ISO 9001 Quality Management Systems & ISO 17025 certification implementation

The advantages, disadvantages and requirements of the ISO 9001 International Standard are much talked about in business circles though still not well understood, even after being around since 1987.

In the global market place organisations are now willing and able to buy and sell locally, nationally and internationally but how do they know, what assurance do they have, that when they deal with you, that your organisation 'can do what you say you can do'. Of course there is no substitute for direct experience with your organisation, yet this is not available to customers until after the contract has been signed and the first consignment delivered? It may be too late for them by then, so what options are left for your customer? The customer may ask others about you and get a jaundiced view, may come out and inspect your facilities which is very expensive or your customers may seek independent confirmation that you have a system in place which should enable you to perform as you say it can perform. This is the basis of 'Certification' to an ISO9001 International Standard.

Market Pressures

Many customers, internationally and nationally, are now requesting and indeed requiring that suppliers achieve 'Certification', the term used for organisations meeting the ISO 9001 standard, to demonstrate that they 'can do what they say they can do'. Certification is achieved through an independent auditing process to assess the compliance of your organisations systems, called the Quality Management System, to the international standard by an independent accredited International Certification Body such as QMS Certification Services.

Following successful audit, a 'Certificate of Approval' is issued by the Certification Body, this is the proof of 'Certification' to the ISO 9001 standard and is taken to provide a measure of assurance of your capability to meet the contractual requirements. Your organisation is then placed on a register of certified organisations available to customers throughout the world.

Following Certification you have proved to customers, employees and competitors alike that your claims to being an organisation committed to quality in its operations are justified and that you have a system in place which has the capability to perform as expected.

The advantages are not only external, internally the process of implementation and on-going maintenance of a Quality Management System often bring about improvements in operational effectiveness and the international standards have a built in continuous improvement methodology of incident investigation, taking corrective action to resolve the root cause of the problem, self audit and management review. Commonly quoted is a 10% increase in Return On Investment (ROI) for certified organisations over those not certified.

Following Certification you should immediately take time to capitalise on the effort expended by all of your personnel through rigorous marketing of your achievement and also to review your system with the aim of improvement to drive down cost and improve efficiency.

Some of the Benefits

The advantages of being an 'ISO 9001 APPROVED COMPANY' are many and varied, some of which are:

• Market differentiation and competitive advantage;
• Meeting basic tender requirements to be certified to an ISO9001 standard;
• Proven that your claim to quality commitment and operational quality are firmly based upon independent assessment and certification by QMS;
• Reduction of liability exposure;
• Safety system compatibility;
• Continuous improvement and cost efficiency;
• Improved organisational morale.

What accredited certification to ISO 9001 means

To achieve conforming products, the accredited certification process is expected to provide confidence that the organization has a quality management system that conforms to the applicable requirements of ISO 9001. In particular, it is to be expected that the organization:

has established a quality management system that is suitable for its products and processes, and appropriate for its certification scope.

analyzes and understands customer needs and expectations, as well as the relevant statutory and regulatory requirements related to its products.

ensures that product characteristics have been specified in order to meet customer and statutory/regulatory requirements.

has determined and is managing the processes needed to achieve the expected outcomes (conforming products and enhanced customer satisfaction).

aims to prevent nonconformities, and has systematic improvement processes in place to: 1. Correct any nonconformities that do occur (including product nonconformities that are detected after delivery) 2. Analyze the cause of nonconformities and take corrective action to avoid their recurrence 3. Address customer complaints.

has implemented an effective internal audit and management review process.

is monitoring, measuring and continually improving the effectiveness of its quality management system.

What accredited certification to ISO 9001 does not mean

It is important to recognize that ISO 9001 defines the requirements for an organization’s quality management system, not for its products. Accredited certification to ISO 9001 should provide confidence in the organization’s ability to “consistently provide product that meets customer and applicable statutory and regulatory requirements”. It does not necessarily ensure that the organization will always achieve 100% product conformity, though this should of course be a permanent goal.

ISO 9001 accredited certification does not imply that the organization is providing a superior product, or that the product itself is certified as meeting the requirements of an ISO(or any other) standard or specification.

What’s next? How can HKCT assist you in the above?

HKCT can provide you an obligation free assessment of your facility to set you on your path to being certified to either ISO9001 or ISO 17025.

We will provide you a cost structured to achieving your desired certification and an estimate of costs.

Because HKCT has a strong presence around Australian capital cities, we are also able to provide you a cost effective cost related to your instrument calibrations as required by the standards.