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How to address the ISO 9001 Quality Management Standard - Faster, better, and Smarter

 

How to develop and maintain an ISO 9001 Quality Management System faster, better, and smarter

ISO 9001 is an international standard that sets out a model for implementing an effective Quality Management System (QMS). It is the most widely accepted model for quality systems. Although there are other standards and models, these tend to be variations on a similar theme.

A quality system is intended to help an organisation to systematically meet the requirements of customers and other stakeholders. As such, it makes good business sense – but can require a bit of organising. Many a well-intentioned system has floundered due to its design making it difficult to input data or get meaningful information out, and time-consuming to administer. Lets’ face it, we all have busy lives these days, and a quality system needs to be as efficient as possible. The good news is that there is a dedicated software solution available!

Developing your system can be quite a major project. Like any such project, it may at first appear to be daunting and too complex to get a firm grip on. However, it can be more easily managed by being divided into bite-sized pieces. The following is an example of how that can be done. Initially the project is divided into 5 stages:

Organisations have traditionally developed control measures to meet applicable legal, regulatory and contractual requirements. There is a trend towards greater 'systemisation' and basing the system on the ISO 9001 standard. Of course, you still need to meet those legal, regulatory and contractual requirements. The intention of a standards-based system is to provide a solid base for your organisation to consistently comply with them - now and into the future.

There are a number of development options available to you, and each has its own particular advantages. The development option that you choose will affect your method of system development. Consultants and other sources of external help will have their own standard methodologies. The options include:

  • Working on your own
  • Using a consultant
  • Attending workshops / training courses
  • Using a software package
  • A combination of the above

A Gap Analysis and Project Plan may be prepared to guide and record progress.

The documentation stage may include preparing:

  • Policies
  • Procedures
  • Project-specific plans
  • Forms
  • and other documents

Documenting a system from scratch can take up a great deal of time – particularly if it’s a task that you are not used to. However, remember that the documentation should be appropriate to the nature of your organisations’ activities and the risks associated with its operations.

Of course, documents only form a part of a system. They are a means to an end - not an end in themselves. People, their commitment, and the training / resources / methods they are provided with are vitally important.

To be of maximum true value, your system needs the broad support of people within your organisation. This is often best achieved with a softly, softly approach - consultation, communication, then participation in introducing changes. The following guidance may be useful:

One senior person should have overall authority and responsibility for managing the system

In larger organisations, a team of co-ordinators or local representatives can assist them.

Consult and communicate with employees
Apart from being a requirement of the standard, this can help to allay any fears and suspicions that people may have about the reasons for process and/or organisational change.

Participation should be encouraged
All employees have a role to play. Workload can be shared and a range of ideas can come from people with different perspectives.

Results should be monitored, and the system fine-tuned as you go.

Following the principle of the PDCA (Plan-Do-Check-Act) cycle, having planned our system and put it into practice, we need to check or verify that it is working effectively.

All control systems need feedback mechanisms to help their controllers keep the system on track. Management systems are no exception, and internal audits are their key feedback mechanism. To illustrate the importance of internal audits, they are a mandatory requirement of the ISO 9001 standard. Audits offer a very beneficial and low-cost method to help your organisation maintain compliance, and achieve its objectives. There are also other aspects of verification, including measurement and monitoring, surveys, and periodic review by top management.

For a new system, or one that has had a major upgrade, it would be good practice to audit the system thoroughly after quite a brief period of implementation. It is quite likely that a little bit of fine-tuning to your system will be necessary. After that, your audit schedule may be on a risk basis - with those processes that are most important or that have had problems in the past being audited more regularly than others. You may also choose to have an external audit of your system by a certification body or registrar.

Results of audits and other verification techniques should be fed back to the management review process, for top management to consider progress, and plan any remedial action or perhaps set new objectives.

Introducing Qudos 3

Qudos 3 is probably the world’s most comprehensive software for the effective long-term operation of a quality system. It will help you meet the requirements of ISO 9001 faster, better and smarter.

Qudos 3 provides a task-based, modular approach - Helping you set up your system quickly and run it cost-effectively. Its combination of web and SQL database technology offers multi-site/off-site capability to:

 

 

 

 

Plan Objectives/targets and how they will be achieved 
Document policies, procedures, forms, letters etc. with our huge 
library of samples and templates 
• Make documents easily accessible over your intranet or internet – 
with powerful search facilities to find the right document 
quickly and easily 

• Plan and record document reviews and revisions 
• Schedule and record internal audits 
• Schedule and record equipment checks and calibration 
• Plan and record minutes of management review and other 
meetings
, and distribute them 
• Maintain records of training and employee development 
Assess performance of your quality-related activities - or those 
of your suppliers / contractors 
Consider and evaluate risks that might affect the quality of 
your products or services 
• Record nonconformances, issues, customer complaints 
and suggestions 

• Plan preventive / corrective / improvement action and 
then assign, record and track those actions 
Remind people about tasks that are due / overdue with 
automated emails 
Escalate overdue actions 
Create Reports in pie, bar and tabular form 

 

Qudos 3 includes an integrated Quality Manager Toolkit – packed with sample documents, training materials and other resources. Independent research has confirmed that Qudos 3 offers the most comprehensive suite of tools to help you develop and maintain a management system that complies with ISO 9001 faster, better and smarter.  The following chart illustrates how.

 

 

 

 

 

 

 

Qudos 3 modules

 

 

Objective

Documents

Audits

Actions

Meetings

People

Training

Risk

Benchmark

Quality Manager

 

ISO 9001 Requirements

 

Notes

 

Clause 4 General Requirements

Documentation

 

 

 

 

 

 

 

 

 

P

Guidance on requirements, and methods of creating documents. Comprehensive collection of sample documents.

Control of documents

 

 

 

 

 

 

 

 

 

P

Guidance on requirements, and sample procedure

 

 

P

 

 

 

 

 

 

 

 

Master Document List to provide easy and controlled global access to the current version of policies, procedures, and any other important documents.

Global list of distribution for any hard-copies.

 

 

P

 

 

 

 

 

 

 

 

Revision control - maintaining a history for each individual document.

 

 

P

 

 

 

 

 

 

 

 

Automated archiving facility to look after superseded versions of documents.

Maintains searchable lists of revisions and deletions.

 

 

P

 

 

 

 

 

 

 

 

Automated scheduling of document reviews.

Email reminders to document owners.

Record of review findings.

Control of records

 

 

 

 

 

 

 

 

 

P

Guidance on requirements, and sample procedure

 

P

P

P

P

P

P

P

P

P

 

Records for all modules maintained in centralised, robust SQL server database

Clause 5 Management responsibility

Quality Policy

 

 

 

 

 

 

 

 

 

P

Explanation of requirements and sample policy statements

 

 

P

 

 

 

 

 

 

 

 

Policy statement maintained and made available via Master Document List.

Planning / Quality Objectives

 

 

 

 

 

 

 

 

 

P

Explanation of concept / requirements, gap analysis, planning tools, and sample procedures

 

P

 

 

 

 

 

 

 

 

 

Recorded in Objective Details Form. Objectives may be established, described, assigned to a responsible person, quantified for priority against 4 user-definable drivers, assessed for progress, and include an attached external document.

 

 

 

P

 

 

 

 

 

 

 

Each Objective may generate up to 100 separately tracked Action plans. Actions List includes a category for "Raised by Objective" - enabling the list to be filtered and queried to provide custom reports.

Responsibility and authority

 

 

 

 

 

 

 

 

 

P

Sample Organisation chart, Table of Authorities, and Job descriptions

 

 

P

 

 

 

 

 

 

 

 

Documents maintained and made available via Master Document List.

Management review

 

 

 

 

 

 

 

 

 

P

Explanation of requirements and sample procedure

 

 

 

 

 

P

 

 

 

 

 

Management reviews scheduled and recorded in Meeting Minutes. Default agenda provided. This may be customised as required.

Agenda / minutes may be emailed to all attendees - with separately tracked actions for each agenda item. A training presentation on meeting management is included.

 

 

 

 

P

 

 

 

 

 

 

Each Discussion item may generate up to 100 separately tracked Action plans. Actions List includes a category for "Raised by Meeting" - enabling the list to be filtered and queried to provide custom reports.

Clause 6 Resource management

Competence, awareness and training

 

 

 

 

 

 

 

 

 

P

Explanation of requirements and sample procedures and other documents

 

 

 

 

 

 

 

P

 

 

 

Training records are created for each person in the organisation. These are maintained in the Training Schedule, and may be queried for planning / review purposes.

 

 

 

 

 

 

P

 

 

 

 

Individual Development Plans may be created for each employee. This provides a tool for planning their development path and assessing progress against targets. Password-controlled sign-off by the individual and 2 levels of management.

 

 

P

 

 

 

 

 

 

 

 

Induction checklist template and other documents promoting staff awareness of quality issues maintained in Master Document List

Infrastructure and work environment

 

 

 

 

 

 

 

 

 

P

Various maintenance / equipment status workbooks

 

 

 

P

 

 

 

 

 

 

 

Housekeeping and other checks recorded in Audit record

 

P

P

P

P

P

P

P

P

P

P

The software itself provides infrastructure for the quality management system

 

 

 

 

 

P

 

 

 

 

P

Consideration of infrastructure needs and the work environment may be included in Management Review meetings. Guidance and sample procedure are in the Quality Manager toolkit, and the process is managed in the Meeting module

 

 

 

 

P

 

 

 

 

 

 

Issues relating to infrastructure or work environment may be raised as Actions

Clause 7 Product realization

Customer-related activities, design and purchasing, product and service provision

 

 

 

 

 

 

 

 

 

P

Explanation of requirements and sample procedures and other documents

 

 

 

 

 

 

 

 

P

 

 

Risk Assessments of contract and design activities

 

 

 

 

 

 

 

P

 

 

 

Records / refresher reminders for licences & repeatable training

 

 

 

P

 

 

 

 

P

P

 

Assess suppliers using Benchmark Assessment, Risk Assessment, and/or Supplier Audits

Statutory and regulatory requirements

 

P

 

 

 

 

 

 

 

 

Maintain register

 

 

 

 

 

P

 

 

 

 

 

Consider at Management Review

Calibration / maintenance of monitoring and measurement equipment

 

 

P

 

 

 

 

 

 

 

Schedule and record as types of Audits

Clause 8 Monitoring, measurement and improvement

Customer satisfaction

 

 

 

 

 

 

<

 

 

Integration 

With its modular design, high level of user-configuration, robust SQL database and web technology, Qudos 3 offers 
the power of integration of: 
 
• Your key activities for addressing the standard 
• Similar activities for other standards and compliance issues (OHSAS 18001 or AS/NZS 4801 Health & 
  Safety / ISO 14001 Environment etc.) 
• Activities relating to one or many sites 

The tools are here right now to help you make an immediate start on developing faster, better, smarter 
management system. Qudos 3 is available as Self-hosted server-based software, or cloud hosted with fully licenced 
or leased options. 
 
Gap analysis, coaching, training and system development / maintenance services are also available from Qudos 
and its partners. Contact us to find out more. 
 
Qudos Management Pty. Ltd. 
Quality | Health & Safety | Environmental management 

Level 36/71 Eagle Street, Brisbane, QLD 4000
Tel: +61 (07) 3121 3200
Email: info@qudos-software.com
Web: www.qudos-software.com