Iso in lab

ISO stands for International Organization for Standardization, which offers a standard for operating a firm from management through manufacturing. It is more encompassing than GMP. The ISO system pays more attention to the management of the firm and places a number of reporting loops in the firm to ensure attention to issues. If, for whatever reason, we cannot meet every aspect of the order, we must inform you of this prior to accepting the order.

This also applies to changes to orders in-house. Each changed order must be handled as if it is an order just received for the first time. When doing business with an ISO certified company, you know what you are getting: the promised product within the promised time period.

Requirement: The ISO standard requires that systems are in place to ensure that only the current version of a document is available for use and that the document has gone through the appropriate approval process. How We Meet the Requirement: Each department has a person responsible for keeping documentation up to date.

These people place the most current documents in a specified location and remove any outdated ones, so that they cannot be used by mistake.

Benefit to You: A document control system guarantees that your scopes are fixed according to the most current information. This ensures that your scopes are fixed using the latest techniques with the most effective processes. Requirement: The ISO standard requires that only vendors that have been through extensive trials and passed rigorous product evaluations can be used.

The trials are conducted to ensure that product quality, customer service, delivery time, etc. Only approved products from approved vendors may be purchased. For parts, this includes verifying the function, appearance, ease of use, etc. For the company, this includes overall service and lead time. These trials typically last at least ninety days to ensure that the part does not cause any warranty issues. Benefit to You: These purchasing requirements protect you from substandard parts and delayed delivery because the company cannot get parts in time to meet your delivery expectations.

If for some reason, a vendor sends a nonconforming part to a certified company, it is immediately segregated from approved parts and is returned to the vendor.

Systems are in place at Total Scope to ensure that no nonconforming parts are used in the repair of your scope. Requirement: This ISO standard requires that all parts used on your scopes are completely traceable back to the manufacturer.

Also, the utmost care must be taken with customer products. Systems are required that track your scope the entire time it is in our possession and keep it from being damaged. How We Meet the Requirement: All parts used in the final product are assigned a unique lot number.

This lot number can be used to track the parts used in your scope, in case of a quality problem. All customer products are tracked by serial number. The serial number and customer name appear on all paperwork and are verified at each stage of the process. Requirement: ISO requires that a company do everything the same way every time unless there is management approval for a change as in the case of improving processes. Strict job procedures must be followed and can only be performed by trained individuals.

How We Meet the Requirement: We establish our procedures and use employee refresher training programs, in-process testing, early warning detection systems for quality problems, statistical analysis, and many other tools to ensure their adherence. Benefit to You: You get the same quality repair every time. It makes no difference who does the repair. All technicians perform the same repair the same way every time. This eliminates any possibility of a low quality repair getting back to you. Requirement: The ISO standard requires that no part or product shall make it to the next stage in the process until the part or product passes the prescribed tests.

That testing status of all parts and products must be obvious to relevant personnel at all times. Companies must maintain Master Device Records that contain all product specifications. How We Meet the Requirement: Tests and specifications are defined at various points in the process, including one set of final tests completed prior to shipment.

Benefit to You: These testing and status requirements and the Master Device Records ensure that you do not receive a product that does not meet all specifications. You never have to send your scope back because it was fixed, but not to specification.

Requirement: All measuring devices must be properly calibrated. This is critical to ensure that your scope is repaired properly and is accurately tested to ensure that it meets specifications. Benefit to You: If a company does not calibrate its measuring devices, you could end up with scopes returned to you that do not meet specifications. You might also experience longer turn times while rework is performed on your scope. Requirement: All nonconforming products any part to be used in a repair that does not meet specifications or scope that does not meet specifications must be controlled so that they are not inadvertently used or shipped.

This requires segregation and proper disposition of the nonconforming products. Although very well known in manufacturing industries, ISO standards are relatively new in healthcare and service organizations. As the certification of different organizations became more common, its applicability in services and, more specifically, in clinical laboratories, was finally understood. The International Organization for Standardization, or ISO, is a non-governmental organization with members from international institutes of more than a hundred countries, coordinated by a central office in Geneva, Switzerland.

The main purpose of ISO is to develop standards internationally recognized. The word ISO originated from the Greek isos, meaning equal.

That expresses the desire of the institution in developing standards intended to be useful for industries and business organizations of all sizes and types. ISO standards are developed by specific committees and contain a series of requirements and specifications usually presented in numeric itens. When a committee decides to set up a new standard, some steps must be followed until the final publication:.

These standards can be acquired directly from ISO or its member institutes and other authorized organizations. The standards can be used as guidelines for orientation or adopted as rules to be followed. They are classified as generic or specific. Generic standards — used for certification purposes: there are two main generic standards: ISO and ISO , which contain essential criteria for implementing quality and environmental management systems, respectively.

As previously described, these standards are intended for certification of companies of all sizes and types, which explains why they have a generic approach. Another characteristic is that both are management standards and must be used by top management as a tool to achieve the expected results of the organization by improving customer satisfaction and reducing negative environmental impacts.

A very important point is that these ISO certification standards are not product standards. They are more concerned about management and processes and do not contain requirements for specific products. Even supposing that a controlled process can lead to a good product - which is not always true - they cannot be considered product guarantees.

Specific standards — usually guidelines for orientation: they are not intended for certification purposes and have a more technical and specific approach. This is the reason why they can be used as guidelines for organizing and standardizing processes in order to achieve better results. They are very useful for understanding how the requirements of a generic certification standard can be applied to a specific activity. ISO - Medical laboratories: particular requirements for quality and competence - is one example of specific standard that can even be adopted by international bodies for accreditation purposes.

Do not expect specific requirements from certification standards. Do not expect good results without top management involvement. Remember they are management standards intended to improve the overall performance of an organization. Do not expect good results without people involvement. This prevents personal preferences or a top-down management style from inhibiting process and quality improvement.

Continual improvement is a permanent objective of ISO quality management. This does not mean, for example in anatomic pathology that every conceivable effort should be made to reduce the frozen section turnaround time by 1 min. The laboratory should find meaningful metrics that are aligned with the laboratory's mission.

Improvements may affect any aspect of the quality management system and its processes. They may involve issues such as saving control tissue for immunohistochemical stains, making the work instructions for lymphoma workups more succinct and accessible, or automating frozen section versus final diagnosis correlations using the laboratory information system. Similarly, in clinical chemistry, continual improvement does not mean making every conceivable effort to reduce hemoglobin turnaround time by 10 sec.

However, it may mean making efforts to drive down variation and risk, which can help a core laboratory avoid repeating testing, incorrect results, physician complaints, or even possibly having to add a satellite lab with its associated overhead costs.

More importantly, continual improvement also refers to the improvement of the quality management system, for example 1 performing better, more thorough internal audits; 2 increasing the use of personal protective equipment and thus better implementation of safety procedures in the gross room to prevent eye splashes or scalpel injuries; or 3 sending staff members to training courses for performing root cause analysis, an integral part of the standard for occurrence management.

Occurrence management refers to the resolution of nonconformities. Nonconformities are routinely identified through a plethora of sources, the most important of which include internal and external audits as well as errors made. RCA is often thought of as one step in the investigation of a major, potentially life-threatening, patient safety event.

In an ISO accredited laboratory, RCA is a commonly and regularly used tool addressing a wide variety of problems, ranging from the most minor usually recurring to the most complex usually rare. In general, the scope and magnitude of any corrective action should be appropriate to the nonconformity and its effects. RCA also provides an opportunity to engage staff in the process of quality improvement. Staff is viewed as a most valuable asset and should always be considered part of the solution, rather than part of a problem.

As a corollary, errors in an ISO accredited laboratory are not attributed to individuals, but to process failures. By definition, removing the root cause s of a nonconformity should prevent its recurrence. Blaming and retraining staff following an error usually does not eliminate the risk of recurrence in the long term.

Most laboratories are struggling with document control, evidenced by its being a common deficiency cited in CAP LAP inspections. They also become subject of internal and external audits. Document control is more than having procedures signed on time, eliminating cheat sheets with outdated information, and finding a document during an accreditation visit.

Document control means that pathologists and other staff have the correct information needed for a task readily available when needed. This reduces risk of error, need to rework, incorrect results, time spent on fixing mistakes, and cost. For example, a laboratory scientist receiving an unexpected flow cytometry sample on a Saturday afternoon should be able to find the information on how to submit the material in the correct medium with the right form to the right section in the shortest amount of time required for successful acquisition.

When a new process is developed, the laboratory will identify the process owner, map the process, and identify its risk points. In most cases, risks will be identified during internal or external audits eg, inspections or PT events. Review of the occurrence management data will allow identification of future risks based on past errors. No matter how risks are identified, in an ISO QMS, each risk will be assessed on the basis of its probability, severity, and impact on patient care.

The laboratory should then discuss and agree upon the level of risk it is willing to accept. In the vast majority of instances, risk cannot be eliminated. The ISO accredited laboratory will take appropriate steps to control risks. This may require mistake-proofing of an existing process or complete redesign of a process if risk is severe.

Care must be taken that process changes do not introduce new, unanticipated risks. We find that the management requirements are often more difficult to implement, but we cannot stress enough that their implementation, driving effective outcomes and improved patient care, are the most rewarding aspect of an ISO QMS.

When a laboratory applies to the CAP accreditation program, the assessment team first conducts an off-site review of the laboratory's documents in order to evaluate the components of the QMS and the laboratory's readiness for accreditation. The laboratory also performs an internal audit in order to assess readiness on its own. Prior to the on-site accreditation assessment, the laboratory has the option to undergo a gap assessment. A gap assessment is a detailed on-site assessment against the ISO standard and adherence to the laboratory's QMS that reveals holes in the system and issues that need to be addressed before accreditation could be granted.

Nonconformities have to be addressed before accreditation can be granted, requiring an RCA, a plan on how to fix the problem, and a plan to check whether the fix was effective.