ISO 9001

Your system should meet the minimum requirements of ISO 9001 before it can be certified. Here, we outline the steps for developing your quality management system to be ready for certification. Our company IMS can provide support to you in any of the following steps.

1. Read through the ISO 9001 standard, or use our ISO 9001 PDF Gap Analysis Checklist to become familiar with the terms used, the intent and the requirements set out in ISO 9001.
2. Perform a gap analysis using the checklist to determine the shortcomings of any existing company management systems that you may have. This will highlight the areas that need further development.
3. Develop your management system according to the standard. IMS can help you integrate ISO 9001 into your business processes and systems ready for external certification.
4. To undergo external certification to ISO 9001 you will need to contact an external certification body. IMS can assist with the process of obtaining quotations from several reputable certification bodies. IMS remains independent of the external certification process to avoid any conflict of interest.

If an organisation attempts to obtain a management system certification without assistance from a specialised consultant such as IMS, typically the following steps are required.

1. Gap Analysis (optional): An optional gap analysis to evaluate your management system against each clause of ISO 9001:2015.

2. Stage One Audit: A desktop assessment to evaluate the adequacy and suitability of your documented systems including scope and context and processes such as the treatment of opportunities and risks.

3. Stage Two Audit: The final step of the initial certification process is to ensure that your management system is compliant and fully implemented in line with ISO 9001 requirements. This involves a visit by external auditor/s to your offices and premises and discussions with relevant individuals in your business.

4. Certification: If your management system is assessed as meeting ISO 9001 requirements a ‘Statement of Certification’ is issued by the external certification body confirming compliance with the relevant standard which is valid for three years from date of issue. Surveillance audits are also required by the certification body usually on an annual basis to maintain your certification.

Simplified IMS approach: IMS offers a more direct path to certification. IMS specialises in developing management systems that are tailored to your exact business requirements, compatible with your existing systems, simple to use and compliant with ISO 9001. Having dealt with a great variety of companies and certification bodies we have the experience to know the optimal approach. Systems developed by IMS in consultation with the company’s representatives achieve certification in a one step cost effective manner.

ISO 9001:2015 is the latest version of ISO 9001, replacing ISO 9001:2008. The standard was updated in 2015 to meet the requirements of today’s business world. It provides a framework to continually improve  processes, products and services of the business and customer satisfaction.

Upgrades to management system standards occur at least once in a decade as global business requirements change over time.

ISO 9001:2015 is the most internationally recognised Quality Management System (QMS). It is an international standard, and is the same standard as ISO AS/NZS 9001:2016. The difference is only the time at which the standard was released in Australia, compared to the rest of the world.

The latest quality management system standard provides the framework for creating and implementing a quality management system that helps organisations to meet customer needs and continually improve.

ISO 9001 belongs to the ISO 9000 ‘family’ of quality standards, which includes:

ISO 9000:2015: Quality Management Systems – Fundamentals and Vocabulary (definitions)
ISO 9004:2018: Quality Management – Quality of an Organization – Guidance to Achieve Sustained Success (continuous improvement)

Note that only ISO 9001 is a certifiable standard. There are no certifications available for ISO 9000 or ISO 9004.

There are two sources of cost to getting certified to ISO 9001.

1. Setting up or changing your system to be compliant with ISO 9001.
2. Having your management system externally audited against the requirements of ISO 9001.

To avoid conflict of interest and to remain within IAF (International Accreditation Forum) guidelines, one company should not provide these two services together.

IMS can assist you set up your quality management system and we can also assist you to find the most suitable external auditor that will conduct the assessment and provide the certification.

The cost of setting up a management system for up to about six employees with no further services is about $5,000. The cost of external certification is typically less than that.

We need to gain a thorough understanding of your company’s size, scope of operation before we can provide you with a firm quotation and for that reason we prefer to conduct a free initial face to face, virtual or phone consultation.

Our quotations rates are all inclusive and transparent with no hidden fees. Please contact us to find out more information.

ISO 9001:2015 is the quality management system standard that defines the requirements that must be met by a company to achieve certification. These requirements are contained in clauses that provide the framework for your management system. ISO 9001:2015 follows the new 10 clause structure of ISO management system standards and can be further grouped into 4 sections

Plan: Context of the Organization (clause 4), Leadership (clause 5), Planning (clause 6), Support (clause 7),

Do: Operation (clause 8),

Check: Performance Evaluation (clause 9) and

Act: Improvement (clause 10).

The new structure is a significant departure and improvement from previous versions of ISO 9001 with a stronger focus on a process approach and business risk. The new structure makes it more clear what ISO 9001 is all about.

ISO 9001 is the benchmark that shows to customers and stakeholders that you are able to reliably meet customer expectations. To become certified to ISO 9001, your management system needs to be externally evaluated against the requirements of standard. Ongoing surveillance audits and three yearly recertification audits are required to ensure ongoing compliance and maintain certification.

Note that external auditors must maintain their independence of the outcome to avoid conflict of interest.  They are not consultants and therefore should not give advice.  IMS, as consultants, are not constrained in this way. Our experience and advice fast tracks the improvement of your operations and becoming ready for certification.

Some companies need their new quality management system (QMS) to be fully developed in consultation with busy staff efficiently and simply handed over. Other possibly larger companies with personnel resources want to be significantly involved in the QMS development and need some QMS training.

Various organisations offer ISO 9001 training. Face to face or online group training cannot be specific to your organisation’s particular circumstances. On the other hand there is quite a lot of suitable generic information on ISO 9001 available online.

What is needed, and what IMS can provide, is specific training that meets your organisation’s exact training needs and circumstances. This approach can be discussed and included in the quotation process achieving a better and more cost effective outcome.

ISO 9001:2015 allows organisations to provide evidence of meeting customer needs to interested stakeholders. ISO 9001 provides numerous benefits and opportunities, including:

• Tender for work – Declare conformance with the standard and tender for work, including government contracts​ and large corporate jobs.
• Provide evidence for stakeholders – Enhance your reputation by providing formal recognition of your management processes to customers and interested stakeholders.
• Legal compliance – Provide evidence your organisation meets regulatory requirements, as ISO 9001 mandates your organisation must meet legal obligations.
• Improve products and services – Create efficiencies and ensure continuous improvement of your product or services with the Plan, Do, Check, Act cycle, an integral element of ISO standards.​
• Create your marketing advantage – Create a competitive advantage and marketing opportunity as certification can be a key differentiator in today’s challenging marketplace. Place ISO logos on letterheads, email footers and marketing materials.

Once you are ISO 9001 certified, your certification expires three years after your certification has been granted. To maintain your certification regular annual external surveillance audits are conducted by the certification body. IMS can assist you in the ongoing tasks required to prepare for future external audits to maintain external certification

Sometimes a certification body can significantly underperform, such as failing to provide a suitably qualified external auditor, excessive fees, poor communication and mistakes making it hard for you to maintain certification.

IMS can help you transfer your ISO 9001 certification by recommending certification bodies to you that are better in our experience. IMS is unbiased in this matter as it is not in any way financially involved with any external certification bodies.

Transfers of certification can be done seamlessly without changing your external audit schedule. This can result in better service and potentially also significant cost savings.