Some scope repair companies are ISO certified. Others aren’t. “So what?” you might ask. Why should you care one way or another? All scope repair companies are the same, right? Certification makes no difference, right?
Wrong. It does matter.
ISO certification puts some companies’ heads above the rest and its requirements have a direct – and very positive – impact on the work and service you receive as a customer. Here’s how it affects you and your scope repair service.
What is ISO, anyway?
ISO (International Organization for Standardization) is a worldwide federation of national standards bodies, representing 127 countries. The object of ISO is to promote the development of standards around the world that facilitate the exchange of goods and services, and develop cooperation in intellectual, scientific, technological and economic activity.
Why is it ISO, and not IOS? Since the “International Organization for Standardization” would have different abbreviations in different languages (e.g. “IOS” in English; “OIN” in French for Organisation Internationale de Normalization), it was decided at the outset to use a word derived from the Greek isos, which means “equal.” Therefore, whatever the country, whatever the language, the short form of the organization’s name is always ISO.
What is ISO 13485?
ISO 13485 is a quality management standard produced by the worldwide ISO federation to ensure consistency in the quality control and assurance process in medical device manufacturing and service industries. These standards are written to fit all medical device businesses regardless of what the organization does and no matter its size or whether it’s in the private or public sector.
ISO certification is very similar to JCAHO. Companies that are ISO certified go through an audit process that is similar to what the hospitals go through for their JCAHO certification. Audits can be conducted annually or semi-annually depending on the size of the company and the complexity of the processes. There is one difference between the ISO and JCAHO certifications though: ISO certification is voluntary. Companies choose to go through the ISO certification process to improve themselves. These companies (like Total Scope) realize the importance of customer focus, consistent quality repairs, continual improvement, etc.
Some companies claim to be ISO “compliant.” This claim means absolutely nothing. No third party has verified that the company does, in fact, meet all the requirements of the ISO standard. This is like a hospital claiming to be JCAHO compliant. Without the audit, there’s no way to prove it.
To become ISO 13485 certified, all companies must meet stated quality requirements in a range of areas. Here’s a rundown of affected company functions:
- Management responsibility and quality assurance system
- Order review
- Document control
- Supplier qualification and part verification
- Lot identification, traceability, and customer product
- Process control
- Inspection, testing, and status
- Control of measuring devices
- Control of nonconforming product
- Corrective and preventive action
- Handling, storage, packaging, preservation, and delivery
- Control of quality records
- Internal quality audits
- Competence and training
- Product servicing
- Statistical techniques
- Internal communication
- Customer feedback system
- Risk assessment
- Process based system
- Resource management
- Continual improvement
- Process and software validations
Following are brief explanations of what these requirements mean for each area and how they benefit you, the customer.
1. Management Responsibility and Quality Assurance System
Requirement: The ISO 13485 standard requires that management establish a policy and system that assures quality performance. The quality policy and system must be periodically reviewed by management. Management is responsible for initiating continuous improvement, guiding all processes, implementing solutions to quality problems, and allocating resources, all in support of the quality assurance policy and system.
How We meet the Requirement: We have created a quality policy and a quality system that includes all aspects of the ISO requirements. Management meets routinely to review all aspects of the quality assurance system and make adjustments to processes as needed.
Benefit to You: Your scopes are fixed by a company that has tightly controlled quality assurance processes that cover every aspect of the scope repair business. The company’s management is actively involved in making sure that all systems are functioning properly to ensure your scope is fixed correctly and in a timely manner.
2. Order Review
Requirement: The ISO 13485 standard requires that a company is positive that it can meet all of the customer’s requirements prior to accepting an order. This includes the ability to fulfill the order and delivery time.
How We Meet the Requirement: A qualified employee reviews the order in conjunction with the company’s abilities and available resources, including capacity. This review must be conducted prior to order acceptance. 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.
Benefit to You: In your dealing with vendors, you’ve surely had situations where the company was unable to provide the product or did not do so in the promised time period. When doing business with an ISO 13485 certified company, you know what you are getting: the promised product within the promised time period.
3. Document Control
Requirement: The ISO 13485 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.
4. Supplier Qualification and Part Verification
Requirement: The ISO 13485 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. meet the company’s needs. Only approved products from approved vendors may be purchased.
How We Meet the Requirement: Each new part and/or new supplier goes through a trial to ensure that the part and/or supplier meet the company’s needs. 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.
5. Lot Identification, Traceability, and Customer Product
Requirement: This ISO 13485 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. And we use specialized software to track your scope’s status while at Total Scope.
Benefit to You: By using a certified tracking system, we ensure you get back your scope, not someone else’s; you can call us anytime to find out your scope’s progress; and in case of a problem, we can track where a part came from and prevent the problem’s recurrence.
6. Process Control
Requirement: ISO 13485 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.
7. Inspection, Testing, and Status
Requirement: The ISO 13485 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. We determine status by the physical location of the material in our lab and by accompanying paperwork and/or tags.
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.
8. Control of Measuring Devices
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.
How We Meet the Requirement: All critical measuring devices are calibrated to NIST traceable standards by an independent calibration service. Preventive maintenance is performed on all measuring and process equipment according to manufacturer’s recommendations.
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. These things aren’t an issue at TSI.
9. Control of Nonconforming Product
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.
How We Meet the Requirement: Nonconforming products are identified based on their physical location in the repair facility and accompanying paperwork or attached label or tag. This identification includes the customer, model number, serial number, and status in the repair process.
Any non-conforming parts are immediately segregated from conforming parts to prevent inadvertent use. The supplier is immediately contacted to provide a replacement part to minimize delay in returning your fixed scope.
Disposition (rework, scrap, or return to vendor if a purchased product) may only be determined by qualified personnel.
Benefit to You: Through these systems, you are guaranteed to never have an inferior part used in your repair or a nonconforming product delivered to you by mistake.
10. Corrective and Preventive Action
Requirement: A documented system for implementing corrective and preventive actions must be maintained. Corrective and preventive actions are initiated based on internal audit findings, customer complaints, employee suggestions for improvement, etc. Corrective actions can address repair issues or procedural and system issues. Preventive actions may include ideas for cost savings, increased productivity, improved quality, etc.
How We Meet the Requirement: Whenever we uncover a situation that can be improved, or something that needs to be corrected, the idea is recorded and evaluated, we specify any required change, establish a procedure if needed, and train personnel as required.
Benefit to You: You know that systems are in place to improve the repairs and service you get by eliminating problems or potential problems. You also know that if you do have a concern with your repair or service, you will be addressed promptly.
11. Handling, Storage, Packaging, Preservation, and Delivery
Requirement: All products and parts must be handled, stored, packaged, and preserved to protect against damage. This protection must take place while on the vendor’s site and during shipping/delivery.
How We Meet the Requirement: All products and parts are stored and shipped in the manufacturer’s packaging wherever possible. If this is not possible, appropriate storage and packaging is determined and provided.
Benefit to You: You know that your equipment is properly protected from damage while out of your hands. You also can be sure that parts used to fix the scope were properly handled prior to installation.
12. Control of Quality Records
Requirement: Quality records must be maintained to demonstrate conformity to requirements. These records must be maintained for the expected life of the product. All quality records must be identified, collected, indexed, accessible, and maintained.
How We Meet the Requirement: A document retention location is determined with all required records being filed, properly labeled, and organized.
Benefit to You: Any time you would like a repair history on your equipment, an ISO certified repair service – like Total Scope – can provide all the information you need.
13. Internal Quality Audits
Requirement: Internal quality audits must be conducted to ensure that all systems are adequate in meeting ISO requirements.
How We Meet the Requirement: Internal quality audits are conducted by reviewing procedures to make sure that they address all aspects of the standard and reviewing practices to make sure that the procedures are being followed properly.
Benefit to You: You can be assured that all systems are functioning properly and proper controls are in place. Any possibility of a system failing or functioning ineffectively would be removed during the internal audit process.
14. Competence and Training
Requirement: The ISO 13485 standard requires that employees be competent in the job they are in, receive training, and that the training was effective.
How We Meet the Requirement: An employee is provided training in either a classroom or an on-the-job training setting as needed. The employee is then permitted to study or practice what was taught in the training session. After a specified period of time, the employee either takes a written test or performs the task covered in the training session with an experienced employee observing. If the employee does not pass the written test or is unable to demonstrate the mastery of the learned task, the employee is given additional training and a retest.
Benefit to You: This prevents you from having to send your scope to be fixed multiple times for the same problem, receiving incorrect invoices, etc. This training is ongoing, as it is critical to keep all employees abreast of the latest technologies and review existing practices on a continual basis.
15. Product Servicing
Requirement: All equipment service done by the company must be performed according to procedures. When completed, it must be verified that the work was done according to specified requirements.
How We Meet the Requirement: Procedures are developed to cover all types of repairs. Technicians are trained according to the procedures and audited periodically to ensure that repairs are done according to procedures. After repairs are completed, the repaired equipment is tested to make sure the repair was done properly.
Benefit to You: You can be sure that repairs performed on your equipment are done by trained individuals who do not deviate from proven procedures. You also know your equipment passed all required tests prior to it being returned to you.
16. Statistical Techniques
Requirement: Management identifies statistical techniques that are useful in running the company’s quality management system. These statistical techniques are used to assist in establishing, controlling, and verifying process capability and product characteristics.
How We Meet the Requirement: We track and analyze process and product data at prescribed intervals to determine if any modifications need to be made to the process to improve it.
Benefit to You: You know that your repairs are conducted in an optimal process that has early warning signals should any quality problems arise. This assures no delays in getting your equipment back to you due to major process problems.
17. Increased Internal Communication
Requirement: All employees will be made aware of all regulatory and customer requirements that could affect their job.
How We Meet the Requirement: Paperwork describing regulatory or customer order requirements are distributed to all employees that need to know these requirements.
Benefit to You: You know that employees who can affect the customer service you receive are aware of your requirements.
18. Customer Feedback System
Requirement: A formal system for gathering customer feedback must be implemented and maintained. This system is one of the drivers for management to continually improve the company’s processes.
How We Meet the Requirement: Various customer surveys are conducted to determine customer satisfaction levels and identify areas that need improvement and things we should continue doing.
Benefit to You: You have a chance to give feedback to the company that does your repairs. You know that the company values and will act based on this feedback.
19. Risk Assessment
Requirement: Risk assessment must be conducted during all planning processes. Any aspect of a plan that has too high of a risk (risk of patient injury, employee injury, or a quality problem) associated with it must be modified to reduce the risk. If modification is not possible, steps should be taken to alert employees and customers to the risk.
How We Meet the Requirement: Risk assessment is conducted during the planning process through common risk assessment tools such as Failure Mode and Effect Analysis (FMEA) and Fault Tree Analysis (FTA).
Benefit to You: You know that all customer service and repair processes have been analyzed for risk prior to implementation. There is little risk of a problem during the repair process because all potential problems have been worked out prior to implementation.
Requirement: ISO 13485 requires that companies go through proper planning before implementing anything. How many times have you seen a company introduce a product/service only to remove it later because they really weren’t ready to release it? How many times have you noticed that customer service suffered because of a change made by a company? With the ISO 13485 standard, this cannot happen. Companies must look at all aspects of the change, perform risk analysis, review required resources, and ensure that the change does not adversely affect other processes.
How We Meet the Requirement: Planning is controlled through a checklist-type form. The form ensures that none of the above items is overlooked. No plan can be implemented without the completed form stating that all angles have been explored.
Benefit to You: You can be assured that any service offered by a company that is ISO 13485 certified has been properly planned to ensure that no “surprise” problems will occur after implementation and affect your customer experience.
21. Process Based System
Requirement: ISO 13485 is a process-based approach to running a business. Older quality systems were departmentalized. The left hand did not know what the right hand was doing. ISO 13485 is very different in that it ensures that things do not get lost in the cracks when going between employees or departments.
In many older quality systems, department members did not understand how the tasks they were responsible for fit into the big picture and did not understand how other departments relied on their work. This lack of knowledge caused errors, things getting lost in the shuffle, etc. Now procedures are written for the process or mapped for employees. Now employees see how the entire process works and how what they are responsible for affects the entire process. The process approach leads to increased communication, which leads to better products and service.
How We Meet the Requirement: The process approach is accomplished through process mapping. This shows all employees how things are to be accomplished, who is responsible for every piece of the process, and the interconnectivity of processes. Process mapping is also a tool to help a department manager see where a system is lacking or has “holes.”
Benefit to You: A process approach ensures that your scope will never suffer slip through the cracks because of an information gap among staff. Your scope will follow the same proven process every time.
22. Resource Management
Requirements: Management must determine and provide the resources needed to maintain the effectiveness of the quality system and to meet customer requirements.
How We Meet the Requirement: During the planning process, needed resources are determined.
Benefit to you: You know that your equipment repairs will not be delayed because the company is short on resources needed for the current demand level.
23. Continual Improvement
Requirement: ISO 13485 certified companies must show evidence of continual improvement. This continual improvement affects all aspects of the business, but particularly quality.
How We Meet the Requirement: We use various methods to ensure continual improvement, including customer feedback review, customer complaint resolution, defining management objectives, planning, and taking corrective and preventive actions, among others.
Benefit to You: Total Scope continually strives to improve the quality of your scope repairs and your customer service. Also, we stay on top of the changes in scope technology.
24. Process and Software Validations
Requirement: Any process whose end result cannot be directly tested must be validated to prove that the process is producing the desired result. Software validations must be completed to prove that software is functioning exactly as expected.
How We Meet the Requirements: Every step of the process is examined to make sure that each step is producing the desired result. Every feature of a software program is examined to make sure that it is producing the desired result.
Benefit to You: You can be sure that there are no surprises in your scope repair. All processes and programs are guaranteed to be functioning properly due to the validations, so there will be no delays or quality problems with your equipment repairs.
As you can see, a company’s ISO 13485 certification has a direct and very positive impact on you, the customer. So why settle for anything less? Yes, an un-certified company may have some or even all of the above attributes. But it may not. Is it worth the risk? You know for certain that an ISO certified company has all of the above. If you decide to use a company that is not ISO certified, your scopes may be in danger of substandard repairs and your suite may be vulnerable to long delays in getting your scopes back.
Another word of caution: a company can have a portion of their business certified, but not the rest. For example, a company could have the manufacture of equipment certified, but not the repair of the equipment. Be sure that the scope repair portion of the business is certified, or you are taking the same risks as using a company with no ISO certification.
Even the OEMs’ repair processes are not certified. Total Scope was the first to take the initiative to adopt, implement, and earn the ISO certification. And we undergo semi-annual audits by an outside certifying organization to ensure that our quality systems are properly maintained and continual improvements occur.
The choice is yours. Don’t settle. Demand ISO certification from your scope repairer.