

а) the training and (or) certification of the personnel who carries out monitoring and measuring is provided (cl.2.5.b)

3. The requirement "b) are maintained to ensure their continuing fitness for their purpose" is ensured in ‘Monitoring and measuring resources’ Process via:

-       completion of schedule of verification;

-       completion of schedule of calibration;

-       protection against unauthorized actions;

-       ensuring the timely personnel re-certification,

-       updating of measuring techniques (if necessary).

Got QMS related question? Get it answered by an expert! support@c-bg.com (put 'QMS question' in the subject line)

More questions answered in the ISO 9001:2015 QMS Transition Program Workshop

•        0.7 CEU credits

•        .PDF Certificate accepted by IRCA and RABQSA as evidence of continual professional development

$189.00  Register Now!