Governance, Risk and Compliance Blog

How EQMS helps you manage ISO 9001:2015 (Clause-by-Clause)

Posted by Emily Hill on Fri, Feb 24, 2017

Every day we get quality professionals asking us how they can use EQMS to meet the requirements of ISO 9001, ISO 14001, and other management system standards. 

Below we have broken down many of the main requirements for ISO 9001 and provided a small example of how EQMS will help manage each of these requirements. 

Please use the below guide to get a taster of how EQMS can help you to manage your ISO 9001:2015 requirements. In no way is this an exhaustive list of all the ISO 9001 requirements, nor does it share all of the functionality of EQMS, but it should help you visualise how quality management software can help you achieve ISO 9001:2015 compliance.

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Clause  Requirements  Example how EQMS helps 
4. Context of the organisation     
4.1 Understanding the context of the organisation Identify, monitor, and review external and internal issues that are relevant to its purpose and strategic direction. 

Issues and risks relevant to the strategic direction of the organisation can be identified, monitored, and reviewed in EQMS to help understand the Context of the Organisation.

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Image: Example risks in EQMS

4.2 Understanding the needs and expectations of interested parties The organisation is required to determine the relevant requirements of relevant interested parties. It must then monitor and review the information about these parties and their requirements. 

The relevant requirements of interested parties can be monitored and reviewed in EQMS. For example, EQMS Training Records Manager can be used to assess training requirements and any gaps in performance. 

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Image: Example training matrix in EQMS

4.3 Determine the scope of the quality management system The scope of the quality management system must be made available and maintained as documented information. 

The scope of the quality management system can be stored in EQMS and communicated to the whole organisation and versions are easily controlled. All changes can be viewed using the audit trail. 

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Image: Example Document Navigator Tree in EQMS

4.4 Quality Management System and its processes 

The organisation must establish a process-based quality management system.

Once in place, the QMS needs to be maintained and continually improved.  

 

EQMS ensures all processes can be managed, monitored, and evaluated - at the click of a button. 

Learn more about a process-based quality management system here. 

Performance-related indicators are viewed either through the EQMS KPI Dashboard or via customised reports.

5. Leadership    
5.1 Leadership and commitment 

Leadership must ensure that their quality policy and objectives are consistent with the strategic direction of the organisation. 

Leadership must promote awareness and adoption of the process approach and risk based thinking. 

 

EQMS ensures leadership are able to easily have a "hands on" approach.

Learn how Sodexo's Leadership communicates policies with EQMS here. 

The EQMS Dashboard ensures there is one single source of truth for all activity across the organisation, enabling the leadership team to get more visibility, promote awareness and know how the business is performing. 

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Image: Example KPI Dashboard in EQMS

5.2 Policy Top management must establish a quality policy that is appropriate to the purpose and strategic direction of the organisation.

EQMS makes it easy for top management to implement and systematically maintain the quality policy and ensure it is applied throughout the organisation. For example, EQMS Document Manager ensures all employees have read and acknowledged required documents.  

acknowledge and password.pngImage: Example document acknowledge in EQMS

5.3 Organisational roles, responsibilities and authorities  Top management needs to ensure assignment of the necessary responsibilities and authorities to the organisational roles within the organisation to carry out quality-related objectives. 

EQMS has customisable workflows built into the framework to ensure that necessary responsibility and authorities are completed within required timeframes. 

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Image: Example workflow

 

6. Planning

   
6.1 Actions to address risks and opportunities  The organisation must determine the risks and opportunities that need to be addressed for its given context. 

EQMS Risk Manager enables organisations to employ ISO 31000, COSO, SOX, Basel, AS/NZS 4360 or your own unique control framework to identify, quantify, and prioritise risks and opportunities. 

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Image: Example risk categories in EQMS Risk Manager

6.2 Quality objectives and planning to achieve them  The organisation must set quality objectives for relevant functions, levels and processes within its quality management system. 

EQMS enables organisations to set quality objectives and monitor progress against the achievement of objectives. 

See KPIs with EQMS

6.3 Planning of changes  When the organisation determines there is a need to change the quality management system, it must be carried out in a planned and systematic manner. 

With EQMS, any changes to the quality management system are managed through a workflow, enabling the organisation to assess whether the integrity of the quality management system could be compromised. 

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Image: Example changes paths in EQMS

7. Support    
7.1 Resources  The organisation must determine and provide all the resources necessary to establish, implement, maintain, and improve the quality management system.

EQMS enables you to document all of the necessary resources for a management system, including people, infrastructure, the environment for the operation of processes, monitoring and measuring resources, and organisational knowledge. 

EQMS Resources.pngImage: Plan resource requirements in EQMS

7.2 Competence  The organisation must determine the competency requirements for those people performing work under its control. 

EQMS Training Records Manager enables organisations to identify competency issues with quick and easy overviews or drill-down records.

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Image: Run 100s of different custom reports about training records in EQMS

7.3 Awareness  The organisation must ensure that all people doing work under the organisation's control are aware of the quality policy and objectives, and how they are contributing to the effectiveness of the QMS. 

EQMS makes it easy to ensure that anyone who is working under the organisation's control is aware of the implications of not conforming to the quality management system. 

For example, a new employee can be sent the quality policy and the objectives. They can then acknowledge that they have read and understood the implications of not conforming to the quality management system.

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Image: How to acknowledge quality policy in EQMS

7.4 Communication  The organsation must determine the quality management system related matters on which it wishes to communicate. 

EQMS makes it easy to communicate quickly and effectively with stakeholders. Emails and push notifications can be sent to staff when they wish to communicate quality management system related matters, or staff can view activity on their 'To Do' list. 

To do list notifications.pngImage: To do list in EQMS

7.5 Documented information  The organisation must document information required for ISO 9001:2015 and for the effective operation of its quality management system. 

EQMS makes it easy to control documented information to ensure it is available where and when needed, and that it is suitable for use. All documented information is controlled within EQMS, with unique identifiers, authors, reference numbers etc. 

 

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Image: Documented information follows a best practice approach in EQMS

8. Operation     
8.1 Operational planning and control  The organisation must plan, implement, and control processes to meet the requirements for product and service delivery. 

EQMS makes it easy to plan, implement and control processes. 

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Image: View all activity related to a process on one screen.

8.2 Requirements for products and services  Organisations must be able to determine and review requirements for products and services, and document customer communication and feedback. EQMS Issues Manager makes it easy to log and manage customer feedback. Any user can raise an issue, so an organisation has an up-to-date real-time overview of customer communication issues at any point.
8.3 Design and development of products and services   Organisations must establish, implement, and maintain a design and development process.

EQMS enables organisations to apply controls to its design and development process. For example, even complex CAD drawings can be annotated and controlled with EQMS. All changes can be viewed through the audit trail.  

 

8.4. Control of externally provided processes, products and services  The organisation must ensure that externally provided processes, products or services meet requirements. 

EQMS provides a framework to monitor the performance of external providers and to have the results of the evaluation, any further re-evaluation, and any necessary actions as documented information. 

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8.5 Production and service provision  The organisation must control the way in which they produce their products and services. 

EQMS ensures monitoring and measuring activities will be undertaken at appropriate points. It enables organisations to verify processes are being controlled and that outputs, products, and servcies are meeting their acceptance criteria. 

The integrated EQMS modules make it easy to understand control changes. 

8.6 Release of products and services The organisation must carry out predetermined arrangements at appropriate stages of the production / service delivery in order ro verify that products and services meet all requirements.  By using EQMS to plan, manage, and control workflows, it becomes easy to retain documented information. Internal audits are made quick and easy with EQMS Audit Manager, and audits can be scheduled to recurr at any frequency required.
8.7 Control of nonconforming ourtputs  The organisation is required to identify any outputs that do not conform to their intended requirements and controls need to be established and implemented to ensure that these non-conforming outputs are not delivered to the customer or their unintended use is prevented. 

EQMS Issues Manager ensures that any changes are managed and controlled prior to being released to customers. Authorities deciding the action can be predefined using the EQMS workflows. 

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Image: EQMS Issues Manager enables easy change management

9. Performance Evaluation     
9.1 General  Requires the organisation to determine what it needs to monitor and measure.  EQMS consolidates all information providing a plethora of different custom report types, making it easy to adapt the quality management sysrtem to the changing requirements e.g. customer satisfaction can be measured through the number of complaints/ time to respond to issues. EQMS provides many analysis and evaluation options to manipulate the data. 
9.2 Internal audit  The organisation must carry out internal audits at planned intervals. 

EQMS Audit and Inspection Manager makes it easy to schedule, plan and manage audits. Any non-conformities or issues raised can then trigger a workflow. 

The integrated modules makes it easy to wholistically manage audits from the planning phase. 

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Image: iEQMS Audit Manager app allows audits on-the-go without the need for duplication of effort.

9.3 Management review Top management must undertake reviews at planned intervals to ensure the quality management system's continuing suitability, adequa,cy and effectiveness. 

EQMS Audit and Inspection Manager has predefined checklists and audits which makes it easy to determine the effectiveness of the quality management system. 

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Image: Quickly review using visual reports

10. Improvement    

10.1 General 

Organisations must actively seek out and realise improvement opportunities that will better enable the organsiation to meet customer requirements and enhance their customers' satisfaction. 

EQMS ensures risk-based thinking is embedded into all processes. Permissions controls in EQMS Document Manager ensure security of information without detriment to business performance. Ongoing commitment to improvement can easily be carried out using EQMS Audit Manager to schedule and conduct internal and supplier audits.

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Image: EQMS Audit Manager lets you schedule repeated audits with ease

10.2 Non-conformity and corrective action 

The organisation must set out how it acts when a nonconformity occurs.  Processes for following non-conformances can be documented in EQMS Document Manager. In addition, EQMS Issues Manager has customisable automated trigger workflows to ensure clear corrective action paths are taken.

10.3 Continual improvement

The organisation must use the outputs from analysis and evaluation and from management revview to determine areas of underperformance and to identify any opportunities for improvement.  EQMS KPI reporting enables management to view real-time reports with a range of custom widgets. Continuous monitoring of activity within EQMS and its reports enables the organisation to commit to ongoing improvement with regular performance reviews.

 

What you should do now: 

Download the ISO 9001:2015 toolkit for more information to guide your organisation to full compliance or request a demonstration of EQMS here

 

ISO 9001:2015 Toolkit

 

 

 

Tags: ISO 9001:2015

Qualsys shortlisted for Document Manager Awards

Posted by Annie Grace on Fri, Feb 24, 2017

In December 2016 Qualsys were shortlisted for three categories at the Document Manager Awards, alongside a high calibre of candidates.

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michael_ord_picture.png"We are honoured that our hard work and commitment to improving quality using technology innovations has been recognised alongside such a high standard of entrants,” said Michael Ord, New Business and Marketing Director at Qualsys.

“It’s great to have acknowledgement of the innovations we deliver to our customers. It’s also a reflection of the dedication and positive relationships our customers have with Qualsys, as they are often the driving force behind our ongoing improvements with EQMS software. Their unique insights allow us to really get under the skin of the needs of quality managers across the world, and it’s with their feedback and commitment to continued improvement that we can carry on creating new and innovative features for the software.”

The awards Qualsys were shortlisted for included:


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“We were proud to stand with some excellent examples of quality technology innovations, and would like to congratulate the winners in each category,” Michael commented.

A key module considered in the Compliance Product Of The Year nomination was EQMS Document Manager, which has led a number of customers to acheiving full ISO 9001:2015 compliance. The module is designed to allow full document version control, restrict viewing permissions by individual or group for improved security, and improve business efficiency. 

 

What you should do now

Learn why global blue chips and hundreds of SMEs across the UK choose EQMS Document Manager to deliver unshakeable control over their documentation by requesting a 30 minute free demonstration with one of our friendly experts or read our case studies and watch customer testimonial videos here

Document control software

 

Tags: Document Control Procedures, Awards

Managing External Provisions Best Practice Process

Posted by Emily Hill on Fri, Feb 24, 2017

Supplier management is undergoing a major transformation. The days of simply managing spend and negotiating the best deal are long gone: it's no longer sufficient or easy to use such outdated practices.

ISO 9001:2015 New External Provisions Management Requirements

The new ISO 9001:2015 requirements reflect the more complex supplier management requirements. Not only are there now more rigorous requirements to monitor suppliers on an ongoing basis, but the processes also need to be audited. 

Read here for more information about the new ISO 9001:2015 requirements for Clause 8.4. 

 

Below, we explain a step-by-step best practice approach to managing suppliers. 

While there is no prescribed method of managing your strategic suppliers, a simple and pragmatic approach consists of six key steps. (Please note - you do not need to do this for every supplier, just those who would influence the delivery of your products or services provided). 

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Step-by-step approach 

1) Supply marketing

The first step is to define the requirements of the process, product, and service required.

This may detail: 

  • Scope 
  • Regulatory requirements 
  • Risk appetite 
  • Standards
  • Supplier competency requirements
  • Explanation of the verification and validation processes. 

You must then inform potential suppliers about your requirements.

 

Keep a record!

ISO 9001:2015 requires you to maintain a record of your supplier requirements. With EQMS Document Manager, you can be confident correct and controlled supplier documentation is shared with your stakeholders, keeping a record at every stage. 

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2) Supplier Selection

Once you have a specification, which has been verified and approved, you should undertake a supplier risk analysis. 

In this risk analysis, you will want to:

  •   Identify any risks associated with the product or service itself, such as -
    • Credit
    • Health and safety
    • Supply chain 
    • Slavery
    • Sustainability
    • Quality 
    • Operational 
    • Currency fluctuations
    • Substitutes 
    • Compliance 
    • Health and safety 
    • Product / technical
  •   Identify any risks associated with producing or delivering the product or service
  •   Quantify these risks using a consistent methodology
  •   Identify the controls required to mitigate unacceptable risks.

This information will inform the details of your supplier evaluations and the controls you need to impose on your suppliers. In particular, you should consider risks associated with Single Sourcing. 

 

Keep a record! 

Using EQMS Risk Manager, a thorough risk assessment can be performed to ensure you mitigate and address any risks, making it much easier to manage a supplier risk assessment. You can employ any risk framework, including ISO 31000, COSO, SOX, Basel, AS/NZS 4360 to identify, quantify and prioritise risk. 

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3) Supplier Onboarding 

After a identifying risks, you can move onto supplier onboarding. The purpose here is to identify potential suppliers who are capable of meeting your requirements. 

Start with a standard supplier checklist, to promote consistency and ease of reuse. However, the findings of your evaluation should be analysed with regard to the risks you identified earlier. 

When onboarding a supplier, you will want to evidence your requirements (ITT, RFQ), the response confirming that they can and will commit and a contract of agreement. 

The contract of agreement may detail:

  • Specifications
  • Volumes
  • Lead times
  • Payment 
  • Processes
  • Traceability records 
  • Constraints to supply
  • Reassessment details. 

Keep a record! 

iEQMS Auditor makes it easy to capture checklists of information from your supplier audits. Attach any type of multimedia evidence to demonstrate compliance. 

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5) Supplier Development 

Once the contract commences you will need to monitor supplier performance, nurture the relationship, and manage issues. Some issue management processes will have measurable costs, so if you cannot quantify these costs and provide evidence of how they were incurred then you may have difficulty recovering them.

Once you have identified the things you need to monitor you need to consider how to do so in a way that captures critical information, alerts interested parties as to what to do about it, and enables easy progress monitoring, all in real time. Paper, electronic paper, and spreadsheets only tend to work for small organisations where one person is responsible for end-to-end process management.

Keep a record! 

EQMS Supplier Manager enables you to view an entire record of the history of your supplier. 

 

6) Re-evaluate Suppliers

How often and when to re-evaluate suppliers is a strategic decision for the organisation. Some issues may be very costly, which will result in more frequent re-evaluations. 

A best practice approach would be to monitor CAPA associated with the supplier. Even seemingly minor issues could add up significantly over the years if they reoccur. When looking at supplier issues, it is important to find out why they occured by asking questions such as: 

  • Why did the process fail? 
  • How could we optimise the process to prevent it from happening with this supplier and others?
  • How do we communicate the failure to necessary parties? 

On the other hand, if a supplier has no issues associated with them, you may want to ask questions about how you can strengthen the relationship. For example, are there any additional services or products they could offer your organisation? 

Keep a record! 

EQMS CAPA Manager enables you to access a log of all issues related to a supplier. Using the workflows, you can see whether issues have been successfully managed and the results of issues. 

 

What you should do now

Learn how EQMS can help you to systematically manage your suppliers, develop supplier relationships and ensure your processes meet the requirements international standards such as ISO 9001:2015 by downloading the webinar here. 

 

Watch "ISO 9001:2015 Clause 8.4 External Provisions" Webinar

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Tags: Supplier management

What our Customers Say About Using EQMS

Posted by Emily Hill on Mon, Feb 20, 2017

It can be very difficult to choose an electronic quality management system provider. Each system is different. Pricing models are difficult to compare. And it's not always easy to get a real understanding of how good the service will be after you sign up. 

We talk to a lot of quality professionals, and those who have the most success are those who seek out more information, talk to existing system users and even visit them to learn more about their experiences. 

To help you get started, we've put together ten customer reviews with links to detailed case studies. 

Alternatively, you can read our reviews on the third party reviews site, Capterra, here

 

 

1) Sodexo

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 "In an IT career spanning over two decades, I've never come across a software supplier who is so determined to see you succeed with their product as Qualsys." 

- Rob Gibson, EQMS Manager at Sodexo 

Read case study here

 

 

2) University of Leeds  

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 "We chose EQMS because of it's user-friendly interface. We use the system to manage our EMS and QMS for the facilities directorate where we have over 1,000 employees." 

- Jo Firth, Head of Facilities Directorate at University of Leeds

 Read case study here

 

 

3) Diageo

"EQMS is a brilliant user-friendly system for the end user. It can be a bit time consuming doing the work and getting it right in the background, but it is all very much worth doing at the beginning to ensure you have the best system possible for years and years to come."

- Product Manager, Diageo 

Read case study 

 

4) Aberdein Considine

 

“EQMS is the central system for all our ISO  policies, procedures, records and training /  awareness materials which is accessible by all staff within the firm.”

- Greig Robertson, Project Manager at Aberdein Considine 

Read case study here 

 

 

5) BT

"You are not only able to answer any question, teach us and provide training, and establish the system as we jointly designed, but it is your professionalism, excellent customer service, openness and flexibility that really impresses me."

- Ellen Boone, Transition Director at BT Global Services 

Read case study here 

 

6) W. E. Rawson Ltd 

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 "EQMS is simply the best solution on the market. It is cost-effective, modern and user-friendly."

Lee Clack, Quality Assurance Site Manager, W.E. Rawsons 

Read case study here

 

 

7) Diageo

"Qulasys are demonstrating real engagement with its customer base developing and progressing proposed changes from the user group. EQMS development appears to picking up real pace."

Douglas MacFarlane, Process Improvement Specialist, Diageo

Read case study here

 

8) Sodexo

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 "On a recent audit I conducted, my estimate is that I saved around 60% of my time through using the app when compared to conventional ways of working. It’s my belief that once the application is used the first time, it will be used everytime."

Carl Stanbridge, Global Quality and Compliance Director, Sodexo

 Read case study here

 

 

9) Guinness Supply and European RTD

"EQMS provides the ability to adapt the Quality Management System to rapidly changing business needs and thus keeps pace with practice on the ground." 

Laeona McGrath, QMS Manager, Guinness Supply & European RTD 

Read case study here

 

10) Carillion Direct Sourcing 

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 "With EQMS, I recieve an audit report at the end of the day once QE's can get back onto WiFi.The data is available, clear and correct. EQMS copes with the whole audit. I was surprised about that."

Nigel Mangnall, Head of Quality and Compliance, Carillion Direct Services 

Read case study here

 

 

What you should do now: 

Download the EQMS Buyer Toolkit for free templates, guides and project planners to help you put together a business case which will impress your BOD. 

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Tags: Case Studies

Data on People in Europe? Your Countdown to Achieve ISO 27001

Posted by Annie Grace on Wed, Feb 15, 2017

From 25th May 2018, any company with data in the European Union must comply with the European Union General Data Protection Regulation (EU GDPR). However, only 68% of people feel their business will be compliant in time for the deadline – risking massive fines. The impact of these changes will be significant – but you have still got 16 months to implement a robust process for data protection compliance.

How will EU GDPR affect your business?

If you handle any personal data from any country in the EU, you’re required to comply with the EU GPDR – even if your business isn’t based in the EU. This means greater protection of personal data (including customers and suppliers), and prevention of misuse. With the rise in large and very public security data breaches, such as those experienced by Yahoo, personal data protection has never been more under the spotlight.

A data breach will affect your business in at least two ways. Firstly, your company will face potentially massive fines up to €20million. While such fines are expected to be rare, a worst case scenario is always the best approach with risk management.

Secondly, your business reputation will be put at serious risk. Customers are likely to walk, delete their accounts, stop using your product or service, lose trust in you, and not refer to you other potential customers. The impact of a data breach extends beyond the violation of personal information – it goes right into your business’ future and could affect sales and growth for a long time.

How ISO 27001 Will Help Your Business Achieve EU GDPR Compliance

ISO 27001, the international framework for information security management, is a valuable asset to any company wanting to comply with EU GPDR.

The framework enables you to develop a comprehensive information security management system (ISMS) that paves the way for easy EU GDPR compliance. Processes and workflows developed during ISO 27001 implementation make data protection and regular audits a much easier and far less daunting task.

3 Ways ISO 27001 Will Help You With EU GDPR 

The international framework will help you lay a path for compliance. Specifically:

#1 Privacy

  • Section A.18.1.4 Privacy and protection of personally identifiable information ensures you have a suitable process in place for protecting data to the required levels (as set in A.18.1.1 Identification of applicable legislation and contractual requirements – which includes EU GDPR).

#2 Manage Security Incidents

  • Section A.16.1 Management of information security incidents and improvements ensures you have a suitable process in place to report a security breach and actions within 72 hours of discovery – essential for EU GDPR.

#3 Privacy by Design

  • Control A.14 System acquisitions, development and maintenance implements a culture of information security as an integral part of day-to-day working – ensuring compliance with Privacy By Design, a clause in EU GDPR.

  Receive the latest GRC information with our FREE monthly newsletter! Sign up  here >>>

Tags: ISO 27001, European Data Regulation, EU GDPR

Reducing the Cost of Compliance at Sodexo - Case Study

Posted by Emily Hill on Mon, Feb 06, 2017

The pharmaceutical industry are increasingly asked to meet new regulatory mandates.  It's often a race to keep pace in these ever-evolving environments. 

Processes, procedures and policies need to be efficiently and effectively updated and communicated across the entire organisation. 

In the interview below, Rob Gibson, Quality Manager at Sodexo, shares how EQMS has helped to reduce the cost of compliance at one of the world's largest pharmaceutical sites.  

 

reduce the cost of compliance

Read the transcript below or watch the 3 minute video here:

 

 

 

What is your role at Sodexo? 

My role at Sodexo is EQMS Manager. My role involves working with the technicians at Qualsys to make sure we are getting the benefits of using the system. 

reducing the cost of compliance with EQMSImage: EQMS KPI Dashboard

 

Prior to using EQMS, what were the main challenges faced by Sodexo? 

"Lots and lots of paper"

The main challenge prior to using EQMS was reducing the cost of compliance in this heavily regulated market. There are a lot of Regulations and Standards that we need to comply with. That means having a lot of records, processes, procedures and policies. All of these were manual process with lots and lots of paper. Trying to keep on top of that is a major challenge. EQMS helps do all of that automatically and electronically.

"Subject-matter experts across the globe"

 EQMS also helps us with our communciation. We are an International organisation, with subject-matter experts across the globe, just trying to find the time to talk to your colleagues across all of the different sites in itself is a challenge. 

"Keeping up with the volume of activity"

The volume of activity is so high, just trying to take a few minutes when everyone is so busy to refresh what we are doing and to get up to speed, EQMS helps us with all of that. 

 

Who benefits from using EQMS? 

"Management team benefit from more visibility and control"

Sodexo management team benefit in that they have more visibility and control over what is happening in the organisation.

"Local site managers benefit from knowing what processes are being improved"

We have our own local site managers where we know what processes are being improved. We are using iPads which ensures that things are happening quickly.

"Our clients get a better and faster service, and a higher standard of work"

We can get documents to people faster, we can update versions of documents faster and all of that leads to our clients getting a better and faster service and a higher standard of work. 

 

What is Sodexo's vision for EQMS? 

"EQMS rolled-out into all contracts"

Sodexo's vision for EQMS is for the system to become ordinary. To have EQMS rolled-out into all contracts for storing records, for managing training records, for new processes. My vision is for EQMS to become an every day, run of the mill activity, and helps us to keep the costs down. 

 

What are the long term benefits of EQMS? 

"Improved processes, better control, more visibility."

The long term benefits of using EQMS is that it reduces the cost of compliance with our International Regulations and everything else we need to be compliant with. We have improved processes, better control, more visibilit.  

"Fewer incidents, fewer accidents and a higher quality service"

We have fewer incidents, fewer accidents and a higher quality service. We are able to keep up with innovation and best practice. When we have other new innovations and techniques, we are able to cascade it out through the organisation rapidly and effectively so everyone has access.

 

How have you found working with Qualsys?

"The relationship we have with the team at Qualsys is outstanding."

In an IT career that spans over 20 years, I don't think I have ever worked with a supplier who is so keen for us to succeed with their product. The relationship we have with the team at Qualsys is outstanding. They are really keen to ensure that we get the system, that we are using it well and that we are keeping in touch with new innovations and ways of using the system. Qualsys makes sure that we are evolving the system to meet our needs and the needs of our client. We are very happy. We have a very healthy relationship. 

 

What you should do now: 

Download the EQMS Buying Toolkit to read more interesting case studies about using EQMS or learn how EQMS can be configured to meet your unique requirements by requesting a demonstration here

 

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Pharmaceutical Facilities Compliance Management with EQMS - Sodexo Customer Interview

Posted by Emily Hill on Fri, Feb 03, 2017

Carl Stanbridge, Global VP of Quality and Compliance at Sodexo shares how EQMS helps manage quality, compliance and deliver competitive advantage.

 

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Watch the video here or read the transcript below. 

 

 
 
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What is your role at Sodexo? 

My role at Sodexo is to look after Quality and Compliance globally. There are two main parts to my role. At the moment Sodexo has been through a fairly significant transformation, so we have re-organised ourselves across various geographies.

We are now looking at how we can implement a programme of quality and compliance across the whole Sodexo group. This is something that I have been leading on behalf of Sodexo. In addition to that, my main role has been to look after the pharmaceutical and consumer-health business.

 

Prior to EQMS, what were the main challenges Sodexo faced? 

"Decentralised, legacy systems"

The main challenges for us around managing and implementing quality and compliance before EQMS is that we had lots of legacy systems which were all decentralised. As we picked up new clients and we picked up new business, we inherited many different systems. There were lots of legacy IT systems, paper-based systems and processes and ways of working.

"Consistent but flexible"

The challenges for us was how we could deliver something that was consistent where it needs to be consistent, but also recognise that there are different clients and different geographies that need different things. How can we do things that are right in terms of consistency when we have so many different processes that keep coming into the organisation? 

 

What led to your decision to get EQMS? 

"Innovation tool"

The lightening-bolt moment for us was after I had just been to see one of our very big and important clients and as part of that discussion we were talking about the next big steps for Sodexo. We talked about what else can we deliver around quality and compliance for our customer.

"Quickly and effectively deploy a system to the whole organisation"

The discussion quickly led us to looking for an IT tool or an innovation of technology to support our quality and compliance processes. Quite a lot of work had been done up until that point to harmonise and standardise our systems. The next stage then was how can we quickly and effectively deploy this to the organisation. So I left that meeting and got in a taxi to go back to the airport. In the ten minute journey of going back to the airport, I knew that we needed this system. 

 

How does EQMS help Sodexo to achieve their objectives? 

"EQMS ensures we do things in the most efficient way"

The objectives of Sodexo are to improve the quality of life of all the people that we serve. We are very proud that we interact with more than 75 million consumers and customers every day.

A big part of the business that we have in Sodexo is around ensuring that the services we provide are compliant to regulatory expectations and the needs of our customer.

"No wastage in our processes"

The key way EQMS helps us to achieve our objectives is by making sure that we are doing things in the most efficient way. There is no wastage in our processes. We are delivering cutting-edge technology for the services that we provide. We are able to always comply with the regulations, client contract and their expectations.

This is an environment which is always changing. There are always new compliance requirements and we have to make sure that we are managing EQMS accordingly. 

 

How do Sodexo's customers benefit from Sodexo using EQMS? 

"Our customers can demand more"

Our customers benefit in a number of different ways from Sodexo using EQMS.First and foremost is that we are able to do something that our competitors are not. In many circumstances, our customers are dealing with Sodexo and lots of other service provides, and what happens is that by using EQMS, Sodexo are able to improve the level of compliance that the customer can expect. Whether that is the effective closure of corrective actions, the effective management of risk, that is making sure that training has taken place or have all the documentation available.

"EQMS is the key for us to deliver 100%"

We have very tight key performance indicators, service level agreements and critical performance indicators. EQMS allows us to not only deliver against those key performance indicators, but it also allows the client to increase their demands on Sodexo. Pre-EQMS, we were able to deliver 95, 96, or 97% based on the tools we were using at the time. The customer will now demand of us 100%. EQMS is the key for us to deliver 100%. 

 

What is your long-term vision for EQMS?

"Roll out EQMS across the business"

Our long-term vision for EQMS in Sodexo is the pharmaceuticals customers that we have are continuing to grow. The EQMS product answers all of our needs in terms of functionality. But the critical thing for us in Sodexo with EQMS is that we have been able to validate the system to meet the very high demands of providing IT tools in a heavily-regulated pharmaceutical environment. So really, EQMS is a fantastic fit for our pharmaceutical business. EQMS is now part of the formal offer that we offer for our clients. 

Wider, out-side of pharmaceutical, there are a lot of benefits. There are a lot of principles that we have in our processes that EQMS executes brilliantly. Right now we are exploring where else in Sodexo we can make use of EQMS. It could be used in Health Care, Oil and Gas or Energy and Resources. Right now, EQMS is best fit for pharmaceuticals, but our vision is to expand the use EQMS throughout Sodexo. 

 

How has your experience with Qualsys been so far? 

"Qualsys fit our culture - very collaborative, very transparent, very honest"

In Sodexo, we've made it no secret that the tool is part of the solution. The rest is really about the type of organisation that develops the tool and provides us with the ongoing service for that tool.

Qualsys for us were a great fit. In terms of why we chose EQMS and Qualsys, the tool was there, and great functionality, but we also chose Qualsys because they fit our culture with Sodexo. At Sodexo, we encourage empowerment amongst our employees, so decision making is at a very junior level.

So we wanted to chose a vendor that was open to that, who was very collaborative, very transparent, very open, very honest with their abilities of where they can deliver and where they can't deliver things.

"Qualsys have delivered time and time again"

When we were going through the process, it was as much about testing the product as it was about testing the vendor. For us, Qualsys have delivered time and time again. We're not an easy client to work with. We're a huge organisation. Some of the things we do are very complicated. Some of the demands we have are very high, as are our clients, and rightly so given the industry that we work in, so we needed Qualsys to be quick, resilient, and effective with their communication. That is what we have got.  

 

What challenges does Sodexo now have? 

"Consistently delivering the very best for our clients"

The challenges for us are that we have just been through a major transformation. There are new departments and lots of people in new roles. 

We face challenges in terms of the ever-increasing demands of the client. It's right that our customers want more innovation, more value, at a lower cost. We are constantly faced with this challenge - we always want to deliver the very best for our clients, for the least amount of cost.

We face challenges in the general marketplace that we operate in. It is a tough economy in parts of the world where we are delivering our services. There is social media and lots of other new technologies, like EQMS, which we need to make the most of. 

 

For more interviews, articles and resources about why organisations choose EQMS, download the EQMS Buying Toolkit.

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Tags: Case Studies

3 Reasons To Audit Your Suppliers (Hint: It Saves You More Than Cash)

Posted by Annie Grace on Fri, Feb 03, 2017

Many organisations handle so many suppliers it feels inconceivable to conduct regular supplier audits. Maybe when on-boarding a new supplier a suitability check is conducted, but after that how do you know you can continue to trust your suppliers?

 

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Supplier failure costs business hugely. It’s not just about money, either: your reputation can hang in the balance, and you even risk losing your talented staff if an incident is poorly handled. They might choose to go elsewhere, you might suffer such financial loss you need to make job cuts, or they might take the fall for what was – actually – the supplier’s fault, if your audits are not comprehensive.

Supply chain disruption costs are huge. Not only do you have to manage production downtime, you’ll also need to satisfy end customer expectations, and re-jig other production schedules to continue maximising profit for your facility.

In fact, one in three businesses last year experienced cumulative losses via supplier failures to the tune of a cool €1m. That study doesn’t take into account the long-term impact on reputation or talent retention, either.

If that’s not enough to look at delivering regular supplier audits, here are three more reasons to consider:

 

  1. It will save you money

The first and most obvious benefits of regular supplier audits is the significant risk mitigation an audit process will allow. You can easily identify how suppliers are performing against SLAs, repeated problems, or highlight potential future issues before they happen. 

Audits will enable to you to prevent foreseeable supplier failures, and create contingency plans should supply chain disruption occur. No more million Euro annual losses from supplier failures!

 

  1. You’ll ensure compliance to your standards

Without a regular audit of your suppliers, how do you know you’re on the same page? While you have high standards to remain compliant to, do they follow the same? How do you know they practise what they promise?

Standards are ever-changing and adapting, so it’s essential for suppliers to be regularly audited in line with the relevant changes. For example, upcoming changes to ISO 80000 reveal the differences in measurements between suppliers. If your supplier prices by the kilogramme, for example, how do you know you are getting a fair price – is it the kilogramme measurement YOU use, or another version?

Back in 1999 there was a worldwide omnishambles when NASA lost the Mars Climate Orbit satellite. It burned up, all $125m of it. All because the international teams had used two different measurements: the English had used Imperial measurements, and the US team metric. Incorrect interpretation of measurements led to the loss of an extremely expensive piece of kit.

 

  1. You’ll ensure continuous quality improvement

Without ongoing supplier audits, it’s difficult to know whether you are receiving consistent products, on time, to the right standard, without defects. That makes your own commitment to continuous quality improvement nigh on impossible. You need a full and comprehensive overview of supplier performance in order to set in place best practice touch points for continued quality improvement.

Regular supplier audits also strengthen relationships with your supplier. If you previously let your suppliers ‘just get on with it’ then you’re missing out on opportunities for further partnerships, better prices, and knowledge share opportunities.  

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Regular supplier audits are possible and even easy with software tools such as EQMS Audit Manager. Audits can be conducted on-site without the need for wireless internet access at the time, so your auditors can visit sites and complete an audit without the need to return for further paperwork completion.

Optimise your supplier management system here.

 

Supplier management

 

 

Tags: Supplier management

ISO 9001:2015 Clause 8.4 - Control of Externally Provided Processes, Products and Services

Posted by Emily Hill on Thu, Feb 02, 2017

In the new ISO 9001:2015 standard, there are more rigorous requirements for managing suppliers. 

The following forms part one of three installments of our ‘ISO 9001:2015 and Supplier Management’ series which focuses on the major changes of the Standard. Today will focus on explaining the key changes introduced in ISO 9001:2015, Clause 8.4. Control of Externally Provided Processes, Products and Services.

 

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Why is it so important to manage suppliers? 

Supply chain networks are expanding and evolving at an unprecedented pace. At the same time, companies face enormous pressures to improve supply chain efficiency, reduce costs and mitigate risks involved in supplier compliance.

Poor supplier quality results in reputational damage, not to mention huge costs to your business. A supplier delay could push back your product deadlines and cause significant costs on a per day basis. Last year, one in three businesses felt the blow, experiencing cumulative losses over one million euros due to supplier failures.

Read more here

 

Clause 8.4 - Key Changes 

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Clause 8.4 of the standard focuses our attention on our responsibility to control externally provided processes, products and services.

There are three main changes: 

1. Who your suppliers are: 

You will notice that there has been some small terminology changes. “Purchasing” and “Outsourcing” are now called "externally provided processes, products and services”. While this doesn't mean you need to update your terminology, ISO 9001:2015 has now made it more explicit who a supplier is.

A  supplier is anyone who is a provider external to the scope of the quality management system.

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ISO 9001:2015 requires the organisation to address all form of external provision, whether it is by purchasing from a supplier, through an arrangement with an associate company, through the outsourcing of processes and functions of the organisation, or by any other means. 

It is also worth noting that an external provider is a provider external to the scope of the quality management system. This means that if a quality management scope covers a single site in a wider group structure, then anything sourced from other members of the group would be classed as externally provided and subject to the requirements.

 

2. Record the results of supplier activities: 

In ISO 9001:2008 sub-clause 7.4.1, it was required to keep records of the criteria for selection, evaluation and re-evaluation of the suppliers.

In ISO 9001:2015, there is now an explicit requirement to ensure monitoring and measurement activities are undertaken at appropriate points.

The organisation is required to record not only the criteria, but also the results of these activities, including performance and monitoring. This has many implications for you if you haven’t previously maintained records of the results of supplier performance activities.

 

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3. Verification activities 

In ISO 9001:2008, the organisation needed to ensure the purchased product met specified purchase requirements. In ISO 9001:2015, the verification needs to ensure "the externally provided processes, products and services meet requirements." 

If organisations were previously only verifying external provisions against the initial purchase requirements, rather than the ability of the provision to help the organisation to achieve their overall objectives, the organisation will need to update their processes and management system accordingly. 

 

In the next article, we will explain a simple and pragmatic approach to managing your suppliers, focusing on EQMS. 

 

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Tags: Supplier management

A Tool To Drive Continuous Quality Improvement for W. E. Rawson Ltd, a Non-Woven Textile Manufacturer

Posted by Emily Hill on Mon, Jan 30, 2017

W.E Rawson Ltd has been manufacturing and distributing Non-Woven Textiles from their site in Wakefield for 150 years. 

In this case study, you will learn more about the journey that Lee Clack, Quality Manager at W. E. Rawson Ltd, went thorugh to get EQMS implemented.  

 

A Short Interview with the Client

 
 
 
 
 
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Wistia video thumbnail - Lee Clack Explains why EQMS
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A transcript of the video: 

 

Why did you need EQMS? 

We needed EQMS because we had internal systems which were mostly access based. What I wanted to bring in was a main driving tool for continuous improvement.

"A driving tool for continuous quality improvment"

With EQMS by Qualsys being module-based, it was very versatile and ticked all of the boxes for all of the business areas we needed to cover.  

"very versatile and ticked all of the boxes"

Continuous quality improvement journey

 

Image: EQMS Training Records Manager - the Training Matrix 

 

What were your main challenges before EQMS? 

Everything really. There were internal access based systems and databases which did not give me the reports I needed. Specifically, I wanted to look at trending in regards to customer complaints, non-conformances and other areas we want to drive continuous quality improvement.

"direction for continuous quality improvement"

Previously, there were no reports, documentation or solid data that we could collect which would point us in the right direction for continuous quality improvement. 

Continuous Quality Improvement

Image: EQMS KPI Dashboard

 

What is your vision for EQMS at W. E. Rawson? 

My vision for EQMS at W. E. Rawson is to firsly get EQMS fully utilised. I want to get every member of staff using the system. Obviously, EQMS will give us the knowledge and the data that we require to drive continuous quality improvement. 

"EQMS will help us to drive continuous improvements across the whole business"

 

The continuous improvements are not just in production, we are driving improvements now across the whole site in all of the departments - across transport, finance, sales. 

The vision is to put EQMS in at the other sites. It will help them to drive continuous improvement, so the business as a whole will improve.  

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Image: EQMS Document Navigator Tree

 

What do you want everyone at W. E. Rawson Ltd to do now? 

I want everyone to get familiar with the system. What we have found with the system is that it is very user-friendly.

"EQMS is very user-friendly and quite straightforward"

That is what ticked another box for us in chosing EQMS. This is because we have had people who have worked here for 30 years who are used to paperwork. The general feedback we've had on the system is that EQMS is very easy to use and quite straightforward.

The aim is that we will have everyone using the system on a daily basis. This means we will start getting the data and the information required. 

"We can now start getting the data and information required"

 

 

What you should do now 

 If you want to read more customer stories like this, sign up for the EQMS Newsletter or if you would prefer to see how EQMS can give you the insights you need to drive continuous quality improvement, request a free 30 minute demonstration here. 

 

 

Tags: Case Studies