Governance, Risk and Compliance Blog

Brexit Boom: Quality Professionals Across the World Take Advantage of Falling British Sterling

Posted by Emily Hill on Mon, Nov 28, 2016

Qualsys Ltd reports a record breaking quarter as falling UK exchange rates sees international demand soar, following Britain's vote to leave the European Union. 

 

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Enterprise quality management software (EQMS) provider, Qualsys Ltd, already had a portfolio of clients based in Europe, America and Australia, but since the June 23rd referendum the company has reported a dramatic rise in the number of international businesses investing in the solution, believed to be due to a falling exchange rate. 

Michael Ord, New Business Director at Qualsys Ltd, comments: 'Since the decision to leave the European Union, we've noticed a 30% year-on-year increase in the number of new business enquiries from overseas as quality professionals are finding that the software is now around 20-25% cheaper than the same period the previous year.

A falling exchange rate has also given many of our international customers a golden opportunity to extend their contracts with us. Clients who have used our EQMS Document Manager module for years, now want the full-suite of EQMS modules. Many of our long-term customers are now using EQMS for everything from managing risk and suppliers to auditing and training records.

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Great time to invest in Enterprise Quality Management Systems

Qualsys Ltd also reports a leap in enquiries from businesses in the United Kingdom.

'Leaving the European Union is an unavoidable risk for many organisations. There is a lot of uncertainty about what 'Brexit' means, but what we do know is that there will be a number of changes to regulations and legislation. Managing this change without appropriate systems in place is an expensive process and can leave the organisation exposed to risk,' adds Ord, 'Business leaders want future-proof systems such as EQMS because it helps reduce compliance burden, improves accountability and ensures the right message is communicated to the right person at the right time.' 

For more information about EQMS, please download datasheets or read how EQMS helps manage multiple management systems and international standards.

 

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ISO 13485 Overview

Posted by Emily Hill on Fri, Nov 25, 2016

The UK has one of the largest medical device markets in the world, and it is forecast to grow by a culumative 16% by 2020.* Demand for medical devices is largely driven by innovation and an aging population. For organisations wishing to enter the market, one of the main challenges is navigating a complex regulatory landscape.

ISO 13485 is the world's most popular medical device quality management system which harmonises many international regulatory requirements to ensure products and services are fit for purpose. 

The below article gives those who are new to the Standard and medical device industry an overview of ISO 13485 which can be read in under 5 minutes. 

 

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What is a medical device?

A medical device is anything related to healthcare that does not have a pharmaceutical action (i.e. it is not absorbed into the body or based on pharmacology / chemistry) as it's primary mechanism. Medical devices range from simple tongue depressors and bedpans to complex pragrammable pacemakes with microchip technology and laser surgical devices. 

The FDA defines a medical device as:

 "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Examples:

  • Delivery of medicines: syringes, tubing, inhaler
  • Patient monitoring: software
  • Repairing or replacing: stends, joint replacements
  • Diagnostic equipment: ECG, x-ray
  • Equipment with power sources: hearing aid, pacemakers

 


medical device manufacturerDySIS Medical: Innovative Medical Device Manufacturer 


 

Who needs ISO 13485? 

A quality management system is a set of policies, processes and procedures that help an organisation to meet the requirements of their stakeholders, based on the plan-do-check-act cycle.

In some countries, like Canada and in the European Union, it is a legal requirement to have the a quality management system if you: 

  • Design or manufacture medical devices. 
  • Supply raw materials or provide services related to medical devices, e.g. sterilization, installation, labeling, technical publication. 

ISO 13485, although not a legal requirement, demonstrates an effective quality management system. 

In contrast, however, to ISO / TS 16949, an organisation does not need to be actively manufacturing medical devices or their components to seek certification to this standard. This means it can be a strategic decision to get the standard if a company has the capability of manufacturing components for medical devices or providing services to medical devices companies. 

 


 

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York Instruments: Evolving brain scanning technology using EQMS 

 


 

Why get ISO 13485?

ISO 13485 is a voluntary standard, but it satisfies most European Union quality management system requirements and demonstrates compliance to medical device directives. As well as harmonising regulatory requirements, there are many other benefits of being certified to ISO 13485, here are 8 of them: 

  1. Increase customer confidence - ISO 13485 demonstrates an organisation's commitment to quality. 

  2. Meet customer expectations - ISO 13485 requires organisations to assess their ability to consistently provide medical device products and services that meet customer requriements and comply with all relevant regulatory requirements. 
  3. Promotes better communication - ISO 13485 sets out the requirements for establishing communications processes and encourages communication about the effectiveness of the quality management system.  

  4. Increase efficiency - ISO 13485 requires organisations to demonstrate robust processes which means they can benefit from reduced wastage and a better ability to monitor their supply chain.   
  5. Improves supplier relationships - ISO 13485 requires organisations to establish supplier evaluation, selection and monitoring processes.  

  6. Increases speed to market - The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for a quality management system. ISO 13485 is recognised globally which means companies who are certified get access more markets worldwide

  7. Demonstrate that you provide safer medical devices - ISO 13485 follows the process approach, whcih treats the quality management system as a set of interrelated processes. Any changes need to be controlled and documented. 
  8. Enhances brand equity - Increased credibility ultimately leads to increased brand equity. This also means there are enhanced marketing and promotional opportunities. 

     


  

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Inivata, medical device manufacturer who uses EQMS 


 

Want more information about ISO 13485:2016? Sign up for the Newsletter here.

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* http://www.espicom.com/uk-medical-device-market.html 

 

Tags: ISO 13485

ISO 9001:2015: 5 Challenges for Internal Auditors - Friday Feature

Posted by Emily Hill on Fri, Nov 18, 2016

Back in July 2014, prior to the release of ISO 9001:2015, Richard Green, former head of IRCA Technical Services, stated he believed that the changes to ISO 9001:2015 meant there would be a transition in the auditor's role from 'auditor' to 'assessor'. Green highlighted that auditors will increasingly need to deal with 'shades of grey; and 'new evidence sources will need to be examined.' Read more on this: ISO 9001:2015 Next Generation Auditing Whitepaper

Two years down the road, ISO 9001:2015 has been released and many organisations have transitioned to ISO 9001:2015. But how have auditors coped with the new changes? Have the changes been logical? And what are the challenges internal auditors are now facing? 

We asked Richard Green to share 5 of the main challenges internal auditors now must face. We've cut up the interview so you can watch all 5 videos in under 10 minutes. 

Changing role of the auditor: 

#1 A Box-Ticking Exercise

Moving from procedure based auditing to process based auditing requires a more informed and analytical process. Colin Partington, a Quality Management Consultant and ISO 9001 expert said in 'Next Generation Auditing' this will drive a cultural shift from procedure auditing where 'findings are discovered, corrective actions and made, and ultimately, boxes are ticked, to a more analytical approach which focuses on process auditing.'

So, is there still a perception that ISO 9001 is a box-ticking exercise? Richard Green shares his thoughts: 

 

 
 
 
 
 
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To summarise: 

  • ISO 9001 makes top management responsible and accountable for carrying out a certain number of activities themselves.
  • Clause 5.1.1. gives you a list of top management activities that they need to be involved with. Some of those they can delegate, but there are some of them that they can not delegate.
  • This is all designed to bring people at the highest levels into the quality management system. No longer can it centre around the quality management representative.
  • Leadership must promote a process approach and they need to understand how all processes fit together.
  • There are also requirements around risk.
  • Leadership now need to make decisions around whether the system is effective. And if the system is not being effective, they must act to make sure that the quality management system is effective.
  • It has come as quite a shock for some organisations but the changes are logical.
"In those organisations which were properly embracing quality,I think you find that the leaders were already meeting the new ISO 9001:2015 standard, because it was previously implied that they should be doing it. It was not explicit, but it was very much implied."

 

 

#2 Moving from Procedure to Process Based Auditing

Clause 4.4 and 6.6 in ISO 9001:2015 states that auditors need to look at the processes of the organisation and check that the organisation is monitoring, measuring and evaluating them to determine how effective they are in helping the organisation to achieve the desired outcomes. This requires process based auditing.

In 'Next Generation Auditing', Colin Partington, Quality Management Consultant and ISO 9001 expert says: 

“Process based auditing is more about following through a trail by taking a job from start to finish and reporting what is seen as it passes through the various departments. By taking this approach, a number of clauses can be covered in one audit.”

So how are auditors coping with the new challenges? Richard Green explains in this video: 

 

 
 
 
 
 
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To summarise:

  • Things are now less clear cut than they used to be.
  • Context is amorphous - your perception of context is different from the auditor’s interpretation.
  • There needs to be a discussion between the auditor and the commonality of view. I think the challenge for auditors, especially checklist auditors, is that now there is quite a lot of things which are grey.
  • It used to be black and white, but this has disappeared. That is where the assessor comes in.
  • There now needs to be judgment calls based on objective evidence that they see." 

 

#3 Leadership Buy-in

ISO 9001:2015 requires senior management to take accountability for the effectiveness of the quality management system. As stipulated in ISO 9001:2015 5.1.1 Leadership and Commitment for the Quality Management System, 'Top management shall demonstrate leadership and commitment with respect to the quality management system.'

This means that top management must ensure the quality management system is effective and that it delivers real business improvement.

But are auditors getting the buy-in they need from top management? And are top management listening to their internal auditors as much as they should be?

Richard Green explains in this video: 

 
 
 
 
 
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To summarise: 

  • Internal auditors are the most valuable auditors out there.
  • It is not your external auditor who perhaps comes in once or twice a year who has a look at your business. Internal auditors understand the business, the standard processes, they know where the weaknesses are.
  • Too often you see internal auditing is a secondary part of the role.
  • The organisation and top management need to recognise the real worth that lies in their internal auditors and they need to nurture, develop and make use of their insight.  
  • These are the people who are completely familiar with the business management system and can significantly impact the bottom line, if you listen to what they are saying.
  • It is a continuous feedback loop." 

 

#4 Challenging top management 

In 'Next Generation Auditing', Richard Green said:

"Going forward, assessors are going to need to be able to speak the language of the Boardroom. They will need to engage with top management regarding strategy and context, not minor operational matters. They will need to feel comfortable challenging individuals at this level." 

But are auditors comfortable challenging top management? What about when they have to deliver bad news? Richard Green shares his thoughts:

 

 
 
 
 
 
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To summarise: 

  • Auditors have always had to deliver bad news.
  • It is more challenging when bad news is not directed at quality managers and it is being directed to those at the helm of the business.
  • Of course, culturally, in certain parts of the world, the very notion of challenging what top management do is completely alien.
  • It's going be difficult and take a while for auditors to find their feet.
  • In terms of how we go about doing that, for instance in the whole issue around reporting. The skills that we see set out in ISO 9011, in terms of the approach of auditing, diplomacy and tact are all coming into the forefront now. 

  

#5 Training to meet new requirements 

Colin Partington, Quality Management Consultant, said in 'Next Generation Auditing'

"Many auditors come to me overwhelmed with increasing commercial pressures and time constraints. Such issues can result in constrained or irrelevant information being delivered to senior management.

To rectify this, as stated in ISO 9001:2015 4.1, Understanding the Organisation and its Context, the auditor must understand what the organisation does and what influences there are upon the organisation. How the auditor will establish these factors needs to be considered, almost certainly needing the top management to be interviewed to discover these." 

This requires a whole new skill set. So are auditors getting the training they require to meet the new requirements? Richard Green shares his thoughts: 

 

 
 
 
 
 
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To summarise: 

  • When we saw the new version of ISO 9001:2015, the requirements were significantly different for auditors in terms of their skills set.  
  • CQI's transition courses now actually lasts two days.
  • 85% of this course focuses on skills and behaviours. 
  • Auditors need to be able to interpret all the diverse evidence sources, which are going to require upskills and its raising the bar. 

 

Want more information about ISO 9001:2015? Download the toolkit. 

ISO 9001:2015 Toolkit

Tags: ISO 9001:2015, Quality Culture

Why You Should Migrate Your Documents from Lotus Notes to EQMS - 3 Reasons

Posted by Emily Hill on Thu, Nov 17, 2016

It used to be commonplace for IT teams to own the document management system. They would use a system like Lotus Notes by IBM, and then manage all configurations either internally or contract the work to external parties. 

But before long, the cracks started to show, and many quality professionals have recognised a growing gap between the functionality of their system and the requirements of their organisation. 

Accolade Wines, Honeywell and Yazaki are but a few organisations who have recognised the benefits of migrating their documentation from Lotus Notes to EQMS Document Manager, a highly configurable, off-the-shelf solution which enables you to track, search, retrieve, route, review, approve and annotate documents and technical drawings. 

Why are so many organisations migrating their documentation to EQMS? We've put together 3 of the main reasons below. 

 alternative to lotus notes for documentation

 

 

1. We are compliance experts

A large majority of IT professionals do not have a background in compliance. This means that when your IT team configures a system like Lotus Notes, there is often a gap between the functionality of the system and your organisation's real compliance requirements. And unfortunately, it is often too-little too-late when an issue with the system is detected.

With EQMS, advanced compliance is built-in to the system: 

  • Document Audit trail: Full version control - retain each superseded document and also find out who, when and what was changed in a document. 
  • Flexible Workflow: Drive review and approval processes with system messaging which integrates with your email system.
  • Works with Everything: Flexible API and web services integrate EQMS with your ERP, HR and or Financial Systems. 
You will also be assigned an experienced Service Implementation Manager who will configure your EQMS to meet your regulatory requirements. 

 

2. We will help you Spring Clean

EQMS Document Manager

Does the thought of migrating your online and offline documentation give you a headache? You are not alone. Many organisations have hundreds and even thousands of important documents in their Lotus Notes system which are duplicated, out-dated or siloed. Unfortunately, ignoring the issue will not make it go away. 

Now imagine this - the lifecycle of every critical document is managed systematically. Even better, it has all been done for you by an expert. 

Over the past 20+ years, our services team have migrated thousands of documents from Lotus Notes, SharePoint and desktops to EQMS Document Manager. They get under the skin of your processes and will support you as little or as much as you need to ensure your document management system is future-proof.  

Following a best-practice approach, the services team at Qualsys will: 

  • Audit your Documentation Requirements: They will help you to prepare a document audit plan, conduct feasibility and scoping exercises and review your processes. 
  • Configure the System: The services team will help you to ensure the terminology in your document management system suits your organisation's requirements. 
  • Migrate all documentation: By extracting documentation from your legacy systems and uploading them to your EQMS, your system will be ready for you and your organisation. 

For more information about our document migration processes, download EQMS Document Manager Datasheet here. 

 

3. We are always investing

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Businesses have an increasing number of requirements from their document management system. However, many IT teams do not have the resources to keep the system up to date. 

EQMS is continually being enhanced. New features, resources and training guides are being produced to ensure our customers maximise their use of the system. 

Customers can even request changes to EQMS in a number of ways, including: 

  • Account Managers: Every customer has a dedicated Account Manager who is available to help you maximise your use of EQMS. They will put forward your change requests and build it into the EQMS roadmap. 
  • Events: Qualsys hosts regular Development Forums and User Groups which gives you the opportunity to hear from other EQMS customers, the development team and the Directors at Qualsys. 
  • Annual Health Check: Every customer also has an Annual Health Check, which is where we audit your use of EQMS and help you to find more ways to optimise your document management system. 

See the latest developments in our Software

 

Ready to see how EQMS Document Manager can work for you? 

If you are one of the many quality professionals who has found that Lotus Notes is no longer working to control your documentation, EQMS Document Manager could be the perfect solution. 

To learn more, talk to one of our technical experts here. 

See EQMS in action - free software trial

Tags: Document Control Procedures

Cross-Functional Teams - Jaguar Land Rover Shares Advice

Posted by Emily Hill on Wed, Nov 16, 2016

Many businesses have realised how cross-functional teams can dramatically improve the products and services they provide. It makes the most of different perspectives and backgrounds to reduce product defects, improve efficiency and meet customer needs. 

However, there are two fundamental challenges managing govenance, risk and compliance of cross-functional teams. Firstly, how with an increasingly remote workforce to get the right information to the right person at the right time, and second, how to manage the integrity of the data?

In a talk at The Manufacturer's Annual Leaders Conference, James Dyson, Finance Manager at Jaguar Land Rover discussed some of the challenges cross-functional teams have making decisions. Like many organisations, Jaguar Land Rover has an abundance of data coming in from all areas of the business and faces familiar challenges of turning this into useful information.

In this article, we have summarised 3 key points from Dyson's talk for helping cross functional teams make complex decisions. 

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#1 Elimate Manual Processes 

Costly to maintain, slow to escalate issues and prone to error, Dyson advises that where possible, there are many issues with using spreadsheets to make complex decisions.  

''Teams need to spend less time crunching data and more time acting on the key information. By eliminating spreadsheets, you will open up a new level of insight, be able to make faster decisions and everyone will be better informed."

Spreadsheets can put the organisation at risk. They silo information, often contain outdated data and it is difficult to verify the integrity of the data being used. 

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#2 Single Source of Truth

Cross-functional teams are often making very complex decisions based on a vast amount of data. But data systems have become more complex, fragmented, and chaotic, putting data integrity at risk. 

"You need a single source of truth which enables you to extract valuable information while the data is still in motion."

The 'Single source of truth' will ensure that important decisions are made based on authentic and reliable information. 

Managing authentic and reliable information 

 

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#3 Use Simple KPI Dashboards

Not everyone in the team needs to be able to access all data, but teams need to be able to able to easily drill down to the information they require. 

"Use simple KPI Dashboards. You do not want to throw all the data at everyone."

Organisations must ensure teams can not only access information, but understand the role they need to play. 

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Automote, Control and Assign Responsibility with EQMS

Cross-functional teams benefit from using software such as EQMS, a cloud-based, modular governance, risk and compliance management solution. The software provides a robust framework for managing data integrity, risk and compliance:

  • Highly configurable workflow ensures no issue is overlooked. 
  • Information is controlled. 
  • Every activity has a full audit trail with a time, date and person responsible. 

Here for more information about using EQMS. 

See EQMS in action - free software trial

Tags: ISO 9001:2015

Standards and Small Businesses - Friday Feature

Posted by Emily Hill on Fri, Nov 11, 2016

There is a perception that small businesses consider the implementation of ISO 9001 as daunting and expensive. The implementation of a management system suggests there is a requirement for a whole new system - new documentation, detailed processes, forms and records. But is this true? 

For this week's Friday Feature, we asked Richard Green, Managing Director of Kingsford Consulting Services Ltd if he believes the changes to ISO means presents barriers for small businesses. 

 

 
 
 
 
 
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Video Transcription: 

Are the changes to the ISO standards making it easier for small businesses? 

"One of the intentions in writing the standards was around making it easier for small businesses to apply the standard.

There was a perception that you needed a lot of documentation and a tremendous amount of bureaucracy. That was never actually the case. 

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I think what the new standard does in terms of its wording is that it helps organisations to realise that is no longer the case. If you want to do things in a lot of detail, that is fine. If you want to do things at a lighter level, that is also fine. As long as you meet all of the requirements for the standard.

There is less emphasis placed on how to meet the requirements. Instead, it says what you need to do. IT is a lot less prescriptive in saying how you have to do it." 

What are your thoughts? Was implementing standards expensive or did the benefits outweigh the costs? Leave a comment below. 

If you are implementing a new management system, EQMS supports sustainable processes. Calculate the ROI and recieve your own Business Case Calculator here. 

Business case for EQMS Tool

 

Tags: ISO 9001:2015

Should I Audit Our Extended Supply Chain?

Posted by Emily Hill on Fri, Nov 04, 2016

In this week's Friday Feature, we ask Richard Green, Managing Director of Kingsway Consultancy Services whether companies should carry out audits on the extended supply chain. 

 

 

 

 

 

Video Transcription: 

Should companies be carrying out audits on their extended supply chains? 

"My preference is always to conduct second party audits ourselves, certainly for business critical materials for suppliers. I would always make the time to go and visit the supplier and assess not just the product and the service, but also the management system that is delivering that. 

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I would make sure that the management system is resilient and that it is operating how I would want it to operate. I don't think that anything has happened recently to remove that requirement. 

I would still stress for business critical requirements that there is no substitute for going out to your supplier and having a proper look at how operations are being managed and how the products or services you are buying is being developed." 

Supplier management

 

 

Tags: Supply Chain Management

Role of the Quality Professional - Friday Feature

Posted by Emily Hill on Fri, Oct 28, 2016

Today's quality professional faces a bevy of challenges, from improving business systems, ensuring the organisation is adhering to the latest regulations and maintaining a customer-centric view of the organisation. But how will the role of the quality professional change in the future? 

For this week's Friday Feature, we asked quality guru Richard Green, founder of Kingsford Consulting Services his thoughts on how the role of the quality professional should change over the next five years. 

 

 

 

Video Transcription: 

How do you see the role of the quality professionals changing over the next five years?

"Hopefully the quality professional will become invisible. Invisible as a separate entitiy.

I would like to see quality managers actually becoming business managers and business directors, so that quality is not seen as a separate function. Going back to the culture of quality - it needs to be just the 'way things are done around here'. Quality is how we get the job done. 

I would like to see the quality professional becoming more of a generalist, where they will have an understanding of how companies work and be able to advise how businesses can get results.  

They will still need to understand and interpret the different quality terms and techniques. But I think quality professionals will become much more engaged in terms of the running of the business, rather than being seen as a separate entity that we talk to ocassionally if we have a problem or if we are trying to make some changes." 

 

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Do you think 'quality' has a branding problem?

"Yes. Massively. There is even an argument that we should drop the word quality. I think there are all sorts of connotations with it because it is a distinctive label and it sets quality aside as a separate function. And it really should not be. 

It should be about ensuring good governance, providing assurance and driving improvement."

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I've seen more and more people getting the job title 'Operational Excellence Manager' because they are trying to close the gap. I think it will also do a good job attracting graduates aswell.

"Absolutely. I have been lucky. I have had a wonderful career in the quality environment, and I think one of the great things that a career in quality gives you is a remit to really look at organisations and how they work, what works and what doesn't work.

Apart from top management, you are really the only people who get a helicopter view of what is going on in the business. It is incredibly rewarding to have that role and to be able to identify new opportunities for the business." 

 

For more articles, information and advice, download the ISO 9001 toolkit. 

ISO 9001:2015 Toolkit

 

Yazaki Europe Ltd opts for EQMS

Posted by Emily Hill on Mon, Oct 24, 2016

International automotive parts manufacturer, Yazaki Europe Ltd, is in the process of implementing a range of EQMS modules to improve overall business efficiency. EQMS will assist the manufacturer to optimise processes by providing rapid response to business issues and automating time-heavy administrative activities.

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Yazaki was founded in 1929 by Sadami Yazaki and now employs almost 300,000 people worldwide in 45 countries across over 400 locations. The world's largest producer of wiring harnesses also supplies terminals, connectors and other electronic components for automotive vehicles.

In a move to continuously improve all processes, Yazaki Europe Ltd recognised an opportunity to implement a new electronic quality management system which could manage their complex audit requirements. After a competitive tendering process, Yazaki Europe Ltd selected Qualsys Ltd.

A full suite of EQMS modules are now being configured to meet Yazaki Europe Ltd's unique quality requirements. The solution will be used to cut out time-heavy administrative activities and ensure internal and supplier audits are managed in a closed-loop.

 

About EQMS 

Robust Audit Scheduling   

EQMS Audit and Inspection Manager provides end-to-end functionality for managing the complete audit lifecycle. Authorised users are able to:

  • Plan and schedule audits. 
  • Develop standard audit plans and checklists. 
  • Control data field collection and built-in remediation workflows. 

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360-Degree Visibility into Performance

iEQMS, a permission controlled mobile auditing application, provides critical functionality for a multi-location workforce. Within the application, auditors are able to: 

  • Raise findings and actions.
  • Attach sound, video or documentation as evidence.
  • Work offline, as the application automatically re-synchronises once WiFi connectivity is restored.

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100% Accountable

Any issues, completed and overdue actions can then be viewed through the EQMS Dashboard. The dashboard has a 1-click drill down functionality, enabling rapid response to business issues. Actions can even be directed at Supplier staff without giving them access to other records in the system. EQMS features: 

  • Built-in remediation workflows.
  • Time tracking.
  • Email based notifications and alerts.

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Want end-to-end functionality for managing your complete audit lifecycle with easy status tracking?

Request a demonstration: 

See EQMS in action - free software trial

 

 

Tags: Audit Management Software, New Customers, ISO/TS 16949

ISO 9001:2015 Analysing the Context of the Organisation - Friday Feature

Posted by Emily Hill on Fri, Oct 21, 2016

A new clause has been introduced to ISO 9001:2015 relating to the Context of the Organisation. But what does this actually mean? And how can you properly analyse the Context of the Organisation? 

For this week's Friday Feature, we asked Richard Green, Founder and MD of Kingsford Consultancy Services to share more insights into the new requirements for Context of the Organisation. 

 
 
 
 
 
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Video Transcription: 

What is the best way to analyse Context of the Organisation? 

"Context of the Organisation is one of the new clauses in the Standard.

What the standard writers wanted to do was ensure there is an appreciation of how events outside the organisation impact the quality management system - as well as what is going on internally. 

There are two essential elements in respect to Context of the Organisation: 

1) Issues: Understanding the issues that an organisation faces, both internally and externally e.g. threats, weaknesses, opportunities and strengths. 

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Image: Porters 5 Forces

 

To be honest, if your organisation is still trading, you have probably have already got a pretty good idea about what the issues are anyway, so you will not need to start from scratch.

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Image:SWOT Matrix Example

 

2) Stakeholders: Relevant interests of relevant interested parties

In terms of the relevant interests of relevant interested parties - again, organisations will understand who their stakeholders are. If they are still in business, they will have satisfied the requirements of their stakeholders to a large degree anyway. 

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Image Stakeholder Management Matrix Example

The thing about Context of the Organisation is to not get too hung up on it.

 A lot of the requirements for Context of the Organisation involves documenting what you know already. You are the person who is responsible for saying this is the Context of the Organisation. The auditor can challenge it, but they can only challenge it if they have evidence that your measure of context is incorrect, e.g. you have not identified a stakeholder and this has led to a problem, or you have missed an issue that has caused a problem."

 

Find an in-depth step-by-step guide to Context of the Organisation by downloading the ISO 9001:2015 Toolkit. 

ISO 9001:2015 Toolkit

Tags: ISO 9001:2015