Governance, Risk and Compliance Blog

ISO 9001:2015 Explained: The Process Approach

Posted by Emily Hill on Thu, Sep 29, 2016

While the process approach is by no means a new requirement, anecdotal evidence suggests that it is poorly understood.

The process approach was first introduced in ISO 9001:2000. And while the concept of a process-based quality management has not changed, the requirements in the latest version of the standard, ISO 9001:2015, have become more specific and less ambiguous. 

So, what actually is a process approach? And why is a process approach important? And, most importantly, how can you get your employees to follow a process approach?  Richard_Green-2.png

In this article, Richard Green, founder and Managing Director of Kingsford Consulting Services, answers all of your questions about a process-based quality management system. 

What is a process approach? 

‘Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system’ - Introduction of ISO 9001:2015.plan_do_check_act.jpg

The process approach is a management strategy which incorporates the plan-do-check-act cycle and risk-based thinking. It means that processes are managed and controlled. It also means that we not only understand what the core processes are, but we also consider how they fit together. 


Key Changes from ISO 9001:2008 - ISO 9001:2015


The requirement for a process-based quality management system is nothing new. The requirement to "establish, implement, maintain and continually improve" is familiar from both ISO 9001:2000 and ISO 9001:2008. The key changes are:

  • For organisations already adopting ISO 9001:2008, a key factor in transitioning to ISO 9001:2015 is the extent to which the process approach has been adopted. 
  • Clause 4.4 of ISO 9001:2015 sets out specific requirements for the adoption of a process approach e.g. organisations must monitor, measure and use related performance indicators to determine effective operation and controls. 
  • Top management must promote, engage and support employees to follow a process approach.  


Why a process approach is so important



Organisations are typically structured into departments which are managed by a department head. The head is responsible for what comes out of the department. 

Most departmental heads never interact with the external customer, only internal ones. As such, they are divorced from how the customer really feels. 

If key performance indicators are set by departments this compounds the problems. Heads try to maximise the performance of their departments to the possible detriment of other departments further down the line. 

The process approach introduces horizontal management, controlling processes which flow across departmental boundaries. Someone is accountable from start to finish. They see the whole picture from process initiation to process completion. They understand what the stakeholders in the process want and have delegated authority to act to realise this. An employees first loyality is to their assigned projects, products or services - rather than their own departments. 

Using a process approach in a quality management system facilitates: 

  • understanding and consistency in meeting requirements,
  • viewing processes in terms of value-add,
  • achieving effective process performance, 
  • improving process performance based on analysis and evaluation of the data and information. 


Implementing a Process Approach (Step By Step) 

ISO 9001:2015 Toolkit


ISO 9001:2015 employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. This means the organisation needs to:

  1. determine required process inputs and expected outputs,
  2. assign responsibilities and authorities for processes,
  3. identify risks and opportunities for processes, and plan to address these. 


1) Define your quality management system processes 

ISO 9001 does not provide you with a list of core quality management system processes you need to include. Your organisation must determine these for themselves. So, what should you include? 

Richard Green says: "Focus on your core processes - the ones which keep you awake at night." You do not need to include things like raising an expenses claim or booking a meeting room.

Some example processes:


  • how are we constantly providing products and services which meet customer and applicable statutory and regulatory requirements?
  • how are we enhancing customer satisfaction? 

These are the processes which need to be controlled. Your organisation must then map out the inter-relationships between your core processes. 


2) Assign responsibilities and authorities for processes

Your organisation then needs to work out who is responsible for what process. Rather than focusing on functions, focus on the process across the department. Pay particular attention to the interdependencies and the interactions. It can also help to:

  • Involve employees in building the process-based quality management system. 
  • Train individuals so they understand their roles and accountabilities in respect of the core processes to ensure they see their processes end-to-end.
  • Restructure the audit programme around processes not functions
  • Train auditors to follow processes across departments, paying particular attention to interdependencies and interactions. 
  • Provide documented information to support the operation of processes and ensure you have confidence that the processes are being carried out as planned. 
  • Give procedures and work instructions another name.


See how you can use EQMS to optimise your management systems!  

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3) Identify risks and opportunities, and plan to address these

Risk-based thinking is an extension of preventive action. It requires organisations to determine risks and opportunities to processes, products and services, as well as the quality management system. And the organisation must take proportionate steps to address these actions. This means monitoring and measuring the performance of processesFor more information about risk-based thinking, please see this article. 


A process-based quality management system requires careful planning, structure and continuous optimisation. Key to this is ensuring your stakeholders are engaged. Employees must always be looking for opportunities to meet customer requirements and enhance customer satisfaction. Download the Stakeholder Engagement template for more information about driving enagement with the quality management system. 

  Stakeholder Engagement toolkit

Tags: ISO 9001:2015

8 Essential Food Safety Resources

Posted by Emily Hill on Wed, Sep 21, 2016

Staying on top of the latest news and alerts in food safety is not always a walk in the park. In fact, sometimes it can feel more like a sprint in a swamp. That being said, there are plenty of tools out there to help you stay on top of the latest trends and issues in the industry.

During the Food Safety Trends Conference held at Museum of London Docklands, food safety experts from across the globe gathered to network and share their expertise. Below is a list of 8 of their recommended food safety resources. 

1) European Commission 


The European Union has one of the highest food safety standards in the world. A key tool to ensure the cross-border follow of information to swiftly react when risks to public health are detected in food.

The European Commission's Rich Site Summary (RSS) feed, known in industry as the Rapid Alert System for Food and Feed (RASFF) was created in 1979 to share information between members. You can access the RASFF portal to: 

  • react rapidly when risks to public health are detected in the food chain,
  • avert serious risks before any harm to consumers is caused, 
  • understand trends and issues in food across a global supply chain. 

Access RASFF resources here


2) US Pharmacopeial Convention


US Pharmacopeial Convention, also known as USP, offers a number of different e-Newsletters to help you to stay on top of industry news, trends and information. Subscribe to their quarterly FCC food newsletter to: 

  • learn about new standards,
  • read the latest news from USP,
  • understand the latest trends in the USA. 

Subscribe to the e-Newsletter here 


3) Global Food Safety Initiative


The Global Food Safety Initiative (GFSI) is an industry-driven initiative providing guidance on food safety management systems necessary for safety along the supply chain.

Members include manufacturers, retailers, food service companies, governments, academia and service providers. Add GFSI on twitter to:

  • get advice and network with experts,
  • information on getting certified, 
  • news, events and more. 
Follow GFSI here



GFSI also provides you with a free manufacturing toolkit. The spreadsheet helps you identify weaknesses in your food safety management system.

Download it here. 


4) NSF International


NSF International develop public health standards and certification programs to help protect the world’s food, water, consumer products and environment. NSF International produce a monthly 'Food Safety Bites Newsletter' to help you to: 

  • stay informed about food safety trends,
  • alert your team to any potential upcoming threats, 
  • identify opportunities for growth. 

Get the latest Food Safety Bites Newsletter


6) FoodIntegrity


FoodIntegrity is a 5 year project made up of organisations across Europe to consolidate and harmonise information to combat food fraud. FoodIntegrity will give you: 

  • an opportunity to network with others in the food industry,
  • learn from others at events,
  • latest news in the food industry.

See homepage here 


7) Campden Bri


For scientific, technical and regulatory food safety information and support, Campden Bri will provide you with plenty of news articles, case studies, videos and podcasts. 

  • join a network of 2000+ companies,
  • 100's of resources, including whitepapers, webinars and blog articles, 
  • share case studies with your stakeholders. 

To access a load of free resources from Campden Bri, email with the subject line: SEND INDEX. 


8) New Food Magazine


You may already subscribe to the New Food Magazine, but are you following them online? The website gives you a range of multimedia content, including:

  • webinars covering hot topics in food safety, 
  • opportunity to join events
  • watch videos on food safety. 

Browse resources here 

What food safety resources do you find useful? Please leave a comment below this blog article. 

To keep up to date with the latest quality news, advice from experts and more resources, subscribe to the GRC Newsletter. 


A Cult(ure) of Quality: 3 Lessons from Leading Brands

Posted by Emily Hill on Wed, Sep 21, 2016

You are part of a cult, right?

Before you answer, consider this - a cult is a group of people who are wholeheartedly devoted to a cause. They are not afraid to champion their beliefs through their actions. And they will share their devotion with others. So, what quality department would not want a cult following? 

Yet getting everyone to put quality-first is not always easy and few quality teams ever completely master itSo how can you make your stakeholders devoted to quality? What does the road to success look like? And where can you get advice? 

During the Food Safety Trends Conference, we sought advice from quality professionals at some of the world's largest food manufacturers. Below are 3 tips for a getting cult-like following from quality professionals at some of the world's leading food manufacturers.

#1 Put the brand first

Demonstrating the cost of poor quality is essential when getting your team behind you. But what is even more important than revenue over the next few months? Keeping a reputable brand for decades to come. 

Chris Moore from Compass Group UK & Ireland suggests communicating potential reputational damage when discussing the importance of quality. He says:

"Don't always focus on cost when engaging top management with quality. Highlight potential reputational and brand damage."

Every sector has countless examples of when poor quality and compliance management has hit the headlines. Take the horsemeat found in Findus lasagna in 2013 as an example. After more than 50 years as a UK favourite, the European arm of the Findus Group was sold to Nomad Holdings last autumn. Following this, a separate company, Young's Seafood International Holdings, was spun out in the UK, but decided to drop the Findus brand in early 2016 following the damage to the brand caused by the horsemeat scandal. 

Even Findus Crispy Pancakes, who won 'Favourite retro food' in 2009, has been dropped.


But not all quality issues are scandals. Some could be a customer complaint. Take this review of Haribo Sugar Free Gummy Bears on Amazon as an example: 


The review went viral. Over 50,000 people have found the review helpful. It made headline news on The Guardian and Buzzfeed. And it has probably been read hundreds of thousands, if not millions of times. Who would buy Haribo Sugar Free Gummy Bears after reading these reviews? 

Discussing the importance of the brand and the potential damage to the brand due to poor quality will help you ensure quality is top of mind for all of your stakeholders, all of the time. 


#2 Market your quality team

The words you use, the stories you tell and your routines say a lot about you. The same is true in business. If the quality team are only around when things are going wrong, they will soon be associated with being negative, and they will probably be met with hostility or fear. 

John Carter from Danone suggests promoting quality to the rest of the organisation: 

"Think carefully about the language you use: if your quality team are saying "this is a nightmare" or "we are having a crisis", the rest of the organisation will be quick to associate quality as something negative." 

Carter suggests building a positive culture of quality starts with the messages conveyed by your quality team. 

These articles have ideas for promoting quality in your organisation: 


#3 One single source of truth 

Accountability. It helps people know who needs to do what, when and why. Without it, employees will be confused, there will be a lack of coordination among functions, failure to share ideas, slow decision-making - bringing all of your employees and suppliers an extra layer of complexity, stress, conflict, and ultimately, this leads to a poor customer experience. 

Paul Isherwood from SHS Group Drinks Division says a centralised system is key for a culture of quality: 

"If you do not have one single source of truth, you are not doing your job. If you must negotiate capex, this should be on your non-negotiables list." 

A centralised system will ensure all employees in your organisation know who needs to do what and when. Systems such as EQMS are key for improving accountability, exposing the truth, and essentially, a culture of quality. EQMS assigns roles and has an advanced, configurable workflow so individuals and teams know what they need to do and when. And as EQMS has a built-in audit trail, authorised personnel can see who has said what and when. 

Request pricing information for EQMS or watch EQMS webinars


Getting a cult-like following for quality is not for the faint-hearted and it will not happen overnight. But by focusing on brand value as well as cost of poor quality, taking time to promote the quality team internally and consolidating all quality initiatives into 'one single source of truth', you will be one step closer on your journey. 

For more information about using EQMS as your 'single source of truth' watch the webinars here. 

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EQMS in Food Manufacturing - Download HACCP Toolkit

Posted by Emily Hill on Mon, Sep 12, 2016

Food and Beverage manufacturers are only too aware how poorly trained staff, inconsistent production processes and poor products inevitably lead to failure.

Global competition, international standards and tighter regulation are compelling producers to focus on food safety and quality more than ever before. Regulators such as the FDA in the USA and the Food Standards Agency in the UK are prepared to issue the severest of sanctions and safety incidents are subject to intense public scrutiny with social media capable of inflicting catastrophic damage to reputations in no time at all.


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The challenge to systematically apply a HACCP approach to eliminating hazards in production processes must be met to ensure finished product safety and quality.

Manufacturers are increasingly turning to international standards such as ISO 22000, ISO 9000 and BRC/IOP to validate processes, assure performance and evidence compliance. Despite the burden of compliance, certification to ISO 22000 is growing by more than 10% per year and now covers over 140 countries worldwide.

BRC Issue 7, introduced in January 2015, focuses the audit towards the implementation of good manufacturing practices. Increased emphasis is now placed on areas with the highest rate of recalls and withdrawals, such as labeling and packing. Issue 7 continues to highlight management commitment and promote HACCP-based food safety programmes.

Aligning employee behaviour with the quality and safety demands of standards and regulations requires unwavering management commitment and creates a huge operational and administrative overhead. Automation and innovation are key to minimising the impact and driving profitability.

Food safety Manufacting

EQMS provides a holistic, web-based quality management solution that supports compliance with food safety and quality regulation. Our food quality management solutions enable companies in the food and drink industry to record, route, correct, prevent, and analyse problems, providing realtime views of quality data, and enabling issue-tracking with closed-loop compliance processes.

The delivery of standard operating procedures and process information is assured and training records maintained ensuring competency gaps are identified and addressed. Many food and drink businesses have departmental silos recording data in spreadsheets, distributing paper-based procedures, and manually measuring processes.

EQMS unifies all quality and compliance data into one central repository, allowing food and drink companies to leverage robust reporting, dashboard, and alerts to easily identify trends, overdue actions, and other performance metrics while monitoring key performance indicators (KPIs).

Find out more about using EQMS in the food and beverage industry by downloading the HACCP toolkit. 



9 Pieces of Awful ISO 9001:2015 Advice

Posted by Emily Hill on Tue, Sep 06, 2016

All of us want a smooth, successful transition to ISO 9001:2015. The problem is there is a lot of misleading advice out there. Advice that means well, but is... wrong. 

So, how are you supposed to distill the right information from the deluge of rubbish?

With the help of Richard Green, Founder and Managing Director of Kingsford Consultancy Services, we've put together 9 pieces of awful advice we have heard and explained what you should really be doing. Read on...

1. "Don't worry about talking to top management"

False! You need to keep your top management informed before, during and after your transition. They need to be engaged throughout. Not only will they need to understand their new requirements and cascade these requirements throughout the rest of the organisation, they need to understand the value of ISO 9001:2015 to your organisation. If management decide ISO 9001:2015 is not worth the effort, the project will fail. 


2. "Contact your Certification Body just before you are ready for your audit"

Unless you are very confident about your (re)certifcation audit, it is probably worth contacting your Certification Body very early to get their help. It also helps to book an audit even if you are not ready to go yet, it will help you to prepare well ahead of the deadline.

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3. "Do a gap analysis last" 

Actually, a good place to start your ISO 9001:2015 transition is with a gap analysis, this will give you a 'departure' point. Only when you understand the extent of the work to be completed can you meaningfully start to plan your transition journey. You can always revisit your gap analysis when you are ready for your ISO 9001:2015 audit.

Download the ISO 9001:2015 Toolkit for a free Gap Analysis tool. 


4. "You do not need to do a risk assessment regarding your transition to ISO 9001:2015"

When you start planning for your transition to ISO 9001:2015, you should look at all of the risks and the opportunities associated with transitioning to the new Standard, and also put in place the necessary arrangements to address the risks and opportunties.  Stakeholder Engagement toolkit


5. "You don't need expert help" 

One of the ways it could all go wrong is if you misunderstand what you need to do to satisfy the new requirements, and therefore, you make inappropriate adjustments to your quality management system. To avoid this, we would recommend consulting ISO 9001 experts to ensure you do not make any costly or unnecessary errors. 


6. "You can make all of the necessary ISO 9001:2015 transition requirements without any extra resources"

You need to treat your transition as a corporate project. This means applying project management techniques. This will mean that you will probably need extra time, money and personnel to help you.

Take EQMS for a spin! 

7. "Don't send your transition plan to your stakeholders" 

You need to keep your stakeholders advised about your progress as the changes will impact them. Failing to engage your colleagues means that the changes are not positively changing your organisation. You need to communicate your intentions to your stakeholders and get them engaged throughout. This stakeholder engagement plan can help. 


8. "Don't bother creating a transition plan"

You need to put in sufficient time and effort into planning your transition. Otherwise, you risk underestimating the extent of the required changes. Create a transition plan using our ISO 9001:2015 toolkit.


9. "Always listen to your Certification Body"

If something sounds strange, always seek a second and third opinion on the matter. It could be that the person you spoke to misunderstood you. Check out these 5 ISO 9001:2015 myths.


For more information about ISO 9001:2015 requirements, download the ISO 9001 Toolkit. 

ISO 9001:2015 Toolkit

Tags: ISO 9001:2015

6 Critical Building Blocks of a Quality Culture

Posted by Emily Hill on Mon, Sep 05, 2016

Behind every great company is a great culture of quality - when every stakeholder from top management to those at an operational level seamlessly embed quality improvement into their daily activities.

Without a culture of quality, an organisation may fail to function efficiently, or even collapse. As Mike Bendall, Qualsys Service Implementation Director noted -

“Poor organisational culture results in chaos and contradictions: confusion within roles, failure to effectively communicate, a lack of coordination, and slow decision-making, bringing employees unnecessary and frustrating complexity, stress, and conflict, and ultimately, this results in a poor customer experience.”

In this article, we invited Richard Green, Managing Director and Founder of Kingsford Consultancy Services, to share the essential building blocks of a quality culture.

Here are the 6 critical building blocks Richard Green identified for a quality culture. 


1) Systems and structures must be in place


Essential to a quality culture is having the necessary systems and structures in place to support quality improvement. Processes need to have clear performance criteria which focus on the customer. This means: 

  • a strong governance structure must exist to drive quality initiatives and to ensure the organisation is held accountable for delivering against its quality related goals, and
  • systematically identify and eliminate potential sources of error, and
  • data analysis and reporting must be both efficient and effective, and
  • performance data drives decision making and improvement activities.


2) Leaders who are quality advocates

Commitment from Leaders is a must. It is the driving force for a culture of quality. Clearly visible, engaged and unwavering Senior Management support for quality initiatives is essential. This means that Leaders at all levels of the organisation must actively support and promote quality improvement activities. 

  • Top management proactively provide the necessary resources to sustain the quality culture, and
  • are committed to quality, and
  • hold their staff accountable for engaging in quality improvement, and 
  • clearly articulate vision and values, and
  • if a Leader leaves the organisation, quality improvement goes on. 

In addition to this, the company's reward system must recognise quality improvement efforts. These incentives can favour monetary or recognition-based awards, depending on individual circumstances. 


3) Employees who are empowered 

Stakeholder Engagement toolkit

Leadership must also empower staff to embed quality improvement into their daily work. This means there is support for change and the challenge of tradition.

  • Employees must feel trusted to introduce quality improvements relating to their roles,
  • leaders must ensure all employees have the competence neccessary to fulfil the quality aspects of their roles,
  • open and honest communication at all levels. 

 This means employees are able to self-assess their own performance.


4) Customer-centric operation 

The organisation offers products and services which are customer-centric.

  • The customer needs and values are central in decision making and daily operations,
  • internally, employees percieve the organisatin as truly customer oriented,
  • externally, the organisation is viewed as being customer focused, it not only meets customer expectations but regularly exceeds them. 


5) Collaborative working is the norm

An essential building block for a culture of quality is collaborative working. The team understands why quality is important and works together to solve quality problems. This means: 

  • Teams routinely gather to brainstorm, solve problems, implement quality improvement projects and share lessons learned, and
  • cooperation exists across work groups and departments / divisions, and
  • Team work blends capable people in project teams to make improvements.



6) Continual improvement is taken as a given 

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Continual improvement is everywhere. The organisation is never content with its operational performance, it constantly strives to be better.

  • Employees routinely use quality improvement tools and methods to solve quality problems and deliver quality improvements, and
  • everything has a process focus.



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6 Food Safety Management Experts You Should Follow on Twitter

Posted by Emily Hill on Thu, Sep 01, 2016

While you can definitely learn a thing or two from food safety news, consultants and your peers, there is also lots to learn from the food safety management experts that share their knowledge online. 

From bloggers to politicians, to revered food safety publications, there are a lot of voices discussing food safety news, trends and relaying their perspectives. But with so many people you could potentially follow, how do you pick the ones that will add the most value in your Twitter stream?

While we definitely could not include all food safety specialists, we have put together a list of 6 food safety management experts you should follow on twitter. Here are several of the best food safety related Twitter accounts out there today.

marion_nestle.jpg1) Marion Nestle

Every food safety manager, whether you are new to the industry or an experienced veteran, can definitely gain expert knowledge from Nestle. The author of several books about food policy, Nestle tweets only the best posts and insights about food safety. 



V_Andriukaitis.jpg2) Vytenis Andriukaitis 

Andriukaitis has approximately 13K followers on twitter. The EU Commissioner for Health and Food Safety tweets the latest food safety news from Brussels. 



Julie_Pierce.jpeg3) Julie Pierce 

Having spent many years working at the Department for Environment, Food and Rural Affairs as Chief Information Officer, Julie is definitely one to follow on Twitter. The Director of Openness, Data and Digital at the Food Standards Agency provides regular insights and shares the latest food safety news.



4) Tina Brillinger 

Tina is an accomplished networker in food safety, having founded 'Global Food Safety Resource' and was previously Publisher of Food Safety and Quality magazine in Canada. One to know in the industry, Tina tweets the latest articles and resources from GFSR, including blogs about food safety, food management standards, food risk and food science.



5) Matthew Regusci mattregusci.jpg

Regusci specialises in supply chain food safety and compliance from farm to fork. Matthew tweets about the latest issues in the food industry and shares articles from his blog. 



6) Doug PowellDoug_powell.jpg

Former professor of Food Safety, Doug Powell, uses twitter to broadcast the latest articles from his blog. Barfblog offers evidence-based opinions on current food safety issues. 



Don't forget to follow Qualsys on twitter! @QualsysEQMS for the latest news, views and resources to optimise your food safety management system. 


Supplier management


Tags: Food Safety Management

ISO 9001:2015 - 3 Tips for Choosing KPIs

Posted by Emily Hill on Wed, Aug 24, 2016

ISO 9001:2015 requires you to determine, monitor and measure output. However, ISO 9001:2015 does not prescribe specific key performance indicators (KPIs) you must track. Neither does it prescribe how you should monitor or measure your quality management system, when to monitor or measure your quality management system, or how and when you should analyse and evaluate your key performance indicator data.

All of these decisions must be made by the organisation. Richard_Green-KPI for ISO 9001

So how do can you choose what KPIs to monitor? And how often should you track them? 

In this article, quality guru Richard Green, founder and MD of Kingsford Consultancy Services gives you three tips to choosing your key performance indicators. Kingsford_Consultancy_Services.png

1. Base Your KPIs on Your Quality Objectives  

goal_setting-1.jpgYour quality objectives should be SMART, e.g. Specific, Measurable, Achievable, Realistic and Time-bound. Clause 9.1.3 'Analysis and Evaluation' requires the organisation to analyse and evaluate appropriate data and information that it has obtained either externally or internally for a variety of pre-defined purposed (e.g. linking back to your quality objectives).

It requires you to analyse data and information to evaluate: 

So, as a minimum, you should construct your quality management system key performance indicators which evidence the above.


2. You can choose both qualitative or quantitative Key Performance Indicators

Net-Promoter-Score-Formula.jpgCalculate NPS

A principal change in ISO 9001:2015 is that you must determine the degree (i.e. how much) the customer perceives their needs and expectations have been met. So, how can you obtain and use customer satisfaction information? 

You can measure whether customer expectations have been met both quantitatively or qualitatively, for example:

  • Net Promoter Score (NPS) 
  • Satisfaction Benchmark Survey
  • Revenue driven by existing customers or customer retention analysis


  • Feedback forms 
  • Issue analysis / audit results 
  • Workshops with customers

Furthermore, clause 6.2 requires organisations to set quality objectives for relevant functions, levels and processes within its quality management system, so it may be that you use different types of feedback for different areas of your organisation. 


3. Focus on trends over time 


ISO 9001:2008 required evaluation of trends in data or information relating to products and processes. ISO 9001:2015 extends this and explicitly requires top management to consider trends at management reviews. 

This means it is necessary to examine performance through time, not just a single point in time. Although the frequency will depend on the context of the organisation, for example, a consultancy firm will require a different number of KPI reviews than a medical device manufacturer, a system such as EQMS which gathers data from across your organisation and notifies relevant parties when there is something outstanding can help provide a robust, systematic and agile system. 

So, when determining how often you will review your outputs it is necessary to consider what is reasonable for the context of the organisation.

Successfully transitioning to ISO 9001:2015 requires robust, agile and flexible systems. EQMS software consolidates and integrates all of your quality management system initiatives across your organisation in a single solution. 

Learn more about EQMS. 

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Tags: ISO 9001:2015

Busted! 5 ISO 9001:2015 Myths

Posted by Emily Hill on Thu, Aug 18, 2016

Even though the changes to ISO 9001:2015 have been welcomed by many quality professionals and leadership teams across the globe, there are still some companies that are shackled with misconceptions about what the chanRichard_Green-2.pngges mean and how they must go about updating their quality management systems to meet the new requirements. 

We recently invited quality guru, Richard Green, founder and MD of Kingsford Consultancy Services and former Head of Technical Services at the Chartered Quality Institute, to bust the myths about ISO 9001:2015.

Here are 5 myths Richard Green shared with us! 

1) 'You must get rid of your management representative' 

While the requirement for a management representative has now been removed, it does not mean you need to get rid of them. Although they can no longer be the 'sole focus' for your quality management system, their role will change so that they:

  • mentor and coach top management,
  • help others understand their management system duties and obligations,
  • take on the role of 'facilitators', rather than 'doing' themselves. 


2) 'You cannot have a quality manual or documented procedures'

The ISO 9001:2008 required organisations to have a quality manual. In the revised standard, this has now been removed, as well as six other mandatory procedures. 

If your current manual and documented procedures work for you, you do not need to get rid of them and you should develop them to address the new requirements of the ISO 9001:2015 standard.  

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3) 'You must rename your quality management system documentation to reflect 2015 clause references'

You do not need to rename or renumber your quality management system to reflect the ISO 9001:2015 clause references.

It is your quality management system and you can reference it anyway that it suits you. For example, if you want to reference 'context' as 'our external and internal operating environment', it is not an issue and your auditor will be able to link it back to the standard. 


4) 'You must restructure your management system to follow the sequence of requirments set out in the standard'

Providing all of the requirements of the Standard are met, you can address them in any order you wish. However, be aware that standard writers give a lot of thought to the structure of the standards to give it a logical order. 

  Supplier management

5) 'You must update your management system terminology to reflect that of the 2015 standard'

There are many changes in terminology in the new standard, for example:

  • Suppliers -- External Providers
  • Work Environment -- Environment for the operation of processes
  • Documents, records -- Documented information
  • Monitoring & Measuring equipment -- M&M resource
  • Products -- Products and services
  • Human resources -- People

However, this does not mean that you need to change all of them in your quality management system. 

For videos of Richard Green discussing ISO 9001:2015 in more detail and for a chance to earn CPD points, please download our toolkit. 

ISO 9001:2015 Toolkit


Tags: ISO 9001:2015

5 Quality Key Performance Indicators You Should be Tracking

Posted by Emily Hill on Thu, Aug 18, 2016

As a quality professional, you must be the eyes and ears of senior management. But with so much data available at your fingertips, it can be difficult to decide what you should report on. 

When you are choosing which Key Performance Indicators (KPIs) to track, we believe it is always much more valuable to focus on the critical few, rather than the trivial many. But what are they? And what do they tell you about business performance? 

In this article, we have put together 5 essential KPIs you should be tracking and what they tell you about the health of your quality management system.

If we have missed any out which you believe are important, please let us know by leaving a comment at the bottom of this article. 

1) Documents: Notification response rate

All of your organisations' documented procedures for identifying, collecting, storing, maintaining and amending quality and technical records are essential for keeping a healthy quality management system. But how do you know whether these procedures and records are being followed by all employees? 


An essential KPI is whether employees have acknowledged document changes. 

In EQMS Document Manager, documents can be sent out to be acknowledged by different groups or individuals. Employees recieve notifications and must log in, read the updated documents and acknowledge that they understand the updated procedures.

The response rate to these notifications is then displayed on the EQMS Dashboard. From the Dashboard, you can then see a list of everyone who has not acknowledged the document. You can then give this list to your leadership team or follow up yourself. 


2) Audits: Findings closure performance 

During the EQMS Audit and Inspection Manager webinar, 58% of the quality professionals said that their main auditing challenge was following up recommendations and actions. So how can you make sure that issues identified in audits are actually being addressed? 








Another KPI which should be tracked is whether audit findings have been cleared or if they are still outstanding. 

In EQMS Audit and Inspection Manager, when an issue is found in an audit, a workflow is triggered and notifications are sent to the appropriate individuals. Employees then receive information about what they need to do and a target date. On the EQMS Dashboard, you can then see how many audit findings have been cleared, how many are still outstanding and whether they were actioned on time or not. 

If there are actions overdue, the list of who is not performing can be accessed from the dashboard and sent to the relevant people to ensure it gets actioned. 


3) Training: Overdue training requirements

Ensuring health and safety, product and quality training is up-to-date is essential for many regulatory requirements. Training days can be missed, re-scheduled or cancelled for a number of reasons. So how do measure if all employee training is current? 

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You should be able to track whether there is any overdue training. 

In EQMS Training Records Manager, the system keeps a record of all new, overdue and completed training, as well as those which have never been scheduled or were scheduled but then completed late. Employees receive a notification about upcoming training, then must give their feedback about the training. This is key for management to understand the status of training activity. 


4) Risk: Overdue risk assessments

Regulators are increasingly requiring Leadership to demonstrate that they are managing risk. There often needs to be documentation on risk appetite, how risk is being managed and the actions from risk assessments. So how can you demonstrate that risk is being effectively managed? 



One key risk indicator is the number of overdue risk assessments. If there are lots which should have been completed, but haven't been, it exposes the organisation to more risk. 

EQMS Risk Manager enables you to assess, address, analyse and assign responsibility for risks. All the data for approved, assessed, submitted, overdue and risks under assessment can be viewed from the EQMS Dashboard. This enables the leadership team to instantly view whether they are at risk or if risk is being managed appropriately throughout all levels of the organisation. 


5) Issues: Overdue issues

Raising and closing issues is important, but what about the time it takes to actually close the issues? If a customer is waiting longer than your procedures say they should be, then quality is failing. 


It is important to track the number of overdue issues. In EQMS Issue Manager, when an issue is logged, a deadline is set to say when it needs to be dealt with. All the data about the issue status is then aggregated into the EQMS Dashboard to demonstrate whether it is raised, closed, approved, on hold or under review. 

This KPI gives management a key indication into whether employees need better training in managing issues. 


For more information about managing KPIs in EQMS, please download the datasheets from our the EQMS Datasheet Library

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