ISO 9001 is an international standard that focuses on implementing a Quality Management System (QMS). The parent organisation that has created this standard is ISO, which has published more than 23,000 international standards covering different aspects of technology and manufacturing.
ISO 9001 is a part of the ISO 9000 family concerned with helping organisations understand quality management; however, ISO 9001 is the only standard in its family against which organisations can get certified. Over one million businesses worldwide are ISO 9001 certified. The structure of the standard is such that it is designed to be universal. Therefore, its recommendations can be applied to every business, regardless of sector, size or industry.
ISO 9001 certification can virtually benefit every business. When an organisation implements an ISO 9001-compliant QMS, they enjoy the following benefits:
To get ISO 9001 certification, businesses in Australia need to develop and implement an ISO 9001-compliant QMS, which needs to be certified by an independent accredited certification body; however, technically, it is a two-step method:
To prepare for ISO 9001 certification, business owners can either engage the help of an ISO 9001 consultant or develop the management system on their own. A consultant will conduct a detailed gap analysis to determine where your current QMS and documentation are lacking against ISO 9001 requirements. After identifying these areas for improvement, the consultant will help design and implement new processes to ensure that your QMS is ISO 9001 compliant.
The consultant will then assess the efficiency of your QMS through internal audits. After they are satisfied with its performance, they will inform you that your QMS is ready for certification.
Once your QMS is ready for the certification, you can look for ISO certification bodies using the JAS-ANZ website.
Listed below are the steps that outline the certification process:
During the first step of the certification process, it is necessary to conduct a gap analysis to prepare for compliance. During this first stage, you will need to:
Identify the benefits you want your ISO 9001 certification to bring and create goals around these highlighted benefits.
Define the scope of your QMS, including the locations, departments and products that your management system will cover. In an ideal situation, you should aim for your entire organisation to be included under the QMS.
Decide whether you are attempting to achieve compliance on your own or you will hire the help of a professional ISO 9001 consultant.
Designate an ISO 9001 management representative or ISO 9001 head to oversee all the procedures related to the QMS. You must designate a representative in each branch if your organisation has multiple locations.
Conduct an in-depth gap analysis to highlight areas where you are already compliant and need adjustments.
Create a plan of action that delineates the steps, milestones and deadlines, going on to delegate the tasks and responsibilities to the appropriate individuals. Remember not to overcomplicate the plan.
To achieve compliance, your documentation should comply with the ISO 9001 requirements. Hence, the documentation should be prepared by someone who has the experience, adequate training and in-depth knowledge of the QMS, your industry, your organisation and the requirements of ISO 9001. In-depth knowledge is essential, as you need to tailor the documents to suit the unique needs of your business. Documentation includes the scope statement, quality objectives, quality policy, procedures, work process instructions, and process map for workflows and records.
There is a strong correlation between documentation and the effectiveness of implementation. Thus, you must create detailed, comprehensive, clearly written documents, procedures and policies for your management system to be effective.
TIP: Hiring an ISO 9001 consultant makes the entire documentation process faster, more effective and more concise.
Introduce all new procedures: For your workflow to be smoother and your QMS efficient; your team should be aware of all the new procedures. Smaller businesses can introduce the new procedures through a team meeting, and larger enterprises can take the help of department heads.
Improve processes: After introducing your team to the new procedures, you need to improve the current processes to match the desired quality of the new procedures. Hence, workflow updates should be made collaboratively to eliminate any inefficiencies, delays and double handling.
Prepare work instructions for high-risk/occasional activities: Relevant work instructions must be put in place for high-risk or occasional activities, as they require a different type of skillset. Here, your consultant can advise you on which work processes require further instructions in your organisation.
Maintain records: Reports act as proof of what you have implemented. To achieve compliance, your reports should be accurate, comprehensive and transparent. The external auditor will assess every page of your records when assessing your controls and compliance.
Before your business can apply for certification, you need to conduct a detailed internal audit that covers your entire QMS to ensure that there are no areas where you are lacking. Since the audit is critical, there is no need to rush it, and you can take a few months to cover your whole management system.
Moreover, do not rush into the process, as your organisation needs at least a few months’ worth of records to verify the implementation of your QMS. The ISO 9001 consultant will conduct the internal audit. Once they are satisfied with the efficiency of your QMS, they will lead your business into the final stage, namely, the ISO 9001 certification.
Apply to a certification body: Once you feel fully prepared and ready to acquire your ISO 9001 certification, you must begin searching and applying to an accredited certification body. Remember, ISO does not grant the certificate, but these independent third-party businesses that have themselves cleared audits can grant certificates.
Stage one and stage two audits: Stage one audit is also called a desktop review, where the external auditor will review the documentation of your organisation and check its compliance with the ISO 9001 recommendations. The external auditor will observe your processes in the stage two audit and interview your people on-site.
Address non-compliance: If the auditor has identified areas of non-compliance that can potentially lead to a failure of your QMS, you will need to rectify them before your certification. You will be given a rectification period, and the audit will continue after the predetermined period.
Receive your ISO 9001 certification: Once your business is deemed ISO 9001 compliant, you will receive your certificate, which will last for three years. To maintain its validity, you need to conduct yearly surveillance audits.
To acquire your certificate, you need to become ISO 9001 compliant. This means you must ensure that your QMS is compliant, safe, efficient and reliable. Although many businesses attempt to gain compliance themselves, engaging the help of an independent ISO consultancy agency is beneficial, as they have years of expertise. ISO 9001 consultancy services are adept at identifying gaps in your QMS that you may miss so that you can become compliant on paper and in real life.
At business basics, we specialise in helping organisations quickly achieve their ISO 9001 compliance and certification. We customise our services so that the entire process becomes stress-free for you.
Contact us to find out how to get your ISO 9001 certificate the easiest way.
