Nov 13, 2017

How to get certified to the ISO 9001 standard

In its simplest form, getting certified to the ISO 9001 standard consists of three main steps:

  1. Plan, design and create you Quality management system
  2. Implement the QMS
  3. Get an accredited certifier or ‘registrar’ to audit your system and issue the certificate

These three steps are the same to get certified to any ISO standard, for example ISO 14001 or OHSAS 18001, although the details of what is contained in the management system will obviously be different depending on the requirements of the specific standard.

Let’s have a look at the detail of each step:

Plan, design and create you Quality management system

Before you start planning a QMS, it is critical that you get buy-in from top management. At the end of the day, they’ll not only need to provide the resources to implement and maintain the system, but the ISO 9001:2015 standard also very specifically requires that top management is responsible for certain actions within the system. If top management does not fully support the implementation, or does not appreciate the value and benefits it will give the company, there is very little chance of the implementation succeeding.

Once top management is behind the implementation, it makes sense to designate a specific project manager who will ultimately be responsible for the implementation. Using project management disciplines is logical as this is after all a fully blown project with unique challenges.

There are three major routes companies take when implementing ISO 9001, and the resources required will depend on which route is taken:

  1. Do everything in-house. With this approach, the organization requires a person with knowledge of ISO 9001 working for the company. This could either be someone who has implemented QMSs before, or an inexperienced person whose first task would be to gain the required knowledge. The advantage of this method would be that the organization does not rely on an external party, but has all the knowledge at their own disposal. Although this is probable the least expensive avenue in terms of direct costs, the time taken to certification is often the longest.
  2. Use an external consultant. External consultant have the knowledge and experience to ensure that the implementation can happen in a relatively short period. They are however normally costly, and if the organization no longer wishes to make use of a specific consultant, some knowledge may be lost. To mitigate this risk, the organization could designate an employee to gain as must knowledge as possible from the consultant while the project is ongoing.
  3. Use ISO software such as MyEasyISO. This is a combination of the previous two options and the one that will save you the most time and money. Although users will have to learn how to use the system properly, nobody has to understand the full requirements of the standard as these requirements are catered for and built into the system. Organizations going this route generally save up to 84% of the time normally used to implement an ISO 9001 Quality Management system

Once you have determined the route you’ll be taking to get certified, the next step is to determine where you are now, versus where you need to be for certification. Use a gap analysis to create plans and schedules and map out the way forward, i.e. create a project plan.

Once the gaps have been identified, the quality system can be developed. This often means that your existing system needs to be improved by filling in the gaps. You may also have to develop new procedures, processes, quality controls or documents. If you decide to use MyEasyISO, most of this work has already been done for you. All you need to do is capture your company’s specific detail in the templates and modules provided.

Implement the QMS

This step will take the most time and effort, and you’ll need to ensure that all the relevant people are trained, not only in using the system, but they also need to understand why the system is being implemented, and what the benefits are. While some organizations prefer to only start implementing the system once it has been fully developed, others prefer a phased approach where each section is implemented once that specific procedure or process has been developed. Neither approach is better than the other, but it depends purely on your personal preferences.

While implementing, make sure you use the Plan, Do, Check, Act (PDCA) cycle to improve the system as you go along.

During the implementation stage, use your internal audit process to check that the system does what is required, including the 9001 requirements. This will help you determine early on if the actual practices matches the quality manual and procedures. When weaknesses or problems are identified (and it will happen), use the formal non-conformance and corrective action processes that should now be part of your system.

Get an accredited certifier or ‘registrar’ to audit your system and issue the certificate

The final step in the process is to select an accredited certifier. You will need to formally apply for certification, pay any fee due and schedule an external audit.

The certifier will audit every element, procedure and document of your quality management system to make sure that all the requirements of ISO 9001 have been met. During this audit, the auditor may log findings where the system does not fully comply. Once all findings have been cleared to the auditor’s satisfaction, the certifier can award the certificate.

You will receive the formal certificate sometime after the audit has been completed successfully. Certificates look slightly different depending on the certifier, but it will state the scope of the certification and the Standard against which you are certified.

ISO certificates are valid for three years. You now need to run, maintain and improve your system. External audits, although shorter than and not as comprehensive as the original audit, will be conducted at least annually. After the 3 years, another full audit will have to be done for recertification.

ISO 9001 quality management systems (QMS) are implemented using MyEasyISO software in Siena (Tuscany, Italy), while ISO 14001 & OHSAS 18001 Health Safety Management Systems (HSE) are implemented with MyEasyISO in Isfahan (Iran).

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