Why Businesses Need Business Continuity Management Certification and How to Get it?

The ability of an organization to continue essential operations in the face of a variety of events that could interrupt regular company operations is known as business continuity. It involves ensuring that your business can carry on with the least amount of disturbance feasible in the event of a disaster, such as power outages, natural disasters, cyberattacks, and other external threats. Specifically, business continuity refers to the use of effective risk management procedures that enable you to promptly and cost-effectively recover from incidents while maintaining key activities in the event of a disaster. You must concentrate on building and maintaining a strong BCMS if you want to make sure that your business processes are resistant to a variety of disturbances.

The Reasons Why Companies Need Business Continuity Certification

If your objective is to grow your business, attract new clients, and generate the best company image, then getting a Business Continuity Management Certification will help you to achieve these objectives and more. Establishing suitable processes thoroughly and concisely ISO 22301 document your BCMS are crucial steps in becoming ready for the ISO 22301 certification.

By Business Continuity Management System certification, you can:

• Be prepared for any hazards. A business continuity plan that includes comprehensive instructions on how to handle various disruptive situations will help you be ready for any kind of calamity.
• Boost the resiliency of your firm. By having a solid strategy and explicit procedures for staff to follow, you can continue running your business even in the event of a tragedy.
  bolster system safety.
• Create a business continuity strategy that includes cybersecurity to make sure that processes are in place to safeguard assets and data and can quickly recover from any threats.
• Preserve essential operations. With a business continuity strategy in place, you can keep your company running in the case of unforeseen circumstances and maintain the integrity of your key systems.
• Reduce the number of corporate losses. Prevent being negatively impacted by unforeseen events like losing money or damaging your reputation.

Business Continuity Management Certification Process for Your Businesses

The Business Continuity Management System certification includes several key stages, which are according to your organization, its activities, and the type of organization.

Step 1: Implement an ISO 22301 Awareness Program: Plan training workshops to acquaint staff members at all levels with the guidelines and tenets of ISO 22301. This guarantees that all parties are aware of their respective roles and duties in carrying out the business continuity management system successfully.

Step 2: Assemble Committees and Policies: Form committees at different levels and create business continuity process policies that adhere to ISO 22301 standards. To enable effective implementation and management of the BCMS, this entails establishing roles, responsibilities, and decision-making frameworks.

Step 3: Create the Certification Documentation for ISO 22301: Provide the necessary documentation, such as the formats, methods, and instructions for implementing and maintaining the BCMS, to obtain ISO 22301 certification. These records are used in certification audits as proof of compliance.

Step 4: Implementation and Employee Training: Introduce the BCMS to the entire staff and provide them with thorough instructions on how to use the formats and processes listed in the documentation. This guarantees that staff members have the abilities needed to successfully support business continuity initiatives.

Step 5: Conduct the Internal Audit: To gain Business Continuity Management System certification first you need to carry out an internal audit. This evaluation is the first stage in figuring out how much compliance there is with the standards and what resources are required to meet the requirements as stated.

Step 6: Create an Action Plan to Close the Gaps. You might need to add to or change your program based on the results of your initial evaluation. Establish clear guidelines for the precise steps to be followed, the resources needed, and the due dates for achieving compliance.

Step 7: Audit Certification Procedures: Make arrangements with an outside certifying authority to conduct an ISO 22301 certification audit. Your BCMS’s compliance with ISO 22301 criteria will be evaluated by the certifying body. Certifications and conformance evaluations are not performed by the ISO organization itself.

Step 8: Get Your Business Continuity Management System Certification: Upon the assessment of your BCMS’s compliance with ISO 22301 criteria, you will ultimately obtain your official certification. This attests to the fact that your company has implemented an international standard-compliant business continuity management system.

Differentiate Between ISO 9001 and ISO 14001

The International Organization for Standardization (ISO) created a diverse range of standards. Promoting consent-based expectations worldwide for governments, companies, organizations, and markets. This important contribution has greatly facilitated the processes of globalization. The ISO 9001 and ISO 14001 are the most popular standards, and both standards are important for businesses seeking excellence.

In this post, we differentiate the ISO 9001 and 14001. Both these standards are crucial for the worldwide and know their differences which is grow the businesses. In the end, you should know the ISO 9001 and ISO 14001 benefits and focuses and helps to determine which standard is most for your organization’s needs.

Know the ISO 9001

The ISO 9001 is an International Standard which stands for Quality Management System (QMS) The ISO 9001 standard outlines a systematic approach to process management and guaranteeing that products and services satisfy the needs and expectations of consumers consistently.  ISO 9001’s main concepts include customer focus, continuous improvement, a process approach, evidence-based decision-making, and employee involvement. Implementing ISO 9001 allows organizations to improve customer happiness, increase efficiency, eliminate waste and errors, and demonstrate their dedication to providing high-quality products and services.  

The ISO 9001 certification is not mandatory, but many organizations, however lots of companies choose to pursue it to obtain a competitive advantage and create trust with their consumers and stakeholders. The standard applies to all types of organizations, regardless of their size or industry, and it is one of the most extensively used management system standards globally.

Know the ISO 14001

ISO 14001 is an International Standard which stands for Environmental Management System (EMS). ISO 14001 is a global standard that specifies the standards for an organization’s environmental management system (EMS). It focuses on recognising environmental impacts, formulating goals, and carrying out programs. ISO 14001 compliance can demonstrate a commitment to sustainability, minimise pollution, and increase resource efficiency. Implementing an efficient EMS can result in cost savings and improved access to environmentally responsible markets.

ISO 14001 certification is optional, but it is sought by organizations around the world to demonstrate their commitment to environmentally responsible practices and gain a competitive advantage in a market where environmental issues are becoming increasingly relevant. The guideline applies to organizations of all sizes and industries, assisting them in taking proactive actions towards a greener, more sustainable future.

The Difference ISO 9001 and ISO 14001

ISO 9001 and ISO 14001 are both internationally recognised management system standards, although they perform different functions and address various aspects of organizational management. Let’s look at the main distinctions between these two standards and their relative advantages:

ISO 9001 – Quality Management System (QMS)

ISO 9001 focuses on building and maintaining a Quality Management System (QMS) inside an organization.

Key characteristics of ISO 9001:

• Customer Focus: ISO 9001 lays a strong emphasis on addressing customers’ needs and increasing their satisfaction with products and services.
• Process Approach: The standard encourages organizations to identify and manage interrelated processes to accomplish desired results efficiently.
• Continuous Improvement: ISO 9001 encourages organizations to strive for improved performance throughout time.
• Evidence-Based Decision-Making: The standard promotes making decisions based on data and information.

Advantages of ISO 9001:

• Increased client satisfaction and loyalty
• Improved product and service quality.
• Streamlined operations and improved efficiency
• Reducing waste and errors
• Enhanced competition and market opportunities

ISO 14001- Environmental Management System (EMS)

On the other side, ISO 14001 focuses on EMS to help businesses effectively address their environmental roles and responsibilities.

Key Characteristics of ISO 14001:

• Environmental Impacts: Environmental Impact: ISO 14001 demands organizations to identify and assess their environmental aspects and impacts, taking into account their operations, goods, and services.
• Compliance: The standard emphasises adhering to applicable environmental laws, regulations, and other criteria.
• Objectives and Targets: ISO 14001 requires organizations to establish environmental goals and targets for improvement.
• Lifecycle Perspective: The standard supports environmental considerations throughout the lifecycle of products and services.

Advantages of ISO 14001

• Decrease the environmental impacts and pollution
• Cost savings
• Increased the Environmental image and stakeholder trust
• Access to concerned with the environment markets and customers

Find the Relevance to Organizational Needs

To establish which standard is most relevant to an organization’s needs and goals, it is critical to evaluate their specific context and objectives.

• Choose ISO 9001 if your organization wants to improve overall quality, customer satisfaction, and process efficiency.
• Choose ISO 14001 if your company wants to improve its environmental performance, minimise its environmental footprint, and demonstrate a commitment to sustainable practices.

Why is an Education Institute Required to Implement ISO 37001 Certification?

A global standard called ISO 37001 was created to assist organizations in controlling and reducing the risk of bribery. However, because of its criteria, costs, and structure, development assistance organizations are rarely interested in obtaining accreditation or completely implementing it. Despite this, the standard can act as a model and a roadmap for development projects and relief organizations in certain crucial sectors. When it comes to managing the risks associated with corruption and bribery, organizations might find great value in the global standard ISO 37001. Development aid organizations, however, have not demonstrated much interest in ISO 37001 accreditation thus far. Furthermore, no donor organization has managed its corruption risk management (CRM) procedures using the standard. Although ISO 37001 certification is more frequently linked to corporations and businesses, educational institutions can also gain advantages from it. Here’s how to do it:

• Improved Reputation: Obtaining ISO 37001 certification is indicative of a dedication to moral behaviour and openness. An educational institution’s reputation may be improved in this way, increasing its appeal to potential partners, teachers, and students. It demonstrates the organization’s commitment to upholding strict moral principles.
• Risk Management: A methodical approach for recognizing, evaluating, and reducing the risk of bribery is offered by ISO 37001. Educational institutions can lessen the possibility of bribery-related occurrences, which can have negative effects on their reputation, finances, and legal standing.
• Legal Obedience: Educational institutions can better comply with anti-bribery laws and regulations in their home countries by adhering to the ISO 37001 standard. This might be especially crucial for organizations that have relationships or activities abroad because bribery rules differ greatly between countries.
• Enhanced Governance: Organizations must set up explicit ISO 37001 documents like anti-bribery policies, processes, and controls by ISO 37001. This may result in better governance in educational establishments, guaranteeing ethical and transparent decision-making procedures.
• Efficiency and Effectiveness: The standard promotes the simplification of bribery prevention procedures. While resources are concentrated on essential instructional activities rather than addressing bribery-related issues, this can result in greater operational efficiency and effectiveness.
• Competitive Advantage: An institution may stand out in a crowded educational field with ISO 37001 certification. It can make a significant difference for students in picking their study locations and collaborating with other organizations.
• International Collaboration: International research projects, student exchanges, and collaborations are common among educational institutions. By assuring foreign partners that the organization follows anti-bribery best practices, ABMS certification can promote cooperation and trust.
• Stakeholder Confidence: There may be worries in the community at large, among funders, parents, and students, and over the moral behaviour of schools. The institution’s commitment to ethical behaviour can be reassured to these stakeholders by the ISO 37001 certification.
• Continuous Improvement: The continuous improvement culture is promoted by ISO 37001. To keep up with changing dangers and legislative changes, educational institutions can evaluate and update their anti-bribery policies and practices regularly. Understand the requirements for managing anti-bribery.
• Reduced Liability: If there is a bribery occurrence, ISO 37001 may lessen the institution’s legal liability. An institution may have more legal leverage if it can show that it took reasonable steps to prevent bribery.

In conclusion, educational institutions can gain a great deal from ABMS certification, including greater governance, risk management, reputation management, and legal compliance. Additionally, it can support increased stakeholder confidence, efficiency, and competitiveness—all of which are beneficial for the education sector and that’s the reason why education organizations are required to implement ISO 37001 ABMS Standard.

By ISO 22301 Standard, How Should Activities be Defined When Establishing Business Continuity?

The International Organization for Standardization (ISO) publishes ISO 22301 business continuity management systems, an international standard that outlines how to manage business continuity within an organization. The greatest framework for managing business continuity in an organization is provided by the standard, which was authored by top professionals in the field. Business continuity management is defined by ISO 22301 as a component of an organization’s total risk management, with some overlap with information security and IT management. To demonstrate the company’s compliance with partners, owners, and other stakeholders, implementation and ISO 22301 certification are helpful. Additionally, ISO 22301 facilitates the acquisition of new clients by simplifying the process of proving superiority in the field.

The most recent revision of ISO 22301 was released in October 2019. ISO 22301:2012, which was created using the British standard BS 25999-2, has been replaced by ISO 22301:2019. Although there are not many significant changes in this 2019 revision, there is more flexibility and less prescriptiveness, which will benefit both businesses and their clients. There are eleven sections or clauses in the ISO 22301 standard. Clauses 0 to 3 are introductory (and are not required for implementation), whereas the important clauses (from 4 to 10) are mandatory – that is, all of their requirements must be implemented in an organization if it wishes to be compatible with the standard.

Before beginning the ISO 22301 implementation project, the organization must determine how to assign the business continuity task to the various departments, business units, and processes. Even with 50 workers, it would be challenging to design a single business continuity plan that included the specific recovery procedures for both your marketing and IT departments or to do a single business impact study for the entire organization at once. For precisely this reason, firms are required by ISO 22301 to segment their businesses into these kinds of operations. You can use one of these two methods to segment your business into different activities:

• Organize your tasks according to processes
• Organize your activities on divisions within the organization.

So, let’s first understand the process-based activities: With this option, the organization have to list their processes, and each of these processes becomes an activity in terms of BCMS.

For example, if a company is a law firm, the process of representing the clients in divorce cases is considered an activity. Such a process probably includes not only the lawyers who work on such cases but also the couriers who handle the mail, administrative personnel who handle the phone calls and correspondence, etc. For each such process, you have to perform business impact analysis and risk assessment, develop the strategy, and write the recovery plan. You can also consider a set of related processes as a single activity, using the law firm as an example, a single activity could include processes related to all types of law practice – not only family law but also intellectual property law, tax law, corporate law, etc. The advantage of this process-based approach is that it is easier to understand activities in terms of the ISO 22301 definition of activity in the ISO 22301 documents, and if individuals already have such processes documented, it might be easier to analyse them.

Let’s now better understand department-based activities – the strategy in which activities are split based on organizational units. This is how a company can ensure that each employee reads only one plan when it is required. In a law firm, this means that the legal department is one activity, the finance department is another, the general affairs department (which includes couriers and administrative people) is another, and so on. The biggest downside of this strategy is that it is impossible to quantify all of the effects during a business impact analysis (BIA) if the organization do not know where the process begins and finishes; this is why BIA requires extensive cross-departmental communication and coordination. The second issue is that recovery plans only cover parts of numerous processes, which means the organization must describe exactly which inputs you need and from whom, as well as when and to whom you need to deliver the outputs, otherwise organization plans will fail.

This department-based approach to activities is permitted under ISO 22301 since it enables activities to be a group of processes, and departments are frequently nothing more than collections of smaller processes. This is also supported by practice, where certifying bodies permit this technique.

Understand How to Structure ISO 20000 ITSMS Documentation

The International Organization for Standardization (ISO) and the International Electoral Commission (ICE) jointly developed ISO 20000, an international standard for IT service management (ITSM). The majority of member nations are required to approve ISO 20000 for it to be recognized as a global standard, meaning most nations have adopted it.

The standard outlines a series of management procedures intended to make it easier for organizations to provide IT services (to clients as well as employees within the company) that are more effective. The firm may demonstrate that it adheres to best practices by using ISO 20000, which also provides the methodology and structure that are needed to manage the ITSM and enhance the quality of the IT services that provides. Any industry and any size of business are enclosed by ISO 20000.

Before beginning the ISO 20000 implementation, you must establish your strategy for handling documents that must be produced within the parameters of your Service Management System (SMS) — what is required, within what parameters, in what sequence to write the documentation, etc. This will make things easier. So let’s look into how to structure the SMS documentation collection and how to choose what documents are required. Policy, plan, process, and record documentation are mandated by the standard. The phrase “documented” is frequently used in the standard to indicate that the information for a requirement must be recorded (either in a document or in the tool).

Whether a company utilize a tool or not will affect how much documentation and record-keeping is required for ISO 20000 implementation. The necessity for recorded information (or documented information) for the ISO 20000 standard can be satisfied if you have a tool. Additionally, if you don’t utilize a tool, you will need a lot more paperwork to meet all the requirements. For instance, if you have a tool, you should use it to log events and service requests. However, if you choose not to use a tool, you will need to find another method of recording them because it is mandated by the standard. For fewer events and service requests, a spreadsheet will work just well.

No specific method for structuring the ITSMS documentation is required by ISO 20000. However, it is mandated that records and documents for every process are covered by ISO 20000. When attempting to organize your SMS documentation, the following crucial components, i.e., may be helpful:

• Documentation structure – Create ITSMS policies, regulations, and process descriptions using the same model. The ISO 20000 documents kit will be simpler to navigate as a result.
• Sequence – SMS requirements and processes are the two main components of ISO 20000. Writing documentation in that order is also a good idea; for example, creating documents relating to SMS setup first, then documents about the process, and finally, documents required for internal audit and management review.
• Content – Policies, or procedures, must adhere to certain requirements outlined in ISO 20000. This means that your change management procedure, for instance, must specify how to deal with urgent changes. Because the requirements are stated plainly in the standard, that is the simpler part. However, you’ll also need to include a few optional components to make your procedures appropriate to your business. The Incident and Service Request Management procedure, for instance, is not initiated according to the standard. So, based on your circumstances, document it. That will make the procedure clear-cut.

Recognize the Importance of Safety Awareness in the Laboratory

Improving awareness of safety in the laboratory is crucial for lowering occupational risks. Chemicals, electrical equipment, and biohazardous items are just a few of the various safety risks that can be found in laboratories. Consequently, it is crucial to comprehend the significance of laboratory safety awareness. The schedules for testing and research projects may also be impacted if something goes wrong. Employees may sustain injuries at work, and equipment may be destroyed.

Hazards can be reduced or completely avoided by being familiar with the laboratory safety awareness and constantly adhering to the correct safety practices. Knowing the right actions to take in the unfortunate event that something goes wrong is also crucial. Although laboratories are made with safety in mind, accidents can still occur, therefore it is vital to be ready and aware of any potential threats.

Since the safety of any laboratory is of utmost importance, the safety resource was developed to encourage and promote safe and effective working procedures. The main causes of laboratory accidents and issues include haste, taking shortcuts, and not adhering to established procedures. To prevent wasting samples, money, or time, as well as to ensure your safety, it is imperative that you take your time. The proper safety equipment must be worn by anyone operating or visiting the lab, and food and beverages must not be consumed. It is more likely that meticulous, accident-free work will be encouraged in a tidy, uncluttered environment.

The Laboratory Safety Awareness Training PPT will help to get the training to the staff members and it contains an overview of the laboratory safety management system, laboratory safety responsibility, safety rules, implementation of OH&S, hazard/risk assessment, risk assessment and evaluation, safety documentation, MSDS and safety for use of chemicals, electrical safety, compressed gas cylinder safety, emergency preparedness, fire safety & best safety practices, safety checklist, and safety manual. Throughout, we reiterate the significance of safety and stress that the first step in establishing safety awareness in the lab is becoming familiar with all the necessary tools and working methods. In order to ensure remedial and preventive actions are taken, as well as ongoing improvement, safety in the workplace requires a review of common laboratory audit safety results.

In addition to the significance of lab safety for preserving employees and researchers, there are a number of crucial tactics that companies may implement to help maintain the secure running of their labs. These consist of:

• Creating a thorough program for laboratory safety, complete with policies, procedures, and training for handling and using hazardous compounds safely. This program needs to be periodically reviewed and modified and should be customized for the specific risks that exist in the lab.
• Making available the proper personal protective equipment (PPE) to all employees who use hazardous materials in the lab. Depending on the dangers present in the laboratory, this can also include gloves, safety glasses, lab coats, and respirators.
• Personnel with the necessary training and familiarity with the risks that exist in the laboratory should conduct these checks. They should entail examining the safe handling, labeling, and storage of hazardous materials as well as the quality and upkeep of PPE and other safety gear.
• Putting into practice protocols for waste disposal, spill containment, and emergency response. All employees should receive a thorough explanation of these protocols, and they should be routinely reviewed and put into practice to make sure that everyone is capable of handling emergencies in the lab.

Overall, maintaining the health and safety of workers and researchers in lab environments depends on laboratory safety awareness training. Employers can contribute to the prevention of accidents and injuries as well as the protection of the larger community from potential risks by putting in place a thorough safety program and granting access to the necessary PPE.

Fundamentals of ISO 13485 Medical Device Manufacturers’ Standard Documentation

According to ISO 13485:2016, a company must be able to deliver medical devices and related services that consistently meet customer and regulatory criteria. The system must meet certain requirements. The design and development, production, storage, distribution, installation, or servicing of a medical device, as well as the provision of related services like technical assistance, are all fields in which these organizations may be active at any number of stages of the life cycle. It is also possible for suppliers or outside parties to apply ISO 13485:2016 when offering these organizations’ products or services connected to quality management systems.

Companies know they can expect a tonne of documentation when it comes to ISO certifications. It is particularly true for certification to ISO 13485 for medical device quality management, as medical device manufacturers must produce comprehensive documentation as proof of the safety of their products—and the efficiency of their quality systems. A Quality Management System (QMS) that conforms with the standard and all relevant regulatory criteria is required to obtain the ISO 13485 certification. In addition to the documentation required by the jurisdiction, ISO necessitates documentation that includes like:

• Quality policy and objectives: Organisations must have written policies that outline both their commitment to quality and the specific goals that will enable them to achieve it.
• Quality manual: The scope of the QMS and references to established quality processes should be included in the quality manual.
• Computer software validation procedure: Medical device makers are required by the U.S. Food and Drug Administration (FDA) to validate any software used in the creation, production, packaging, labelling, storage, installation, and maintenance of finished products.
• Quality procedures and records: These must include instructions for ISO 13485 documents and records control as well as all other operations.
• Medical device file: Both the technical documentation for the device and its device master record are referred to in this document.

Documenting Management Participation

A growing focus on managerial responsibility is something we notice in international standards everywhere. In terms of managing management participation, what are ISO auditors looking for?

• In the documentation, specify roles and responsibilities in detail
• keeping track of the dates for QMS reviews and other preparatory activities
• keeping records of planning sessions and evaluations

Employee Training Records

Manufacturers require a documented employee awareness training program that outlines procedures for evaluating team members’ knowledge and competency. A fully integrated QMS that can push and pull data from other systems like human resources (HR) would make it simpler to keep track of records and other personnel information.

Infrastructure and Maintenance

ISO 13485 requires documentation of organization requirements for quality assurance. Documenting standardized maintenance methods and keeping records of any maintenance or repairs is a significant focus here.

Contamination Control

According to the standard, medical device manufacturers must record information about things like:

• How to keep the quality of final products from being impacted by environmental factors
• personnel attire or hygiene considerations
• the steps to take when handling contaminated products

Product Realization

Several documentation requirements are covered in ISO 13485’s Product Realisation Clause 7. These cover the following subjects:

• Process and outcomes of the customer requirements review
• A process for contacting customers
• Plans, outputs, and files related to design and development
• Verification of raw materials and products from third parties
• Traceability
• Installation and calibration documents
• records of computer validation

Supplier Documentation

Typically, medical device manufacturers collaborate with several vendors and contract manufacturers. The ISO 13485 standard includes demands to proactively address supplier quality because of the magnitude of risk that suppliers might provide to products. Structured supplier quality agreements are particularly mentioned as necessary in the standard. Another best practice suggested by the FDA is the use of supplier quality agreements, which aid in establishing official standards for product requirements and supplier behaviour.

Documenting Measurement and Monitoring

Monitoring and analysis are essential components of the ISO approach, and ISO 13485 standard is not an exemption. ISO 13485 Clause 8 goes into a wide range of monitoring requirements, including documentation and records of processes such as:

• Complaint Handling and customer feedback
• Regulatory reporting
• Internal audits
• Nonconforming product
• Corrective and preventive action
• Reporting

What Information has to be Included in the ISO 55001 Asset Management System Documentation?

The primary goal of the ISO 55001 standard for the asset management system, is to assist organizations in more efficiently managing the lifecycle of their assets. Organizations will improve everyday operations through the implementation of ISO 55001, increase the returns on their assets, and lower overall risk costs. All corporate organizational models and all asset kinds are subject to this standard. A rise in efficacy and a sharp decrease in unit cost make up the tangible results. Additionally, this framework encourages performance improvement over time and provides enhancements for businesses of any size, style, or sector. Some of the essential components that the documentation kit must include are listed below.

• The scope of the asset management system: To determine the scope of the asset management system, you must first define its boundaries and applicability. The scope must be provided as recorded data.
• The asset management system: You must create a strategic asset management plan (which may be termed whatever you choose). This must include evidence of the asset management system’s function, demonstrating how it aids in the attainment of asset management objectives.
• The Policy: The asset management policy must be recorded and accessible.
• Asset management objectives: Asset management goals must be established at all relevant departments and levels. The asset management objectives must be documented.
• Planning for asset management: When determining how to meet its asset management objectives, you must first determine and then document:
  • The decision-making approach and criteria, as well as how it will prioritise the activities and resources required to meet your asset management goals and objectives.
  • The procedure and methods that will be used to manage its assets throughout their life cycles (which might range from creation to end-of-life)
  • What will be done with the assets and procedures linked with them?
  • What resources are needed?
  • Who will be held accountable?
  • How the outcomes will be (monitored and) assessed
  • The most appropriate time frame for asset management plans – (they may need to be rather long if asset life cycles are extensive, or to meet legislative requirements)
  • The financial and non-financial risks associated with asset management strategies
  • Actions to handle risks and opportunities connected with asset management, taking into consideration how these risks and opportunities may vary over time.
• Documented Information: Your asset management system must have the following components:
  • documented information as required by ISO 55001
  • Documented information required to meet applicable legal and regulatory requirements
  • Documented information that you determine is required for the asset management system’s success (we can provide assistance on what this entails).
• Operational planning and control: You will be responsible for planning, implementing, and controlling the processes required to achieve requirements, as well as implementing actions (to address risks and opportunities), asset management plans, and corrective and preventative measures. It means that you must:
  • Determine the procedure criteria
  • Implement appropriate process control based on the criteria
  • Maintain recorded information that is required to have confidence and evidence that the procedures were carried out as intended (you do not have to keep written records of everything – we can advise you on what this entails)
  • Risks must be managed and monitored
• Performance evaluation: You will have to keep appropriate documented information so that you can provide evidence of the results from the monitoring, measurement, analysis, and evaluation.
• Internal audits: Internal audits must be conducted at regular intervals to offer conformity information and to keep recorded information so that you have ISO 55001 documentation of the results of executing the audit program as well as evidence of the audit results.
• Management review: Top management must assess the asset management system on a regular basis to ensure that it is appropriate, adequate, and effective. You must preserve documentation as proof of the outcomes of management reviews.
• Improvement – Nonconformity and corrective action: You must preserve documentation as proof of the following:
  • The non-conformities or incidents as well as any actions taken
  • The results of any corrective action that was taken. 

Do you believe that the document preparation process might be exceedingly challenging and time-consuming? The ready-to-use ISO documentation kit from Certificationconsultancy.com makes it possible for anybody to create documents in just a couple of working days. Certificationconsultancy.com offers ready-to-use ISO 55001 documents for the asset management system, the documents are designed to help global clients in preparing ISO 55001 asset management systems. The Asset Management System documentation kit contains a well-designed sample editable document set, which is designed as per requirements for ISO 55001:2014 certification. The documents are user-friendly and easy to adapt, it also written in plain English and provided in editable MS Word format. Any organization can easily modify the ISO 55001:2014 documents as per their organization’s assets and processes and within three days their total documents with all necessary controls can be ready for implementation.

5 Documents That are Important for the IATF 16949 Documentation Procedure

IATF 16949:2016 is the global technical specification and quality management standard for the automobile sector, based on ISO 9001:2015. Rather than being a stand-alone QMS, it is intended to be used in conjunction with ISO 9001:2015 and includes extra requirements relevant to the automotive industry. IATF 16949:2016 standard brings together requirements from throughout Europe and the United States, describing all that needs to be known about achieving best practices while designing, developing, producing, installing, or maintaining automotive goods. It can be utilized by any business and is intended for usage by organizations of any size or industry. Many businesses regard this as the minimum necessary for an organization to be a supplier because it is recognized as the foundation for any business to build a system to assure customer satisfaction and improvement.

Developing documentation and a record control system is an important aspect of adopting an IATF 16949-based Quality Management System (QMS). The organization must generate the most appropriate documentation, as it will determine how the QMS is maintained and enhanced, as well as how documents and records must be created, published, withdrawn, and used. Before commencing to generate IATF 16949 documents, the organization should first understand each document, its purpose, and its location in the document structure. A quality policy, quality manual, procedures, work instructions, guidelines/Standard Operating Procedures (SOPs), records, and forms are all required when establishing an IATF 16949 Quality Management System. Each document and record type has a purpose in the QMS and has a specific place in the documentation structure.

When people are just getting started with creating documentation, they frequently become confused about what order the documents should be in and which is more significant than the others. So, some of the most usual documentation are included below to help make the documenting process easier and faster. Certain documentation is required as part of the Quality Management System according to IATF 16949 standard. There are several reasons why this documentation is required:

• To provide a comprehensive overview of the company’s operations
• To provide a more comprehensive understanding of the QMS
• To improve process consistency
• To demonstrate achievement of goals and objectives

It is critical that the individual focus on what the organization needs to document throughout the preparation of the QMS documents: What documents can help boost efficiency? What documents are relevant to the company and the industry in which it operates? The last thing that is required is a slew of unnecessary documents that no one uses since they are irrelevant.

• Quality manual: The IATF 16949 quality manual must be customized as per the organization, with its structure and content depending on factors including the size of the organization, the complexity of its operations, and the skill level of the staff. Smaller businesses will be able to contain their entire QMS in a single manual; however, larger businesses with multiple locations will probably have multiple different quality manuals. The following fundamental components will often be present in the quality manual:
  • Document title
  • Table of contents
  • QMS scope and exclusions
  • Information on version and approval
  • Description of the Quality Management System
  • The company’s business process model
  • Definitions of employee responsibilities
  • References to relevant documents and appendices
• Quality policy: In particular, “policy” refers to a statement of an organization’s assertion. A quality policy should indicate the company’s commitment to quality and continuous process improvement. Because it is frequently utilized for promotional purposes, displayed on the firm premises, and posted on its website, this policy should be succinct, concise, and to the point. The quality policy’s purpose is to create the framework for accomplishing quality objectives inside the organization. By quantifying these quality objectives, the company’s quality targets are defined.
• Procedures: The document title, purpose and scope, responsibilities and authority, descriptions of all actions, and references to any applicable SOPs, work instructions, and records should all be included in QMS processes. It is up to you how you document this information: processes can be written in narrative style, illustrated with diagrams and flow charts, structured with tables, or a combination of formats. Appendices may be included if necessary.
• Work instructions: Work instructions might be included in a procedure or merely referred to in the procedure. Work instructions typically contain the same parts as procedures and have a comparable structure. The difference is that work instructions are more explicit, covering activities that must be completed, stages to be taken and in what order, tools and procedures to be utilized, and accuracy requirements.
• Records and forms: In brief, the organization must demonstrate the actions and processes carried out by the procedures and work instructions. This is when records and documents come into play. The majority of them will be performed by employees, but a few will be the duty of top management (for example, Management Review Minutes). Focus on brief, easy-to-complete records and forms to keep them practical (and staff using them).

A Closer Look on ISO 15189 Medical Laboratory Standard Quality Manual

A comprehensive description of an organization’s quality management system can be found in the quality manual. It is essential to the procedure and acts as the system’s overall manual. The requirements for quality will be spelt out in detail in the manual, which will also outline how the other laboratory records should be organised. A quality manual is required in every laboratory using a quality management system. However, there is a lot of edibility in the preparation, and a laboratory can design the manual so that it is most helpful and appropriate for the situation at hand. The ISO 15189 clause 4.2.4 requires laboratories to have a quality manual, however the style and organisation are not prescribed.

According to the standard a ISO 15189 quality manual is a document that details a company’s quality management system. It’s intended to:  

• Information must be conveyed clearly
• serve as a foundation for fulfilling the needs of quality systems  
• demonstrate management’s dedication to the quality system

All laboratory personnel should receive ISO 15189:2022 awareness training on how to utilise and apply the quality manual, which serves as a crucial roadmap or guide. It is necessary to keep the manual up to date, and updating responsibilities should be allocated. Although ISO 15189 requires laboratories to maintain a quality manual, the style and organisation are not prescribed. A laboratory can create the manual in a way that is most beneficial and appropriate for the purposes of the laboratory and its clients because there is a great deal of flexibility in how to make it.  

A group of experts as well as ISO 15189 consultant is an excellent strategy to take advantage of when creating a high-quality manual. Each facility should carefully consider how to incorporate those who are necessary because the quality manual needs to be customised to the laboratory’s particular demands. Include the laboratory’s policymakers in your efforts. Involving the bench technicians is also crucial to benefit from their knowledge and get their support.  

The quality manual should include policies for each of the twelve essentials of the quality system. Also, describe how all relevant quality processes occur, and make a note of all versions of procedures (SOPs) and where they are located. SOPs, for example, are part of the larger quality system. Although there are frequently too many to include directly in the quality manual, the manual should stipulate that SOPs be produced and advise that they be compiled in the SOP manual.

A quality manual’s objective is to explain information effectively and to serve as a framework or roadmap for satisfying implemented quality management system requirements in the medical laboratories. The manual is the responsibility of laboratory management, and as such, it communicates managerial commitment to quality and the quality management system. The ISO 15189:2022 manual should follow:

• The quality manual serves as the foundation for the entire quality management system, it must be accurate and up to date at all times. To ensure this, the laboratory will need to develop a procedure. The stages below provide advice for creating, maintaining, and implementing a quality handbook.  
• When the quality manual is written and prepared, it must be approved by the head of the laboratory. In some laboratories, approval by another appropriate person, such as the quality manager, might also be required. This approval should be indicated by having official signatures and dates of signing recorded in the manual itself.
• It is necessary to set up an upgrading procedure or system. This system should outline how often the manual will be reviewed, who will be in charge of updating it (often the quality manager), and how modifications will be incorporated and recorded.
• The quality manual will need to be updated regularly even after receiving approval; this approval should be demonstrated by the signatures of the person(s) with the appropriate authority, along with the date of the modification, being noted in the manual.  
• All laboratory staff members should receive training on how to utilise the manual; they also need to be fully aware of the importance of adhering to the guidelines outlined in the quality manual at all times.