Qudos Management Pty. Ltd. Quality | Health & Safety | Environmental management

Qudos Management Pty. Ltd.
Quality | Health & Safety | Environmental
management
320 Adelaide Street, Brisbane, QLD 4000
Tel: +61 (07) 3010 9259
3 Spring Street, Sydney, NSW 2000
Tel: +61 (02) 8249 4670
Email: [email protected]
Web: www.qudos-software.com
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 wellintentioned 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:
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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:
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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.
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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. They 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 costeffectively. Its combination of web and SQL database technology offers multi-site/off-site capability to:
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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.
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Quality Manager
Benchmark
Risk
Training
People
Meetings
Actions
Audits
Documents
Objective
Qudos 3 modules
ISO 9001 Requirements
Notes
Clause 4 General Requirements
Documentation
Control of documents
Control of records
Clause 5 Management responsibility
Quality Policy
of requirements and
Explanation
sample policy statements
Planning / Quality Objectives
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Guidance on requirements, and
methods of creating documents.
Comprehensive collection of sample
documents.
Guidance on requirements, and
sample procedure
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.
Revision control - maintaining a
history for each individual document.
Automated archiving facility to look
after superseded versions of
documents.
Maintains searchable lists of revisions
and deletions.
Automated scheduling of document
reviews.
Email reminders to document owners.
Record of review findings.
Guidance on requirements, and
sample procedure
Records for all modules maintained in
centralised, robust SQL server
database
Policy statement maintained and
made available via Master Document
List.
Explanation of concept /
requirements, gap analysis, planning
tools, and sample procedures
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.
Quality Manager
Benchmark
Risk
Training
People
Meetings
Actions
Audits
Documents
Objective
Qudos 3 modules
ISO 9001 Requirements
Notes
Responsibility and authority
Management review
Clause 6 Resource management
Competence, awareness and
training
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.
Sample Organisation chart, Table of
Authorities, and Job descriptions
Documents maintained and made
available via Master Document List.
Explanation of requirements and
sample procedure
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.
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.
of requirements and
Explanation
sample procedures and other
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documents
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.
Individual Development Plans may be
created for each employee. This
provides a tool for planning their
development path and assessing
progress against targets. Passwordcontrolled sign-off by the individual
and 2 levels of management.
Induction checklist template and
other documents promoting staff
awareness of quality issues
maintained in Master Document List
Quality Manager
Benchmark
Risk
Training
People
Meetings
Actions
Audits
Documents
Objective
Qudos 3 modules
ISO 9001 Requirements
Notes
Various maintenance / equipment
status
workbooks
Infrastructure and work
environment
Housekeeping and other checks
recorded in Audit record
The software itself provides
infrastructure
for the quality
Clause 7 Product realization
Customer-related activities,
design and purchasing,
product and service provision
of requirements and
Explanation
sample procedures and other
documents
Risk Assessments of contract and
design activities
Records / refresher reminders for
licences & repeatable training
Assess suppliers using Benchmark
Assessment, Risk Assessment, and/or
Supplier Audits
Maintain register
Statutory and regulatory
requirements
management system
Consideration of infrastructure needs
and the work environment may be
included in Management Review
meetings – discussed in Quality
Manage toolkit and managed in
Meeting module
Issues relating to infrastructure or
work environment may be raised as
Actions
Calibration / maintenance of
monitoring and measurement
equipment
Clause 8 Monitoring, measurement and improvement
Customer satisfaction
Consider at Management Review
Schedule and record as types of
Audits
Internal Audits
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Record surveys in using Benchmark
Assessment
Explanation of requirements and
sample procedures included in
Quality Manager toolkit
Audit Schedule and records. Facilities
to replicate checklists + Audits
training presentation.
Each Audit item may generate up to
100 separately tracked Action plans.
Actions List includes a filter for
Actions raised by audit - enabling
custom reports to be generated.
ISO 9001 Requirements
Notes
Monitoring and measurement
of processes and product
Control of nonconforming
product
Corrective action.
Preventive action.
Improvement.
Quality Manager
Benchmark
Risk
Training
People
Meetings
Actions
Audits
Documents
Objective
Qudos 3 modules
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Auditor training records planned and
maintained in Training Schedule and
course records. Optional, certified onsite training facilities available.
Benchmark assessments for userdefined applications
Record in Action forms
Action Forms are used to record
suggestions, actual and potential
non-conformances, action planned,
action Taken, and any follow-up. Up
to 99 related actions may be
generated for root cause analysis etc.
Each may be separately assigned,
and emailed. The Actions List may be
queried in numerous combinations to
generate custom reports.
Integration
With its modular design, high level of user-configuration, robust SQL database and web technology, Qudos 3 offers
the power of integration of:
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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
320 Adelaide Street, Brisbane, QLD 4000
Tel: +61 (07) 3010 9259
3 Spring Street, Sydney, NSW 2000
Tel: +61 (02) 8249 4670
Email: [email protected]
Web: www.qudos-software.com
How To Address ISO 9001– Rev 5 – August 2013
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