The International Standards Organisation (ISO) committee responsible for ISO/TC 207/SC1 carried out a survey of the environmental management system standard ISO 14001 in 2013. This survey sought to gain information from users in relation to the standards current benefits and what could be improved, as the standard is currently being revised. It received over 5,000 responses and the general feedback was that ISO 14001 is particularly useful in meeting legal requirements and improving environmental performance. However, a clearer focus on preventing pollution, eco-efficiency and life-cycle thinking should be provided in the next version of the standard.


  • Responses from 110 countries
  • 94% maintained ISO 14001
  • >50% of respondents from Europe
  • >52% of organisation had 250 or more employees
  • Almost 70% from manufacturing / processing industries
  • 46% from SME’s

Value of ISO 14001

  • Close to 75% of participants indicated ‘high’ or ‘very high’ value for meeting legal requirements and improving the organization’s environmental performance
  • >60% indicated ‘high’ to ‘very high value’ for management commitment and employee engagement
  • Responses from users  suggest ISO 14001 has provided considerable value for business management including:
    • Satisfying Stakeholder requirements
    • Improving public image
    • Achieving strategic objectives
    • Integrating with business management systems

Future Challenges

According to the survey results  the most important issues that required more attention were:

  • Reducing and controlling pollution
  • Strategies for efficient use of resources
  • Reducing waste and pollution
  • Identifying and evaluating the environmental aspects related to the life cycle of products and services.

For all future challenges other than prevention of pollution, a majority of responses suggested a limited to moderate approach that provides clarification and guidance, rather than new requirements. However, for prevention of pollution, 46% indicated a strong approach, consistent with the weighted average rating results.


The survey indicated a number of areas where there could be more focused attention including:

  • Prevention of pollution
  • Eco-efficiency
  • Life cycle thinking
  • Clearer information and guidance in ISO 14001 Annex A and ISO 14004

Per Arne Syrrist, Convenor of the group responsible for the revision to ISO 14004 responded to the survey results by saying:

“Our challenge in the ongoing revision of ISO 14004 will be to provide a deeper insight into environmental management for a wide variety of users. This survey has shown that people are not as aware of this resource as we had hoped.” 

ISO 14001 is currently at the Committee Draft phase (CD). The group dealing with the revision is meeting in Panama City in May to address comments and prepare a draft for public enquiry later this year. The revised version is expected by mid-2015.

The full survey results and accompanying report can be found here.

Source: ISO.org

Submitted by Ronan O’Sullivan, Antaris Consulting

To read more blogs from Antaris, click here


Gauge R&R and Attribute Agreement Analysis as it Applies to Non-Measurement Assessments

Many organizations now undertake Gauge R&R studies on their measuring instruments. However, the facilities now available for undertaking similar studies for non-measurement type instruments, such as Go/No-Go gauges, are less well known. Strictly speaking, the term “Gauge R&R” applies only to the study of instruments which measure characteristics on a continuous scale, such as force, length, viscosity, pH, etc. When the performance of the gauge or procedure being studied is used to make assessments on a non-continuous scale, such as Pass/Fail or a rating, then it is more usual to refer to the study as Attribute Agreement Analysis.

The Attribute Agreement Analysis study can be set up in much the same way as a regular Gauge R&R study. A number of parts are selected from the process, and are assessed by two or more operators. It will be possible from the study to determine how consistent the operators are within their own assessments, as well as the degree of consistency between operators. If it is possible to set a standard for the assessment of each part, then the performance of each operator can also be compared to standard.

The Attribute Agreement Analysis study doesn’t just apply to Pass/Fail type assessments, such as those used with Go/No-Go type gauges, but can also be used to test the consistency of operators where they make assessments on a rating scale.

Modern statistical software, such as Minitab, can be used to collect the study data and undertake the analysis. Graphical output and Kappa statistical values can be used to study the effectiveness and accuracy of the operators in carrying out their assessments.

Learn more about Gauge R&R and Attribute Agreement Analysis by attending our Measurement Systems Analysis training course.


What are the Hidden Skills of a Project Manager?

With the increased attention given to leadership in today’s business community, one could argue for the simple substitution of the expression project management with project leadership. You are right to think this but we must also understand there are so many other hidden skills to a project manager.

Truth be told, not everyone is a leader. It’s just not meant for everyone but we can all work on the hidden skills of for a project manager. Here are some of them … but look at them as you read, tell me if you agree or not?
  • Lead By Example … lend a helping hand, and making sure that the work you do is clearly understood by your team.
  • Be Organised … if you’re messy, those around you will be too. When you’re organised you’ll be much more productive and so will everyone else.
  • Focus on Priorities … don’t get sucked into the detail when you do not need to, a good expression is to focus on you top 3 priorities rather than the bottom 30
  • Delegate … you think you can do everything but you can’t. Make sure people feel as if they own the project.
  • Be Responsible … stand up and be counted for your actions and also other to do the same
  • Communicate Effectively … be concise and considerate in communication … communicate what people need to know … do not communicate what people do not need to know
  • Listen, Listen and Listen more … a huge part of being a great communicator is being a great listener. If all you want to do is talk, you’re not going to understand what is going on …
  • Know Your People. You have to know your people. You don’t have to be
There are many more that we could add but for now that give you a sense of what some of the Hidden Skills of a Project Manager are. These are more will be demonstrated through examples and studies shown in our workshops
Submitted by Liam Dillon, Turlon, SQT Project Management tutor

5 tips on Managing a Transformation team

How To Avoid Change Failure | Mind The Gap From Change Design To Execution

In this article, we discuss the challenges, traps and blind spots facing change and transformation leaders and map out the five things all change programmes need to do to avoid failure.  Our advice is applicable to all change programmes irrespective of size and scale, namely:

  1. Change the composition of the change team at the execution stage.
  2. Assess the change members belief and passion for the change goals.
  3. Introduce new management practices.
  4. Recognise and reward the right behaviours.
  5. Be guided by the vision and ideals when making change adjustments.

Transitioning from the design to execution phase is fraught with risk.   To start with, if you have created a comprehensive transformation strategy, it will include a strong and compelling vision, end state design, detailed plans and roadmaps and a solid project governance structure. You and your team will be feeling good and will probably have generated the essential momentum and demand for the next phase.  However, if you have not achieved these design outcomes, then you do need to revisit the situation and invest in getting the set-up conditions re-configured and properly rooted.

The next stage requires two significant steps. First, successfully on-boarding colleagues beyond the core project team and second, driving actions and getting relevant things done.  This is where a transformation programme gets a reality check.  We outline below, five key recommendations that address the issues that arise, in moving beyond the transformation design phase.

  1. Change the composition of the Change Team. This may seem foolhardy, particularly if the design phase was a major success.  This counter-intuitive approach reflects the fact that many of the skills and competencies required to design a change programme, are no longer required once you move into execution.  In fact, one of the biggest risks is to continue to over invest in the analytical capability of the team and then expect that this team can and will deliver the change.  Change at the implementation stage, is about investing in the emotional management of change. It quickly becomes about doing and not about thinking.  Whilst it may appear easier or simply about getting lower level people involved, it is one of the most difficult aspects of change.  Bringing on-board pragmatic doers, and key influencers from the mid-levels within the organisation, requires discipline and skill. It needs good listening skills and the ability to coach and mentor. The change leader needs to win the hearts and minds of the extended team and transfer the passion that the leadership team possess for the change programme objectives, to the wider team and employee groupings.
  2. Assess the change members belief and passion for the change goals. It is one thing to have the ability to design great change programmes, but what if the passion and commitment is not there for the implementation?  Some team members are more comfortable planning and designing.  Furthermore, they may see themselves as managers who do not have to rollup their sleeves and get stuck in.  Keeping such team members engaged is a mistake.  Transitioning into delivering requires the leaders and members of the change team to walk the walk.  If they do not feel passionate about the programme goals, vision and destination for the change programme, they will not be able to bring along the wider team.  Recognising this challenge and addressing it now, is important.  Either the team needs to develop conviction for the programme or accept they need to move on.  Most hired consultants don’t invest in the required passion, and therefore, most organisations simply don’t get this from their external partners.  As organisations move from planning to execution, it will prove timely to replace resources and invest in injecting passion, conviction and belief into the team.  We strongly advocate using diagnostic listening and Commitment-based Management as the basis for assessing and injecting passion into the team.
  3. Introduce new management practices. Once a change programme moves into the delivery phase, it requires a change to the project pattern and short-term rhythm and focus.  There is a requirement to shift the programme into getting things done.  The governance structures need to be reinvigorated.  The types of meetings, their frequency, content and structure, need to reflect a focus on getting things done and short-term outcomes.  Introduce high levels of personal accountability to deliver short-term action based results and track these actions through to completion.  Focus meetings on exceptional reporting. Do not tolerate those who deflect energy and determination to achieve the programme objectives or who are not forthright in coming forward and declaring a lack of progress.
  4. Recognise and reward the right behaviours.  Stay attuned with the progress of the programme and reward team members that get things done.  Knowing what needs to be done, should be replaced by doing what needs to be done.  Introduce real-time training and learning.  Do not punish those that are trying but failing. These team members need to be managed carefully to see if they can become competent or, if not, they need to be sympathetically and carefully moved off the programme.  By adopting this approach, change and transformation leaders will demonstrate they are ‘walking the walk’ and stand as exemplars for the behaviours of the change team.
  5. Be guided by the vision and ideals when making change adjustments. Implementing change requires hard work to change people’s mind-set and perceptions.  There are winners, losers,  resistor’s and advocates.  Successful change implementation works through the impact on individuals.  Individuals transition through several psychological stages when changing.  Therefore, even well constructed plans can never predict with accuracy, the human aspect of change.  The practical question remains, when is it okay to adjust the plan and revise the end destinations?  There is no black and white answer, however, leaders should ask themselves, ’does such an adjustment undermine the overall vision or ideals that underpin the rationale for the programme?’ If the answer is yes, then the adjustments need to be re-examined and changed.

Submitted by Ian Duncan, Ennovate, SQT Strategic Change Management tutor


EN 14971: 2012 Compliance – Treatment of Negligible Risks and Risk Acceptability

In our EN 14971: 2012 blog, we discussed the changes to EN 14971: 2012 in broad terms and we have seen that to comply with the EN version of the standard, manufacturers will have to move away from the ALARP system of risk analysis and evaluation. This will mean significant changes to the risk management process. In this newsletter and subsequent newsletters, we will deal with each of the seven Content Deviations* in detail. In this newsletter, we deal with the first two Content Deviations: Treatment of Negligible Risks and Risk Acceptability Assessment. In Annex D8.2 ISO 14971 Standard indicates that the manufacturer may ignore negligible risks. However, the Essential Requirements of the three Medical Device Directives (MDD), state that “All risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device”

Content Deviation 1: Treatment of Negligible Risks

In Annex D8.2 ISO 14971 Standard indicates that the manufacturer may ignore negligible risks. However, the Essential Requirements of the three Medical Device Directives, state that “All risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device”

The first step in risk analysis process is to identify hazards – best practice is to identify as many as possible at the beginning of the process and divide them into two categories – those that need to be analysed for risk as they could cause harm and those that cannot possibly cause harm (even in the case of misuse) often due to the design of the device. If you choose not to analyse a hazard, you must record the rationale for choosing not to conduct the analysis. Another alternative is to analyse the hazard and show that it has been reduced as far as possible.

How to Address Content Deviation No. 1

Annex D8.2, of ISO 14971 indicates that negligible risks may be disregarded. However, the Essential Requirement 1 and 2 of the MDD specifically require that all risks must be considered. This means that where possible controls need to be generated for all risks listed in your risk analysis documents (such as FMEAs). If no further controls are possible, then record a statement to this effect in the risk analysis documentation. It is important to remember that even for negligible risks an economic justification is not permissible for not reducing the risk as far as possible (See also Content Deviation No. 3 Risk Reduction Economic Considerations the subject of our next Newsletter). In achieving compliance with EN 14971: 2012 the Treatment of Negligible Risk will not be your highest priority. Discuss with your Notified Body a timeframe for implementation of reducing Negligible Risk as far as possible.

Tip: Do not include business risks or risks to manufacturing personnel in the risk analysis that you conduct to fulfil the Medical Devices Directives; this will simplify your risk analysis and exclude a number of (negligible) risks that would otherwise have to be reduced as far as possible in order to comply with EN 14971: 2012 and the MDD.

Content Deviation No. 2: Risk Acceptability Assessment.

This Deviation relates to the process of evaluating risks. The ISO 14971 states that the acceptability of risk must be decided by the manufacturer. Clause 3.2 of the 14971 Standard, states that, “Top management  shall: define and document the policy for determining criteria for risk acceptability.”   The manufacturer’s risk management policy must define and record the criteria that it uses for deciding which risks are acceptable or not.   Essential Requirements 1 and 2 states that risks be reduced as far as possible, and that all risks shall be included in a risk/benefit analysis—not just the risks that meet a certain criteria. Therefore, the requirement to establish a risk policy for the acceptability of risk directly contradicts the MDD.

The question is: how does a manufacturer establish acceptability criteria?

Robert Packard of www.medicaldeviceacademy.com in his excellent blog on the Content Deviations recommends the following:

“For new devices, I recommend benchmarking the risks of the new device against existing devices. In other words, if the new device presents equal or lower risks than existing devices, then the risks of the new device are acceptable. For existing devices, I recommend performing a risk/benefit analysis, evaluating adverse events observed with the device against the benefits of using the device”.

 What is Acceptable?

In order to comply with the EN ISO 14971:2012 version of the risk management standard, you will need to implement risk controls for all risks, regardless of acceptability. However, you will also need to perform a risk/benefit analysis. The risk/benefit analysis should consider not only the benefits to patients and the risks of using the device, but the analysis should also consider relative benefits of using other devices.

The clinical evaluation report and the risk management report for the device should be based upon clinical evidence of the device for the intended use—including adverse events. For new devices that are evaluated based upon literature review of equivalent devices, Notified Bodies expect a Post-Market Clinical Follow-up (PMCF) study to be conducted in order to verify that the actual risk/benefit of the device is consistent with the conclusions of the clinical evaluation. In order to perform this analysis, a clinical expert is necessary to properly evaluate the risk/benefit ratio of the device, and to create a protocol for a PMCF study.

MEDDEV 2.12/2 rev 2, Post Market Clinical Follow-up Studies, indicates that the PMCF study protocol should indicate the study endpoints and the statistical considerations. In order to do this, your company will need to establish quantitative criteria for acceptability of the identified risks. Therefore, your documentation should make it clear that risk acceptability criteria should be based upon clinical data. Acceptance of risks should be conducted at a later point in the risk management process than under the ALARP system (e.g., – as part of the overall risk/benefit analysis).

How to Address Deviation #2

As your company becomes aware of the second deviation between the ISO 14971 Standard and the Essential Requirements of the MDD, your risk management team will need to change the risk management process to clarify when risk acceptability should be evaluated, and the risk management policy should specify how acceptability should be determined.

The risk management process at your company will need to specify that implementation of risk controls is required for all risks—regardless of acceptability. You should also consider eliminating the evaluation of risk prior to implementation of risk controls. Instead, your company should base acceptability of risk solely upon the clinical risk/benefit analysis, and should involve the manufacturer’s medical expertise in making this determination.

Finally, your risk management process should specify the need for Post Market Clinical Follow-up Studies in order to verify that actual clinical data supports the conclusion that the risk/benefit ratio is acceptable over the lifetime of the device.

The proper place to document this conclusion is in the conclusions of the clinical evaluation report and risk management report. Both of these documents should cross-reference to one another and the conclusion should be reassessed as new post-production data is collected over time.

*Content Deviation: During the process of making ISO 14971 an EN standard (a process known as harmonisation), it became apparent that the standard did not comply with all the requirements of the Medical Devices European Directives, namely 90/385/EEC, 93/42/EEC and 98/79/EC. The differences between EN 14971: 2012 and the Medical Devices Directives are known as Content Deviations.


The seven Content Deviations are:

  • Treatment of Negligible Risk
  • Risk Acceptability Assessment
  • Risk Reduction Economic Considerations
  • Risk-Benefit Analysis Not Optional
  • Risk Control Options
  • First Risk Control Option
  • Labelling Information Cannot Influence Residual Risk

Submitted by John Lafferty, SQT Healthcare Tutor



A second committee draft (CD2) of the revised environmental management systems standard was published in October 2013 and ISO countries had until 23 January 2014 to vote on whether CD2 should become a draft international standard. CD2 has received overwhelming support from ISO members, ensuring the draft international environmental management system standard will progress to the next step. In excess of 80 percent of ISO members who were balloted voted to move the revision of ISO 14001 to a draft international standard.

The next meeting of the international working group that is drafting the standard takes place between 25 February and 1 March. It will consider the comments submitted during the latest consultation and look to build a stronger consensus on the changes that are being proposed.

Martin Baxter, executive director of policy at Institute of Environmental Management and Assessment (IEMA) and the UK’s appointed expert on the revision to 14001, said the response to the draft standard from environmental professionals had been “overwhelmingly positive”.
“The changes being proposed are significant, integrating environmental management into organisational strategy and decision-making and adding further emphasis on improving environmental performance,” he explained.

An increasing number of organisations are pursuing ISO 14001 certification. In its annual survey of certifications, the International Organization for Standardization said the number of ISO 14001 environmental management system certificates at the end of 2012 was up 9 percent to 285,844 over the previous year.

Revision timeline

Early 2014: IEMA submits comments on CD2.

Mid 2014: Final Ballot takes place for adoption of the new 14001 standard.

Jan 2015: Final Draft International Standard.

May 2015: The revised ISO 14001 will be adopted and published, and the transitional period for organisations with certifications will begin.

Submitted by Ronan O’Sullivan, Antaris Consulting

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8 ways to improve the quality of a meeting

How Do You Improve Strategy Execution Capability?

Improve The Quality Of Your Meeting Practices; Eight Ways To Improve Quality Of Your Meetings

Our claim that the quality of an organisation’s meeting practices is a lead indicator of the leadership’s ability to execute strategy.  Put differently, organisations that improve their meeting and coordination practices, greatly increase the likelihood of delivering on their strategic objectives.

Ask any manager why they attend meetings and you will be surprised to hear just how many managers attend them without any understanding of their role in the meeting. It is common for meeting attendees to have little idea if their participation will deliver on their expectations and in addition, what they will take away in terms of actionable deliverables.  Clearly, meetings like these are contributing little towards the attainment of organisational goals. Further, ask most people what motivates them to attend meetings and you will learn that many people are driven by a need to be seen to attend, to know what is going on and a concern not to miss out on some knowledge that their peers have acquired.  Such a meeting culture as this is depressingly uninspiring.  However, allowing it to continue is not an individual failing but an organisational malpractice that requires leadership and courage to rectify.  A failure to put in place strong and appropriate meeting practices can end up costing an organisation literally millions.

In writing this article we conducted some research. This revealed a good understanding of the efficiencies to be gained through benchmarking and workflow analysis. However, the research also revealed a distinct lack of management literature and quantitative evidence regarding organisational waste due to poorly designed and ineffectual meeting practices.

There is a basic lack of understanding concerning the organisational cost incurred through weak coordination, poor cross-functional alignment and badly conceived and run meetings.

Well-run meetings are an important aspect of work place coordination and are vital to drive forward organisational strategy.  If done well, they connect executive teams, managers and employees to the organisational mission. They create meaning and purpose for individuals and bind them to organisational objectives.  Crucially, they also create understanding, can be highly motivational and generate the ‘corporate energy’ that drives organisations forward towards delivering on their strategic goals.

We believe that the quality of an organisations meeting practices is an effective barometer of an organisation’s leadership capability. Thus, the quality of an organisation’s meeting practices is a bi-product of its leadership quality.

Where organisations build their capability to run effective meetings effectively, they dramatically improve their ability to execute strategy.  Using a discipline called Commitment-based Management to design and manage meeting practices, is a very effective way to build management capability and dramatically improve the effectiveness of an organisations meetings.

We consider that there are eight conditions necessary to set-up an effective meeting practice and create high performing teams. They are as follows:

  1. Get the right attendance: Every person attending has clear responsibility and authority to make decisions. In practice that means no one in the room should have to seek authority from others not attending and no one in the room is there without clarity of purpose.
  2. Clarify the Goal and outcomes required: Ensure there is a clear articulation of the goals and purpose of the meeting and circulate this to attendees in advance and ensure people understand the meeting context.
  3. Promote conflict:  It is healthy to publically debate the right things to do and meetings are a perfect forum for these discussions.  Without robust debate, individuals may not commit themselves to the outcomes sought. This results in passive resistance and non-effective actions and follow through.
  4. Seek individual commitment:  Each request for action is personal to an individual. By asking them to directly take responsibility for an outcome you are making them personally accountable for its delivery.
  5. Openly discuss what individuals need to be successful: In delivering on actions, if an individual is unclear what is required of them, suggest they reconsider the original request and come back with a formed view of what conditions need to be in place for them to be successful.
  6. Hold individuals accountable for their commitments: When a commitment is due to be delivered on, ensure it is accepted as being complete, and that the requestor to declares their satisfaction or dissatisfaction with the result.
  7. Only discuss exceptions and the future action required to deliver on the original commitment:  Do not waste valuable meeting time on reporting progress but instead, save that for a written report, circulated to meeting attendees for review prior to the meeting. Instead, focus on areas that are not achieving the right outcomes in relation to the commitments made.
  8. Be supportive and encourage people to take on commitments: Praise success and do not punish the holders of under or non delivered commitments. Instead, focus on how to avoid the situation reoccurring in the future. Use one-to-one check-ins to unearth problematic commitment holders.

In reality the conditions will not be easy to achieve. Ennovate adopts a pragmatic and flexible approach. This tailors adherence to the eight conditions, to the length and difficulty of the journey the client organisation needs to undertake to create the conditions for an effective meeting practice.

Changes to practices in the workplace require individuals to change their behaviour.  Whether it is a conscious decision or not, all individuals make trade-offs when deciding to change their behaviour.  For the individual, the benefit of a change in behaviour needs to outweigh the opportunity cost of giving up a behaviour that has benefited them in the past. To achieve a successful execution of strategy, a key requirement for leaders, is to tie together the personal benefits of individual changes in behaviour with the organisational benefits.  This essential alignment of personal benefit to organisational benefit requires one-to-one coaching between the meeting leader and the individual attendees.

Engaging in working to build this alignment is the foundation of effective meetings and is inextricably tied to the effectiveness of commitments made within those meetings.  Creating a purpose and meaning that explicitly links an individual’s actions to the attainment of an organisational objective, may be all it takes to drive a fundamental improvement in strategy execution.

Submitted by Ian Duncan, Ennovate, SQT Strategic Change Management tutor


Are you EN 14971:2012 compliant?

Why is there currently so much controversy surrounding ISO 14971?

During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the Medical Devices European Directives, namely 90/385/EEC, 93/42/EEC and 98/79/EC. Seven discrepancies were identified; these discrepancies are described in EN 14971 as “Content Deviations”. What does this mean for the medical device manufacturer?

This means that conforming to ISO 14971: 2007 no longer guarantees conformance with the Medical Device Directives. If you are selling devices in Europe then you will need to revise your risk management process to become EN 14971: 2012 compliant, unless you have already done so. *

(*EN 14971: 2012 applies only to manufacturers selling devices on the European market – if your devices are not sold in Europe or countries requiring compliance with the Medical Devices Directives, then ISO 14971: 2007 is still the applicable standard for your company.)

What does EN 14971: 2012 require?

In summary; EN 14971: 2012 has the following implications:

  • All risks identified, whatever their size, must be reduced as far as possible, without consideration being given to the cost of doing so.
  • Risk Benefit Analysis is always required
  • Providing safety information on labelling cannot be considered a risk reduction measure

Only the Annexes of EN 14971 have changed in the 2012 version, the rest of the content of the standard remains the same. The differences seven between the Medical Devices Directives’ Essential Requirements and the requirements of ISO 14971:2007, known as Content Deviations are outlined in the new  “Z” Annexes of EN 14971: 2012

The seven Content Deviations are as follows:

  1. Treatment of Negligible Risk
  2. Risk Acceptability Assessment
  3. Risk Reduction Economic Considerations
  4. Risk-Benefit Analysis Not Optional
  5. Risk Control Options
  6. First Risk Control Option
  7. Labelling Information Cannot Influence Residual Risk

Does this mean an end to ALARP?

Yes. For devices sold in Europe, the ALARP concept will no longer be permissible as a means of risk acceptance because it involves an economic element in the justification of acceptable risk.

In future, there will only be two categories of risk;

  1. Intolerable risk – the presence of which means a device cannot be placed on the market unless justified through risk/benefit analysis.
  2.  Acceptable risk – risks that have been reduced as low as possible and have been justified through risk/benefit analysis. (Risk/benefit analysis must be conducted for each individual risk and for the totality of the risk)

What lead-in time do I have to comply?

For a new or revised standard, the lead in time is normally three years but for EN 14971:2012 immediate compliance is what is expected. This is because the Medical Device Directive has been in place since 1993 and manufacturers should have already been compliant with the Directive.


What should I do if not already compliant?

Follow these 3 steps

  1. Draw up a plan to achieve full compliance.
  2.  Prioritise the highest risk items
    -      Remove economic considerations from ALARP risk acceptance.
    -      Conduct risk/benefit analysis.
  1. Talk to your Notified Body as soon as possible; well in advance of your next audit or submission, and outline your plan for compliance to them.

Submitted by John Lafferty, SQT Healthcare tutor




ISO recently announced that ISO Committee ISO/PC 283 – Occupational Health & Safety Management Systems, has been formed with an objective to develop and publish an international standard for Occupational Health and Safety (OH&S) based on OHSAS 18001. The new standard will be known as ISO 45001. The standard’s publication is still some time off, but the result will hopefully be an up-to-date health and safety management system which will allow practicable and efficient integration with standards such as ISO 14001 and ISO 9001.

This standard, designated as ISO 45001, will establish globally-accepted requirements for third-party certification of an OH&S management system. It is intended to replace the OHSAS 18001 standard.

At the first meeting of the committee ISO/PC 283 in October 2013, an outline project plan for the development and publication of ISO 45001 was created:

  • ISO/CD 45001 (first committee draft) to be published by May 2014
  • ISO/DIS 45001 (first draft international standard) to be published by February 2015
  • ISO/FDIS 45001 (final draft international standard) to be published by March 2016
  • Final ISO 45001 to be published in October 2016

The new standard will follow the “High-Level Structure” format defined in Annex SL, meaning that it will be aligned with the revised versions of ISO 14001 and ISO 9001 scheduled for publication in 2015.

ISO/PC 283 – the committee responsible for ISO 45001 – held their inaugural meeting in October. It was agreed that, ISO 45001 will fall in line with the Annex SL high-level structure,. This means that all the management system standards will eventually be aligned. This decision was taken by the ISO Joint Technical Coordination Group (JTCG) in an effort to make life easier for organisations who wish to have a single management system.

This will mean the structure of the standard will be:

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Context of the organization
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance evaluation
  10. Improvement

Moving forward, the committee established a plan for the development and publication of the standard:

  • ISO/CD 45001 (first committee draft) to be published by May 2014
  • ISO/DIS 45001 (first draft international standard) to be published by February 2015
  • ISO/FDIS 45001 (final draft international standard) to be published by March 2016
  • ISO 45001 to be published in October 2016

The next meeting for the ISO/PC 283 committee will be held in March 2014 in Morocco in order to get the working draft of ISO 45001. It will then be open for comment, in order to ensure the standard reflects the needs of users around the world.

With poor health and safety management costing around 4% of global GDP, the new international standard’s impact has the potential to save lives, reduce accidents and improve employee morale. Its impact on industry will be closely watched by business leaders and safety professionals around the world. If done correctly it has the potential to improve safety standards, performance and ultimately reduce accident rates. However if not managed properly it could end up being just a paper exercise and a new certificate on the wall.


Submitted by Ronan O’Sullivan, Antaris Consulting

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Increase in ISO Uptake in Ireland

Figures released from ISO show a large uptake over the previous twelve months.  There are over 19,573 standard developed by the ISO since its formation in 1947. The reach of the organisation has expanded with national members 164 countries, rising from 162 in 2011. Ireland’s representative body is the NSAI. The national members consist of 111 member bodies, 49 correspondent members and four subscriber members.

The number of active projects in 2012 has increased to 4056, from 4007 in 2011. Consequently, the number of standards published has also risen from 1208 in 2011, to 1280 in 2012.

A summary of the statistics is shown in the table below.

Table 1 Global Distribution of Certificates 2011 and 2012

Standard No. of Certs Issued 2012 No. of Certs Issued 2011 Increase Increase (%)
ISO 9001 (Quality) 1,101,272 1,079,647 21,625 2%
ISO 14001 (Environmental) 285,844 261,957 23,887 9%
ISO 50001 (Energy) 1,981 459 1,522 332%
ISO 27001 (Information Security) 19,577 17,355 2,222 13%
ISO 22000 (Food Safety) 23,231 19,351 3,880 20%
ISO/TS 16949 (Quality Automotive) 50,071 47,512 2,559 5%
ISO 13485 (Quality Medical Devices) 22,237 19,849 2,388 12%
Total 1,504,213 1,446,130 58,083 4%

Source (ISO, 2013)

From Table 1 above, it can be seen that the uptake for the seven most popular standards have all increased over the past year. The greatest increase in uptake has occurred with ISO 50001, with an increase of 332%.

This increase is due to the fact that ISO 50001 was released in June 2011, and therefore the 2011 figures represent six months of uptake. In addition this is the first internationally recognised energy management standard.  The large increase may be the result of companies with existing standards upgrading their systems to comply with the requirements of ISO 50001, as the standard is in its infancy.

Sustainable Energy Authority Ireland’s Large Industry Energy Network (LIEN) is a voluntary network comprising of 140 companies representing 60 percent of Ireland’s industrial energy usage. A staggering €60m in avoided energy costs has been achieved since 2008 with the Scheme. SEAI also have a scheme under the LIEN, called the Energy Agreements Programme (EAP), over which there are 80 members which requires organisations to implement an energy management system.

In addition to this Ireland is home to many of the world largest MNCs (e.g. Google, Pfizer) and these companies are paving the way for best practice energy management for their colleagues in other countries and this has been enforced further with the swift implementation of ISO 50001. Germany and the UK are the market leaders in the largest number of ISO 50001 certificates issued but Ireland is coming up behind these countries, and is driven by SEAI’s goal to ensure that all members of the EAP have achieved ISO 50001 certification by the end of 2013. (Brogan, 2012)

The global uptake of ISO 50001 over the first twelve months has exceeded that of ISO 14001 in its initial twelve month period, and is rivalling the number of uptakes of the ISO 9001 in the 1990’s.

ISO 9001 makes up the majority of the certificates issued with over 73% of the global total awarded in 2012.

Table 2 Distribution of Certificates 2011 and 2012 in Ireland

Standard Intro Year No. of Certs Issued 2012 No. of Certs Issued 2011 Change (%) Total Certs Issued
ISO 9001 (Quality) 1993 2,331 1,875 +24% 43,462
ISO 14001 (Environmental) 1999 417 663 -37% 4,947
ISO 50001 (Energy) 2011 35 n/a n/a 35
ISO 27001 (Information Security) 2006 48 30 +60% 146
ISO 22000 (Food Safety) 2007 49 49 0% 246
ISO/TS 16949 (Automotive Quality) 2004 23 21 +10% 187
ISO 13485 (Medical Devices Quality) 2004 193 159 +21% 975
Total 3,096 2,797 +11% 49,998

(Source: ISO, 2013)

From Table 2, it can be seen that the distribution of ISO 9001 makes up the majority (over 75%) of the total number of certificates distributed. The uptake of this standard has increased 24% on the previous year also. The large uptake for this standard has been driven by the introduction of EU directives on products which specify minimum standards

ISO 9001

ISO 9001





Figure 1 ISO 9001 Annual Distribution of Certificates

The distribution of ISO 9001 conformance certificates peaked in 2000 and 2001 where 3700 certificates were being issued annually. The uptake of the standard has dropped off since then to more modest levels. Yet 2012 saw an increase of 24% in certificates issued versus 2011, as 2331 certificates were issued.  From all the certificates distributed in 2012 in Ireland, over 75% of them were for ISO 9001.

ISO 14001

ISO 14001



Figure 2 ISO 14001 Annual Distribution of Certificates

417 certificates distributed in 2012. This is lowest distribution rate of ISO 14001 certification for the previous five years. This drop off may be due to maturity of standard and proposed introduction of the new ISO 14001 in 2015.

ISO 50001

The number of ISO 50001 certificates issued in 2012 was 35. This number quite big considering it is a voluntary standard. The standard was only introduced in June 2011 and many companies with existing EnMS standards in place, such as EN 16001, may be waiting for their existing certification to expire prior to acquiring the new standard. The next ISO survey will give a good indication as to whether the SEAI met their goal stated above.


ISO 27001

ISO 27001



Figure 3 ISO 27001 Annual Distribution of Certificates

There has been significant growth in the uptake of ISO 27001 since its uptake in 2006, where only six certificates were distributed, to 48 certificates being distributed in 2012.

ISO 22000 (Food Safety)

ISO 22000



Figure 4 ISO 22000 Annual Distribution of Certificates

Launched in 2007, 23 ISO 22000 certificates were issued, and annually since 2010, the number of certificates issues has risen to 49.


ISO/TS 16949 (Automotive Quality)

ISOTS 16949




Figure 5 ISO/TS 16949 Annual Distribution of Certificates

The adoption of ISO /TS 16949 has grown from seven in 2004 and 2005, to over 20 annually for the previous 6 years.


ISO 13485 (Medical Device Quality)

ISO 13485




Figure 6 ISO 13485 Annual Distribution of Certificates

Progressive growth has occurred in the uptake of ISO 13485 since 2004. The number of certificates has increased tenfold from its introduction in 2004, where 19 certificates were issued, to 2012 where 193 certificates were issued.


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