ISO 9001:2015 Certification Guide

11/07/2022by admin0Read: 7 minutes

ISO 9001: 2015 Certification is an assurance that an organisation has a robust quality management system essential to delivering quality products and services. It labels an Australian business as a trusted firm offering quality and commitment. A company should fulfil ISO 9001: 2015 standard’s essential requirements to get certified.

It is therefore essential to understand ISO 9001 and ISO 9001:2015 respectively.

ISO 9001 standard

ISO 9001 Standard is a set of principles an organisation must fulfil to achieve quality management systems eligible to receive ISO 9001: 2015 certification. It caters to customer satisfaction and provides them with top-notch services and products, which in turn brings many benefits, including satisfied customers, management, and employees. ISO 9001 standard is compatible and easily integrates other standards like ISO 45001, ISO 27001 and ISO 14001 etc.

The International Organisation for Standardization (ISO) first published ISO 9001 in1987. The current and in-use version was released in September 2015.

Its last amendment in 2015 is currently in practice and complies with modern business requirements.

ISO 9001:2015 Standard

ISO 9001: 2015 is the amended and in-use version of the ISO 9001 standard and specifies the requirements for a quality management system (QMS). Businesses and organisations use the standard to exhibit their capability to consistently provide products and services that meet customer and regulatory requirements. It is the most basic and popular standard of the ISO 9000 series and the only one that enterprises can certify.

Why should Australian businesses opt for ISO 9001: 2015 certification?

Here are the top reasons why Australian businesses must opt for ISO 9001: 2015 certification:

1. ISO 9001: 2015 aims to improve customer satisfaction through effective system application that includes enhancement processes and the assurance of conformity to customer and applicable statutory and regulatory requirements.

2. It’s an outstanding framework to assist effective business management so that an enterprise is operationally resilient and can build long-term success. It is the fundamental building block for organisations to improve risk and quality management.

3. ISO 9001:2015 requirements are generic and can be applied to any enterprise irrespective of its size or type, or the services and products it provides.

4. Furthermore, ISO 9001: 2015 is easy to integrate with other management systems with a similar structure. These include ISO 14001:2015 (Environmental Management Standard), IATF 16949:2016, and ISO 45001:2018 (Occupational Health and Safety Management standard).

Read more:

Quality Management System – A Guide to Key Principles and Types

Steps to follow for ISO 9001:2015 Certification

The ISO 9001: 2015 certification consists of the following steps businesses must take in order to be eligible for certification:

1. Understanding and Fulfilling Key Principles

An organisation must fulfil the requirements of and comply with the key principles of ISO 9001 that are the fundamental building blocks of a successful Quality Management System. Each principle is a step towards getting ISO 9001:2015 certified.

ISO 9001 focuses on the following fundamental principles instrumental to QMS’s consistent improvement:

  • Customer Focus
  • Leadership.
  • Engagement of People
  • Process Approach
  • Improvement
  • Evidence-based Decision Making
  • Relationship Management
  • Quality Instruments
  • Document Management

that provide the certifications. Check out which one is popular and suits your resources. These bodies will assess all the areas in your quality management system and will share with you if any more gaps need to be filled.

2. Gap-analysis

Gap analysis helps organisations in understanding their criterion status. Companies must analyse their current standing and the gaps that need to be filled to get ISO 9001: 2015 certification.

Pre-assessment will help in understanding the current quality management system (QMS), and its comparison with ISO 9001:2015 standard will provide insights on gaps that need to be filled.

3. Documentation preparation

This step involves documentation preparation prepared that will include objectives, procedures, and policies instrumental for your organisation to stay ISO 9001 compliant. Documentation is a fundamental element required to help your organisation in achieving the ISO 9001: 2015 Quality management system.

4. Plan implementation

The plan implementation stage involves the ISO 9001 requirements’ integration into your organisation. It is the most time-consuming step. It consists of business planning, educating and training employees, and internal audit schedule development. QMS tests your organisation’s management system once the plan has been implemented.

5. Audits

Organisations should undergo internal as well as external audits to comply with ISO 9001:2015 standards. There are two types of audits performed – Conformance audits and Performance audits.

  1) Conformance audits

Conformance audits if companies have all the processes and documentation complying with the standard exactly.

  2) Performance audits

The performance audits check if an organisation’s quality management system (QMS) is reaching the desired company goals and is achieving the right results.

Some performance audits can be done separate from conformance audits, though many audits combine both, checking for standard compliance and positive results. Stage one of these combined audits usually consists of checking documentation, and step 2 is conducting the actual audit on the performance of certain systems or processes.

Internal audit

To get ISO 9001: 2015 certification, a company should upgrade their QMS such that it complies with the ISO standard’s requirements prior to external audits. This will involve the development of new controls, processes, and policies as per the standards. Internal audit is therefore an important step in achieving the certification.

6. Ongoing Improvement

ISO 9001 Certification is not a simple one-off process, it’s about creating a culture of continual improvement. Through ongoing auditing from independent assessors, your organisation will continually improve and stay up to date with ISO standards.

ISO 9001:2015 training

To understand ISO 9001: 2015 standard and certification, employees can pursue a formal ISO 9001:2015 training or certification course. It will give them a learning opportunity, increase their knowledge and they will be aware of what is happening at the different stages of the certification process.

Besides organisations that want to opt for certification without professional QMS consulting, can also benefit from the training.

Receiving ISO 9001:2015 Certification

An organisation will receive an ISO 9001:2015 certification once it has fulfilled all the requirements of the QMS standard and undergone internal and external audits and has overcome risks any gaps found in the analysis.

The certification is valid for three years from the date of issuing. Enterprises should continue improving and maintaining their quality management system for future certification renewals. Hence, it is important for them to be well versed with ISO 9001: 2015 certification.

Benefits of ISO 9001:2015 QMS

Successful implementation of ISO 9001:2015 quality management system will provide an organisation with the following benefits:

1) The company will be able to continually offer services and products that meet customer requirements and applicable regulatory and statutory requirements.

2) ISO 9001: 2015 QMS will provide opportunities to improve Customer Satisfaction.

3) Organisations will be able to acknowledge risks and opportunities relevant to their objectives and context.

4) Enterprises will be able to exhibit conformity to specified QMS requirements.

Other benefits of ISO 9001: 2015 Certification

The other benefits of ISO 9001: 2015 certification include:

  1. Integration to improvement
  2. Better Decision-Making
  3. Credibility and Recognition
  4. Increased Revenues
  5. Improved Consistency
  6. Empowered Employees
  7. Meets Requirements for Government Contracts
  8. Reduced Costs
  9. Smoother Ordering and Customer Interaction

QMS Consultants

Enterprises can hire certified QMS consultants for professional guidance and assistance on ISO 9001: 2015 certification. They will analyse your company’s management system and provide you with a robust plan based on the findings. The strategy will help you in overcoming gaps preventing your organisation from succeeding. QMS consultants will help your company in accomplishing the requirements of the key principles essential for developing successful QMs.

Their responsibilities include understanding an organisation’s project goals and requirements; analysing the current QMS and performing extensive research; collecting and analysing product information; identifying strengths and weaknesses of the current quality control procedures; and studying customer feedback.

What are ISO 9001:2015 standard’s 7-9 clauses?

ISO 9001: 2015 standard’s 7-9 clauses are Support, Operation and Performance Evaluation respectively.

Businesses that need ISO 9001:2015 Certification

While ISO 9001: 2015 Certification is not industry-specific, certain organisations can benefit from it.

We have listed below businesses that need ISO 9001: 2015 Certification:

1. Healthcare

ISO 9001: 2015 certification can help health care organisations in establishing a quality management system that will improve clinical, support, and business processes. It will also help them in complying with other ISO standards.

2. Construction

The construction industry has a lot of issues like high budgets, tough quality requirements and deadlines. To attract investors, construction enterprises should be able to prove their systems’ reliability and transparency. Compliance with ISO 9001: 2015 requirements can help them in qualifying for government projects and winning tenders. A robust quality management system will also help in supply chain management and waste reduction.

Decision-makers are more likely to trust an organisation with ISO 9001: 2015 certification and documentation.

3. Manufacturing

In big large-scale manufacturing production units, the cost incurred on mistakes is very high. Any mistake in one batch can cost mass reclamation for hundreds or even thousands of products. Certain severe manufacturing mistakes can also lead to workplace injuries and even death. For example, if you own a car manufacturing company, each element has to be tested.

Since ISO 9001:2015 has process-based requirements, the certification is an assurance that manufacturers have overcome quality issues at each production stage. It enhances the final product, transparency for team cooperation and manufacturing efficiency. Customer satisfaction will increase as they will get quality products.

4. Hospitality

Hospitality industry witnesses massive competition among businesses to find new ways to attract customers and stand out. Compliance with ISO 9001:2015 will help in demonstrating to customers that they invest in quality and self-improvement.

5. IT

The IT industry is prone to data breaches and cyber-attacks. A quality management system backed with required documentation can help to troubleshoot and recover lost data.

6. Engineering

Engineering firms operate in a complex regulatory landscape and should maintain the highest accuracy of work. Compliance with 9001:2015 ISO certification allows them to deal with both these challenges at once.

Good documentation will improve accountability and help to record important details.

ISO 9001: 2015 is a bonus for engineering start-ups new to the market as it is a sign of commitment to quality.

Anitech’s QMS Consulting Services

Anitech has an identity of offering exceptional QMS consulting services in the Australian business circle. Our consultants are experienced, certified professionals who can guide and help you in achieving a successful Quality Management System essential to getting ISO 9001: 2015 certification. They will assess your current systems and formulate a robust plan that will help you in overcoming gaps. Our consultants are professional and will provide you with timely assistance and services. We will also support you post receiving the professional certification.

To know if your business is ready for ISO 9001: 2015 certification, call us on 1300 802 163. You can email us at – info@anitechgroup.com or enquire here.

For more updates and the latest QMS insights, stay tuned to Anitech’s website.


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