Please read my earlier blog posts in this regard.
I designed a format for this purpose that may be useful.
Thanks,
Keshav Ram Singhal
Wednesday, November 30, 2016
Context of the organization - Determining external and internal issues
Please read my earlier blog posts in this regard.
I designed a format for this purpose that may be useful.
Thanks,
Keshav Ram Singhal
Monday, November 28, 2016
Build A Risk Culture In Your Organization
If you wish to build a risk culture, organize a 'Building A Risk Culture Awareness' program (lecture series) in your organization and motivate all employees to answer the question 'What can go wrong at my desk/job function?' Compile information and address all relevant risk issues. This will facilitate in building a risk culture.
Risk-based thinking must be adopted in every organization.
Decision making should be on the basis risk-based thinking. Define unacceptable to desired in every process. Identify and critically prioritize the mechanisms that can influence the behaviour of employees to adopt risk-based thinking. Enforce risk-based thinking in the organization's activities as usual activities. Leaders (top management) need to continually live and breathe the risk-based culture values.
All the best,
Keshav Ram Singhal
Wednesday, November 23, 2016
ISO published 'Guidance for SMEs wishing to implement ISO 9001:2015 QMS'
International Organization for Standardization (ISO) has published its guidance handbook 'ISO 9001:2015 for Small Enterprises - What to do?' for SME’s wishing to implement ISO 9001:2015 QMS. The guidance handbook includes practical advice and concrete examples tailored specifically for small businesses.
The handbook is written by a group of experts from ISO/TC 176/SC 2, the technical subcommittee that developed ISO 9001:2015 QMS standard. The handbook includes useful information on everything from how to get started right through to guidance for those who choose to seek certification. It includes practical advice on the different ways of approaching a quality management system (QMS) as well as detailed guidance on each clause of ISO 9001:2015 standard.
The handbook can be purchased from national ISO member (BIS in India) or from the ISO Store. For more information, please visit ISO Website.
- Keshav Ram Singhal
ISO published ISO/TS 9002:2016 - Guidelines for application of ISO 9001:2015
ISO published ISO/TS 9002:2016 - Guidelines for application of ISO 9001:2015
International Organization for Standardization (ISO) has published ISO/TS 9002:2016 that has been developed to assist users to apply ISO 9001:2015 QMS standard's requirements.
The title of ISO/TS 9002:2016 is Quality management systems - Guidelines for the application of ISO 9001:2015. This technical specification document provides guidance on each clause of ISO 9001:2015 QMS standard. This document also provides examples of what an organization can do. The examples in this document are not definitive and only represent possibilities, not all of which are necessarily suitable for every organization.
ISO 9001:2015 QMS standard contains requirements that can be objectively audited or evaluated. ISO/TS 9002:2016 does not provide any additional requirements, but ISO/TS 9002:2016 includes examples, descriptions and options that aid both in the implementation of a quality management system and in strengthening its relation to the overall management system of an organization. While the guidelines in this document are consistent with the ISO 9001:2015 quality management system model, they are not intended to provide interpretations of the requirements of ISO 9001:2015 QMS standard or be used for audit or evaluation purposes.
As the requirements of ISO 9001:2015 QMS standard are generic, this document can be used by organizations of all types, sizes, levels of maturity and in all sectors and geographic locations. However, the way an organization applies the guidance can vary based on factors such as the size or the complexity of the organization, the management model it adopts, the range of the organization’s activities and the nature of the risks and opportunities it encounters.
ISO/TS 9002:2016 document can be purchased from national ISO member (BIS in India) or from the ISO Store. For more information, please visit ISO Website.
- Keshav Ram Singhal
Thursday, October 27, 2016
RISK MATRIX
A Risk matrix is a matrix that is used during risk assessment to define the various levels of risk as the product of the harm probability categories and harm severity categories. This is a simple mechanism to increase visibility of risks and assist management decision making.
Risk Matrix Chart Diagram
Likelihood = How likely is the event of risk to occur
Rare / Very Unlikely = Only in exceptional circumstances
Unlikely = Might occur in future time
Moderate /Possible = Might occur at some time
Likely = Probably occur in most circumstances
Very likely = Almost certain = Expected in most circumstances
Impact = A marked effect or influence
Negligible = No injuries, No damages
Minor = Minor injuries, Minor damages, First aid required
Moderate = Some injuries, Medium damages, Medical help necessary
Major / Significant = Extensive injuries, High damages, Medical help necessary
Extreme / Severe = Death or major injuries, High level damages, Medical help necessary
Note: Above 'Risk Matrix Chart Diagram' is an example. Every organization may have its own Risk Matrix Chart.
Wednesday, October 19, 2016
ISO 9001 QMS CERTIFICATION WORLDWIDE - ISO SURVEY 2015
International Organization for Standardization (ISO) has released the 2015 results of the ISO Survey, showing the number of certifications to ISO management systems worldwide. The ISO Survey of certifications is an annual survey of the number of valid certificates to ISO management system standards worldwide.
ISO 9001 QMS Certifications results as per ISO Survey 2015 are as under:
Number of ISO 9001 certificates in 2014 - 1,036,321*
Number of ISO 9001 certificates in 2015 - 1,033,936**
Change in comparison to 2014 - (-) 2,385
Change in % - (-) 0.2%
* All certificates in 2014 were issued to ISO 9001:2008
** In 2015 - 1.029,746 Certifications to ISO 9001:2008 + 4,190 Certifications to ISO 9001:2015 = 1,033,936
A total of 1,036,321 certificates were issued to ISO 9001 in 2014 and 1,033,936 certificates (including 4,190 issued to 2015 version) were issued to ISO 9001 in 2015, there has been a slight decrease of 0.2% on 2014 figures.
Top 10 countries
Top 10 countries (with number of certified organizations) for ISO 9001 certifications in 2015 are as under:
China - 292,559
Italy - 132,870
Germany - 52,995
Japan - 47,101
U.K. - 40,161
India - 36,305
U.S.A. - 33,103
Spain - 32,730
France - 27,844
Romania - 20,524
Although there is a slight decrease for ISO 9001 QMS certifications in 2015, however still this is the standard that is being used world-wide.
- Keshav Ram Singhal
Courtesy: ISO Website
Friday, October 14, 2016
RISKS AND OPPORTUNITIES IN ISO 9001:2015 QMS - PROCESS-DIAGRAM
PROCESS-DIAGRAM
- Keshav Ram Singhal
For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.
For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.
World Standards Day 2016
Each year on 14 October, the members of the IEC, ISO and ITU celebrate World Standards Day. World Standards Day is a means of paying tribute to the collaborative efforts of the thousands of experts worldwide, who develop the voluntary technical agreements that are published as international standards.
The themes of earlier 'World Standards Day' were as under:
World Standards Day 2015 - "Standards - the world's common language"
World Standards Day 2014 - "Standards level the playing field"
World Standards Day 2013 - "International standards ensure positive change"
World Standards Day 2012 - "Less waste, better results - Standards increase efficiency"
World Standards Day 2011 - "International standards - Creating confidence globally"
World Standards Day 2010 - "Standards makes the world accessible for all"
World Standards Day 2009 - "Tackling climate change through standards"
World Standards Day 2008 - "Intelligent and sustainable buildings"
World Standards Day 2007 - "Standards and the citizen: Contributing to society"
World Standards Day 2006 - "Standards: big benefits for small contributors"
World Standards Day 2005 - "Standards for a safer world"
World Standards Day 2004 - "Standards connect the world"
World Standards Day 2003 - "Global standards for the global information society"
World Standards Day 2002 - "One Standard, one test, accepted everywhere"
World Standards Day 2001 - "The environment and standards: close together"
World Standards Day 2000 - "International standards for peace and prosperity"
World Standards Day 1999 - "Building on standards"
World Standards Day 1998 - "Standards in daily life"
The theme of 'World Standards Day 2016' is 'Standards build trust'.
IEC President Dr. Junji Nomura, ISO President Zhang Xiaogang and ITU Secretary-General Houlin Zhao, in their joint message have conveyed the following message on the World Standards Day 2016:
"Standards connect us with reliable modes of communication, codes of practice and trusted frameworks for cooperation. Introducing common interpretations on reciprocal sides of a communication or transaction, standards are essential to mutually beneficial trade and resource efficient international commerce.
Social interaction relies on common respect for fundamental sets of norms, concepts or meanings – international standards codify these norms to ensure that they are accessible to all.
A product or service conforming to an international standard is imbued with a trusted symbol of quality, safety or compatibility. Standards speak to the diversity of our interconnected world, introducing uniformity at the interfaces where we need to be certain that we are speaking on the same terms."
World Standards Cooperation
The World Standards Cooperation is a high-level collaboration between the IEC (International Electrotechnical Commission), ISO (International Organization for Standardization) and ITU(International Telecommunication Union). Under this banner, the three organizations preserve their common interests in strengthening and advancing the voluntary consensus-based International Standards system.
IEC, ISO and ITU have undertaken several initiatives that are organized under the World Standards Cooperation (WSC) banner. Such initiatives include workshops, education and training, and the promotion of the international standards system.
IEC, ISO and ITU believe that International Standards are an important instrument for global trade and economic development. They provide a harmonized, stable and globally recognized framework for the dissemination and use of technologies. They encompass best practices and agreements that encourage more equitable development and promote the overall growth of the Information Society.
International Standards are consensus based and transparent. They invite the contribution of all interested stakeholders through an extensive network of national members. International Standards increase market relevance and acceptance and are the corner stone of global trade and development.
International Organization for Standardization (ISO)
International Organization for Standardization (ISO) is an independent, non-governmental international organization with a membership of 163 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. ISO has published more than 21000 International Standards and related documents, covering almost every industry, from technology, to food safety, to agriculture and healthcare. ISO International Standards impact everyone, everywhere.
Let us strive to create awareness on standards. Happy 'World Standards Day 2016'.
With best wishes,
- Keshav Ram Singhal
*Courtesy sources*
- ISO Website
- World Standards Cooperation Website
*Please keep visiting my blogs and keep commenting too.*
Blog on "Quality Concepts and ISO 9001:2015 QMS Awareness"
Blog on "Quality Concepts and ISO 9001:2008 QMS Awareness"
Blog on "Senior Citizen Awareness"
Blog on "ISO 9001 QMS Awareness" in Hindi
Blog on "Risk Management Awareness"
Blog on "EMS Awareness"
Tuesday, October 11, 2016
WHY WE NEED RISK-BASED THINKING?
WHY WE NEED RISK-BASED THINKING?
Please read my earlier articles:
(i) 'DETERMINING AND ADDRSSING RISKS AND OPPORTUNITIES'
(ii) 'A SIMPLE METHOD TO DETERMINE RISKS AND OPPORTUNITIES'.
Why we need risk-based thinking? A general question needs answer. Risk is an inherent part of daily life. Risk also depends on the fragilities and capacities in a system, which are often not manifested until there is a triggering event. Risk may lead to disaster. Risk may be a path to disaster if protective capabilities of the system cannot deal with the negative consequences of the event.
Risk is a dynamic concept as it changes over time as the vulnerabilities or weaknesses in the system or society changing in time. Risk is not static, constant but rather a dynamic term that is constantly adjusting to changing vulnerabilities, weaknesses and hazards.
Risk is a fundamental reflection of the normal life. We calculate and deal with risk in everyday life - wear safety belts to reduce the likelihood of injury, get vaccination to reduce the risk of illness. Life or any system without risk is generally neither possible nor conceivable. Our response to natural and environmental hazards is often influenced by our perception of risk. Sometimes we choose to take a risk, knowing the associated risk. For example, people choose to smoke or drink, knowing the risks associated to their health. Risk perception is influenced by past experience and knowledge. Understanding a risk allows us to make informed decision by weighing the risk of certain activity or process with the benefits or outcomes derived from that activity or process. Without factual information, or with misinformation, we are faced with making an uninformed decision.
Risk-based thinking thus helps us to understand risks through a systematic valuation of determining risks associated in each process or system.
- Keshav Ram Singhal
For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.
For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.
Monday, October 10, 2016
A SIMPLE METHOD TO DETERMINE RISKS AND OPPORTUNITIES
Please read my earlier article 'DETERMINING AND ADDRSSING RISKS AND OPPORTUNITIES'.
There may be various methods by which an organization can determine its risks and opportunities. My earlier article 'DETERMINING AND ADDRSSING RISKS AND OPPORTUNITIES' provides details of FEMA method, a commonly used method of risk identification and risk analysis.
ISO 9001:2015 QMS standard does not provide any specific procedure or method to determine risks and opportunities. It is for the organization to apply any procedure or method to determine risks and opportunities.
This article provides you a simple method by which, you can identify risks and opportunities associated with all functions and processes in the quality management system of your organization.
Top management of the organization should form a team of identified personnel, well versed with organization's processes and functions, with a coordinator to determine, monitor and review organization's risks and opportunities. The coordinator of the team should design a simple format for identification of risks and opportunities that should have following details:
- Process
- Department
- Risk/potential problem identified
- How critical is the risk/potential problem?
- Is risk acceptable or unacceptable?
- Proposed action to address the risk/potential problem (What should be done?)
- Opportunity identified with relevant details
- Proposed action to address the opportunity, so that it remains an opportunity and not turns to risk (What should be done?)
- Remark, if any
The above parameters are indicative. You can add a few more as per your needs. An illustrative example of the format designed for this purpose is shown in the below figure:
Suitable instructions should be issued to all process owners and department heads of the organization to fill the designed format and submit the same to the coordinator by a given date. For the first time, the management of the organization will set up a target date, but thereafter all process owners and department heads should report new identified risk or opportunity as soon as it comes to their notice. The coordinator of the team should collect relevant data, compile them, discuss with other team members through formal and informal meetings. He should make a summary of determined risks and opportunities with proposed actions and report the same to the top management. The top management of the organization should issue relevant guidelines and instructions within the organization, including department heads and process owners. This activity should not be a one-time activity. The top management and the coordinator need to take proactive active action regularly. Regular reviews (say quarterly or half-yearly) should be done and the author hopes that this simple method will be able to address the determined risks and opportunities in a proactive way.
A few examples of a few risks are mentioned in my earlier article. Here-in-below you will find a few examples about opportunities.
Opportunities
Opportunities lead to progress. Opportunities give assurance that the system can achieve its intended results. Opportunities enhance desirable effects. Opportunities prevent, or reduce, undesired effects. Opportunities achieve improvement.
Examples of opportunities
- NABL certified laboratory within the organization that provides verification and calibration services. Monitoring and measuring resources are verified and calibrated within the organization.
- Particular process is well defined and documented. Dealing person is well aware of the process.
- Learning from the past.
- Organization strives to implement 5-S Practice in the organization.
- Maintenance schedule is monitored and maintained.
- Process workers are trained and well-versed with the associated process.
- Organization provides complete engineering installation and commissioning service to customers.
- Organization provides after sales service support to its customers.
- Excellent team of work force.
- High standard of work culture.
- Use of information technology (IT)
- Keshav Ram Singhal
For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.
For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.
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