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- Keshav Ram Singhal
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Friday, June 30, 2023

हुर्रा ! मैं बहुत खुश हूँ .... Hurrah ! I am too happy ...








हुर्रा ! मैं बहुत खुश हूँ ....

90 से अधिक देशों/अर्थव्यवस्थाओं से

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मेरे ब्लॉग https://qmsawareness.blogspot.com/ का दौरा किया, देखा और पढ़ा। 


साथ ही 90 से अधिक देशों/अर्थव्यवस्थाओं से

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मेरे दूसरे ब्लॉग https://iso9001-2008awareness.blogspot.com/ का दौरा किया, देखा और पढ़ा। 


मेरे ब्लॉग की लोकप्रियता से मैं प्रेरित और सम्मानित महसूस करता हूँ। 

मेरे ब्लॉग के सभी पाठकों के निरंतर समर्थन के लिए धन्यवाद। 

मैं आशा करता हूँ कि मेरे अन्य ब्लॉगस को भी इसी तरह का समर्थन मिलेगा। कृपया मेरे ब्लाग का समय-समय पर दौरा करते रहे,

उन्हें पढ़ते रहें और टिप्पणी करते रहें। 


पुन: आभार,

केशव राम सिंघल

जागरूकता के लिए प्रतिबद्ध










Hurrah ! I am too happy ...

More than one lakh (100,000) visitors

from more than 90 countries / economies have

visited, seen and read my blog https://qmsawareness.blogspot.com/.


In addition to this more than five lakh (500,000) visitors

from more than 145 countries / economies have

visited, seen and read my previous blog http://iso9001-2008awareness.blogspot.in.


I feel motivated and honoured with the popularity of my blog.

Thanks for the continuous support of the readers of my blog. I hope that I will get similar support to my other blogs. Please keep visiting, reading my blogs and keep commenting too.


Again Thanks,

Keshav Ram Singhal

Committed for Creating Awareness 




Thursday, June 29, 2023

ISO 9001:2015 QMS Awareness – Improvement – Continual improvement

ISO 9001:2015 QMS Awareness – Improvement – Continual improvement  

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Improvement = Activity to enhance performance

 

Improvement activity can be recurring or singular.

 

Continual activity = Recurring activity

 

Continual improvement = Recurring activity to improve or enhance performance

 

Continual improvement is not a one-time or singular activity. It is a regular activity.

 

ISO 9001:2015 QMS standard is based on the quality management principles that include improvement. Any management approach centred on quality should be based on the fundamental assumption that there is always scope for improvement in every area of business including organization’s processes. Focusing improvement efforts bring better results. ISO 9001:2015 QMS standard describes requirements for continual improvement.

 

The organization needs to consider – (i) Results of analysis and evaluation, and (ii) Management review outputs.

 

The organization needs to determine – Needs / opportunities for improvement.

 

The organization needs to address – Determined needs / opportunities.

 

The organization needs to continually improve – Suitability, adequacy and effectiveness of its quality management system.

 

Some of the areas within an organization that can be continually improved are:

 

(1)   Leadership and management – Enhancing leadership commitment and improving overall top management role in quality management system activities

 

(2)   Customer satisfaction – Focusing on understanding customer needs, taking and analyzing customer feedbacks, and addressing customer complaints

 

(3)   Process efficiency – Identifying and optimizing organization’s processes to enhance efficiency and streamline operations

 

(4)   People involvement – Promoting people involvement by improving their competence and by fostering a culture of quality and continual improvement

 

(5)   Relationship management – Strengthening relationship with suppliers, contractors and stakeholders

 

(6)   Risk-based thinking – Determining risks and opportunities and taking actions to address them

 

(7)   Analysis and evaluation – Analyzing and evaluating data and information to monitor process performance

 

(8)   Corrective action – Taking corrective action to address nonconformity

 

(9)   Criteria and methods – Determining, applying and improving criteria and methods needed to ensure effective operation of processes

 

(10) Documented information – Regularly updating, maintaining or retaining documented information

 

All above areas provide a foundation for continual improvement as these are not one time activity. It should be noted that continual improvement is an ongoing process, and regular review will help identify additional area for improvement.

 

Continual improvement is such a necessity, which should be implemented in every walk of life. Likewise, there is a great need for continual improvement in the management systems. Although the requirements for continual improvement are briefly given at the end of ISO 9001:2015 QMS standard, however it deserves special attention. Continuous improvement will be effective in strengthening the quality management system of the organization and will provide great benefits to the organization, including increased customer satisfaction, improved efficiency, enhanced performance, enhanced competitiveness, culture of innovation, better process / product / service, etc.

 

 

Think of the following Questions

 

(1)   What do you understand by improvement and continual improvement?  

 

(2)   How will you apply continual improvement requirements in your organization?

 


Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

 

Wednesday, June 28, 2023

Understanding the meaning – Continual improvement …. Constant improvement …. Continuous improvement

Understanding the meaning – Continual improvement …. Constant improvement …. Continuous improvement

Please CLICK THIS to get the blog post on the above subject.

Thanks,
KRS

ISO 9001:2015 QMS Awareness – Improvement – Nonconformity and corrective action

ISO 9001:2015 QMS Awareness – Improvement – Nonconformity and corrective action

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Nonconformity = Non-fulfilment of a requirement

Nonconformity = Deviation from a specification, a standard requirement or an expectation

 

Correction = An action to eliminate a detected nonconformity

Corrective action = An action to eliminate the cause of a nonconformity

Corrective action = An action to prevent recurrence of the nonconformity

Correction focuses on rectifying the immediate nonconformity, while corrective action aims to eliminate the root cause of the nonconformity and prevent its recurrence.

 

 

The requirements related to nonconformity and corrective action mentioned in ISO 9001:2015 QMS standard (clause 10.2) are applicable when a nonconformity occurs (happens / takes place / exists / be found to be present) and arising from complaints.

 

The purpose of the requirements related to nonconformity and corrective action mentioned in ISO 9001:2015 QMS standard (clause 10.2) is to eliminate – (i) The causes of nonconformity, (ii) Correct the nonconformity to conformity.

 

The organization needs to react to the nonconformity (as applicable) – (i) Take action to control and correct the nonconformity, (ii) Deal with the consequences / effects), (iii) Evaluate the need for action (by reviewing and analyzing, determining the causes, determining if similar nonconformity exists or could potentially occur) so that the nonconformity does not recur / occur elsewhere, (iv) Implement any action required, (v) Review the effectiveness of corrective action taken, (vi) Update risks and opportunities determined during planning, if necessary, (vii) Make changes to the quality management system, if necessary.

 

Corrective action needs to be appropriate to the effect of the nonconformity encountered.

 

The organization needs to retain documented information (records) – (i) Nature of nonconformity, (ii) Any subsequent action taken, and (iii) Result of corrective action taken.

 

The requirements (regarding nonconformity and corrective action) basically relate to learning from errors to prevent their repetition. The following process can be a suggestive way –

 

(i)              Begin with identification of a problem or nonconformity

 

(ii)             Continue with identification of the root causes of the problem or nonconformity

 

(iii)            Plan corrective action initiatives

 

(iv)           Start corrective action for the root cause

 

(v)             Check the result of the corrective action taken

 

(vi)           If desired results not achieved after checking, carry out root cause analysis again and plan-do-check-act cycle process for correction

 

(vii)          In case problem is not solved or nonconformity is not eliminated then to control such nonconforming product (output), please deal as per requirements of clause 8.7 (control of nonconforming outputs) that include segregation, containment, return, suspension, informing the customer, obtaining authorization for acceptance under concession

 

(viii)         Standardize the improvement in the similar related activities – Use of learning from the corrective action for the improvement of the organization’s processes

 

Think of the following Questions

 

(1)   What is a nonconformity?  

 

(2)   What is corrective action?

 

(3)   How will you proceed when you find a nonconformity?

 

(4)   How will you deal with situations when you are not able to get desired results after taking corrective action?

 


Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

 


Tuesday, June 27, 2023

ISO 9001:2015 QMS Awareness – Improvement – General

ISO 9001:2015 QMS Awareness – Improvement – General

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Improvement = Activity to enhance performance

Improvement activity can be recurring or singular.

The organization needs to determine and select – Opportunities for improvement.

 

Opportunities for improvement to include – (i) Improving product / service to meet requirements and to address future needs / expectations, (ii) Correcting / preventing / reducing undesired effects, (iii) Improving performance and effectiveness of the quality management system.

 

The organization needs to implement – Any necessary action to meet customer requirements and enhance customer satisfaction. Such action may include correction, corrective action, continual improvement, breakthrough change, innovation, reorganization etc.

 

One of the opportunities for improvement is addressing future needs and expectations. Future needs and expectations refer to the evolving requirements and desires of customers, users, stakeholders and the market. These can vary depending on the product, service, industry and specific organization. In the software industry, future needs and expectations may involve developing more user-friendly interfaces, incorporating artificial intelligence capabilities etc. Organizations, now a days, are expected to address future needs and expectations, such as reducing carbon footprints, implementing green practices, developing eco-friendly products. We know, legal rules and regulations evolve over time. Compliance with new regulatory requirements may become future needs.

 

Undesired effects are outcomes or consequences that organizations aim to avoid or minimise. These effects can be related to the product, service or process. High level of customer complaints indicates a need for improvement. Excessive waste generation, inefficient process, or high error rate can lead to more cost, lower productivity, and low customer satisfaction.

 

The organization can improve the performance and effectiveness of its quality management system through various means. A few are:

 

(i)                  Conducting regular assessment (monitoring ad measurement) to identify area of improvement.

 

(ii)                Enhancing skills and knowledge of employees through training, motivation and guidance.

 

(iii)               Organization should identify bottlenecks, inefficiencies, areas of waste within the process to take improvement action.

 

(iv)               Encouraging a culture of continual improvement.

 

(v)                 Conducting regular internal audits and management reviews as per schedule.

 

(vi)               Allocating resources timely.

 

(vii)             Top management actively involving itself in quality management activities.

 

(viii)           Assessing risks and opportunities related to the quality management system.

 

Above are indicative. There may be more ways and means.

 

Think of the following Questions

 

(1)   Why is improvement to the quality management system important?

 

(2)   What are opportunities for improvement?

 

(3)   How to address future needs and expectations?

 

(4)   What are the ways to improve performance and effectiveness of the quality management system?

 

 


Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

Sunday, June 25, 2023

ISO 9001:2015 QMS Awareness – Performance evaluation – Management review

ISO 9001:2015 QMS Awareness – Performance evaluation – Management review

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Management review = Management + Review = Review carried out by the top management of the organization

 

Management = People with authority and responsibility for conduct and control of the organization

 

Review = Determination of the suitability, adequacy and effectiveness of the quality management system of the organization

 

Purpose of the management review – (1) To ensure continuing suitability, adequacy and effectiveness of the quality management system (being implemented in the organization), and (ii) To ensure the alignment of the quality management system (being implemented in the organization) with the strategic direction of the organization.

 

Responsibility – Top management of the organization

 

Top management of the organization needs to plan and define – Intervals to conduct management reviews.

 

ISO 9001:2015 QMS standard does not provide specific intervals for conducting management reviews. It is for the organization to determine suitable intervals for conducting management reviews based on the organization’s needs, context, size, complexity, industry requirements, risks considerations and effectiveness of the quality management system (QMS). Typically, management reviews are conducted at regular intervals. Some organizations choose to conduct management reviews annually. Some other organizations may choose for more frequent reviews, such as quarterly or half-yearly.

 

Top management of the organization needs to plan management review by considering inputs. Management review inputs are – (i) Status of actions from previous management reviews, (ii) Changes in external and internal issues relevant to the quality management system of the organization, (iii) Information on performance and effectiveness of the quality management system of the organization, including information on trends in customer satisfaction, information on feedback from relevant interested parties meeting quality objectives, process performance, product / service conformity, nonconformities, corrective actions, monitoring and measurement results, external providers’ performance, (iv) Adequacy of resources, (v) Effectiveness of actions taken to address risks / opportunities, and (vi) Opportunities for improvement.

 

Top management of the organization needs to conduct management review at defined (planned) intervals by considering inputs and by taking decision and action on – (i) Opportunities for improvement, (ii) Any need for changes to the quality management system of the organization, (iii) Resource needs.  

 

The organization needs to retain documented information (records) of the results of the management review.

 

There may be some questions, such as (i) What may be the opportunities for improvement? (ii) What may be any need for changes to the quality management system of the organization? (iii) What may be resource needs? Let us understand.

 

Opportunities for Improvement – Opportunities for improvement refer to areas within the organization’s quality management system where change, enhancement or refinement is made to have a better process, product or service. Opportunities for improvement can arise from various sources, such as: Feedback from relevant interested parties including customer feedback, internal audit, monitoring key performance indicators (KPIs), suggestions from employees working for the quality management system of the organization.

 

Any need for changes – Any need for changes to the quality management system of the organization refers to find out (identify) changes to the organization’s quality management system that can be prompted by various factors, such as: (i) Revision in legal (statutory and regulatory) requirements, (ii) Technological advancement, (iii) Changes in organization’s structure, process, product or service, and (iv) Lessons learned and experience gained from nonconforming outputs, incidents, corrective actions that can reveal weakness in the quality management system of the organization.

 

Resource needs – Resource needs refer to the allocating and providing necessary resources to address improvement in the quality management system of the organization that can include human resource, infrastructure including upgrading / acquiring new equipment / technology / facility, improvement in the skill and knowledge of employees by providing relevant training.

 

Think of the following Questions

 

(1)   Why is management review important?

 

(2)   Who to conduct management review?

 

(3)   What are the management review inputs?

 

(4)   What are the management review outputs?

 

 


Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.


Saturday, June 24, 2023

ISO 9001:2015 QMS Awareness – Performance evaluation: Internal audit

ISO 9001:2015 QMS Awareness – Performance evaluation: Internal audit

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Audit = A process for obtaining objective evidence

 

Audit = A process that is systematic, independent and documented

 

Audit = A process for evaluating the objective evidence objectively to determine the extent to which the audit criteria (set of policies, procedures, requirements) are fulfilled

 

Purpose of internal audit – To conform (i) Whether the quality management system of the organization conforms to the requirements of ISO 9001:2015 QMS standard and requirements determined by the organization, and (ii) Whether the quality management system of the organization is effectively implemented and maintained.

 

The organization needs to consider – (i) Importance of processes concerned, (ii) Changes affecting the organization, and (iii) Results of previous audit(s).

 

The organization needs to plan and establish – Audit programme (that also include the frequency, methods, responsibilities, planning requirements and reporting). 


It should be noted that specific frequency for conducting internal audit is not mentioned in the ISO 9001:2015 QMS standard. The organization should determine the frequency of internal audit based on the organization’s needs, importance of the processes being audited, and the results of previous audits. 

 

The organization needs to define – Audit criteria and scope (for each audit).

 

The organization needs to select auditors to carry out internal audit (Ensure objectivity and impartiality).

 

The organization needs to implement and maintain – Planned and established audit programme.

 

The organization needs to conduct – Internal audit at planned intervals (ensure objectivity and impartiality).

 

The organization needs to report – Results of the audit to the relevant management of the organization.

 

The organization needs to take – Appropriate correction and corrective actions at an early date (without undue delay).

 

Here it is important to understand the terms ‘correction’ and ‘corrective action’.

 

Correction = An action to eliminate a detected nonconformity

 

Corrective action = An action to eliminate the cause of a nonconformity

 

Corrective action = An action to prevent recurrence of the nonconformity

 

Correction focuses on rectifying the immediate nonconformity, while corrective action aims to eliminate the root cause of the nonconformity and prevent its recurrence.

 

The organization needs to retain documented information (records) of – (i) Implementing audit programme, and (ii) Audit results.

 

For more guidance on auditing management systems, it is suggested to please refer to ISO 19011:2018 standard, Guidelines for auditing management systems.

 

Think of the following Questions

 

(1)   Why is internal audit important?

 

(2)   Can an internal auditor audit his own work?

 

(3)   What are the requirements for internal audit?

 

(4)   What is the difference between the term ‘correction’ and the term ‘corrective action’?

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.