General

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Choosing to apply for ISO9001:2015 Certification can be a daunting experience – as the third-party audit date approaches you are wondering why you have applied for it, will it bring a positive change to your company and is it really a necessary step for your business? But ask anyone who has achieved and embraced this certification and it is clear the benefits far outweigh the labour involved in obtaining and maintaining the standard. In fact, like a positive lifestyle change, once in place it feels a natural process in the everyday life of your organization. So, all you need to do is; choose a starting point, set a plan and begin the changes one step at a time.

ISO 9001:2015 is one of the world’s most sought after and recognised standards. Its implementation will instil a culture of quality and a sense of responsibility amongst your staff. It will pin-point focus and direction on the company’s quality goals and objectives. Just as the benefits begin to pile up when you implement a lifestyle change, the benefit of implementing ISO 9001:20015 will be vast.

Your customers benefit by knowing the products they are buying or the services they receive are of the highest standard, they know you have listened to what they want and reacted. Customers don’t necessarily need to know your Quality objectives, your KPI measurements and all the internal workings that bring first class quality but what they do need to get from your company is confidence that their needs are being met and that that you go over and beyond to meet their expectations. This establishes a bond of loyalty to your company based on the trust of a solid performing product or service.



Your company benefits by incorporating quality into everything they do. Employees begin to think about quality, they hold each other accountable and by setting measurable objectives they can work together to produce the best quality possible and track their progress. It becomes a team effort and with top management involved at every level, the whole company is striving to meet the same goals. Your business becomes more profitable with less mistakes/waste and this can be re-invested for future improvements. Orders increase as customers approval of your high-quality products creates repeat business, new orders and fresh markets for your business to move into. Being on the pulse of what is required of your company and being able to produce it efficiently will set you apart from the other companies who chose not to embrace quality.

Globally you become accepted into the ISO9001:2015 approved list of companies, a brand as such, that defines the attention to Quality your company places on its products and services – not only a reflection on what you produce but a statement that you chose to supply your company with first class suppliers too. It places you in a league of companies that care about what their customers want, companies that want to offer the best experiences and overall an acceptance and confidence that you know investing in Quality reaps rewards for you and you customers.

If you are ready to be ISO 9001:2015 certified you can find a Registrar on the Registrar listings page of ISO Update http://isoupdate.com/registrar-listing

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Risk-based thinking is one of the major changes introduced in the updated ISO 9001:2015 Standard. While Risk based thinking was addressed in older versions of ISO 9001 implicitly under clause on ‘preventive action’, ISO 9001:2015 increases the focus and explicitly defines the requirement under the clause “Actions to address risk and opportunities”. Therefore, the focus in this new version of the standard is based upon capturing both the risks and opportunities and then, handling them in a structured manner.

ISO defines a risk as ‘effect of uncertainty on the expected result’. Effective management of risk is talked well in advance to ensure there are less surprises, improved planning, effective decision making and better relationships with stakeholders. Effective management of risk leads to better performance, continual improvement and increases customer satisfaction.  Opportunities are considered the positive side of risk which is why, ISO 9001:2015 focuses on reducing risk and enlarging opportunities.



Determining Risk and Opportunities

Risk and Opportunities need to be determined based on the Context of the Organisation, both internal and external and the requirements of applicable Interested Parties. External Context involves the environment in which the organization operate. These can be driven by legal, financial, regulatory, social and cultural factors. Internal Context, involves organization internal environment and is driven by factors such as hierarchy, resource capabilities, organizational structures. Risk which may arise in either of these contexts need to be determined.  Organization then need to determine risks which may arise due to requirements of Interested Parties. The organization need to understand requirements of all its stakeholders and then determine risks involved in achieving these requirements. Some examples of requirements of interested parties are: the customer requires low or zero-defect delivery, employees need for job satisfaction or work-life balance or financial performance. Each of these may lead to risks or opportunities. These need to be understood by the organization and all risks and opportunities which may arise due to context or requirements of interested parties should be determined.

Conduct Risk Assessment and Address Risk and Opportunities

Once risks are identified, a risk assessment will need to be conducted on the risk identified and appropriate actions identified to address these risks. This should result in actions to enlarge the opportunities and mitigate the risks. An organization may define a risk methodology to handle risks. This can involve determining the risk magnitude based on its probability and impact. Risk tolerance criteria may be defined which gives acceptable limit of risk. You can decide based on tolerance criteria and risk magnitude on the level of intervention required to mitigate the risk. Adequate control measures should be identified to ensure the risk falls below the acceptable limit or tolerance criteria.  Alternatively, techniques like FMEA may be used to address the risks. Adequate actions need to be planned to address or enhance the opportunities also.

Monitor and Review Risks and Opportunities

The risks and opportunities identified need to be monitored and tracked on a regular basis. The intent of this is to ensure that after the control measures are implemented, whether the risk falls under the acceptable levels or not and actions taken against opportunities are on track. This should be done on a fixed frequency or on event like changes in staff, process or equipment.

If your organisation still needs to find a Certification Body for its transition to ISO 9001:2015 have a look at the ISO Update Registrar Directory. Here you will find a comprehensive list of Certification Bodies from all over the world.



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Quality Management is the process of monitoring the different activities and tasks involved in producing and delivering a product and/or service in order to maintain its desired quality. The objective of Quality Management is for an organization to develop a long-lasting relationship between the customer and the product or service it provides, and this can only be achieved when these continuously meet customer’s expectations.

To manage the quality of a product or service, organizations are required to establish a set of procedures to successfully oversee the different processes involved within the organization. These different procedures that are linked with each other and which are meant to conduct an organization towards a specific goal is what makes up the Quality Management System. This Quality Management System follows 7 basic principles, which are:

  1. Customer focus
  2. Leadership
  3. Engagement of people
  4. Process approach
  5. Improvement
  6. Evidence-based decision making
  7. Relationship management



Each of these principles are important for the success of Quality Management within an organization. However, the fifth principle Improvement is particularly one of the most crucial ones for the sustained success of an organization.

Quality cannot be maintained if improvement is not achieved. The business environment is continuously changing, and customers are increasingly demanding better products and services at lower costs. In order to adapt to these constant changes, organizations need to continuously improve, not only their products and services, but their processes. Thus Quality Improvement is a systematic and continuous process aimed at minimizing costs, increasing the quality of product and services, and meeting and exceeding customer satisfaction. While the Quality Management process assist organizations in achieving and maintaining quality, Quality Improvement drives an organization forward by helping it innovate, manage and create opportunities. It could be said that Quality Improvement is the most proactive part of Quality Management.

Some of the key benefits that an organization can achieved through Quality Improvement are:

  • Greater adaptive capacity to meet changing customer’s expectations.
  • Decrease of defects and waste, which increases efficiency and lowers costs.
  • Prevents errors throughout the organization which improves the products and services delivered to customers.

 In general, Quality Management focuses on guaranteeing the ability to deliver quality products and services that meet customer’s expectations, and Quality Improvement focuses on increasing an organization’s capacity to meet its customer’s expectations. Thus, these two, Quality Management and Quality Improvement, have to be seen as counterparts, as they are both part of the same story, a story of long term success of organizations.



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The new ISO 31000 Risk Management Standard was released in February. ISO 31000:2018 supersedes ISO 31000:2009. The risks organizations face have changed significantly the last 9 years. Risks such as terrorism and cyber-attacks were not as prevalent a decade ago.  To adapt to these new realities and to facilitate risk management, the standard Risk Management standard ISO 31000 has been revised, and the latest version has just been released.

Simple is the best way to describe the new ISO 31000:2018 standard. It is clear and concise while giving enough detail to be applicable to organization anywhere in the world and applied to different processes from finance to production. It has been presented with a simple language where risk management fundamentals can be understood by everyone. To make the standard accessible and easy to understand, its terminology has been revised and certain terms used in risk management have been moved to ISO Guide 73, Risk Management – Vocabulary.



In addition to the changes aimed at making the standard easier to read and apply, there have also been changes regarding the principles of risk management. In ISO 31000:2018 these principles are designed in order for risk management to provide Value Creation and Protection to every organization. These principles make risk management:

  • Integrated
  • Structured and comprehensive
  • Customized
  • Inclusive
  • Dynamic
  • Based on best available information
  • Aware of human and cultural factors
  • Focused on continual improvement

These principles and the standard’s new definition of risk as the “effect of uncertainty on objectives” will drive organizations to look at the internal and external uncertainties that could jeopardize the accomplishments of their objectives. In this way, risk management is tailored to the needs and objectives of each organization. The integrated and inclusive principles help organizations develop a system which brings risk management to the center of decision making and which supports all activities across the organization.

ISO 31000:2018 recognizes risk as ever changing, therefore the system must be flexible and dynamic to adapt to the changing uncertainties, while always focusing on the continual improvement of processes.

Overall, the new ISO 31000:2018 standard presents guidelines for effective and efficient risk management in a simple manner. These guidelines will help organizations understand and address the different uncertainties which will inevitably appear in their path to achieving their objectives.



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The first topic, which will be provided in multiple installments, is Auditing Multiple and Integrated Management Systems. This first column will cover the background and importance of the topic, the advantages (and the few disadvantages) organizations accrue when integrating and when auditing their systems. And adjusting their auditing programs to fit the new reality of multiple and integrated management systems (intMS) increasingly prevalent today.

The background of this is quite simple and clearly demonstrated. Not only has the adoption of formal Management Systems risen dramatically the past few decades, but an increasing number of organizations have implemented multiple management systems. And more and more organizations recognize the advantages and efficiencies that accrue by their integration, whether it be full, or partial integration. Integration was more difficult prior to the harmonization of the ISO Standards, now guided by ISO’s Annex SL, the high-level structure that provides identical structure, text, and common terms and definitions for management system standards of the future. This will ensure consistency among future and revised management system standards and make their integration, and integrated use simpler. This is highlighted in the recent adoption of ISO 9001 and ISO 14001: 2015, and by the time you read this, ISO 45001, ISO’s Occupational Health and Safety Management System Standard, and ISO’s newest.



With the addition of each management system, auditing resources necessary to ensure their effectiveness could, without integration and streamlining efforts, roughly double. Therefore, those organizations with a QMS, EMS, and HSMS (not uncommon in large organizations) could potentially triple the auditing resources (including time) utilized over that of a single system. For the commonly used two-to-three auditors per system, six-to-nine auditors may, therefore, be necessary for those with a QMS, EMS, and HSMS. For those using three or more audit team members, imagine the audit army this creates, let alone the time necessary to audit separate systems, and the disruption to the organization. Considering all the other financial, customer, supply chain, and other audits organizations are subjected, and you can understand why many organizations are ‘audit weary’!

Professionals who have conducted integrated audits recognize how much more efficient they can be: The process under review, along with all its controls (environmental, health, safety, and quality) has to be evaluated only once. There is less duplication of effort during the planning, execution, and even follow-up phases of the audit. Other efficiencies, often unforeseen, are uncovered or revealed once an organization begins an integrated management system pathway, and is yet another advantage to integrated auditing.

Typically, management systems integration allows the organization to minimize duplication and redundancy of effort, streamline or leverage its use of its limited resources, and reduce or eliminate overlapping responsibilities. This is true of integrated systems in general and is especially true regarding the audit function. This translates to significant cost savings, productivity increases, risk reductions, and enhanced effectiveness and efficiency the intMS are designed to achieve. And when it comes to intMS registration, Registrars (should) confer savings when auditing and certifying intMS through the same efficiencies and streamlining efforts organizations achieve internally.

While there are many advantages to implementing and auditing intMS, it is important to recognize that there are disadvantages as well. One of the more notable disadvantages is that if an organization is seeking third-party registration to one or more standards, a non-conformance against a requirement of one standard may carry over to another standard. In the worst case scenario, if the non-conformance is major, all registrations could be at risk unless effective corrective action is taken.

Another disadvantage is the learning curve (and attendant training) that will likely be required for the
organization’s staff members, many of whom will not be familiar with the requirements of all the management systems involved in the IntMS. Quality staff, for example, may be intimately familiar with ISO 9001 requirements, while needing extensive (and perhaps costly) training on ISO 14001 and the same will be true of OHSMS staff, and vice-versa for each staff function.

In the next installment of this column, we will dive into the mechanics and logistics of intMS auditing, as well as provide tips and techniques to help improve intMS audit team effectiveness and efficiency.

About John Grosskopf: Since a Dr. Deming led quality and environmental paradigm shift at General Dynamics in the late 80’s, John has been a strong management systems (MS) advocate. He has pioneered advances in auditing, integrating MS, a chief contributor to two national MS Standards, and has led the development, implementation, and improvement of hundreds of MS in the public and private sectors. He is an accredited EMS, HSMS, and QMS auditor (accreditations pending), a published author, instructor/trainer, and has presented widely on MSs. Through his firm, DeepGreen Consulting, he is currently assisting clients to improve their triple bottom line through a combination of MS, best practices, collaboration, and leadership

Reference: Auditing Integrated Management Systems: Considerations and Practice Tips, November 2008, Journal of Environmental Quality Management, John Grosskopf, with co-author Jennifer Kraus.



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ISO 14001 is an international standard. An accredited certification to this standard demonstrates a committed stance on environmental management to stakeholders. Moreover, when an organization has correctly implemented an environmental management system it ensures environmental compliance, improves environmental performance and provides a systematic and strategic approach to environmental issues.

There are many benefits to implementing ISO 14001, here are the top 5.

1. Ensuring Management Commitment

ISO 14001 requires top management to commit and lead the implementation and maintenance of best environmental practices. Engaging the leadership team will increase employee engagement. When everyone in the organization is working towards the same goal, the probabilities of achieving it increase.



2. Strengthen Stakeholder Relationships

An ISO 14001 certification can improve an organization´s reputation and improve stakeholder relationships. If a stakeholder requires ISO 14001 certification, it is obvious the relationship will improve upon certification. However, even if stakeholders do not require ISO 14001 certification, having the certification can increase stakeholder confidence.

3. Improve Business Development

If an organization is seeking for new clients, it is possible that an organization might encounter a client that requires its suppliers to be ISO 14001 certified. Thus, having certification can give organizations a competitive advantage.

4. Identify Risk and Opportunities

Every organization is different, ISO 14001 allows organizations to identify the environmental issues that apply to them. It guides organizations in the management, monitoring and control of these issues and the identification of risks and opportunities that could either enhance or prevent the achievement of their environmental goals.

5. Safeguards Process Improvement

The certification audit process can also be beneficial to an organization. A certification body audit ensures that the management system has been implemented and maintained correctly, and it also identifies opportunities for improvement and potential risks that the organization might have missed.

Organization can implement ISO 14001 without seeking certification, however, in many cases it is the certification that will give confidence to stakeholders. To find an accredited certification body visit the ISO Update Registrar Directory.


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ISO 9001 was revised to meet the needs of the changing business environment and to ensure that the standard is relevant to the current needs of the marketplace. Here are the 5 major differences between the old ISO 9001:2008 and the new ISO 9001:2015 standards.



High Level Structure

The most prominent change to the new standard is a new structure known as High-Level structure. This structure is common across multiple standards and increases the ease of implementing several ISO standards within an organization, due to the commonality of the structure being followed.

Risk Based Thinking

There is increased focus on risk-based thinking in ISO 2001:2015. The standard requires organizations to address risks and opportunities in a structured manner. To address this requirement, organization may need to use techniques of risk analysis like FMEA to identify and mitigate risks.

Context of the Organization

ISO 9001:2015 gives lot of emphasis on capturing the context of the organization. Context of the organization means business environment driven by external factors such as legal, regulatory, financial, social and cultural while still considering the internal environment. Internal factors may include; organizational structures, resource capabilities. Context of the Organization is also dependent on the needs and requirements of the interested parties. The context that is relevant to strategic direction of the organization should be used to define your Quality Management System. This is an additional requirement which needs to be handled within an existing Quality Management System.

Requirements of Interested Parties

Suppliers, shareholders, employees, Legal or regulatory bodies, are now included as interested parties, in addition to customers who were predominately the only interested party in ISO 9001:2008. To address this requirement, organizations need to identify all relevant stakeholders and capture their requirements relevant to the quality management system.

Leadership Engagement

ISO 9001:2015 puts lot more emphasis on leadership engagement and management commitment. The standard requires greater involvement of top management in controlling the quality management system.

New requirements on understanding context, capturing risks and opportunities and involving all interested parties to understand strategic direction of the organization requires that the Quality Management System operates in conjunction with business processes and strategies. Involvement of top management becomes important to achieve this and improve the effectiveness of Quality Management System.

In previous version of ISO 9001, there was a concept of appointing Management Representative (MR). This has been removed in the 2015 version. The duties of the management representative are still required however, some of these duties now need to be managed by upper management. This change ensures management is directly involved in establishing and implementing the Quality Management System, therefore integrating it into all elements of the business.

 DOCUMENTED INFORMATION

ISO 9001:2015 does not mandates certain documented procedures or a Quality Manual. The Quality Manual has been replaced by the concept of Documented Information. The information can be any format and can come from various sources.



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The latest version of ISO 14001, ISO 14001:2015 has brought changes to the most widely used standard on Environmental Management Systems (EMS). One of the major changes is its structure. ISO 14001:2015 now has the high level structure that is now common to all ISO management system standards referred to as Annex SL. This new common structure brings a more strategic focus to the standard and facilitates the integration with other ISO management system standards. In addition to this new structure, there are many differences between ISO 14001:2015 and ISO 14001:2004.  Here we will briefly explain the most relevant ones.



Organizational context

Organizations are now required to systematically take into account the organizational context.  Organizational context can be looked at as the environment in which your business operates.  Now you will need to consider which internal and external factors can influence the environmental goals of your organization.

This will allow organizations to have a better understanding of the risks and opportunities it will encounter and to be better prepared to minimize (risks) and maximize (opportunities) in order to favour the organization’s environmental performance.

Needs and expectations of interested parties

Organizations are now required to take a careful look at the needs and expectations of interested parties (stakeholders). They will need to identify relevant stakeholders and understand how these can impact the EMS if their needs and expectations are not met.

Leadership and commitment

Top management is now required to demonstrate commitment and leadership to the EMS. In the new standard there is no such a thing as a management representative, now everyone is required to commit in a number of specified ways.

In ISO 14001:2004, organizations were required to commit, among other things, to reducing negative environmental impacts. Now, the new standard goes further by requiring organizations to also aim at having a positive impact and improve environmental conditions.

Life cycle perspective

The term life cycle has been included many times more in the new standard than in the 2004 revision. While in the last version, organizations were not required to consider the life cycle of products or services for the identification of environmental impacts, the new one does.

Organizations are now required to take a life cycle perspective when identifying and evaluating environmental aspects. For example, procurement, designed, transportation and disposal activities will now need to be considered. The purpose of this life cycle perspective is to contribute to sustainable development and prevent negative environmental impacts from shifting through the life cycle of a product or service.

Environmental performance

The standard is now more specific regarding the evaluation of environmental performance. Organizations are required to use quantitative data in the evaluation process.

Communications

According to this new version, organizations are required to communicate externally relevant information regarding the EMS. This should be done following a communication process that the organization must establish.

In general, this new standard emphasises environmental performance improvement and drives organization to focus on organizational context and relevant stakeholders. It also promotes risk based thinking and a life cycle perspective.



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Determining the Context of the organization is a new requirements in ISO 45001 and, has already been incorporated in ISO 9001:2015 and ISO 14001:2015.

Context of the Organisation is about understanding the entire environment in which the organisation operates. The Context can be external or internal. Utilizing SWOT Analysis and PESTLE Analysis (Political, Economic, Social, Technological, Legal and Environmental factors) are two methodologies which can be useful determining context.



Firstly, the organization needs to determine in internal and external issues which have the ability to affect the outcomes of its Occupational Health & Safety (OH&S) Management System. The internal or external issues can be positive or negative. They can include conditions, characteristics or changing circumstances which can affect the OH&S management system.

External issues can be:

  • PESTLE (Political, Economic, Social, Technological, Legal and Environmental) etc. factors.
  • New competitors, contractors, suppliers, partners etc.
  • Latest knowledge about products and their ability to affect OH&S.
  • Key drivers and trends relevant to industry.
  • Relationships with external interested parties.
  • Changes in any of the above factors.

Internal issues can be

  • Organizational structure, and roles.
  • Policies and objectives.
  • Capabilities in terms of Resources such as capital, human and technological.
  • Information systems.
  • Relationship as well as perception of workers.
  • Contractual relationships such as outsourced activities.
  • Working conditions and organizational culture.
  • Working time arrangements.
  • Changes in products, processes, equipment.
  • Changes in any of the above factors.

Secondly, the organization has to determine the Interested Parties in addition to workers, and their needs and expectations which are relevant to its OH&S Management System.

Interested Parties can be legal and regulatory authorities, parent organizations, suppliers, contractors and subcontractors, workers representatives, workers organizations such as trade unions and employers’ organizations, customers, medical or other community services, media, business associations and NGO’s, occupational health & safety organizations and practitioners.

Some needs and expectations are incorporated in to the laws and regulations and are therefore mandatory. Then there are some voluntary requirements which the organization may have subscribed to. The organization addresses the needs and expectations through the planning and implementation of its OH&S Management system.

Thirdly, the organization has to define the Scope of its OH&S Management System by defining its boundaries and applicability.

To determine the scope, the organization has to consider the Issues relevant to it. Then it has to consider the interested parties and their needs and expectations. After that it has to take in to account the planned or performed work related activities. The boundaries can include the whole organization or a specific part of the organization. The scope shall not be used to evade its legal and other requirements. Those activities have to be considered that can affect the OH& S performance of the organization. The scope has to be maintained as documented information.

Fourthly, the organization must establish, implement, maintain and continually improve an OH&S management system according to requirements of ISO 45001 and establish one or more processes that fulfil the requirements of this standard and implement those processes, control them and achieve the intended outcomes. The organization shall also integrate and incorporate the requirements of this standard into its business processes such as design and development, procurement, training and education, human resources, sales and marketing.



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If your organization is looking to obtain Certification to an ISO Standard there are few areas within your business which will require specific focus, regardless of which Standard you are seeking Certification against.

1 – Policies

Begin by reviewing your organizations policies to ensure they include a commitment to the requirements of the Standard. Make sure the policies have been communicated effectively within the organization and externally to relevant Interested Parties. Auditors will most likely ask several people about the policies of the organization to confirm Interested Parties know and understand how the organization has committed to achieving the standard and how their activities influence those commitments.



2 – Objectives

What are your organizations objectives, in relation to the Standard? They need to be documented. The achievement of these objectives is what drives the entire management system. An Auditor will ask for these objectives and check how they have been established, an outline of the plan to achieve them, and evidence of how they are being measured and monitored. Auditors will now be looking for quantitative data relating to how your organization has measured and monitored these objectives.

3 – Organizational Context

This is a term which has emerged within many of the recent revised ISO standards such as ISO 9001:2015 and ISO 14001:2015. Based upon the notion that your organization does not exists in a vacuum, it requires your organization to consider factor both internal and external issues that could impact the management system into your strategy. An Auditor will require you to show evidence about how your organization has identified, evaluated and incorporated these internal and external issues.

4 – Risks and Opportunities

You need to to identify and evaluate factors which could negatively affect your management system, and the likely hood of achieving your objectives, these are the risks. Your also need to identify the factors which can enhance and improve your organization’s performance, the opportunities. Auditors will need to see an outline of your risks and opportunities along with evidences of how they have been identified and the actions which are in place to address them.

5 – Planning Changes                                                       

Change is both constant and inevitable. Within a well-functioning management system change needs to be identified and addressed. In preparing for an audit, identify and document changes which have and will be occurring within your organization. These could be new and stricter regulations, new products or new equipment. An Auditor will look for evidence that changes were identified and addressed proactively. You may also be asked to identify how you future proof your organization and identify upcoming changes.