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ISO 9001 - Quality Management Systems


ISO 9001:2008  News

ISO 9001:2000 is being amended this year and ISO 9001:2008 is due to be published in October or November 2008. The ISO has published a newsflash giving details of the transition arrangements.

The amendment has a very small impact on most users as, besides editorial changes, there are three areas to look at –

  • Outsourcing New notes help define outsourced processes and controls. Organisations should check that the have all their outsourced processes identified and that suitable controls are in place to support quality.
  • Management Representative The Management Representative now has to be a member of the organisation’s management. This means that the person has to be employed by the organisation (could be on contract), has to have the required authority and has to be shown on the organisation chart.
  • Customer Supplied Product This now includes personal data. If your organisation holds information such as credit card numbers or addresses, it now has to demonstrate that suitable data protection protocols are in place.

NSAI offer pre-registration to the ISO 9001:2008 standard based on the draft document; this means that you can be certified to ISO 9001:2008 as soon as the standard is published. Contact Audrey Cleere for a copy a copy of the checklist and be audited at your next scheduled surveillance or re-assessment audit.

ISO 9001:  Benefits

Amongst the many benefits which can be gained, ISO 9001 helps organisations to improve customer satisfaction levels, internal efficiency and employee involvement.

The key elements are:

  • Establishing the quality management system
  • Using the quality management system
  • Reviewing whether the results are satisfactory
  • Improving the quality management system

These elements are called “PLAN – DO – CHECK – ACT”

Establishing the quality management system (QMS)

Establishing the architecture of QMS is covered in clause 4.1 of the standard where it requires the identification of the processes, their success criteria, the inter-relationship between processes and the system for checking on results.  Appropriate process identification is key to a practical system and the key is to start with two processes (Management and Operations) and then decide if sub-processes are necessary rather than working “bottom up”.

Each process has to have an “owner” and the owner is responsible for the activities that relate to the success criteria of the process.

A Quality Manual is required and a number of documents and records.  The documentation should be kept to a minimum but, besides the Quality Manual, six areas of the standard require a documented procedure (a single procedure can cove multiple areas).  The areas are:

  • Document Control
  • Records Control
  • Internal Audits
  • Non-conforming Product
  • Corrective Action
  • Preventive Action

Additional procedures may be required if, without them, the processes might end up having variable or unpredictable results such as those caused by inexperienced staff, complicated parameters or other risks.  The QMS is, in essence, a system for minimizing business risks.

Records are required to show that the requirements (established through the procedures) have been met.  The standard gives a number of areas where records are required.

The Quality Policy is the area where the owners or managers of the company establish the fundamental direction of the QMS.   This can be supplemented by Vision and Mission Statements but this is not required.  Strategy should follow from the Quality Policy and from the business environment. The process success criteria should be aligned to the strategy.  Key to the strategy will be to recognize the expectations of the customer and to ensure that they are being satisfied;  it will be important that the system processes are also designed to ensure customer satisfaction.

Resources need to be put in place to provide human, technological and environmental resources.  These will include computers, processing equipment, processing areas, offices as well as trained staff.  The QMS requires that each company establish a way of demonstrating that their staff are competent.

Using the quality management system

Having established the system, it has to be used to see that it works the way it was intended.  It will be necessary to use the procedures, forms, equipment, instructions in the way that it was planned.   This should be the easy bit!

Reviewing whether the results are satisfactory

At appropriate intervals, the results of QMS should be reviewed.  The intervals will be short when the system is new but can be longer once the QMS becomes mature.  The reporting of results against the process success criteria should be regular and be used by management to ensure that the business is on track.   Records should be designed to facilitate prompt reporting as well as the early detection of problems.  Every business has some problems (or “challenges” as one may wish to call them!) and it a successful business will identify these at an early stage and deal with them in an effective manner.

Reviewing perceived customer satisfaction is a key metric that has to be reviewed.  It is recognized that the handling of complaints is not enough;  customers may just move their business to a competitor.

A key element of the review is the Management Review.  This meeting reviews whether the QMS is working and whether the results meet the strategic objectives and whether the process criteria have been met.

Improving the quality management system

Improvement is another name for dealing with the challenges of the business.  These challenges may be actual issues (such as being late with a delivery) or be about “near misses” (such as almost forgetting to make a delivery).  ISO 9001 calls these corrective actions and preventive actions respectively.    Corrective actions need to be recorded and may involve actual customer complaints;   some corrective action concerns issues with suppliers as well as issues that have arisen with the processes (non-conforming product).  Preventive action can be handled in a similar way but small companies may feel it appropriate to handle preventive action as part of their management review.

As a checklist, the following questions should be asked:

1. Customer Focus. Have you found out what the customer’s current and future needs and expectations are at a strategic level?

2. Quality Policy. Does it really suit your organisation and reflect your customer’s  expectations, your vision and mission – and the requirements of the standard?

3. Objectives.  Are all the objectives measurable and linked to both the processes and to the strategies?

4. Plan the system. Have all responsibilities been identified and communicated?  Does everyone know what they need to do to contribute to the success of the business – and the QMS?

5. Review the operation of the system at regular intervals.  Are the results of the QMS being reviewed and compared against planned results?   Is action being taken to improve areas where results are not quite as good as planned?

6.  Principles.  Management should review the 8 Principles in ISO 9000:2005 and review how well the system delivers against these.  The 8 Principles are not auditable but they are the fundamental attributes which a successful system should satisfy.

POINTERS

When establishing the system you need to be aware of these key issues:

1. Top management commitment is vital if the system is to be introduced successfully.

2. Look at what system you have in place at the moment. ISO 9001:2000 will allow you to keep the principles that work for you while refining those that don’t.

3. Top management should determine the key processes of the organisation.

4. Ensure there are good internal communication channels and processes within the organisation. Staff need to be kept informed of what’s going on.

5. Involve all your staff in the processes that your organisation uses.

6. Give some thought to process interaction. It’s important that the people within your organisation don’t work in isolation but work as a team for the benefit of the customers and the organisation.

7. The processes should be looked at as good management practice. If your organisation is well managed, the quality should be automatically achieved.

8. Don’t ignore the impact that introducing these systems will have on your customers and suppliers. Speak to them to gain insight as to how they view your service and how they feel improvements could be made.

9. Clearly lay out a well communicated plan of activities and timescales. Make sure everybody understands them and their role in achieving success.

10. Make it fun. Competitions for the first completed process that can be seen working (or similar events) will provide increased motivation.

RH Rev.11




    Last Updated - [29 Aug 2008 @ 16:27:30]

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