What is ISO 9001?
ISO 9001 is an internationally recognised standard of quality. It is used by many organisations as a way to prove it has a sufficiently robust and mature set of systems and procedures, which are being followed. The ISO 9001 seal is recognised as a strong indication of consistency and reliability.
Who uses ISO 9001?
ISO 9001 is becoming a prerequisite for an ever-increasing number of state and federal government departments both within Australia and overseas. For Importers and exporters it is becoming an essential gauge of an established and reliable supplier. More and more governments overseas are using ISO 9001 as a form of regulation of importers.
ISO 9001 is the basis for many industry standards, such as the Feed Ingredients And Additives Association (FIAAA) as well as FSSC 22000. Almost any and every type of business, from general manufacturing to flight training schools to accountancies and training organisations can become ISO 9001 certified.
What does ISO 9001 cover?
ISO 9001, whilst still complex, is far more straight forward from the ISO introduced to many organisations 20 years ago that required a full time consultant for multiple years.
Through analysis of your strategic direction and a SWOT analysis of your markets and business, we are able to narrow the scope of your ISO certification to only what is required. Alternatively, we can write a fully integrated quality management system for multiple site use.
At QMS Audits, the basic guide is “Document what you do, then do what you have documented”. We do our best not to change the processes that are already in place – but we will offer recommendations if we think a process is lacking and could be improved.
How long does it take to become ISO 9001 accredited?
For small to medium size businesses we can usually set up the ISO 9001 system within a few weeks from the first day that we start working in your business. Once the processes are in place and your staff are comfortable using them, we then book in a certification body, such as SAI Global or Compass Assurance, to perform the audit. We try to keep the entire ISO certification process, including writing up the processes, as simple as possible.
If you are not sure which Certification Body to choose, we are happy to make a recommendation based on what you are trying to achieve and the maturity of your organization.
How often are ISO 9001 Audits?
Once certified, your business is required to have an annual surveillance audit, every three years a full audit is completed.
How can QMS Audits help you to prepare for ISO 9001 Accreditation?
At QMS Audits, we build straight forward quality management systems (QMS) for ISO 9001 certification for all types of businesses.
Where possible and if deemed suitable, we write work instructions up as standard work. At QMS Audits, we do this because they are simpler to read and understand. Standard work instructions also detail the reasons why we perform each step. It also means that they are more likely to be followed every day, not just during the audit.
We meet with you on a regular basis throughout the project to ensure we all agree on the next step.
ISO 9001: 2008 vs ISO 9001:2015
Every 7 years, the international standards committee update the ISO 9001 standard to reflect current business practices. This update has seen a further simplification of requirements, greater emphasis on leadership and customer satisfaction.
ISO 9001:2015 was only released in Australia in early 2016.
How long can I be audited against ISO 9001:2008? When do I move to ISO 9001:2015?
From the start of next year, all ISO 9001 audits must conform to the ISO 9001:2015 requirements. It is still possible to be audited for the first initial year under ISO 9001: 2008, however we are recommending to all of our new clients they start with the 2015 version from the start. It saves on any further updates over the life of the current version.
For our existing clients already certified to ISO 9001:2008, they will need to update their quality system to the new version at their next three yearly full audit. For example: If you completed your last full audit in 2015, then you must have your QMS fully updated for your next full audit in 2018. There are some significant changes in the new standard, so it is important that your allow for this update.
ISO 9001 can be set up quite easily using the following steps:
Gap Analysis: QMS Audits will spend time understanding what processes are in place, who your customers are, what they need from you and how to meet their expectations. We will help you to identify your company’s strategic direction (a requirement of ISO 9001: 2015) and to ensure the scope of your QMS is relevant to what you are setting out to achieve. You can broaden your scope prior to any annual audit.
Then we work out what is needed to comply with the ISO 9001 standard. We don’t rewrite every single process.
Put together all of the documents for an ISO 9001 Quality Management system (QMS), and start to write up the work instructions, implement records and procedures as required. We put as many procedures into the quality manual as possible – this helps the audit to flow. If we can’t get them into the manual, or onto the record sheets, then we will put together a separate procedure. It is one of the ways we try to minimize paper and keep everything simple. Nobody wants to spend time looking for documents – especially during an audit.
QMS Audits will put together a maintenance schedule, so that it is simple to keep the ISO 9001 QMS system up to date. We take you through this – so you understand exactly what is required.
Once completed, you are then able to organise for a third party audit to perform the audit and issue certification. We can recommend a reasonably priced independent one, such as Compass Assurance or you can use one of the larger corporate, internationally based certification bodies, such as BSI or SAI Global.