Steps of the ISO 9001 Audit Process

ISO 9001 is a quality management framework standard that enables businesses to be more efficient, while increasing customer satisfaction, as well as gaining a competitive edge against competitors. ISO 9001 Quality Management Systems represent policies, processes, documented procedures, and records that define the internal rules governing how a business makes and provides products and services.

ISO 9001 certification ensures that these elements, and ultimately the business’ operations, are under constant and strict control so that products and services meet a certain level of quality. The standard additionally provides guidance and tools to help you provide your customers with consistent, good quality products and services that meet their requirements and a cycle of continuous improvement.

The value this standard brings to your company is that your customers will be aware of the fact that the ISO 9001 means lessening mistakes, improving communication and better quality and higher standards in general. A company that becomes certified, then, may well see an increase in customer satisfaction and, of course, business.

Steps of the ISO 9001 Audit Process 

The ISO 9001 audit is a required step in becoming and maintaining ISO 9001 certification. It will help you achieve the following:

• Determine and resolve any issues with your quality management system. 
• Determine potential system enhancements. 
• Ascertain that your organisation is taking the necessary steps to achieve its quality objectives. 
• Ensure that your systems, processes and procedures meet the guidelines and best practices set out in ISO 9001. 

An ISO 9001 audit is a methodical, objective, and documented process for gathering facts. These will assist you in identifying areas for improvement and ensuring that best practices are in place. ISO 9001 emphasises the importance of continuous improvement. As a result, the standard recommends that you conduct regular internal and external audits. 

Businesses have found it increasingly challenging to separate themselves from the competition in recent years. Obtaining ISO certification provides an opportunity to improve your company’s reputation and capabilities in the market among stakeholders and consumers. 

The ISO 9001 Quality Management Systems standard helps businesses gain a competitive advantage against their competitors. This internationally recognised standard covers Quality Management Systems, with the most current revision in 2015 – generally referred to as ISO 9001:2015. (QMS). 

Wherein a quality management system is essentially a risk-mitigation and opportunity-maximising system. ISO 9001 is used by many businesses, from multinational enterprises to smaller businesses. 

When you adopt a quality management system in your company, you’ve taken a massive step towards accomplishing your goals and meeting your customers’ needs. Certification to ISO 9001, on the other hand, could propel your company to new heights and open doors to new opportunities. In total, the core of quality assurance activities is quality management systems. 

Businesses utilise ISO 9001 certification as a strategic tool to increase workplace productivity, and reduce the number of errors or workplace challenges. 

What Does ISO 9001 Represent? 

The ISO (International Standard) 9001 defines quality management system (QMS) requirements. ISO 9001 standard is used by businesses to show that they can consistently deliver products and services that fulfill customer and regulatory criteria. It is the most prevalent standard in the series, with over one million organisations worldwide having achieved ISO 9001 certification. 

ISO 9001 stands on seven principles of quality management:

• Engagement of people 
• Customer focus 
• Leadership 
• Process approach 
• Improvement 
• Evidence-based decision making 
• Relationship management 

Your organisation will be set up to continually produce value for your customers if you follow these guidelines. As a result, there are numerous commercial advantages.

How Do You Achieve ISO 9001 Certification? 

To become ISO 9001 certified, businesses must follow a simple two step procedure:

# The business must ensure that they build and implement a quality management system, which complies with the latest ISO 9001 standard.

# The business must have an audit performed by an independent third-party conformity assessment body, to assess the performance of the QMS against the latest ISO 9001 standard. 

For businesses to build their quality management systems, they can either choose to design their own ISO 9001 system, or engage an ISO 9001 consultant to help them prepare for certification. 

Many businesses do opt for the second option, as the process is very detailed and time consuming. A consultant will compare the ISO 9001 standards against the businesses current quality management system. This includes workflows, systems, procedures, processes and documentation. Drawing upon their experience, they will then help design and implement a new quality management system to guarantee ISO 9001 compliance. 

Once your ISO 9001 consultant has confirmed that your company is ISO 9001 compliant, you will be notified that you are ready to apply for certification.

The Procedure for ISO 9001 Certification 

1. Preparation and Gap Analysis 

The first step towards obtaining an ISO 9001 certification, is to complete a gap analysis. A gap analysis is an objective evaluation of the current quality management system, against the latest ISO 9001 standard, and is used to assess the readiness of the businesses’ quality management system. This process helps to identify any gaps that need to be addressed prior to certification. 

For the gap analysis you must: 

• Set objectives for the advantages you hope to gain from your ISO 9001 certification.

• Define your ISO 9001 certification’s scope, including which goods, divisions, and locations it will apply to. The certification should, ideally, cover your entire company. 

• Determine if you will achieve compliance on your own or with the assistance of an ISO 9001 consultant. 

• To oversee your ISO 9001 quality management system, appoint an ISO 9001 head or “ISO 9001 management representative.” You may require a representative for each branch if you have many locations. 

• Carry out an assessment to check where you are already compliant and need to improve. 

• Delegate tasks and responsibilities to an ISO 9001 plan that includes steps, dates, and milestones. Keep your strategy as straightforward and practical as possible.

2. Documentation of Compliance 

There is a detailed list of mandatory documentation required for your ISO 9001 quality management system. The documentation must be specific to your organisation, and should be created by an individual that has extensive knowledge of your business and industry. 

The documentation covers the scope of the quality management system, Quality Policy, Quality Objectives, Scope Statement, Policies and Procedures, Work process instructions, Process maps for workflows, Forms, Records of training, skills, experience, qualifications and Product / Service requirements review records. 

Keep in mind that the documentation is only as good as its execution. It is important for the correct information to be detailed in the documentation, policies and procedures, for your management system to be effective. 

3. Implementing a Quality Management System 

• Introduce your team to all new procedures – It is important to communicate to your team all the new ISO 9001 quality management processes and systems right at the beginning. Smaller organisations may conduct a thorough team meeting, whereas larger businesses may propose new processes to department heads, subsequently deploying the new systems and procedures to their teams. 

• Enhance procedures – When your new procedures are in effect, your team must work to improve their existing procedures to align with the latest procedures. Remember, workflow modifications should be done collaboratively to avoid double handling, delays, and inefficient processes.

• Prepare work instructions for high-risk or infrequent tasks. – Your team must prepare applicable work instructions for duties mandated by the ISO 9001 standard. Your ISO 9001 consultant can help you determine which work processes in your company require instructions. 

• Keep accurate records. – Prepare and keep detailed, precise records of your new work practices. When an auditor evaluates your ISO 9001 compliance, they will look over these records. 

4. Internal Audits and Verification of Compliance 

Before your company can apply for ISO 9001 certification, you must undertake an internal audit to establish compliance with your ISO 9001 QMS. The audit can be done in stages and does not have to be completed all at once, but it must encompass the entire management system. To verify your QMS installation, your company must have at least one or two months’ worth of records. 

For peace of mind, an ISO 9001 expert can conduct your internal audit. Your company is ready for the final stage of the ISO 9001 certification, once you’ve finished your internal audit.

5. Certification 

• Apply to a Certification Organisation – You must apply to an ISO certifying authority once you believe you are ready to receive your ISO 9001 certification. Certifi International can definitely help. We are a qualified, independent third party conformity assessment body that specialise in ISO certification. 

• Audits During the First and Second Stages – The ISO 9001 certification audit is divided into two phases: the first examines your company’s documentation and records, and the second examines your company’s work processes. 

• Work through any identified non-conformities – Your auditor will identify any areas of non-compliance and require you to correct them before certification. If your QMS has significant inconsistencies, you may need a secondary audit to obtain certification.

• Obtain ISO 9001 Certification – Your ISO 9001 Certificate will be valid for three years. Hence, annual audits are performed to ensure that you comply with ISO 9001, followed by re-certification every three years. 

6. Re-certification 

Your ISO certification is valid for up to three years from your certification date. At the end of the three year period, you will need to submit to a reassessment process to renew your certification, often called re-certification.

Typically, numerous organisational changes occur within a company over three years. The re-certification audit ensures that the Quality Management System (QMS) has appropriately assessed and documented any internal changes that have occurred in the business, as well as having implemented the required training. Furthermore, a re-certification audit is carried out to ensure that the business is compliant with the latest ISO 9001 standards, and all new updates have been reflected in their quality management systems. 

Contact Certifi International Today to Help You On Your Journey to Achieve ISO 9001 Certification 

The ISO 9001 Quality Management System is a popular standard, and one which has benefited many businesses across a wide variety of industry sectors. 

Rest assured, you will end up with a system that will continuously enhance all aspects of your organisation. The documented procedures and processes allow employees to carry out their tasks effectively, and for your business to be performing efficiently. 

ISO 9001 applies to businesses of any size and in any industry. According to the International Organisation for Standardisation (ISO), over one million enterprises are already certified to ISO 9001 in over 170 countries. So, what are you waiting for?

The Certifi International team can help you prepare for an ISO 9001 certification in Australia by guiding you through the preparation process. To discover how we can help, visit our website https://certifii.com.au or call 1300 971 044 for a confidential discussion.