ISO 9001:2015 Internal Audit Toolkit, Tool 3


This tool is one of the most effective tool offered by ISO 9001 since the year 2000. It has not been rightly used . Most organization loose their focus as they are more focused on the end output. While the process approach asks you to start with the output in mind – the rest is  all about focusing and detailing the process and improving the same.

A very common approach to process  detailing is the SIPOC approach (Supplier – Input –process-Output-Customer) W can of courses add Key performance indicators(6.2)  , Risk(6.1) and Responsibilities in this to make the approach a modified one as SIPOCKRR.

Generally, it is a good idea to follow the best practice as outlined in clause 6.2.1 of ISO 9001:2015 for setting the Key performance indicator for the particular process.

For defining responsibilities –though it may vary from organization to organization but it is a good practice if  primary , secondary and monitoring responsibilities are defined for each process.

Once the SPOCKRR charts are made – this is just the starting point. If any meaningful benefit is to be derived out of process approach – processes have to be reviewed and improved  and one good way is to always improve the benchmark/KPI  for the process.

Eurotech Training division provides open house and In-house courses for designing and improving SIPOCKRR charts for processes. For open house ISO process design and improvement course check out our calendar.

ISO 9001:2015 Internal Audit Toolkit, Tool 2

While internal audit is focused on process realization and effectiveness,  this second tool actually complements  the Internal audit in making sure that hard work done in the internal audit does not goes to waste.

It is well know how corrective action is different from correction in terms of focus being th prevention of recurrence of the problem.

It is very important that companies make use of this TOOL not only for the nonconformities or gaps identified during the internal audit but also for all kinds of complaints and unplanned emergencies which take away the management’s time.

In essence this is one of the most underutilized and ineffectively used tools in the ISO 9001 Toolkit. To be able to gauge effectiveness of Corrective action Process one can have a look at the quality aspects of corrective action process such as , involvement of people, defined methodology, promptness of action, effectiveness of action, No of process identified as being able to affect this Corrective action or non conforming situation and relationship.

A  simple method to make sure that corrective action is effective is

  • Whether it involves modification of procedure
  • Whether it involves training /retraining
  • Whether it involves monitoring mechanism to detect the initial non conforming situation and the process because of which the initial non conforming situation occurred.
  • Whether it is trying to change the process that could affect the enabling of the initial non conforming situation

Many methods can be used for Root cause analysis but a few common ones are

  1. 5 Why
  2. FMEA
  3. Fish bone diagram

Though more methods are available but it is easy to use these methods

Common Flaws in using Corrective Action Tool :

  1. TIMELINE -The most common defect in using this tool is focus on a time frame to come up with a corrective action . Since the management’s  focus is to hurriedly close the  non conformities before the management review.
  2. SINGLE PERSON RESPONSIBILITY :Another Common flaw is assigning the closure of responsibility to process owner or departmental head only.
  3. PROCESS INTERACTION: focusing too much on the process where the non conformity was found and missing out on other possible process that could be indirectly responsible for the creation of circumstances that lead to the occurrence of the non conformity.
  4. LACK of TOP MANAGEMENT INVOLVEMENT:  The top management is not involved in acceptance of the Root cause and Corrective action  and  most of the times is not able to relate its own responsibility vis-à-vis the occurrence of non conformity

Possible KPI for Corrective Action Processes are

  1. New processes or sub processes identified because of Corrective action processes PER corrective action
  2. New monitoring mechanism or reporting mechanism developed because of Corrective action PER corrective action
  3. No. of training  and changes in job description initiated as a part of corrective action PER corrective action
  4. No. of document changes for procedures and Work Instructions  made as a part of corrective action PER corrective action
  5. No.  of  changes in work environment done PER corrective action


Eurotech Training division provides open house and In-house courses for internal auditor for ISO 9001:2015 which focuses on how to conduct Root cause Analysis and Corrective action effectively. For open house ISO 9001:2015  internal auditor  course check out our calendar.

ISO 9001:2015 Internal Audit Toolkit: Tool 1

What are the Major Tools you should know? 

Internal Audit and its KPI –TOOL ONE: With this tool provided by ISO, the intent is to identify two kinds of gaps on a continuous basis – whether the QMS is being followed as defined (process compliance) and whether the QMS processes are achieving their identified KPI (process effectiveness). One has to remember that Internal audit though may have some objective as outlined but it itself is a process and should have its own Key performance Indicators. The number of key performance indicators can vary from organization to organization depending on the maturity of the organization’s management system. Some of the possible type of KPI for Internal audit process may be

  • Number of non conformities
  • Closure of non conformities
  • Timeliness of the audit

The above KPI are very generic in nature and may not give any INSIGHT on the quality of Internal audit process which is dependent upon the competency of the auditor- (auditing competency and process knowledge), Independence , tools used (checklist) and Time spent(very critical)

So one can increase the KPI for internal audit process to

  • OFI/Non conformities recorded per unit time spent
  • Time spent per process vs planned time per process
  • Process Effectiveness and Realization chart for each process
  • Evaluative comments on the process documentation (adequacy, simplicity etc)

As a programmer of the internal audit – the person responsible should focus on selection of auditor with respect to individual process taking into consideration, Competence, independence.

It is a common feature that the auditing and process knowledge competence might not be available within a small organization – Here creativity and resourcefulness of the program manager is the key constraint more than the financial constraint. Internal audit process is easily outsourced; however it should not be done with a compromise on auditor’s process and auditing competence.

Eurotech Training division provides open house and In-house courses for internal auditor for ISO 9001:2015 which focuses on developing checklist and giving a live experience of auditing with the developed checklist in their own factory/workshop. For open house ISO 9001:2015 internal auditor course check out our calendar