Thursday, April 28, 2016

How to measure training effectiveness according to ISO 9001

International standard ISO 9001:2015 (as well as the earlier versions of the 9001) does not contain any requirements to such an evaluation procedure, thus it is beneficial to use a good production technique.

The most complete evaluating of training effectiveness according to ISO 9001 includes 4 stages:

Stage 1 — Testing the participants at the concluding stage of the training program.
The criterion - evaluation testing.
Typically, testing is organized by the program supervisor. It is a good practice to separate the authority: training is conducted by one organization (or at a least a subdivision), testing – by the other.

Stage 2 — Evaluation of creativity of the participants.
The criterion - the number and the level of proposals for improvement, that the participant of the training program comes up with in the report.
The criterion may be determined by the 10-point scale via expert evaluation. Experts are a quality manager and an executive (manager) who delegated the participant to take training.

Stage 3 — Evaluation of training efficiency.
The criterion - the number and level of the proposals for improvement that were implemented.
The criterion may be determined by the 10-point scale via expert evaluation. Experts are quality manager and owners of processes, where the improvements were implemented. These can be the same experts as were used in Stage 2.

Stage 4 — Evaluation of training effectiveness.
The criterion - the resulting economic effect of the implemented proposals for improvement.
The criterion may be determined by the 10-point scale via expert evaluation. Experts are quality manager and owners of processes, in which the implementation was carried out. These are the same experts as in Stage 2.

To implement the proposed approach the selection can be limited to one or more stages.

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Wednesday, April 20, 2016

Service Provision Quality System Procedure

Service Provision procedure reflects completion of all the requirements of ISO 9001:2015 concerning the provision of services or production of goods. We recommend this procedure for organizations that provide services. Additionally it could be used by small businesses involved in the production of goods.

‘Service Provision’ Process model is displayed below:


‘Service Provision’ Process Model Flows 

More information about Service Provision Procedure.

Download PDF description.

Saturday, April 16, 2016

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).

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Thursday, April 7, 2016

QMS Transition to the ISO 9001:2015 requirements: questions and answers

A saying 'The devil is in the detail' is 100% applicable to the QMS transition to the new version of ISO 9001:2015.
The requirements wording of the Standard is often confusing while the decisions to be made are very important.

We start publishing Questions that other users encountered in the process of their QMS transition with our Answers.

If you have a QMS related question - please email it to support@c-bg.com  and will do our best to get you an expert opinion.


Question: I disagree that ISO 9001:2015 'Corrective Actions' Procedure does not includes preventive actions functions. The verbiage ‘preventative’ was removed, but the functions of preventative actions are still required, right?

Answer: ‘Corrective actions’ Procedure regulates the response to the occurred nonconformity, including correction, identification and elimination of the causes of this nonconformity.

When a nonconformity occurs, including any arising from complaints, the organization shall …

…evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by … determining if similar nonconformities exist, or could potentially occur;

ISO 9001:2015 Cl. 10.2.1.b.3

It is important to note that ISO 9001:2015 cl. 10.2.1.b.3 also refers to the nonconformities that are similar to the occurred identified nonconformity.

With regard to Preventive actions in 9001:2008 version, their main purpose was to identify, analyze and eliminate the causes of potential nonconformities. The main technique to identify potential nonconformities was negative trends of processes identification and analysis.

In 9001:2015 Version, the requirements for monitoring, measuring, analysis and evaluation were enhanced, which, among other things, provide negative trends analysis. In addition, a very effective tool for prevention of potential issues, including nonconformities, was added – Actions to address risks and opportunities. In this regard, 9001:2015 version excluded the ‘preventive actions’ term as being less generic compared to the new techniques.

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
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