Don't raise nonconformities against people!!!

Don't raise nonconformities against people!!!

Nonconformity simply means non-fulfillment of a requirement. You, as an internal auditor, is interested to find out nonconformities for which you may be in search of non-fulfillment of requirements. While carrying out system audits (such as, ISO 9001:2015 QMS audits), don't raise nonconformities against people, rather raise nonconformities against process and system. If your audit looks out for human error issues and mentions them in your audit report, then you will unnecessarily become a targeted critic of organization's people and you will be stamped as 'fault finder', not a proactive auditor who looks for strengthening the quality management system. Looking for a person at fault and mentioning the same in the report is a blame game that should be stopped. There are a few occurrences that issues are caused by people. Faults are more likely to lie with the system/process/procedure and here you have an opportunity to report the non-conformity for improvement.

When you observe a nonconformity, do not see who is responsible. Rather consider why and what caused the problem or nonconformity.

With best wishes,

Keshav Ram Singhal

For details on the Training Handbook on ISO 9001:2015 QMS Awareness, please CLICK HERE

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ISO 9001:2015 QMS - Understanding the needs and expectations of interested parties

ISO 9001:2015 QMS
Understanding the needs and expectations of interested parties

Clause 4.2 of ISO 9001:2015 QMS standard deals with the requirements related to the understanding of the requirements of interested parties. According to the requirements of the standard, following needs to carry out:

(i) Determine: Interested parties relevant to the organization
(ii) Determine: Requirements of the determined interested parties that are relevant to the organization
(iii) Monitor and review: Information about the determined interested parties and their determined requirements.

Clarification:
(i) Interested parties = Persons/organizations that can affect, be affected by, or perceive themselves to be affected by a decision or activity.
(ii) Examples of interested parties: Customers, owners, stockholders, employees, workers on contract, contractors, suppliers, bankers, unions, partners, society, competitors, opposite pressure groups, government, regulatory bodies, neighbours etc.
(iii) Why there is a requirement to understand the needs and expectations of interested parties? Because interested parties' needs and expectations can have an effect or potential effect on the organization's ability to consistently provide products/services that meet (fulfill) customer and applicable legal requirements.
(iv) Needs and expectations = Requirements

An understanding of the needs and expectations of interested parties is an important issue as this can affect the organization's quality management system. As such, it is required that the organization remains familiar with the requirements of interested parties and maintain an awareness through monitor and review and thus make the organization to respond to the requirements appropriately. Unwillingness or reluctance to recognize the needs and expectations of interested parties will hamper a robust quality management system.

Step-by-step process:
(i) Make a team of identified persons.
(ii) The team should be asked to determine interested parties and their requirements.
(iii) The team should make a list of all such requirements with necessary details.
(iv) Assign responsibility to monitor and review such requirements to different persons or groups in the organization, so that effective decisions can be taken for the improvement.

Questions
(i) What are the requirements for understanding the needs and expectations of interested parties in ISO 9001:2015?
(ii) Why should an organization determine interested parties and their requirements?
(iii) Who can be the interested parties?
(iv) What may be the step-by-step process for understanding the needs and expectations of interested parties?


(Written for the Forthcoming Book - Implementing ISO 9001:2015 Quality Management System - A Reference Guide - Dr. Divya Singhal and Keshav Ram Singhal. Suggestions and comments invited.)


For details on the Training Handbook on ISO 9001:2015 QMS Awareness, please CLICK HERE

Thanks.

ISO 9001:2015 QMS - Understanding the organization and its context

ISO 9001:2015 QMS
Understanding the organization and its context

Clause 4.1 of ISO 9001:2015 QMS standard deals with the requirements related to the understanding the organization and its context. According to the requirements of the standard, following needs to carry out:

(i) Determine: Internal and external issues (positive and negative factors or conditions) relevant to organization's purpose, strategic direction and that can affect organizational ability to achieve intended results.
(ii) Monitor and review: Information about the determined external and internal issues (positive and negative factors/conditions)

Clarification:
(i) There are many issues that can make easier the understanding the external context of the organization. Such issues may arise from legal, technological, competitive, cultural, social and economic environments and that can be global, national, regional or local.
(ii) There are many issues that can make easier the understanding the internal context of the organization. Such issues may relate to the organization's value, culture, knowledge and performance.

We see that the requirements of ISO 9001:2015 QMS standard starts with asking for determination of all issues that can enhance or interrupt achievement of the quality management system outcomes. The organizational issues may be internal and/or external that may be well defined, substantially subjective or not so well defined. We need to understand them. A subjective issue may be internal issue within and among groups/people in an organization. It is required for the organization to monitor and review all those issues that can affect achievement of defined goals. With monitoring and reviewing internal and external issues, an organization is better prepared to make improvements and thus leads to a success path. The management of the organization should identify persons, who are well-versed with the organization and its processes and who understand the standard's requirements very well,. These persons should be encouraged to create a suitable, adequate and effective quality management system by monitoring and reviewing internal and external issues. The persons in the organization should make their best efforts to understand related issues and process details, so that they may contribute to achievement of the defined goals.

Step-by-step process:
(i) Make a team of identified persons.
(ii) The team should be asked to think and identify all positive/negative factors and conditions that are relevant and that can affect achievement of organizational goals.
(iii) The team should make a list of all such issues with necessary details.
(iv) Assign responsibility to monitor and review such issues to different persons or groups in the organization, so that effective decisions can be taken for the improvement.

Questions
(i) What are the requirements for understanding organization and its context in ISO 9001:2015?
(ii) Why should an organization determine internal and external issues?
(iii) What can be internal issues that can affect organizational ability to achieve intended results?
(iv) What can be external issues that can affec organizational ability to achieve intended results?
(v) What may be the step-by-step process for understanding the organization and its context.

(Written for the Forthcoming Book - Implementing ISO 9001:2015 Quality Management System - A Reference Guide - Dr. Divya Singhal and Keshav Ram Singhal. Suggestions and comments invited.)


For details on the Training Handbook on ISO 9001:2015 QMS Awareness, please Click Here

Thanks.

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