ISO 9001 CERTIFICATION Consulting for Your Australian Business

ISO 9001 is the internationally recognised standard for quality management systems. The standard consists of a range of principles that help businesses ensure they meet customer needs and needs of other stakeholders.

Obtaining ISO 9001 is of benefit to businesses across Australia as it provides an outline of necessary infrastructure, procedures, processes and resources for companies to improve their performance through increased efficiencies, improved client service and enhanced product.

Compliance is relevant to many organisations, as any business can become ISO 9001 certified regardless of its size, industry or location.

ISO standards such as ISO 9001 are not compulsory for Australian businesses. Created by the International Standards Organisation (ISO), these standards act as a framework for improving quality management and guiding standard best practices for businesses globally.

The ISO is a non-governmental organisation. Its goal is to design standards and assist with their implementation across industries, however the organisation cannot enforce these standards. The ISO is a voluntary body and, as such, does not legislate or regulate its standards. In certain industries, however, some ISO standards can be a market requirement.

In some countries certain ISO standards have been incorporated into the regulatory framework, and are included in government legislation. These ISO standards cover topics such as health, safety and the environment, which are of benefit to the country and its population.

While obtaining ISO 9001 certification is not compulsory for businesses, many still adopt the standard due to its’ numerous benefits. ISO 9001 is a practical and effective Quality Management System that has been designed to improve operations organisation-wide.

The following are some of the key benefits of obtaining ISO 9001 certification:

• Can be implemented by both small and large organisations
• Leads to better internal management
• Decrease in waste and reduced costs
• Improved efficiencies and employee productivity
• Increased profit
• Greater compliance with legislative requirements
• Better customer retention and acquisition
• Improved staff training procedures
• Measured results for continued success
• Structured approach to addressing organisational risks and opportunities (risk based thinking)
• Standard is recognised worldwide
• ISO 9001 is compatible with other ISO standards

It’s important to be aware that some clients and potential clients may require a valid ISO 9001 certificate. Other clients may see it as an added extra when they are evaluating their choice between your business and other suppliers.

Compliance with ISO 9001: 2015 gives your customers added confidence that your business adheres to defined standards and procedures in your management systems. In addition, gaining ISO 9001 can also indicate that they will receive the utmost standard of customer service from your business.

Recognised worldwide, your customers will understand the benefits of having ISO 9001 and the advantages that it provides for them:

• Fewer mistakes
• Improved reporting
• Effective communications
• High-quality products and service
• Reliable production scheduling and delivery

To ensure they stay relevant, ISO standards are reviewed every five years and revised if necessary. ISO 9001:2015 recently replaced the previous version, ISO 9001:2008.

Problems that businesses encounter nowadays are different than those faced by businesses a decade ago. For example, increased globalisation has resulted in a more complex supply chain and changed the way a number of businesses operate. Furthermore, with the widespread use of the internet, customers and other stakeholders have access to more information, which has shifted the balance of power into the hands of the consumer. The business environment is continually changing, and ISO 9001 standards must evolve to address any issues or opportunities that arise.

ISO 9001: 2015 has replaced the 2008 version, with this standard being revised to meet the ever-changing needs of the business environment. It is recommended that, in response to this; businesses update their Quality Management System.

Every business is different, so the specific actions that you will have to take to update your Quality Management System to ISO 9001: 2015 will be unique to your business. However, the following steps may be a good starting point.

• Step 1: Ensure you are familiar with the new standard and understand exactly which parts have changed. A ‘correlation matrix’ can be helpful for this, which is available from iso.org (ISO/TC 176/SC 2).
• Step 2: Conduct a gap analysis to identify which parts of the new standard are not currently being met by your organisation. This will help you to pinpoint the next steps needed to fulfil the updated requirements.
• Step 3: Develop an implementation plan for your business.
• Step 4: Ensure you are communicating with all employees and stakeholders regarding their role in transitioning to the new standard. Appropriate ISO training should be provided for necessary parties.
• Step 5: Start implementing the changes in your existing quality management system to the updated standard.

There are many differences between ISO 9001: 2015 and ISO 9001: 2008. By completing a gap analysis, we can identify any discrepancies your business may have between the standards.

The most obvious change to the new ISO 9001: 2015 standard is its updated structure. Other ISO standards follow the same structure, known as the ‘High-Level Structure’. Previous ISO 9001 standards did not follow this structure, however the updated ISO 9001: 2015 does. This makes it easier for companies that are using multiple management systems. Another notable change is that the new standard puts more focus on risk-based thinking than previous standards.

Other key changes in the ISO 9001: 2015 standard are:

• Greater concentration on leadership involvement and commitment
• Focus on measurement of objectives and managing change
• Greater communication and awareness organisation-wide
• Less prescriptive requirements
• Recognition of service businesses

Once the standard was released in 2015, companies had up until September 2018 to transition to the new Quality Management System. For more information on the latest ISO 9001 standard, see our blog post covering the key changes.

ISO 9001 provides a framework that guides businesses in implementing an effective Quality Management System (QMS). The elements of the ISO standard are applicable to companies across any industry and can be applied to both product and service-based businesses. Due to the vast range of businesses ISO 9001 can be applied to, the standard outlines which elements are mandatory for a certified Quality Management System, but does not detail how to implement these elements.

ISO 9001 requirements can be separated into eight main sections, known as ISO 9001 clauses. Clauses 1 to 3 of the standard do not address the requirements of the standard, but instead deal with the scope of the standard and provide references to understand the standard better as well as specifying terms and definitions. The remaining five of these clauses contain requirements that are mandatory for a Quality Management System, these are:

• General Quality Management System Requirements (clause 4):This section details the standard requirements of a Quality Management System, as well as necessary documentation requirements. It also details what is required for the Quality Manual, Control of Documents, and Control of Records.
• Management Responsibility (clause 5): The Management Responsibility section addresses requirements for customer commitment and focus, as well as Quality Policy and Quality Objectives. It covers the various elements involved with the planning of a Quality Management System, highlighting the need to define responsibility and authority and the importance of communication. It also details the specific requirements of the compulsory management review, including the mandatory inputs and outputs for the review.
• Resource Management (clause 6): Clause 6 deals with resource management, and is one of the shorter sections in the standard. It outlines the requirements of management in providing resources in the areas of infrastructure, work environment and human resources. This section highlights the importance of competence and awareness in the workplace and emphasises the need for training in human resources.
• Product Realization (clause 7): This section of the standard deals with the requirements of planning for a product or service. It details how to determine and review the product requirements, the design and development of products and services, as well as purchasing, which leads to the provision of creating and supplying the product or service. This clause also outlines requirements that deal with the control of equipment that is used to monitor or evaluate the product or service. This is the only section of the standard that allows businesses to exclude certain parts that are not applicable to the business.
• Measurement, Analysis and Improvement (clause 8): Clause 8 is the last section of the standard. It outlines the steps to take to ensure your Quality Management System is working, as well as how to ensure it continues to improve. The Monitoring and Measurement section details requirements for assessing customer satisfaction, Internal Audits, and monitoring the product and processes. The section also outlines how to react to non-conforming products, through analysing and improvements, including how to take corrective and preventive actions.

The most difficult part of implementing the ISO 9001 standard is ensuring that all policies, procedures, processes and records meet the needs of your business and customers, while also allowing for Quality Management System improvements. Continuously improving the system is one of the main reasons for implementing the ISO 9001 standard, as it benefits the company in the long run.

The total amount your business will pay for ISO 9001 will depend on a number of factors. The size of your company, complexity of your operations and whether you already have some elements of a quality management system in place will all affect the cost of the certification.
The main considerations when it comes to the cost of the certification are as follows:

1. Registrar (also called Certification Body) Costs: A Registrar (or Certification Body) must perform the registration audit. The cost of the registrar depends on your organisation and its size and risk profile. Registrars charge based on the amount of time they have to spend working with your organisation, normally based on the number of days.
2. Internal Cost: While you may not have to pay monetary costs internally, the costs of your employees’ time can add up quickly. It can take a significant amount of time to build and implement the Quality Management System.
3. External Costs: Depending on how you carry out the process, you may have external costs in the form of consultant fees or tools to help you with the development and implementation of the system.

There are three main options for an organisation considering implementing the 9001 Quality Management System. How you decide to implement the standard will impact the costs involved.

1. Do it Yourself: Create your own documentation and develop your own training programs internally by interpreting the standard. This can be advantageous as you know your business better than anyone else, and will know the processes and systems that are most likely to work for you. However, obtaining ISO certification can be a big task that involves thorough understanding and interpretation of the standard as well as developing documentation and conducting staff training, so it can be a lot to take on internally. This option is particularly suitable if you have team members who can spend a significant amount of time on this as a project and preferably have considerable experience in working with the standards in the past.
2. Use Pre-prepared Templates for Documentation and Pre-defined Training Programs: Applying documentation and training programs that have already been devised for the standard may help you implement the process more smoothly. You still do it internally, but with training and a system to follow, which can save you time and frustration. The caveat here is that templates only go so far and to be really effective, they should be high quality, industry-specific or just a guideline within which you can design your own system. Templates which are too generic will have a lot of irrelevant information and over-documentation which can bog down the process and create more work for you down the track. It can be hard to know what is necessary to keep and what isn’t unless you are experienced. Either way it is very important that whatever templates are used are customised to the point that they align as closely as possible with how you do business.
3. Hire an ISO Consultant for Part or All of the Process: Many businesses will use a combination of 1. or 2 plus using the support of a consultant to guide them in the right direction. For example a gap assessment at the start of the process and an action plan will help support companies who want to set up the system themselves but don’t want to reinvent the wheel. Periodic support throughout will ensure you are on the right track and meeting all the requirements.

A good consultant can save time and effort and mistakes due to lack of experience or over documenting.

There is also the option of a full-service approach to obtaining ISO certification where the consultant does everything for you. If you do not have the capacity to carry out the process internally or you have limited existing systems in place, this may be the most effective option. However, it is also the most expensive and may limit your opportunities to have understanding and ownership of your own system.

There are a number of available options for obtaining ISO 9001 certification. It’s important to remember that there is no ‘one-size fits all’ approaches, and you should choose the process that works best for your business.