Quality Standards & Regulations

EQMS has been to developed over many years to exceed the requirements of many quality standards and regulations.

This list is not exhaustive, but gives you a flavour of the diversity of pressures facing Compliance and Quality Managers; and the way that EQMS helps reduce these pressures.

In no particular order:

1. ISO 9001:2015 Quality Standard

2. ISO/IEC 27001 Information Security

3. ISO 14000 Environmental Management

4. OHSAS 18001 Health & Safety

5. Care Quality Commission (CQC) 

6. Outcomes Focussed Regulations (OFR) & SRA Code of Conduct for Solicitors in England and Wales

7. FDA/CFR 21 Part 11

 
 

1. ISO 9000 Quality Standards

ISO 9000 is a series of standards for quality management systems. It provides a set of principles that ensure a controlled approach to managing business activities allowing you to consistently achieve customer satisfaction.  

ISO 9001 Quality with EQMS 

EQMS allows you to manage and control companywide documentation consistently in line with the ISO9001 standard.
  • EQMS provides full history and audit trail, it records every action – noting exactly who did what and when. 
  • Set varied permission levels, EQMS only allows users to see the correct up-to-date version of a document, eliminating error. 
  • It highlights non-conformances to the standard

Read the Qualsys GRC Blog for ISO9001 articles

ISO9001 Quality Standard

2. ISO/IEC 27001 Information Security

ISO/IEC 27001 is a management system intended to bring information security under management control. The standards provide best practice guidance on protecting the confidentiality, integrity and availability of company wide information.

ISO27001 with EQMS 

Automate tasks such as controlled document approval and issue. Set dedicated permission levels and utilise the audit management tool to drive ISO 27001 workflows throughout the organisation whilst ensuring companywide compliance.
 

ISO27001 logo

3. ISO 14000 Environmental Management

ISO 14000 is a set of standards developed to assist in reducing the company’s environmental impact, specifying the requirements for an organisation's environmental management system.
 
ISO 14000 Environmental with EQMS 
 
EQMS allows you complete control of your environmental documentation. It supports the training of the standard allows you to easily plan, manage and undertake your audits, enables you to manage any incidence that is not in conformance with the standard, and enables you to manage all your associated equipment.

ISO14001 Logo


4. OHSAS 18001 Health & Safety

BS OHSAS 18001 is the standard for occupational health and safety management systems. It gives a framework to identify, control and reduce the risks associated with health and safety in your workplace.
 
OSHAS 18001 with EQMS
 
Easily control and manage your documentation, process according audits, and identify associated risks. EQMS allows you to ensure all required actions are work-flowed, implemented and that follow up assessments undertaken.
 
ISO18001 logo
 
5. Care Quality Commission (CQC) 
 
The Care Quality Commission was established in 2009 to regulate and inspect health and social care services in England. In place to assure safety and quality, to assess the performance of commissioners and providers, to monitor the operation of the Mental Health Act and to ensure that regulation and inspection activity across health and adult social care is coordinated and managed. 
 
Care Quality Commission (CQC) with EQMS
 
EQMS allows you to easily gather the evidence required to demonstrate compliance with CQC standards. 
  • Automate tasks such as document issue and approval
  • Set dedicated staff permission levels; ensuring staff always view the right version of the right document
  • View full history and audit trails - every action undertaken is recorded noting exactly who did what and when

Watch the Qualsys video for CQC for Ambulances. An EQMS solution is also available for GP's and Care Homes.

  

 

6. Outcomes Focussed Regulations (OFR) & SRA Code of Conduct for Solicitors in England and Wales

The SRA Handbook 2011 introduces Outcomes Focussed Regulation (OFR) of solicitors in England and Wales.

It replaces reactive, rule-based regulation with a more proportionate, flexible focus on adherence to high level principles and outcomes reflecting the interests of clients and the wider public interest. 

OFR is introduced at a time of major market change, and emphasises the importance of individual regulated firms having appropriate management systems and controls and targeted governance, monitoring and risk management arrangements to ensure compliance and achievement of client-focussed outcomes.

EQMS & OFR

EQMS allows firms to ensure adherence to and acknowledgement of policies and procedures whilst lowering the costs associated with firm-wide compliance.

Flexible process controls support firm-wide governance and ensure the use of appropriate precedents, driving quality, efficiency and client handling. A filterable Incident management module enables targeted management, monitoring and reporting on risk and compliance issues.

Learn more about OFR at the SRA website 
 
Solicitors Regulation Authority 
 
7. FDA/CFR 21 Part 11
 
The 21 CFR part 11 rule is applicable to any organisation regulated by the FDA. It is a requirement to implement certain controls: including system validations, audit trails, electronic signatures, and documentation for any software or system used.
 
FDA / 21 CFR Part 11 with EQMS 
 
EQMS automates your internal processes whilst facilitating effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), and other quality and business processes. 


 
8. Sarbanes-Oxley (SOX)
 
The Sarbanes-Oxley (SOX) Act came into force in 2002 and introduced major changes to the regulation of financial practice and corporate governance.  SOX is designed to review dated legislative audit requirements to protect investors by improving the accuracy of corporate disclosures. It requires critical operational controls are documented, assessed for their effectiveness, and that the assessment report is scrutinised by independent auditors. 
 
SOX with EQMS 
 
EQMS allows you to ensure adherence to company policies and procedures whilst lowering the costs associated with compliance with SOX.  Design, evaluate and improve internal controls whilst monitoring compliance processes at any level of detail. When required, easily collate reports to provide evidence to external auditors. 
 
sarbanes-oxley
 
9. GAMP / GxP

Learn more on the Qualsys GRC Blog: Validated Computerised Quality Systems in GxP Environments

13. ITAR Compliance

The EQMS solution provides a range of features to support your organisation’s ability to comply with ITAR requirements.
 
These include:
  • EQMS uses SSL encryption and access controls to ensure only authorized users open and access EQMS documents.
  • EQMS records all access to secured content and also has a simple management interface to allow viewing of existing user privileges and controls. 
  • Comprehensive reporting is available to evidence ITAR compliance.
  • EQMS provides a range of configurable controls to enable your business to reflect changes in ITAR compliance requirements.
  • The EQMS solution can work within an encryption at rest environment.
     
In addition to software functionality, Qualsys Ltd includes the following standard clause in our terms and conditions of supply.
 


Back to top...
Some of our customers
University of Leeds
Sodexo
BT
oxford
diageo
Financial Times
BAE Systems
NHS
Hybrid Air Vehicles
Thomas Miller
SJP Law
Bettal
brigtwell
EME
GCL
XChanging
Aberdein Considine
Liverpool Direct
Lowri Beck
Monosol - Quality Context
AIZLEWOOD'S MILL NURSERY STREET SHEFFIELD, S3 8GG ENGLAND
Tel +44 114 282 3338
Fax +44 114 282 3150
E-mail: INFO@QUALSYS.CO.UK