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Category: Management Systems

Transitioning from ISO/TS 16949: 2009 to IATF 16949: 2016 Quality Management System for the Automotive Industry

Transitioning from ISO/TS 16949: 2009 to IATF 16949: 2016 Quality Management System for the Automotive Industry
Just as the proverbial frog in Basho’s haiku made the water-sound, the arrival of ISO 9001:2015 created quite a splash and ripples are still being felt far and wide in many industries that subscribe to the International Standard. The publication of IATF 16949:2016 came a year after the release of the new version of ISO 9001 and as expected, the changes have been many, if not radical, for the automotive industry.

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Business Continuity - The Art of Crisis Communication, lies on truth?

A crisis is an abnormal situation which threatens the operations, reputation and stakeholders of an organization and normally came along with adverse media attention. The instances of such situations can be ranging from legal exposure, natural disaster, fraud or espionage that could be endorsed to the organization. Likewise, the crisis can also be any situation where in the perception of media and general public, the organization did not respond to a situation in the suitable and appropriate method. About 2 weeks ago,

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Business Continuity - The Art of Crisis Communication, lies on truth?

ISO 13485:2016 is finally here!

ISO 13485:2016 is finally here!
The ISO 13485:2016 was published on 25th February 2016, after a long 13 years gap since the publication of the second edition.

ISO 13485:2016 surprises many, especially the implementers, where it does not adopt the very much anticipated High Level Structure (Annex SL) which already adopted by the ISO 9001:2015; but maintained with the 8 clauses structure with additional requirements incorporated to align with global regulatory requirements.

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EICC version 5.1- What are the changes?

As anticipated due to the release of the requirement relating to recruitment fees in Aug 2015, EICC code has now been revised to version 5.1, effective January 1, 2016.  Tagging along with this imperative change are other minor changes: addition and removal of some sub elements.

EICC version 5.1, what are the changes?

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EICC version 5.1- What are the changes?

Transitioning from OHSAS 18001 to ISO 45001

Transitioning from OHSAS 18001 to ISO 45001
The publication of the 2015 versions of ISO 9001 and ISO 14001 was touted as pivotal in the history of these management systems due to the changes in content and structure. The adoption of the Annex SL framework and introduction of risk-based thinking, among other changes, led Management Representatives and management standard practitioners scrambling to understand the implications of the revisions to their own management systems.  As the dust begins to settle, certified organizations ask with bated breath, “What’s next?”.

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Business Continuity: Surprised, Powerless or Prepared

For most of us, we are just observers to the realities that life is fragile and businesses are vulnerable, no matter how perfect our systems are. For most of us, we ask, “What we could have done to have prevented these from happening?” However, in the end, we realise that we cannot do anything, and just expect that the worst might happen—simply POWERLESS.

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Business Continuity: Surprised, Powerless or Prepared

Is this the right time to Integrate ISO Management Systems?

Is this the right time to Integrate ISO Management Systems?
According to the recent surveys conducted on the application of ISO management system standards, the number of organizations certified to ISO 9001 (quality management) and ISO 14001 (environmental management) has increased steadily worldwide.

Integrated Management System (IMS) is the future trend! Are you ready?

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New Food Quality Management System Module

With the introduction of FSSC 22000-Q, it gives organizations the options to be FSSC 22000 audited and certified for both Food Safety and Quality Management Systems. Now organizations can choose to be audited for food safety only or to have the QMS module added to FSSC22000 certification through an integrated audit for Food Safety and Quality Management Systems.

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New Food Quality Management System Module

EICC Code of Conduct, version 5.0. What are the key changes or newly added requirements?

EICC Code of Conduct, version 5.0.  What are the key changes or newly added requirements?
EICC members have ratified the EICC Code of Conduct, version 5.0.  This version will take effect on 1 April 2015.  The current EICC Code of Conduct, version 4.0, requirement will end on 31 March 2015.

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ISO 39001 for both Multi-National Enterprises (MNEs) and Small & Medium-sized Enterprises (SMEs)

“Apart from Thailand, Malaysia has the highest number of road deaths in South-east Asia”.
Malaysia recorded 25 deaths out of 100,000 people; compared to 38.1 in Thailand.
This was highlighted at the opening of the Inter¬national Crashworthiness Conference 2014, held for the first time in Malaysia. A statement by the Malaysian Institute of Road Safety Research (Miros), issued in conjunction with the event, said it was “more a sense of attitude than infrastructure that caused road deaths”.

Quoted from: The Star online – 26 August, 2014 (Tuesday)


In view of the above news, it is necessary to build a strong foundation of Road Traffic Safety (RTS) in our current road transportation system as a whole through a very systematic Management System such as ISO 39001.

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ISO 39001 for both Multi-National Enterprises (MNEs) and Small & Medium-sized Enterprises (SMEs)

The new ISO 9001:2015 & ISO 14001:2015

The new ISO 9001:2015 & ISO 14001:2015
ISO 9001, the standard for quality management used by more than one million organisations, is now under review, with an updated version due to be published by end of 2015. The impact of the 2015 revision is expected to be major for parties involved in quality management i.e. the standard user, certification bodies, accreditation bodies and consultants.

Similar to ISO 9001, the ISO 14001 is currently also at the Draft International Stage (DIS) stage and it is being circulated for comments. The technical committee for this standard is ISO/TC207.

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ISO 14971 (Medical devices – Application of Risk Management to Medical Devices) CHANGED?

If you ask whether ISO 14971 standard requirements have changed, the answer would be YES and NO
 
In August 2012, EN ISO 14971:2012 has been released and superseded EN ISO 14971:2009 to support the Directives. The changes are described in Annex ZA, ZB and ZC, the core text of the standard remains unchanged. 

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ISO 14971 (Medical devices – Application of Risk Management to Medical Devices) CHANGED?

Responsible Sourcing of Minerals

 We have known civilians’ human rights are abused in the central part of Africa.   Unfortunately, armed conflict continued in Democratic Republic of Congo (DRC).  The war crimes happening in the eastern of DRC have caused untold restlessness in other countries.  

 
The fighting is directly financed by the sales’ profit of DRC’s natural resources, such as tantalum, tin, tungsten and gold.  The mined minerals are extracted and passed through a variety of intermediaries before being indirectly or unknowingly purchased by multinational electronics companies.  Hence, one way of defeating such crimes is to strengthen the corporate social responsibility policies and implement in the supply chain.

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Paradigm shift from Traditional Auditing

In this age and time, Management System internal auditors face greater challenges in their task.   They need to respond effectively to the demands of a rapidly changing and complex business environment, while helping organisations continue comply with growing regulatory mandates and conform to other requirements.  
This pressures internal auditors to indirectly change the way how audit should be organised and carried out. The auditing method will not just merely focus on conformity but value-adding that will contribute to sustained success of the organisations maturing systems.
 
So, shall the audit be assessed based on functional or process approach? At the point of conducting audits, shall the controls be the main audit concern than risks and other requirements? Must internal auditors be trained every time before audits?

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Overview of Food Defence

Overview of Food Defence
Food defence is about implementing controls to reduce the possibility of food supplies from being contaminated intentionally using any means of chemical, biological, radiological or physical. The term “food” would include both foods and beverage. As the production and distribution of foods involve people, the use of equipment, vehicles, and building structures to occur, food defence would also include the protection of these. As such, protective measures relating to personnel, product, physical and electronic security are key focus of managing food defence. Hoax or malicious rumours, thefts, food fraud and work place violence all need to be considered for food defence management as well.

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Food Allergen Management

Allergens are materials that can cause an adverse reaction in certain people. These can be found in a variety of sources, such as dust mite excretion, pollen, pet dander, certain foods and others. The allergy is caused by the body immune system producing antibodies of immunoglobulin Ig E in reaction to such materials by certain individuals. These IgE antibodies then cause a release of powerful cellular chemicals resulting in symptoms of allergic reactions.

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Foreign Material Management

The 4 types of hazards leading to food borne illness would include biological, chemical, physical and radiological. The term hazard indicates a potential to cause harm.  Examples of physical hazard would include glass, sharp pieces of metal, bones, wood, hard plastic shards or ceramics or stones. These objects could cut or damage the mouth, throat, intestine and gums. Some of these items could also become choking hazard to young children and babies. Foreign material or body refer to physical hazards.


The term physical contaminant is more broad based and include those which cause harm and those that may not such as stored product insects, small pieces of food grade gaskets, food grade lubricant, pieces of clean plastic film packaging materials, metal fines and others. 

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Preparing and responding GLOBALLY

The growing magnitude of destruction due to natural calamities and manmade disasters (i.e. terror attacks) puts a question on emergency preparedness and response globally. While climate change and an unstable political environment can be the main culprit of the many casualties of natural disasters and terror attacks, the lack of emergency preparedness and slowness of responses can also be factors that spell a huge difference in saving lives. Emergency preparedness and response should go beyond the distribution of relief good to affected areas and victims. Ensuring a systematic and strategic drive to restore the necessary functions and order in the day to day operations also plays a critical role in the smooth implementation of emergency management. 

 
Situated at a place called the ring of fire, the Philippines is one of the many countries within the area that is frequently visited by natural calamities. Just recently, the historic province of Bohol was shaken by a magnitude 7.2 earthquake which had caused many historical churches to crumble to the ground. But earthquakes are not the only natural calamities the Philippines face. At an average of 26 typhoons per year, the chances of a Super Typhoon hitting the Philippines is something that’s not rare. 
 
Housing the financial and business centres of both local and international corporations, the National Capital Region (NCR) serves as the main artery of the Philippines economy. But the towering buildings, billboards and asphalted roads were no match when Typhoon Milenyo (International name Typhoon Xangsane) and Typhoon Ondoy (International name Typhoon Ketsana) slammed the country in 2006 and 2009 respectively. Peaking as a category 4 typhoon with maximum winds of 230 km/h, Milenyo ripped through Mega Manila causing a massive damage to infrastructures when it passed the country last 2006. Three years later, typhoon Ondoy set record breaking torrential rains which resulted to mass flooding in several cities in Metro Manila. And just a few weeks ago, “Super Typhoon” Yolanda (International name Haiyan) slammed the eastern seaboard of the Philippines with winds of more than 300 km/h. Typhoon Yolanda left a colossal damage in a significant number of regions, provinces, barangays, families and individuals. 
 
The Philippines is just one of the many countries who has experienced firsthand what it’s like to be in a state of panic and chaos after a disaster, and with the growing requirement for a structured approach to emergency preparedness and response, the global community had already taken steps by instituting their own emergency standards which were in response to global natural calamities and terror attacks. 

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Taking-off with BowTie

Taking-off with BowTie

There are many different ways to do risk assessment. BS EN 31010:2010 provides numerous risk assessment techniques. The popular question will be “Which risk assessment technique is best suited for an organization?”.   Instead of immersing with all the techniques, perhaps it will be best to recognize that the purpose of risk assessment is to provide evidence-based information and capturing the essence of the risk and manage it.  The easy way to do risk management is through visual.

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Planned Changes in ISO 14001:2015

ISO 14001 will be having a new look and expected to be published early 2015. What will be the changes in this new revision? Though there will be transition period for addressing new requirement and nothing to be done by those with ISO 14001:2004 certification at this moment until it is released, it will be wise to stay up to date on the changes that might take place.

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Neville Clarke’s 20 Years Journey through the Evolution of Management Systems…

 Neville Clarke Philippines for the last 20 Years...

With quality and international standards evolving continuously to meet market demand, Neville Clarke had also evolved through the years, from its humble beginnings of offering Quality Courses and eventually EHS Courses, Neville Clarke grew in the fulfilment of its mission to contribute to the industry growth and development through relevant, effective and innovative transfer of knowledge, enhancement of management competency with a thrust towards the achievement of business excellence.  Alongside the “Evolution and Management Systems ”, Neville – Clarke Philippines Inc. had also continually evolved to adapt to the changing times, and as with “Quality” Neville Clarke continues and grows  to become the preferred “Global Partner for Business Success”. 

Knotting the pieces of development together and chartering with the industry the path to conformity, growth and sustainability. Neville Clarke’s journey which started 20 years ago when it offered its series of quality and certification courses in the Philippines has these footprints marked in all the trainings and services it had rendered throughout the years and across the various industries.

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The Evolution of Management Systems

Quality Journey

In its very broad sense, “Quality” can be defined as anything that can meet customer requirements. However, with the turn of the century there was a shift on how most organisations view such concept. Recent events in history highlighted these changes, from World War two’s consistency in bullet manufacturing up to the spread of market competition, businesses have realised that going beyond the numbers means becoming more “Quality Centric”.

From Quality Assurance to Quality System to Quality Management System, Neville Clarke has been helping clients walk the Quality Journey through the thick and thin of ISO standards “revision” and “evolution”. This paradigm shift means that main focal point in strategic planning should be on the internal processes and people who would be involved during the undertaking. This “Quality Evolution” gave birth to Quality Management System (QMS) or better known as ISO 9000.
 
From the 20 elements of ISO 9001 back in the lated 80’s to early 90’s, it has evolved to be the PDCA model we know today and towards the   structure we will see onwards containing requirements for Leadership, Planning, Support, Operations, Performance Evaluation and Improvement,  ISO 9001 had evolved to become the baseline standard for companies summarizing the general intent for Management System Planning, Operation Planning and Control and towards Continual Improvement , Sustainability, and Excellence. 
 
However, such flexibility was put into test by some industries as internal processes needed more details to assure its objectives for its customers. Operational differentiation led to a second wave of “Quality Evolution”, this time centring on both quality and other aspects that a specific industry would require. This in turn gave birth to the new sets of ISO management systems that would answer the industry-specific needs and requirements.
 

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Singapore Standard - SS 577:2012 on Water Efficiency Management System

Singapore Standard - SS 577:2012 on Water Efficiency Management System
Water is a scarce and precious resource in Singapore. With the increasing population and growing demand for water, there is a need to manage this scarce resource efficiently for the generations to come. In pursuing an environmentally sustainable path to growth and development, Singapore has developed the world’s first standard to manage this precious resource – SS 577:2012 on Water Efficiency Management System.

This is the new standard to provide guidelines for implementing a robust Water Efficiency Management System (WEMS). This standard will provide public and private sector with management strategies to recognize water demands, increase water usage efficiency, reduce costs and improve water efficiency performance.

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The Increasing Role of Management Representatives in Business towards ISO 9001:2015

We have seen through several years transformations in ISO 9001 which substantiates the important role of Management Representatives (MRs)  from Managing Procedures to Managing Processes to Managing Results .  ISO 9001 has gone past the 25 years since its inception last 1987 and is here to stay. The concepts of customer, process, management review and continual improvement among others have been stable through many organisations and so is the application of the ISO 9001 standard. Everyone can associate with the requirements that guided organisations in managing the assurance for quality products and services all towards increasing assurance for customer satisfaction and the drive for continual improvement.

With its silver years of existence and 4 revisions, it has seen through the transformation of the role of management representatives in various organisations and is yet to see some further developments to address the emerging issues that we have today. Through the years, with the observed  revisions of related management system standards and the emerging revision for ISO 9001:2015, we are about to see further challenges for the  post of being the management representative, be it a QMR : Quality Management Representative or the increasing role of being the IMR: Integrated Management Representative. A growing question then arises in every practitioner for Management System.

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Management Of Change : To Grow And Survive

Management of Change (MoC) is a structured approach to transitioning individuals, teams, and organisations from a current state to a desired future state. Structured approach means process of planning, organising, coordinating and controlling the resources to ensure that the process changes are implemented according to approved plans and the overall objectives of introducing the changes are achieved with as little disruption as possible.

Why we need to change? Organisation has to change to survive its business in the future, to improve the profit, to grow up and to stay competitiveness. While individuals change to improve their skills, to improve career opportunities, to broaden experience, and to improve quality of life. Relates to this change, we deal either lead, follow or resist. Anyway, it’s really better becoming a leader than follower!

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ISO 19011:2011 - ONE for ALL

ISO 19011 has been first published in the year of 2002 to provide guidance on auditing management systems, as well as the guidance on the evaluation of competence of individuals involved in the audit process; however this Standard back then was only to cover mainly on auditing the Quality Management System (QMS) and the Environmental Management System (EMS) as the title of the Standard explains it well - “Guidelines for Quality and/or Environmental Management Systems audit”. However, after the year of 2002, a number of new management system standards have been introduced and trigger a need to consider a broader scope of management system auditing, as well as providing guidance that is more generic.

The second edition of ISO/IEC 17021 that was published in 2011 is also another catalyst that pushes for a consideration in upgrading the first edition of ISO 19011.  Moreover, I’m sure there are also questions / concerns from auditors in regards to which guidelines to be used if they are to conduct auditing on management systems besides the QMS and EMS.

As a result, the second edition of ISO 19011 – “Guidelines for auditing Management Systems has been published in 2011 to replace the first edition.

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Tripod Beta

Accident investigator experts have concurred that 80% of the accidents lies on the Human Factor.   The realm of human factors is complex and incorporates many disciplines such as psychology, physiology, sociology, biomechanics, systems science, and management science.  In simplifying human factors for incident investigation, James Reason’s “Swiss Cheese” model of human error has been specifically used to determine the failed or missing barriers, Figure 1.

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FSSC 22000 Certification Scheme

Food Safety System Certification 22000 (FSSC 22000) is the certification scheme for Food Safety Management Systems. Initially, it was based on ISO 22000, the global food safety management system standard and ISO/TS 22002-1 (formerly PAS 220), a standard developed to address prerequisite program requirements for food product and ingredient manufacturers. The scope of FSSC 22000 has been extended to include prerequisite program requirements for food safety in packaging through PAS 223 - Prerequisite programmes and design requirements for food safety in the manufacture and provision of food packaging. Now with the released of PAS 222 - Prerequisite programmes for food safety in the manufacture of food and feed for animals, the scope of FSSC 22000 will be extended further.

The FSSC 22000 certification scheme is supported by the European Food and Drink Association (CIAA) and the American Groceries Manufacturing Association (GMA).

FSSC 22000 is fully recognised by the Global Food Safety Initiative (GFSI) and Accreditation Bodies around the world.

The inclusion of ISO 22000 requirements in the FSSC 22000 makes it align with other generic management systems such as the ISO 9001 and ISO 14001, this enables an organisation to build an integrated management system covering all aspects relevant for an organisation and its clients.

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Energy Conservation through ISO 50001:2011 EnMS Implementation

Energy Conservation through ISO 50001:2011 EnMS Implementation
Singapore recently enacted a new statute Energy Conservation Act 2012 to introduce mandatory energy management practices for large energy users in the industrial and transport sectors.

In order to meet the objectives of this Energy Conservation Act, it will be mandated that energy management practices and systems focus the companies’ attention on energy issues so as to ensure that energy is used prudently, spotting and rectifying faults that result in energy wastage, and overall help to achieve significant cost savings.

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Risk Management – The Role It Plays In Business Management

Every organisation is on their toes in their effort to achieve their business goals. In the uncertainty of the times, it is important to integrate Risk Management in the way we manage our businesses. We must realize that risk is the effect of uncertainties on our objectives and we need a structure for managing such risks..... if we must ensure the sustainability of achieving our goals.

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Risk Management – The Role It Plays In Business Management

New Standard - ISO 14971:2009?

For those in the medical device industry, keeping up-to-date with standards for both product and system is essential for ensuring product compliance.  Have you heard about ISO 14971:2009?  If you wonder whether this is a new standard for risk management, you are only partly right.

First things first, ISO 14971:2007 Medical devices – Application of risk management to medical devices is the current standard in the ISO library.  There is no ISO 14971:2009 but there is a correction done to the ISO 14971:2007 on 1 Oct 2007 in which figure 1 was corrected.  Figure 1 is a schematic representation of the risk management process, whereby the left side arrow going back to the risk analysis process are from “risk control” and “production and post-production information” instead of “risk control” and “evaluation of overall residual risk acceptability”.

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Gaining New Business Horizon by Adopting ISO/TS 16949:2009

The automotive industry Quality Management System (QMS) consists of ISO/TS 16949 standard and the related customer-specific requirements (CSR).

• The 3rd edition is the latest version and it was published on the 15th of June 2009.  It has been
   technically updated to align with ISO 9001:2008 Standard.  The previous revision was based on ISO
   9001:2000.

• Customer-Specific Requirement (CSR) is the additional requirement imposed by the OEM.  These
   requirements will form part of the audit criteria during the certification & internal audits.

ISO/TS 16949:2008 was developed by IATF (International Automotive Task Force) members and approved by ISO (International Organization for Standardization) for publication.  It is an industry specific Quality Management System (QMS) caters for automotive industries with the following objectives:
a)  Promote continue improvement
b) Emphasis defect prevention, and
c) Continual waste and variation reduction.

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Managing The Business, Its Change and Continuity

In business, risks abound at all angles at any given time. The risk of a customer dissatisfaction, the risks of penalties and closure arising to that of non compliance to prevailing rules and regulations, the risks of attritions, cyber-attacks, fraud, and repudiation, the reputational risk for any smear campaign that can be done against the company image and its personalities. 

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ISO 28000 Certification and Global Supply Chain Security Management

Successful organisations are facing increasing competitive pressures to develop new supply networks, often global and highly interdependent. Supply chain risk is high for these organisations management as they can’t afford to have any security stoppages or losses that would affect their customers.

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Preventive Action – Where Can I find it for my organisations?

In many organisations, whenever there are issues raised by customer, prompt containment actions and corrective actions follows.  In typical operations, the issues are raised through different channels. Some are channeled as warranty claims, others as product returns, or most common through customer audits and complaints. Many successful organisations thrive on solving the customer-originated problems raised. Some are even proud of the fact that they could resolve most cases in record time. However, we need to realise that, this cycle of action after action is still very much reactive in nature. We are still being driven, instead of driving and in control!

Most modern management system standards such as ISO 9001:2008, and the other industry-specific derivatives for automotive (ISO/TS16949), medical devices (ISO13485), aerospace (AS9100) , telecommunications (TL9000), prescribe the application of preventive action as a mechanism for continual improvement. The questions we often get are – how to we do it? We do we start from?

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Thrive on Integration and Innovation

As ISO (International Organization for Standardization) always points out to practice continual improvement, emerging new standards are on queue.  Even if we are certified on several international standards, we will always have options to expand our perspectives in meeting not just customer, but also specific company requirements and operational activities as well.  As ISO 9004 have well pointed the path, here’s to the emerging drive for the sustainable organisational success (SOS). Hence, Just as there are standards for organisational quality ( ISO 9000 ), environment (ISO 14000), information technology service management ( ISO 20000),  information security ( ISO 27000),  here are emerging standards among others that may provide the answers to our operational concerns....

We provide you with the news and insights on the emerging standards, In this list are ISO 14064, ISO 21500,  ISO 28000, ISO 29001, ISO 30301, ISO 31000, and  ISO 50001, as  a short list of the new standards in the pipeline of our sustainability journey that were created, or being drafted, to make the implementation of our processes easier, more effective and efficient:

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The Future of Management Systems

Evolving Quality Management System into a Framework of Operational Excellence

The ever changing global economy coupled with fierce competition and growing sophistication of customer needs warrants a sustained breakthrough performance in key areas of business. While the ISO family of Quality Management System provides the necessary ingredients leading to the success of an organisation, it doesn’t provide the means and the how’s to achieve the company’s vision for sustained breakthrough performance.

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