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QUALITY MANAGEMENT CERTIFICATION TO ISO 9001: EXPERIENCES OF A REHABILITATION ENGINEERING SERVICE

Barry R Seeger, Mark Hartridge, Rob E Garrett, Fiona McDonald, Ian R Mortimer Rehabilitation Engineering Regency Park Centre Regency Park, SA Australia

ABSTRACT

Regency Park Rehabilitation Engineering was certified in October 1995 as complying with the requirements of the ISO 9001 Quality Systems Standard. In our view, the Standard has much to offer the disability field, in terms of clarifying contractual obligations and asserting effective management practices that focus on customer service, continuous improvement, teamwork, measurement and data. This paper describes our objectives in obtaining certification, the documentation that needed to be written, the 20 elements of contractual situations that needed to be addressed, and our impressions of what we have gained. During 1996, we will move on to address Total Quality Management, and by 1998 the rest of our organisation will also achieve certification to ISO 9001.

BACKGROUND

International Standards for Quality Assurance are gaining acceptance in a wide variety of industries as a means of demonstrating confidence that an organisation will deliver what it claims to deliver.

To our knowledge, the ISO 9000 series of Quality Standards (1) has not yet been widely used in the disability field. The introduction of ISO 9000 Quality Systems to a part of the National Health Service wheelchair prescription in the U.K., with particular emphasis on the design of the clinical documentation for the referral, assessment and prescription parts of the process, appears to have been very successful (2). We have previously reported on our experiences in the period leading up to certification (3).

OBJECTIVE

Our objective was to implement AS/NZS ISO 9001: 1994. This terminology means a combined Australian and New Zealand Standard, published in 1994, being a re-badging of ISO 9001. The reasons for taking on this onerous task were:

1.  To give ourselves an external assessment of our management system at a time of change due to an exchange of services with a sister organisation. In 1993, we exchanged services with Spastic Centres of South Australia, taking our Rehabilitation Engineering staff numbers from 25 to 45 (staff numbers are now settling back to 35 as one unit is re-auspiced, maintaining its QA Certification).

2.  Government funding bodies have indicated that they will favour suppliers who have Quality Assurance Certification, and we decided to meet their wishes before they became firm requirements.

3.  Being one of the first in the disability field to be certified enhances our reputation as a centre of excellence.

METHOD

We found that by far the most intellectually difficult part of establishing a Quality System was to interpret the broad, sweeping statements in the Standard to the specific needs of a workplace, which in our case included customised orthotics, footwear and wheelchairs, importing electronic devices, a testing laboratory, therapy and assessments, and fundraising. We found that preparing a Policy Manual was fairly easy because it only needed to be quite general.

The Procedure Manual was the most difficult part. It contains the following 20 elements, and we found the following questions to be useful prompts:

1. Management Responsibility

Have all staff seen and understood their responsibilities in the QA Procedure Manual? Have all staff used a non-conformance report to improve our service?

2. Quality System

Do all staff know where the Quality documents are kept?

3. Contract Review

Are you clearly defining all customer requirements and how? Are you using a contract review stamp for every new job?

4. Design Control Is a design brief form used to begin the design process? Do new designs go through a formal specification, verification and validation procedure?

5. Document and Data Control

Are our procedures and work instructions controlled to make sure you have the latest version?

6. Purchasing

Is your schedule of suppliers kept up-to-date with any supplier problems? Are there clear limits on who can authorise what amount of expenditure?

7.  Control of Customer Supplied Product

How would you know if you had damaged a client's equipment?

8. Product Identification and Traceability

How do you label or tag products in order to identify and trace them?

9. Process Control

Are the important parts of your work procedures documented?

10. Inspection and Test

Is your work checked appropriately?

11. Control of Inspection Equipment

Is equipment or software that is used to measure products or client performance checked?

12. Inspection and Test Status

How would you know whether a particular job had been checked?

13. Control of Non-Conforming Product

How do you prevent a sub-standard product from being issued?

14. Corrective and Preventative Action

How do you correct a mistake? How do you prevent it from recurring?

15. Handling, Storage, Packing and Delivery How do you look after product so that it reaches the client in good order?

16. Control of Quality Records

How are quality records preserved?

17.  Internal Quality Audits

How do you schedule them and keep the records?

18. Training

Are staff educated, trained and experienced in the work they do? Where are training records kept?

19. Servicing

Does not apply to us.

20. Statistical Techniques If you sample, how do you establish that the sample represents the whole population?

Procedures that are important to the quality of the product or service you provide, but which relate to only a part of your organisation, need to be documented in Work Instructions, which are referenced in the appropriate element of the Procedure Manual.

RESULTS

Before inviting the certification body to audit your system, you are required to conduct your own internal audit. It then becomes clear that ISO 9001 is really an elaborate checklist using the questions above and many more besides. The two questions that auditors have to ask are:

Do your written procedures say that you comply with the 20 elements of ISO 9001?

Can you prove by written records that you follow your own procedures?

At both our internal audit and our external audit, we found areas that needed improvement. We passed the external audit at the first attempt.

There have been several positive results for us in having achieved ISO 9001 certification:

1. The Standard directs our minds towards the many aspects involved in the contractual obligation known as customer service.

2.  It sets up a clear system for achieving continuous improvement: staff are expected to raise non-conformance reports when something goes wrong, and management is expected to ensure that that incident is corrected and that recurrences are prevented.

3.  Management teamwork was strengthened through the need to achieve consistent interpretations of the Standard and establish systems that were compatible between departments.

4.  Objective measurement of performance and a statement of goals are encouraged. Trying to meet our own performance objectives required changes which caused stress in the short term in some areas of our operation. In the medium term, we expect to achieve better customer service in those areas.

5.  A procedure manual now exists which is very specific and which assists in the induction of new staff.

6.  We are using supplier schedule entries to feed back any difficulties to suppliers, with the aim of improving customer service.

7.  Our design process has been made more formal, involving more teamwork, and we keep better records of progress on projects.

The major difficulties are in interpreting ISO 9001 to your own organisation, and in making the time available to document your current processes and to improve them where necessary to meet the requirements of the Standard. We are very glad to have all that behind us.

DISCUSSION

Quality Assurance is:

How we organise, supervise, manage, and check our work. How we meet or exceed customer expectations, and How we avoid the common mistakes in contractual situations.

We have found it a useful exercise, and it will be a good discipline for us to have an external review team come in and check our management system against an elaborate checklist every 12 months, in addition to the internal audits we are required to do on the alternate 6 months.

We have also laid the foundations for moving on to Total Quality Management for continuous improvement, in which we will have to continually upgrade the extent to which we meet each of these basic measures:

1.  Quality is defined in terms of customer perceptions.

2.  The system is enhanced by improving processes within the system.

3.  Suppliers and contractors are treated as partners in the system.

4.  Statistical thinking and methods are used to manage and reduce variation.

5.  All people are creatively involved in continuous improvement of the system.

6.  Continuous improvement activities are integrated with the strategic and annual planning cycle.

7.  Continuous improvement is led, managed and supported at all levels in the organisation.

Regency Park Rehabilitation Engineering is a division of the Crippled Children's Association of SA Inc, and the remainder of that organisation intends to achieve Quality Assurance Certification by 1998.

REFERENCES

AS/NZS ISO 9001:1994, published by Standards Australia. Richardson, P and Calder D. Quality Management Systems in Wheelchair Prescription, Proceedings of RESNA Conference, 68-70, 1995. Hartridge, M and McDonald F. 9001: A Quality Odyssey. Proceedings of 2nd Australian Conference on Technology for People with Disabilities, 267-269, 1995.

ACKNOWLEDGMENTS

The authors are indebted to ACROD for their seminars on Quality Assurance and to the Phoenix Society for demonstrating Quality Certification in the disability field.

Dr Barry R Seeger Regency Park Rehabilitation Engineering PO Box 2438 Regency Park SA 5942 Australia Ph: Int + 61 8 243 8261 Fax: Int + 61 8 243 8208 Email: Barry_R._Seeger@eol.ieaust.org.au

QUALITY MANAGEMENT CERTIFICATION