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:
How To Address ISO 9001– Rev 5 – August 2013 Page 1 of 8 – Copyright © 2009-2013 Qudos Management Pty. Ltd.
• • • • •
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.
How To Address ISO 9001– Rev 5 – August 2013 Page 2 of 8 – Copyright © 2009-2013 Qudos Management Pty. Ltd.
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: • • •
• • • • • • • • • • • •
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.
How To Address ISO 9001– Rev 5 – August 2013 Page 3 of 8 – Copyright © 2009-2013 Qudos Management Pty. Ltd.
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
How To Address ISO 9001– Rev 5 – August 2013 Page 4 of 8 – Copyright © 2009-2013 Qudos Management Pty. Ltd.
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
How To Address ISO 9001– Rev 5 – August 2013 Page 5 of 8 – Copyright © 2009-2013 Qudos Management Pty. Ltd.
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
How To Address ISO 9001– Rev 5 – August 2013 Page 6 of 8 – Copyright © 2009-2013 Qudos Management Pty. Ltd.
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
How To Address ISO 9001– Rev 5 – August 2013 Page 7 of 8 – Copyright © 2009-2013 Qudos Management Pty. Ltd.
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: • • •
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 Page 8 of 8 – Copyright © 2009-2013 Qudos Management Pty. Ltd.
