Irrespective of the size of your organization, or what type of products or services you deliver, ISO 9001 accreditation has huge advantages that will help you manage the organization better, while at the same time fostering a culture of continued improvement. Being ISO 9001 accredited does not simply give you bragging rights, but defines a solid framework and structure based on management principles that will not only enable the company to operate efficiently, but will also drive continual improvement in all aspects.
To help you get started in implementing ISO 9001:2015 and get certified, we describe 10 steps that will help you manage the process effectively.
1. Identify the reasons why you want to become ISO 9001 accredited
Deciding to go for ISO 9001 accreditation simply because some of your customers demand it, or because someone in management thinks it might be a good idea, is not good enough and will likely lead to failure.
For an ISO 9001 implementation to be successful, it is critical that top management understands ISO 9001 and the very real benefits it can provide from a business point of view, and that overall business efficiency would be improved by implementing a Quality Management System (QMS). The 2015 version of the standard in fact requires that top management demonstrate to all interested parties that the organization is committed to quality.
Key drivers for implementing a QMS typically includes improved awareness of key processes’ performance, the need for continual improvement and meeting any specific customer requirements.
2. Purchase a copy of the standard
You will need to purchase a copy of the standard to determine the exact requirements. The ISO standard is universal to all industries, so there is no need to search for a specific sector. If your country has a standards authority, there might be a version of ISO 9001 specific to your country. These normally use the ISO standard as a basis, but might have some minor changes to cater for specific legislation.
While being accredited to a country’s ISO standard will not present problems if you only trade in that country, it might not be acceptable if you trade internationally in multiple countries. In that case, the standard of one country might not be acceptable in another and customers might require that you either be certified to their country’s standard, or the original ISO standard. If this differentiation exists in your business, you also need to take care in selecting the certification body you’ll use, as they will be accredited to certify companies to specific standards.
3. Strategy definition
The first step in the actual implementation is for top management to define and write a formal document containing the Quality Policy and Objectives as per the requirements of the ISO 9001:2015 standard. The requirements of the quality policy must be measureable so that you can demonstrate continuous improvements.
4. Planning resources
Resources should be made available and realistic timelines set to ensure that the QMS can be implemented within a reasonable time. Responsibilities should be shared within the organization and as top managements is ultimately responsible, it’s a good idea that they are made responsible for some of the functions within the QMS. Although a formal implementation project plan is not required by ISO 9001, it is a logical method to identify needs and check implementation progress.
You could decide to implement the QMS using in-house resources, hire a consultant or use a software system such as MyEasyISO. Each of these approaches have their own pros and cons. When using MyEasyISO, the major benefit is the reduced time and effort required, which will in turn lead to a substantial cost saving. This does not only apply to the initial implementation, but also to the subsequent maintenance of the system.
While the system is developed, the implementation project plan should be reviewed by senior management regularly.
5. Identify your processes
A key requirement of IS0 9001 is that you need to follow a process based approach. In order to do this, you need to describe the interaction between the processes within you organization. A simple process map specific to your company can be used for this.
For each key process, it’s a good idea to identify the controls, resources, records and documentation needed to meet requirements. Validate this process map across the complete business to ensure no interactions or areas are missed. This process map should be used, reviewed and updated during all stages of implementation and should eventually be included in the Quality system.
6. Training needs
ISO 9001 requires that awareness, competence and training needs for employees coming within the scope of the Quality Management System, need to be identified. This will require internal or external training. There are many courses, workshops and seminars available to meet these needs. It is also a good idea not to wait until the QMS has been fully developed and implemented, before starting with training.
Employees need to be aware of what is happening, how it will affect their job, and what the consequences of non-compliance will be. Training on these aspects should start sooner rather than later, as this will ease the actual implementation process.
You also need to make sure that you will be able to demonstrate the effectiveness of training, so give some thought to how this can be achieved.
7. Develop documentation
ISO 9001:2015 requires controlled documentation of the Scope of the Quality Management System, a Quality Policy, Quality Objectives and a Procedure for the control of outsourced processes.
While these four documents are specifically required by ISO 9001:2015, there will be a number of others deemed to be necessary by the organization. ISO 9001 also requires that numerous different types of records be kept. When developing documentation, it’s always a good idea to involve the employees that will ultimately be responsible for maintaining the documentation and records.
When using MyEasyISO to implement ISO 9001:2015, this step becomes very easy as all the required documents and records have already been defined within the software. It simply becomes a matter of completing the supplied templates with you company specific data.
8. Implementing the QMS
Once the QMS has been developed, it should be implemented. It should be noted however that these two steps don’t necessarily have to run consecutively, i.e. you don’t have to develop the complete system before implementing it. As you complete the development of certain sections, start training and implementing it immediately, while development of the other sections continue.
By doing it this way, you will shorten the overall project time. Another advantage is that you will begin generating records sooner, and will be able to quickly identify any areas that are not working as they should, or identify gaps if any exist.
Implementation of the standard’s requirements should be checked by doing internal audits. It’s a good idea to make the internal audit process one of the first to be implemented, together with non-conformances and corrective action. A management review could also be done to ensure the system’s adequacy, suitability, and effectiveness, although this only makes sense one the full system has been implemented and running for a while.
9. Pre-assessment audit
Although this is not a requirement of ISO 9001, a pre-assessment audit by the certification body will enable you to identify any gaps between the requirements of the standard and your existing processes. This audit can be done at any stage and does not form part of the certification process.
10. Get certified
You need to identify and contact a nationally accredited certification body to perform the actual certification. If possible, select a body that has experience in your industry as they will be able to share the experience they’ve had with similar companies.
Initial certification is done in two stages. The first stage is a document and readiness review, normally performed on site. The second stage consists of the actual audit and an accredited certificate will be awarded on successful completion of this stage.
ISO 9001 quality management systems (QMS) are implemented using MyEasyISO software in Lhasa (Tibet), while ISO 14001 & OHSAS 18001 Health Safety Management Systems (HSE) are implemented with MyEasyISO in Bled (Slovenia).