Risk Management Planning for ISO 17025 Accreditation

 

With the 2017 revision of the ISO 17025 accreditation, labs are expected to implement risk management processes to make sure the overall accuracy of results is not impacted. In earlier versions of the accreditation, this was being addressed via the preventive action protocols but now risk-based thinking pushes labs to take a more strategic look at their risk handling measures. While the accreditation process does not suggest any specific measures to deal with risks and opportunities, there are some commonly set steps for risk planning that could help labs deal with all these uncertain situations. These steps followed in depth should help you set up the right processes to get you the accreditation in one go.

 

1. Identify risks: The base of any strategy setting is exploration. This step is the most crucial one since it builds the base of the entire strategy exercise. To begin risk exploration, it is best to do team-wide brainstorming and discussions. This open forum discussion setting allows people from different departments to voice the various challenges they have faced or anticipate facing and hence gives the leadership a more holistic and ground-level view of possible risks. At this point, you can also involve an ISO 17025 consultant to help you explore and scrutinize your business processes based on past data and performance as well. 
2. Risk evaluation: Every business has a different way of functioning. Depending on how complex your business operations are, you can conduct a qualitative or quantitative analysis of all the risks and opportunities in the business. You could also use 3x3 or 5x5 matrices to assist the calculation of the risk scores and levels. This evaluation helps you understand the low, medium, and high levels of a particular risk. 
   
   
   
   
3. Risk ranking: Once you have all impact levels listed and the whole organization’s opinions notes it’s time to align all the material at hand. This alignment helps you rank all the risks on the basis of the availability of resources to handle them and costs to address them apart from the impact on business. The ranking is an important step since it helps you identify what needs immediate attention and can be addressed right away and what needs not to be prioritized in the strategy.
4. Action planning: Once risks are identified and ranked and the resource planning is in place, it’s time to start working on the plan of action when a risk occurs. These actions could be aimed at eliminating the risk completely, right away, or just keeping things ready when this risk occurs since the cost of taking immediate steps are high as compared to the impact or anticipated frequency of this risk. An ISO 17025 consultancy could play a crucial role here in helping you plan better to address risks.
   
5. Implementation and monitoring: Once plans are set, actions need to be taken. These actions should be constantly monitored and improved wherever necessary as per the results they deliver.

 

These steps help you comprehensively plan for an ISO17025 accreditation. You can however also get ISO 17025 accreditation help from the expert team at Cal Lab Access that constantly strives to help customers achieve 100% results in the first go.

 

3 Easy Ways to Ensure a Smooth 17025 Accreditation

 

The ISO 17025 accreditation is a major step towards the business process streamlining and improving business image for the consumers. This major step hence requires a lot of heavy lifting to bring systems and documentation in place. Not only is it a hectic task to get accredited, but it also requires massive collaboration and planning to happen smoothly. Quality teams need to conduct extensive groundwork to ensure they have a complete gauge of the changes required and the efforts necessary to make them. With companies taking anywhere between 6 months to 4-5 years depending on their size of operations, changes required, and the readiness of plans. Here are 3 things that you should keep in mind to ensure you do not face any hurdles in accreditation.

 

1. Gap analysis and management alignment: These are two of the most important factors in accreditation planning and the best place to start work from. The first step is to get in touch with an ISO 17025 consultancy to get a basic checklist of items needed to complete a scope of accreditation. Using this, a gap analysis should be conducted to understand the misses in the existing system. Next, these gaps must be informed to the leadership to ensure that quality teams work in collaboration with management to successfully plan and execute changes for accreditation.

 

2. Comprehensive change management plan: Now that the gaps are identified and leadership on board, a comprehensive plan must be chalked out to implement the ISO 17025 QMS. This also implies involving staff members since they will be directly impacted by these changes. Instead of making changes to their work, they must be involved in the change management plan to ensure a smooth transition while engaging all levels of the workforce.

 

3. Marketing and awareness: Just assuming that people would know what your ISO accreditation means would be wrong. Most consumers may not fully understand what your accreditation means. This means that investment in marketing your accreditation and making consumers aware about the impact of it is absolutely important. Invest in innovative marketing techniques instead of just a simple letter stating you are accredited.

 

These 3 steps make your journey to accreditation an easy one. It helps you establish a strong base and hence fully capitalize on the power of accreditation. To sail through the process of ISO 17025 Accreditation with minimum friction you can also get help from the experts at Cal Lab Access. Right from gap analysis to helping you prepare a QMS, these experts help you understand the process well and hence reach accreditation quicker.

Things to Remember while Documenting for ISO Accreditation

 One of the most important aspects of your ISO 9001 or 17025 accreditation is documentation of procedures and policies. When implementing the Quality Management System for accreditation or preparing the ISO 17025 Scope of Accreditation, this is the most important element that could also cost you your accreditation. While there is always a threat of over documenting, some policies and procedures that need to be covered to ensure complete documentation and no non-conformances. Using standard templates or getting help from ISO 9001 documentation services could be helpful too. Here are 3 things to remember while preparing these documents that will help ease your task.

 

1. Define process limits: Once you have created a list of procedures to be documented, knowing the steps involved and the limits of the process is very important. Right from raw material procurement to final supplier delivery, every step of the process needs to be documented. Knowing the process and the limits of documentation is a great way of knowing where to stop documenting without missing out on any detail. Getting ISO 17025 accreditation help can ease the process of defining process limits and identify the gaps and misses too.

 

2. Gather and align information: The best way to begin gathering information is to create chart flows that document each part of the process. This will help you find out and focus on all the details and documents that relate to that part of the process and how this process relates to other processes. Once you have the various details available, aligning them to the process flow is important. A common point of aligning focus is the inputs and outputs of every process. This helps you detail your process much better and eliminate any inadequacy of data.

 

3. Define your document structure before writing: A common mistake of preparing the documentation is jumping right into it once you know the details. This might however lead you to rewrite or restructure your document multiple times since you haven’t prepared the flow of it beforehand. Defining the document hierarchy, style of formatting, and style of presentation is a must before you jump into writing the document. This also gives you a clear direction while preparing the QMS documentation.

 

These quintessential pointers are sure to help you better implement your Quality Management System (QMS) and hence make sure you do not miss out on an opportunity to get accredited. If you’re preparing for an ISO accreditation, you could also get in touch with the ISO 17025 and ISO 9001 consulting services at Cal Lab Access. The expert team here helps you prepare documentation and process flow to ease your work. Feel Free to Consult Call Lab Access.

Benefits of an ISO 17025 implementation

There are hundreds of calibration labs popping up every day to meet the growing industrial demand. However, there are only 2 ways to stand out in this ever-crowded market: low pricing and high standards. Pricing is the most commonly used measure of attracting new customers. However, when it comes to testing and calibration labs, quality standards take the forefront. Hence, more and more labs are now stepping up to gain various accreditation certifications. For all such labs, the most common and well-recognized accreditation is the ISO 17025 standard. ISO 17025 consultancy Like the ISO 17025, ISO 9001 is another commonly acquired accreditation by other industries to demonstrate that they can consistently and constantly provide results and services that meet the highest service and regulatory standards. 

While these 2 accreditation standards are usually used just as a way to stand out against the competition, here is what accreditation means to the customers and how it impacts the image of a calibration lab or other companies.

1. Demonstrating competent workflows: As part of the ISO accreditation process, a competency analysis is conducted to check the staff’s skill and technical expertise working within the laboratory or organization. Thus, an accredited organization comes out as a reliable one to the customer who knows that their work is being handled by the best in the industry. This is especially true for calibration labs that need high levels of expertise to deliver quality results. Here, the role of an ISO 17025 Consultant could be important to ensure the right training and certification is made available for the staff to be able to easily clear this aspect of the accreditation process.
2. Reliability of results: As a competent workflow is set up, the outcomes, be it products, services or lab results all come out as per the highest standards. Hence, a certification ensures reliable results for the customers. This is also why ISO 9001 consulting services often focus heavily on creating workflow documentation and revamping processes that help build a trusting relationship between the company and its customers.
3. Government recognition: When you market your product or service post accreditation, you can use the ISO mark on your website or product packaging. Thus you can use an easily recognizable government mark to market your product easily to larger audiences. Customers know when they see this mark that the product or service is of the best quality and will be the use for them.

 

If you are a calibration lab looking for an ISO 17025 QMS set up or documentation or any other organization looking for ISO 9001 certification assistance, get in touch with the expert at Cal Lab Access. Right from training for ISO 17025 accreditation to gap analysis and documentation for ISO 9001 these experts will help you gain the mark of excellence.