There's no need to follow the structure of the ISO standard; instead, your procedures may combine or split up ISO clauses as appropriate to your business. In addition to the more high-level procedures, you'll need to describe the detailed steps of performing work processes though work instructions.
We will address this in Step 3. Forms and checklists aren't specifically mentioned by the standard. However, they can be considered both work instructions before they are filled in and records after they are filled in — both of which are addressed by the standard. We recommend creating forms and checklists where they can save time and effort in meeting ISO requirements.
Process maps are used to provide insights into workflows. We'll cover them in Step 3. It has been argued that documentation isn't an important part of ISO and focus should be on processes. This requires clarification. Of primary importance are, in fact, actual work processes, including your new ISO processes. However, new processes are much easier established and consistently carried out when properly described. Documentation should only be created where it adds value. Good ISO systems strike a balance between over— and under—documenting.
Keep in mind that once a work process is documented, it needs to be carried out accordingly. That's how your ISO documentation directly impacts your operations, efficiency and profitability. Your ISO documents need to fit your business. They can't be written by somebody unfamiliar with your company. Even a company insider shouldn't do it in isolation. Larger companies could have a multi-functional team write their high-level documentation.
If you work for a small or midsize business, you can develop procedures and supporting forms yourself after obtaining staff input. Proceed as follows:. Tackle one clause at a time — study the requirements and generally accepted interpretations. Determine the organizational functions that are impacted. Establish the current level of compliance based on gap analysis. Explain the requirements to affected management and discuss possible ways the requirements could be adopted.
Once you reach consensus on the optimal process, put it in writing. The standard doesn't prescribe any particular format, structure or numbering system so choose what works best for you and follow these tips:.
DO look for the simplest way to meet a requirement and adapt it to your business. DO use diagrams and illustrations rather than long-winded text. DO use layout that's visually appealing and easy to understand. DON'T include time-consuming references to other documents. DON'T include bureaucratic requirements, requirements that are not suitable for your company's circumstances or culture, or requirements that hinder your business operations and productivity. The requirements on document control in clause 7.
It's the ideal procedure to start with before addressing the remaining requirements. Whenever you see record keeping requirements, consider if a form or checklist could be useful. Preparing all ISO documents is quite time consuming, complicated, and prone to mistakes.
But don't worry, there's a shortcut — documentation templates. These pre-written documents are designed to be tailored to your company's needs; the included customization instructions show you how. Templates are a core component of certification toolkits, and consultants use them as well.
Since their quality varies widely, due diligence is needed. Base your evaluation on the above documentation tips and pay particular attention to the extent of the customization instructions. During the implementation phase you will introduce your procedures to affected employees and help them adjust and improve their work processes accordingly.
ISO implementation requires virtually all employees to change the way they work to some extent for example, how they use documents. To make your quality management system succeed, there needs to be an incentive to adopt new work processes. It's essential that your new procedures are efficient, non-bureaucratic, and user-friendly. Introduce staff to one procedure at a time, starting with document control. Depending on the size of your company, you could explain the requirements in staff meetings, or use a trickle-down approach where you leave the explanations to department managers.
Implementing the procedures creates opportunities for process improvement. Empower staff to redesign their work processes along the new ISO requirements. This will create motivation, lead to improved processes, and the ISO procedures will be adopted almost automatically. Teams start by visualizing their existing work processes through process maps on a white board.
These flowcharts will help to identify how different functions interconnect, and where bottlenecks, repetition, and delays occur. Once there is consensus on improvements, the redesigned workflows should be documented. Work instructions are step-by-step directions on how to perform an activity. The ISO standard requires them where they add business value. This could be in the case of rarely-performed or high-risk activities, or work carried out by temporary or untrained staff.
Work instructions should be written by staff who actually perform the work. Any format will do if it's useful to the user, including text, flowcharts, pictures, screenshots and even videos. At least initially, you should review work instructions to verify compliance with ISO and your new procedures.
ISO includes numerous record-keeping requirements. As ISO requirements are gradually incorporated into daily business activities, records should be generated. Auditors will review records when verifying compliance with the standard. You aren't certified yet — but ISO could already pay off in marketing. Experts in a particular subject area gather together to discuss ways of further improvement.
At the end of these discussions, a voting process brings the organization to a consensus. The full process takes about three years on average. For the organization to create standards, the following four situations need to occur:.
In the mids, international delegates met in London to create a new standardization for international cooperation and organization. The result of these meetings led to the formation of the ISO. Their efforts became so prevalent over the decades that they now have almost 23, published standards throughout countries.
Now, companies earn ISO certifications to prove their quality standards to the world. Obtained from third parties, ISO certifications act as a company's proof that they abide by the standards set forth by the International Organization for Standardization. They instill confidence in clients and other stakeholders that a company conducts itself efficiently and to a high standard.
ISO certifications also prove a company's commitment to important business objectives such as customer satisfaction and production. Some public and private sector entities even request that a company has ISO certification before conducting any business with them. There are four common types of ISO certifications:.
One of the most common certifications is the ISO This grouping of quality management systems QMS are standards that help companies meet the needs of both customers and stakeholders. It acts as the most basic form of what the ISO set out to accomplish. Each company is given the autonomy to determine what format is most appropriate for their organization to demonstrate processes and compliance with the standard.
Specific procedures and processes are not included on the required documentation list. Each organization is given the autonomy to determine the best method of organizing and communicating their business conduct practices — from top executive function to day-to-day operations.
For organizations that already employ standardized processes, cohesive teams, and consistently delivered desired outputs, very little will be required in regard to documentation.
Newer businesses and those new to the standard will benefit from the close and careful examination of their business practices as they develop the documents and records needed to meet standard requirements. With its deep-rooted approach, the standard allows businesses to align strategic business goals with the implementation of their ISO-certified QMS.
In developing the context of the organization 4. Furthermore, the evaluation of employee awareness 7. Creating awareness for how each team member affects outputs and deliverables helps create buy-in and participation in the new QMS. Consultants help organizations strategize and determine the minimum amount of documentation required to ensure that the full team understands their roles and responsibilities while also helping businesses use their quality management systems to achieve and record consistency in desired outputs.
If you choose to partner with a consulting agency, be sure to ask if they themselves have successfully achieved ISO certification to the standard. Once developed and implemented, your system must go through a required, third-party ISO audit.
However, obtaining ISO certification is not a matter of passing or failing that audit. When the certification auditor comes and reviews your system, they measure the processes you have in place against the requirements set by the standard. Your business could be seeking to improve internal efficiency and leverage operational best practices.
ISO standard procedures offer ready-made developed procedures to ensure your business operates to a consistently reliable outcome. Standards are maintained by recognised a body that evolves practices and methodology you can adopt and tailor to your oganisational context. As a result, business activities become more efficient and you can focus internal resources on more productivity.
ISO helps your organization to attain recognition. The best companies in any industry are known for their product quality. ISO can illustrate your company is well managed to create better brand recognition and potentially improve sales. Maintaining the certification is an on-going process. Through the regular audit and certification, you can continue to attest the quality of products remains consistent and meets the requirements under the standards for procedures and high quality products.
To attaining ISO certification it is crucial to select an experienced and competent external consultant to help your business through the design and implementation of the project.
There are many considerations to take into account from what standard to adopt, how to modify the standard to creating an efficient implementation plan and certification approach that reduces disruptions to your organisation.
In addition, the standards are not a one-time event and operating to these new requirements involves ensuring your organisation is trained and clear accountability is defined to manage the system. These questions are materially relevant and can create uncertainty and additional costs if addressed incorrectly.
A consultant can better assure the project outcomes and build the approach with greatest probability of audit success with reduced project resources if engaged at the right stage.
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