ISO 13485:2016: Medical device design controls and why they’re important

 

Medical device design controls are a set of policies and practices intended to ensure consistent translation of input requirements into a physical product that meets those requirements. The ISO 13485 Certification is based on the quality management system, which helps to implement the medical device preventive system. 

Good design controls are important to:

·        Reduce product risks

·        Demonstrate your product is fit for purpose

·        Align your organisation

 Prepare procedures for design and development:

Document Manager enables you to prepare ISO 13485 procedures for design and development. So a Procedure is a high-level SOP and a work instruction is more for deep dive, and controlled documents. Under the requirements of ISO 13485, there are certain procedures that must be part of your QMS. Note which items ISO 13485 focuses on and ensure they're part of your plan while keeping the unique needs of your organization in mind.

ISO 13485 include a quality manual and various documented procedures, and add further documentation as needed. Be sure to include all documentation requirements in your implementation plan.

Design and development planning:

Document Manager enables you to:

·        Plan and control product design and development.

·        Document needed resources

·        Retain and maintain planning documents.

·        ISO 13485 Document the design and development stages.

·        Document responsibilities and authorities for design and development.

·        Document the methods to ensure traceability of outputs.

What are the Benefits of ISO 13485 Implementation?

The ISO 13485 emphasizes risk management, risk-based decision making and changes related to the increased regulatory requirements for organizations in the supply chain. 

·        Increase access to more markets worldwide with certification

·        Enhance credibility and recognition of your organization 

·        Improve decision-making processes 

·        Consistently improve your quality and performance 

·        Outline how to review and improve processes across your organization

·        Increase efficiency, cut costs and monitor supply chain performance

·        Demonstrate that you produce safer and more effective medical devices

·        Meet regulatory requirements and customer expectations 

Requirement of ISO 17025: 2017 for Laboratory Measurement Equipment and Related Procedures

The Present research in industry relies heavily on direct measurements. To meet that requirement, modern laboratories have to use high-tech equipment. Also, to obtain the appropriate measurement result, the laboratory must use a systematic approach to the measurement process.

The approach to learn clearly emphasizes the large number of factors that can influence the outcome of a measurement. Whatever test you wish to be approved for, the first point in mapping the processes and activities related to the evaluation test. Then look at the risk and decide which controls should be included:

• Human resource management
• Document management of processes
• Successful technical records
• Appropriate facilities and conditions
• Suitable equipment that can be repaired
• Certified consumables
• Appropriate reagents
• Appropriate test method
• Proven methods
• Proper handling of samples

As per the ISO 17025:2017 Standard requirement is that laboratories must demonstrate their skills, the work done requires the proper use of laboratory equipment and is committed to regulatory processes.

The best tools for working in a laboratory environment are known as laboratory materials. Laboratory equipment can include key measuring instruments, measurement software, auxiliary measuring modules and equipment, reagents, equipment, and verification materials required for the proper operation of the measurement process.

Not all measuring machines guarantee success in the lab. the laboratory must provide proof that it is using special equipment identified and measured, that the equipment is in good condition and that it is regularly inspected and maintained, and, that it provides qualified personnel to perform the work.

The effective use of laboratory equipment is influenced by the area in which the measurement is performed. Measurements can be made on the premises of the laboratory, where environmental conditions are controlled and it is very easy to maintain repetition at any consecutive measurement. However, in some cases, estimates should be made onsite, where environmental conditions vary and may influence the accuracy of the estimate.

In any case, in order for the lab's reputation to be maintained, it is necessary to use measurement equipment to help monitor, control, and record environmental conditions.

The measuring equipment’s quality must be maintained by the following procedures for using laboratory equipment. Such procedures must define, including:

• proper ways to catch
• appropriate methods of measurement in the area of ​​measurement, service adjustment, quality assessment (comparison), or return
• appropriate methods of handling equipment during the evaluation, repair, or retention of laboratory staff
• routine and repetitive testing of basic test equipment to ensure that the equipment can achieve the measurement accuracy and/or uncertain measurement required to give a valid result
• tracking age of laboratory equipment and potential physical damage, firmware version updates, or software failures
• provision of records describing the use of equipment, repairs, skills testing, retrieval, etc.

Monitoring the whole process and control of actions brings consistency to measurement procedures and accuracy to measurement outcomes. Laboratories must create a control system and hire skilled workers. According to process ISO 17025 Documents of Performance and proper use of measurement equipment ensures the expected performance of the method to produce the appropriate measurement result. For implementing ISO 17025 in your company successfully, Visit Punyam.com, which provides ISO 17025 Consultancy for all types of laboratories, such as testing laboratory in the field of civil engineering material testing, metallurgical testing, environmental parameters testing, chemical testing, optical testing, thermal testing, fluid flow testing, etc., as well as calibration laboratories in India.

Key elements for Successful health, safety, and environment management system

In general terms, Health, Safety and Environment (HSE) is regulations, methods and processes designed to help protect workers, the environment and the public from any kind of harm. In essence, HSE management system plays an important role in reducing risk, creating a culture that attaches importance on health and safety and supports the continuous improvement of all business processes. 

HSE Documentation kit based on ISO 14001:2015 and ISO 45001:2018

All with a very different approach to health, safety, and environment (HSE) management systems in a wide variety of industries. e.g., a multinational energy production company has departments staffed with hundreds of people creating systems for health and safety management, while a small manufacturing plant might have two people total in safety. 

No matter how small or large the organizations are, employees can work in any field of industry and will face workplace dangers that can threaten their health and safety. Behind this all, it’s essential that you provide HSE training to your workers and update their knowledge on a regular basis. Also in addition, a well-designed and executed health safety environment (HSE) training is good for business as well as being a key legal and social obligation. With this ISO 14001:2015 and ISO 45001:2018 training, your end will be an Environmental, Health & Safety Management System that works for you and helps your company continually to improve its processes.

Following 11 key elements for most successful health, safety, and environment management systems:

• A way to control and distribute up-to-date HSE Documents: Every HSE system requires a way to distribute up-to-date HSE documents to the right people. Creating protocols in this area helps to make sure that employees always have access to current and correct safety information.
• Safety Inspection checklists: The quality of inspections for a baseline establishment no matter who is performing them, can decrease the amount of time it takes to perform inspections, and improving or declining over time to provide data on areas of safety.
• Risk Assessments: Risk assessments are a successful OHSMS that help you to protect employees from potential harm, and protect business from potential fines and lawsuits. Including the HSE systems, and regularly updating your distributed documents for known or potential risk hazards, can greatly reduce injuries and risk.
• Energy response plan: The requirement for OSHA emergency response plans to include how to report an emergency, evacuation procedures and assembly points, procedures to shut down project operations, rescue and medical duties.
• Training program and documentation system: Employee safety training programs can include fire, tornado, and earthquake drills, accident simulations, etc. While there are no requirements of OSHA documentation of all types of training, and it's a best practice to keep documentation.
• Internal audit policy and Schedule: In HSE Management systems, Health and safety audits are another great way to ensure compliance with safety laws. HSE Documentation from audits can be used to compare improvements and issues from year-to-year, identify trends and create new safety initiatives based on audit data.
• List of Laws and Health, Safety regulations for compliance: This can be beneficial to display additional health and safety law and regulation information in the same space to encourage employee awareness and compliance.
• Experience HSE Team: HSE professionals focus on preventing accidents and injuries, implementing proper guidelines and regulations, and ensuring compliance. In the workplace on a day-to-day basis, health and safety team is a key to ensure that your QHSMS is being properly implemented. 
• Measurable performance metrics: To improve the business bottom line, and HSE departments are no exception. These performance metrics help identify areas that need improvement, as well as trends over time. 

      Following are Key performance indicators for health, safety, and environment include:

1. Lost Time Rate (LTR)
2. Total Accident Rate (TAR)
3. Accident Severity Rate (ASR)
4. Total Recordable Injury Rate (TRIR)
5. Experience Modification Rate (EMR)
6. Working Days Since Last Incident

• Regular meetings and strategy of communicate: Making schedule for health, safety, and environment staff is a key for reviewing current HSE strategies and successfully implementing new initiatives for OHSMS. An HSE staff meetings on a weekly basis, and ensure to assign a meeting leader and prepare an agenda to ensure efficient and effective meetings.
• Regular Management review: An HSE management system needs to be reviewed to verify that current goals are being met and new initiatives are being put in place and practiced regularly.so, the opportunity for discussion between safety personnel and upper management is helpful to give areas of improvement and brainstorm new ideas.

For HSE Documentation, Global Manager Group provides implementation of HSE Management System satisfies all the issues related to health safety and environment with ISO 14001:2015 (EMS) and ISO 45001:2018 (OH&SMS) requirements. Basic requirements of HSE standard are perfect hse manual for ISO 14001:2015 & ISO 45001:2018 integrated management system.

For Sample Integrated HSE Manual Documentation Kit – Click here

ISO 22301 – What Global manager group’s Readymade ISO 22301 documents provide?

The ISO 22301 standard is written by leading business continuity experts and provides the best framework for managing business continuity in an organization. The ISO 22301:2012 is an international standard published by the International Organization for Standardization (ISO), and it describes how to manage business continuity in an organization.

The ISO 22301:2012, which was developed based on the British standard BS 25999-2. The ISO 22301:2012 standard definitely brings more flexibility and less prescriptiveness, adding more value to organizations and their customers. One of the features that differentiate this ISO 22301 standard from other business continuity standards is that an organization can become certified by an accredited certification body, and will therefore be able to prove its compliance to its customers and other stakeholders.

The main focus of ISO 22301 is to ensure continuity of business delivery of products and services after occurrence of disruptive events. The implementation of ISO 22301 will involve not only setting organizational rules that are needed in order to prevent disruptive incidents, but also developing plans and allocating technical and other resources to make the continuity and recovery of possible business activities. ISO 22301 has described how to fit all these elements together in the Business Continuity Management System (BCMS).

An ISO 22301 certification helps organizations implement a BCMS that meet the requirements of the organization, taking into account the legal, regulatory, and industry requirements, as well as the products, services, and processes established in the organization. In addition, the ISO 22301:2012 standard is used to mitigate and control the risks of exposure to internal and external threats, ensuring organizations can effectively respond to security incidents, data breaches, and more.

The initial implementation of an ISO 22301 will require a significant amount of resources such as time and effort in preparation of their ISO 22301 documentation. With that in mind, Global Manager Group has developed ISO 22301 Documentation Kit based on requirements of ISO 22301:2012 standard which includes following readymade templates that can be used as a ready reference tool to accelerate documentation process for BCMS certification.

Which readymade documents are covered in this ISO 22301 documentation Kit?

• ISO 22301 Manual 
• BCMS Procedures
• Exhibits
• Standard Operating Procedures
• Readymade Formats
• Job Description
• ISO 22301 Audit Checklists

Global Manager Group is involved in documentation selling since 1995; here, The ISO 22301 documentation kit is one of the most selling document products of the company. The aim and purpose of providing readymade ISO 22301 documents is to help organization in integration of Business continuity management system for easier management and operations.

The ISO 22301 Documentation kit for Business continuity management system developed by Global Manager Group is consistent in its appearance, and is written and reviewed by recognized authorities in the area. User can also receive support and guidance on using this documentation toolkit. The ISO 22301 documentation kit can also help to understand the management system requirements and make proactive changes to any workflows. By saving time, GMG’s toolkits allows to focus more on ensuring that the necessary processes and procedures are performed and disseminated throughout the organization.

What are the requirements of ISO 17025:2017 for laboratory measurement equipment and related procedures?

Implementation of the ISO/IEC 17025 standard, Laboratory accreditation is obtained through the process that determines the competence of laboratories to provide accurate results. At the global level, with the economic crisis, manufacturers and suppliers must reduce their operating costs. To be able to meet that ISO 17025:2017 requirement, modern laboratories must use the ISO 17025 for high-quality measuring equipment.

To obtain the correct measurement result for equipment, the laboratory must employ an organized approach in the measurement process. As per the ISO 17025:2017 standard’s requirements state that laboratories must demonstrate their competence, practical work requires the proper use of laboratory equipment and commits to following controlled procedures.

Here, the topic highlights the large number of activities that could influence a measurement result. For any testing laboratories you wish to be ISO 17025 accredited for, the starting point is to map the processes and activities related to the measurement test. So, Following are the risks and determine controls that should be placed: 

• Management of personnel competency
• Document control of procedures
• Effective technical records
• Suitable facilities and conditions
• Suitable calibrated equipment
• Certified reference materials
• Suitable reagents
• Suitable test method
• Validated methods
• Correct handling of samples

According to the standard, ISO/IEC 17025, The main tools for work in a laboratory are known as laboratory equipment. Laboratory equipment may include the main measurement instruments, measurement software, auxiliary measurement modules and equipment, reagents, consumables, and certified reference materials needed for the correct performance of the measurement procedure.

There is not all measurement equipment ensures success in the laboratory. With the competence of associated clauses, the laboratory must provide proof that it uses uniquely identified and calibrated equipment, that this equipment is in the correct state and that it is regularly tested and maintained and, of course, that it provides skilled personnel to operate that equipment.

Laboratory equipment is influenced by the place where the measurement is performed and its valid use. For the laboratory premises, Measurement can be done, where environmental conditions are controlled and it is easier to maintain repeatability for any consecutive measurement. But, in some of conditions, measurements must be performed onsite, where environmental conditions are different and may influence the validity of the measurement.

In any case, for the laboratory’s reputation to be preserved, it is necessary to use auxiliary measurement equipment to monitor, control, and record environmental conditions. The quality of the measurement equipment must be maintained through following procedures for use of the laboratory equipment.

Those ISO 17025 procedures must define and continuously provide information about the “health” / suitability of the measurement equipment which including:

• Proper methods of handling
• Proper methods of transport in the case of on-site measurement, service repairs, proficiency testing (inter-comparisons), or recalibration
• Proper methods for handling of equipment during measurement, maintenance, or storage by the laboratory personnel
• Regular and repeatable testing of equipment for basic verification checks that equipment can achieve the measurement accuracy and/or measurement uncertainty required to provide a valid result
• Tracking of laboratory equipment age and possible physical damage, firmware version updates, or software failure
• For detailing equipment usage provision of records, repair, proficiency testing, recalibration, etc.

The audits done by certification firms ensure that the businesses square measure in compliance with the ISO standards or not. The professionals from the businesses assess and valuate the corporate policies, practices and ISO 17025:2017 documents procedures. The ISO 17025 certification involves many alternative processes all levels of labor in among the corporate.

A Guide to BRC Global Standard for Consumer Product

The BRC Standard for Consumer products was first published in 2003 and developed by the British Retail Consortium (BRC), the BRC Global Standards outline requirements imposed by British retailers for a range of products – with the aim of ensuring safety, legality, and quality of products.

And since then it has undergone extensive changes to support the needs of the wide-reaching consumer products industries. Along the way it has developed into a robust Standard based on the principles of risk assessment and good manufacturing practice to deliver safe, legal products of specified quality to the end-consumer.

This BRC standard focuses upon the identification and management of risks and the implementation of preventive measures, with hygiene as a central element of the quality management system (QMS).Basically, the scope of the Global standard of BRC Consumer Products, Issue 3 mainly covers a wide range of non-food products in the global marketplace; including formulated products such as shampoos, paints and cosmetics, etc. and the non-food products may be retailer brands or national brands.

Meeting those BRC Global standards is mission critical for your business, since the majority of UK – as well as many European and global – retailers and brand owners only consider with doing business with suppliers who have gained BRC Consumer products certification of the appropriate BRC Global Standard.

BRC Consumer product certified against this standard to demonstrate their competence in maintaining product safety, legality and integrity for manufacturing and assembly packing companies. The written to address the requirements for BRC Global Standard for consumer product has been in relation to   potential of the product to cause harm to the Consumer.

Requirements for BRC Global Standard Consumer Products 

Following are four different sets of requirements for BRC Global Standard Consumer Products defines for the different product groups. The requirement differentiates between the product groups, but always covers the following topics:

• Product risk management
• Consumer product management system
• Site environmental standards
• Product control
• Process control
• Personnel

Advantages of the BRC Consumer Products Certification

• Stabilize the customer confidence
• Stabilize product safety, -quality and -legality in trading companies
• Security of Higher product 
• Lower product liability risks
• In the sense of product security and steering of processes, Systematic analysis, implementation of safe and more efficient process cycles 
• Timely notice of consumer risks concerning hygiene and security of consumer goods. And Define of appropriate preventive measures.

For ready reference which Contains document template and you could possibly need (both mandatory and optional), as well as additional work instructions, project tools and documentation structure guidance, Global manager group’s BRC consumer product documentation kit really is the most comprehensive option on the market for completing your documentation. The BRC Consumer Products Documents conforming to the requirements of the standard.

Source: foodsafetystandard.wordpress.com

How to get ISO 20000 certified for an Organization?

To get certified with ISO/IEC 20000 for an organization, you must hire a Certification Body. The Certification Body is a company that is responsible for providing such certificates to organizations looking for their services and meeting the requirements of the standard against which they want to be certified.

Standard steps for implementing ISO 20000 and getting certified

To finishing all ISO 20000 documentation and its implementation, the organization must require performing following steps to ensure a successful completion of your project:

• Internal audit - The purpose of an internal audit is to check your IT Service Management processes. The goal is to identify problems and weaknesses.
• Management review - Management review is a formal way for management to take into account all the relevant facts about IT service management and make appropriate decisions.
• Corrective actions - Following the internal audit and management review, There is require to correct any identified problems and document how they were resolved.

The ISO 20000 Certification process is divided into two stages:

• Documentation review - The certification auditor will check whether the ISO 20000 documentation is compliant with ISO 20000.
• Main audit - The ISO 20000 auditor will check whether all their actual activities are compliant with both ISO 20000 and their own ISO 20000 documentation.

Why is ISO 20000 a good idea for any organization?

The Advantages of ISO 20000; The large and small organizations have used this ISO 20000 standard to great effect, discovering and securing tremendous cost and efficiency savings.

So, Following are just a few of these benefits:

• Improve image and credibility - ISO 20000 is the only internationally recognized standard for IT service management. And, it is as a popular and proven standard, you can be sure of the efficiency and scalability of the processes.
• Productivity - To get a competitive advantage through increased efficiency and effectiveness due to more reliable IT services.
• Customer satisfaction increased - Whether it's your internal or external customers, you're able to deliver improved IT services that better meet their requirements.
• Benchmark and improve - For benchmark, to compare your organization's processes and activities against the international standard for ITSM. And, for this cause of independent certification body audits of organization, you can be sure meeting the required level.
• Fully integrated processes - ISO 20000 is beneficial to align IT services with the wider business strategy. 
• Reduce the cost of IT - Better understand and manage the cost of IT. Using simpler processes and clear responsibilities, you can operate a leaner, more efficient service.
• Create a culture of continual improvement - Ensuring your organization is always improving processes in reaction to customer feedback is not just a nice-to-have; it's essential for a company's longevity. 
• More agility and change quickly - ISO 20000 creates the solid framework of best practice that helps support innovation. With modification in your organization can be handled more adeptly and with greater speed to meet organizational objectives.
• Gain a competitive advantage - Through more effective and efficient delivery of IT services, you can give your organization tangible advantages over your competitors. 

Global Manager Group also provides an extensive range of ISO services to help with preparation for certification, maintaining compliance and ensuring improvement. One of our ISO services is that of ISO 20000 auditor training ppt presentation kit which is available online, we enable your relevant employees to develop the needed skills to conduct such audits as required.

Source: itsms20000procedures.wordpress.com