kms software

 

QMS software

QMS software: what does ISO 9001:2015 change in the use of Quality Management System - QMS software tools in quality management in accordance with the quality standard ISO 9001. (And of course also with ISO 14001:2015, ISO 27001:2022, ISO ...)
Some important elements are reviewed below.

First of all, the new and mandatory risk management process within the QMS. It is a cyclical process, which must be repeated periodically (often annually): (re)assessing risks, determining measures, updating the risk treatment plan and finally determining the residual risk. To properly embed this in the organization, more is needed than a simple spreadsheet. Especially if there are multiple stakeholders involved, each with their own actions. In Proware (an application within the Metaware platform), the cycles of documentation and risk management are integrated with the Risk Management software module . Watch the video for more clarity.

Accessibility of documentation (policy, process descriptions, procedures, work instructions, etc.) has also become increasingly important within quality management. With the new ISO9001:2015 standard, there has been a shift towards organization-wide  understood policy and familiarity with relevant (process) documentation. The now well-known 'documented information'. Top management plays an important role in this.
Insight into the lifecycle of the various (quality) documents is very valuable. Supplemented with operational data on the use of documents, management can steer this to get 'quality in the mind' of all employees.

The mandatory 6 procedures from ISO9001:2008 have disappeared, but have been replaced by the aforementioned 'documented information'. Documentation is therefore still needed within quality management in the following areas.
(Click here for an ISO 9001:2015 digital checklist)

 

    Standard QMS - quality management systems
PDCA circle Paragraph ISO 9001:2015
Plan 4.3 Determine the scope of the quality management system
4.4 Quality management system and its processes
5.2.2a Quality Policy
6.2.1 Quality objectives and the planning to achieve them
7.1.5 Resources for monitoring and measurement
7.1.5 Control of monitoring and measurement equipment
7.2 Competence
     
Thu 8.1e Operational planning and control
8.2.3 Assessment of requirements of products and services
8.3.2g Planning of design and development
8.3.5 Design and development outputs
8.3.6 Changes related to design and development
8.4.1 Control of externally delivered processes, products and services
8.5.1 Control of production and delivery of services
8.5.2 Identification and traceability
8.5.6 Change control
8.6 Release of products and services
8.7 Control of abnormal outputs
     
Check 9.1.1 Monitoring, measuring, analysing and evaluating
9.2 Internal audits
9.3.1 Management review
     
Act 10.2.2 Deviations and corrective actions
     
PDCA circle Paragraph ISO 9001:2015

 

In short, more freedom in the design of all documentation, but control of the necessary documentation remains. And risk management is part of that.

QMS software as a platform

Your QMS - Quality Management System has been around since the 90's. First as pApieren manual for all department managers, far too detailed because everyone had recorded all their activities. Later they became digital PDF documents on the central disk. Word documents were provided by the authors and they made the PDFs. But everything is still too detailed. Risk-based management on your goals became the new approach. If you know where your risks lie, what your goals are and how you are performing yourself, you have focus. You can focus on the important things and leave out unnecessary ballast in your described management system, the old 'handbook'. You will link the described management system with the registrations obtained.
What used to be your (quality) handbook is now a management system platform. More comprehensive: quality, safety, environment, information security, .. It is an integrated environment for the described processes, the risk analysis with control measures, all workflow processes and last but not least the performance - the dashboard.

 

Management system - the maturity stages

Good to know where you stand. The stages of a management system can be described in a number of steps:

  1. Ad hoc
    The understanding of quality management is limited. The quality control of processes is fragmented and problems are widely ignored. There is a lot of ignorance in terms of quality and there is a belief that everything is good. Formally, there are no responsibilities and accountability is not given. Documentation of processes and practices is limited and often outdated. Communication by e-mail and access to quality data and documentation is difficult.
    Tooling: We have already passed this stage.
     
  2. Reactive
    In addition to the quality manager, only a limited number of people are involved in quality management. Quality data is collected in a limited way, usually in separate spreadsheets. Users wait for problems to occur and only then react. Important quality problems are recorded, but not yet sufficiently analyzed to prevent recurrence. There is no integration yet.
    Tooling: A simple quality system for a limited number of people
     
  3. Managed
    Quality management is important throughout the organization, not just for the quality manager. Audits and controls are carried out regularly. KPIs have been introduced and are being steered accordingly. Ownership and responsibilities have been established. 
    Tooling: Version management active, revision rolled out, navigation structures, audit system, registration, checklist ISO9001
     
  4. Proactive
    Quality data is available and accessible throughout the organization. Working methods are up-to-date and laid down in a practical way and also accessible throughout the organization. Problems are recognized and analyzed. Actions are identified and implemented to prevent recurrence. 
    Tooling: Monitoring the use of the management system, reports; incident – > problem, 5W's / 8D, risk process, various workflowsfor checklists, assessments, approvals
     
  5. Integrated and optimized.
    Quality management is a spearhead and a value within the organization. A full process integration supports proactive, risk-based quality decisions. Quality data is correlated with each other, if necessary with artificial intelligence. Collaboration is the key to success to drive positive business and customer outcomes. 
    Tooling: Integrated environment, knowledge base, risk analysis at relevant places/activities, risk carousel, quality calendar, FOBO  analyses, dashboards 

    concept kwaliteitssysteem

 

Features

A management system is broad in scope: the description of the processes versus the operational implementation. In fact, the well-known slogan: 'Say what you do and do what you say.' A management system is therefore made up of various components: the descriptive part with document management and references to required standard items, the risk overview including risk treatment plan and then all related control processes (handling deviations, audits, complaints procedure, check operational excellence, ..).

An overview of 'standard' functionalities of a mature KMS software:

Navigation / Search
  • Index of all documents
  • Overviews per function, process, standard item, ..
  • My documents, which I have something to do with
  • Last consulted by me
  • Trending documents within the organization
  • Recently searched within the organization
  • Full text search with filtering and search suggestions
Workflow control
  • Workflow processes for review, authorization, modification
  • Self-definable workflow if required
  • Read receipt if registration is important (e.g. safety instructions)
  • Quality calendar to structure activities
Risk-based
  • Overview of threats, risks with classification
  • Risk mitigation controls
  • Assessment of the effectiveness of operational measures
Integration
  • Bringing together 'say what you do' and 'do what you say'
  • Documentation and registration in a
  • One platform as access, but linked to other environments
  • Access from different devices: desktop, tablet, mobile
Expandable
  • Self-definable forms
  • Multiple applications within the same platform
  • For every work area, activity and own working environment
Monitoring
  • Consultations by document, by type, by period
  • Not found, but searched for
  • Never used documents
  • Knowing what is being looked at
  • Self-definable graphs
  • Personalized widgets
  • Registering weaknesses and specifically monitoring them
Chain / Mobile
  • For customers, who have to 'watch'
  • For subcontractors who are required to read instructions (mandatory)
  • Using corporate documents together
  • At the project location, on your phone
  • At the client's bedside, on your tablet

 

Interested in KMS software?
Just for fun, set up our platform in 60 seconds as a test, KMS software for adult management systems: documentation, risk analysis, complaints, problem reports, audits, supplier management, ... And look for the differences with your current way of working ...

 

 Metaware platform

 Characteristic

  • Fully integrated and modular platform for documents, risks, complaints, improvements, audits
  • Immediately deployable SAAS sovereign cloud software
  • Supports common quality standards such as ISO 9001 with the PDCA cycle

 Motivation

  • Overall picture of 'quality manual' versus checks, inspections, audits
  • Proven compliance
  • Lower maintenance burden

Decision factor

  • High ease of use through visual navigation and clear interfaces
  • Friendly licensing model based on core users and combination discounts

 

Demo systems:

Automatically log in to one of the demo systems and experience how it works:

ISO 9001 - Quality and risk management 

HKZ - Quality Care

VCA - Safety 

ISO 27001 - Information Security 

BIO - Government Information Security Baseline 

NEN 7510 - Information security