Quality Management & Quality Consultancy

For companies choosing for the first time to recognise their systems and processes, maybe to become more recognised in the marketplace, or to meet supplier demands. There are many recognised standards that businesses can adopt according to the industry sector you operate in, and cover anything from making a product, managing a process, delivering a service or supplying materials – standards can cover a huge range of activities.

At Integral Management Systems, we have many years of experience of what goes into making an efficient and effective management system that complies with applying the following standards:

TickITPlus – A process framework that allows organisations to select appropriate processes from a set of defined scope profiles from within a Base Process Library (e.g. Systems & Software Development, Security Management etc).

We can help you establish the essential process requirements and give support and guidance in the development of your management system to satisfy TickITPlus at Foundation level, or to the Capability Levels of Bronze & Silver.

ISO9001 Quality Management System – ISO 9001 is the internationally recognized Quality Management System (QMS) standard that can benefit any size organization.

We can help you establish the essential process requirements and give support and guidance in the development of your management system to satisfy the latest revision of ISO9001:2015.  In addition, we can assist in performing Gap Analysis of your newly formed or existing management system prior to formally applying for certification.

Medical devices — Quality management systems — Requirements for regulatory purposes – The ISO 13485 standard is derived from the internationally recognized and accepted ISO 9000 quality management standard series requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

We also have experience in ISO13485 Management Systems and product requirements.

Please note: For TickITPlus and ISO9001 & ISO13485, formal certification can only be achieved through registered bodies such as LRQA, BSI, DNV etc.

 

Training workshops

See our Training Page for the latest training courses and workshops.

 

Capability & Maturity Model Integrated ®

The Capability Maturity Model Integration (CMMI®) is a world-class performance improvement model for competitive organizations that want to achieve high-performance operations. Building upon an organization’s business performance objectives, CMMI provides a set of practices for improving processes that allows organisations to operate more effectively and improve the maturity of its processes.

We can assist your organisation in Implementing Management Systems and associated processes to address the Capability Maturity Model Integrated (CMMI-DEV) as we have experience in the model requirements as well as performing appraisals.  Working in partnership with Omniprove, we can assist you in planning appraisals to SCAMPI Class A, B and C.

CMMI is registered trademark of the CMMI Institute.

 

Internal Improvement Programmes

When organisations are faced with internal problems or ongoing issues, and often when there is a lack of time or resource to investigate further, it is useful to step back and get an independent viewpoint on what may be happening.

We have previous experience in using basic and advanced Six Sigma statistical tools to analyse common problems and their root causes. Often problems can be solved with staff involved in the process or stakeholders, and we can help facilitate short workshops or sessions to identify causes, risks and potential corrective actions.

 

Gap analysis and Compliance Auditing

If your organisation is building up to a certification assessment, it is useful to get an understanding of how well the Quality Management System implementation stands-up against the standards requirements. This can be achieved by either a sampling of processes or areas of concern within the client organisation, or through a more extensive full baseline audit across all processes in scope, and would be agreed with the client as to what extent they wish to cover.

A Gap Analysis would typically be:

  • Discussions with Senior Management and Stakeholders
  • A check of Management System process documents and their associated mapping to the standard requirements
  • Producing a management report highlighting the areas of compliance and/or any gaps with actions and recommendations for addressing prior to moving forward with any formal certification activities
  • Provide ongoing support and dialogue to the client organisation on corrective action proposals being worked on to ensure that these issues are effectively resolved
  • Recommendations on best practice for process based on industry experience as appropriate

Quality Engineering

Occasionally, depending on availability and needs of a client, we will undertake short term contract work in Quality Management & Quality Engineering disciplines within the following areas:

  • Medical Device companies operating under ISO13485 standard, GMP requirements and FDA regulation, and specialising in Software Validation, Risk Assessment, DHF maintenance.
  • Aerospace – software development, typically embedded software systems as well as general manufacturing/engineering requirements to ISO9001/AS9100 requirements
  • General Quality Management activities within manufacturing/engineering, auditing