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Steps for Implementing ISMS for ISO 27001:2022 Certification for First-Time

An information security management standard known as ISO/IEC 27001 outlines how firms should manage risk related to threats to their information security, including policies, processes, and employee training. The International Electrotechnical Commission and the International Organization for Standardization jointly produce ISO/IEC 27001. Information security standards, recommendations for protecting a company’s data assets from theft or unauthorized access, and a recognized way to certify a company’s dedication to information security management are all defined in the ISO 27001 standard. The ISO 27001 ISMS standard was updated in 2022 as well.

An organization can gain a competitive advantage from having an ISO 27001:2022 ISMS certification by reducing the risks and effects of cyberattacks, as well as by enabling compliance with data protection laws for information systems, preventing legal annoyances that may arise if the information is violated, allowing data recovery systems, and indicating that the organization has expended a lot of time and money on information security, among other benefits.

The updated ISO 27001:2022 ISMS standard is already being implemented by several enterprises. An organization must carry out specific outlined processes to ensure the implementation is effective and advantageous to receive an ISO 27001:2022 certification. With the support of an ISO 27001:2022 Consultant, the implementation procedure which is simple and quick even though, it can be difficult and time-consuming. Punyam.com is one of the leading ISO 27001 consultancy services providers in India, offering a range of ISO standard certification consulting services as well as instructions on how to implement the standard within an organization to maximize advantages.

Here are some of the defined steps that need to follow by the organization while implementing the ISO 27001:2022 standard for the first time. So, firstly start with an understanding of the basic things about the ISO 27001:2022 ISMS standard, basic requirements, ISO 27001:2022 terms, the steps for installation, and the certification.

  • Start with the ISO 27001:2022 awareness training for every level of employee in the organization including top management.
  • The goals, objectives, and targets for information security must need to be identified by the organization.
  • For the purpose of preparing the ISO 27001:2022 documents, the organization must also form a response team and working committee.
  • Defined the list of any threat that may exist to the company’s information security.
  • After performing a risk assessment, a company must develop a risk management strategy to solve potential issues.
  • Create documents that include all the required details about information security management systems, records, and legal requirements.
  • Provide ISO 27001:2022 auditor training to all staff members to assist the business to achieve its goals and objectives by teaching them how to use the information security management system.
  • Also, ensure that everyone is informed, including interested parties and suppliers.
  • Implement the ISMS and associated processes, and teach every employee how to utilize the formats and processes.
  • Create a system for ISMS controls.
  • All individuals who are part of the internal audit must complete the ISO 27001:2022 internal auditor training before beginning the internal audit process.
  • System evaluation should be done using the results of the initial internal audit.
  • Resolve nonconformities by taking corrective action to make a better system.
  • The organization can submit a certification application once all the nonconformities have been corrected.
  • Conduct a second round of the internal audit to evaluate the system.
 

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How to Increase the Lab Efficiency for Better and More Economical Results?

ISO 15189:2012 is an international standard for medical laboratories. Laboratory certification assists labs in developing quality management systems, assessing their competence, and ensuring they are operating by industry and legal standards. Is it possible to increase efficiency in your lab and specialty tests while maintaining quality? ISO 15189 certification provides an answer to this question by providing a comprehensive approach to quality management in medical, central, and referral laboratories. These standards can not only ensure quality, but they can also reduce the risk of costly delays and ultimately save money in trials. Adopting the ISO 15189:2012 standard is a powerful way to highlight our broad quality standards that meet or exceed their expectations.

To ensure quality results, a large output, and additional support, and maximize efficiency in the lab ISO 15189 standard will help, also when the laboratory trying to increase scientific value and staff well-being while minimizing wasted time and energy, putting in place the right process, resources, and people management it will benefits. Here is a 6-step guide to help to improve lab efficiency without sacrificing quality.

Human resources: In all workplaces, having the right people in the right roles is critical for maximum effectiveness. Everyone must understand the scope of their roles and have the necessary education and experience to carry them out without additional training. However, it is also critical that they continue to learn and gain experience, as well as stay motivated to achieve their objectives. The lab’s leadership must ensure that the staff has everything they need to perform their duties while maintaining high morale. They will also need to maintain team cohesion and good communication among lab members. More tips on how to run a lab can be found here.

Equipment optimization: Having the best equipment possible in the lab will aid in increasing productivity and experimental quality while reducing waste. Equipment should always be maintained as directed by the manufacturer and kept clean and fully operational. This will prevent it from breaking down during an experiment and wasting samples and other consumables. Place fixed equipment in such a way that it takes up little space, is simple to set up and use, and all other items required for the experiment are easily accessible. It’s also worth noting that purchasing the cheapest available equipment may end up costing you more in the long run while limiting the quality of the output. If an item breaks and takes a long time to replace, the experiments may be seriously affected, costing to valuable time and energy.

Upgrade from the paper: The advantages of digitizing your lab are extensive, but a few reasons include having all notes in an indexed format, saving time finding information already written down, enhancing sharing, collaboration, and innovative ideas. Also, try to reduce waste paper and storage space. Keep a record of everything in the ISO 15189 documents for future reference.

Get advice from your peers: One of the best ways to optimize lab workflows and experimental protocols is to consult with those who have more experience, such as the ISO 15189 Consultant, who also has all the required knowledge. Individuals may be performing cutting-edge science, but you will not be the first in the world to use many procedures. The vast majority of new experimental protocols are based on previous work. It will be necessary to personalize the protocols as per your specific experiments, but it is also preferable that someone will be able to guide you on how to do so.

Workspace organization: Once deciding where to begin before organizing your workspace, consider what you will be doing in the space and where it is best to place unmovable equipment, frequently used tools, solutions, samples, storage, and waste. All fixed equipment should be placed in the most convenient location for use without taking up too much lab space. Consider how you will maintain and clean these items when deciding where they will go. Electronics and solutions don’t always get along, so they need to be separated by an appropriate barrier to avoid damage.

Write everything down (in detail): Making a note of everything that happens in the lab, while it may appear to be a pain at the time, will be beneficial in the long run, especially if done in a standardized manner. Write down all of the protocols in minute detail so that any member of your lab can look at them and understand exactly how to carry out that procedure. These documents will also aid in task delegation (especially day-to-day items that lab members can spread among themselves). Organize and legibly record all reagents, samples, timings, and results. You might want to revisit these findings in a year and see if you can still interpret them. Make a note of anything that works particularly well.

 

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The Certification Steps of ISO 28000 Standard

ISO 28000 is an internationally recognized standard that addresses the requirements of a supply chain Security Management System (SMS). It describes the elements that will assist the firm in assessing security hazards and managing them as they emerge in its supply chain. Other facets of company management are linked to security management. Organizations can use ISO 28000 to verify if sufficient security measures are in place and to safeguard their properties from various threats. Here is a list of steps to ensure that nothing is overlooked throughout implementation and certification preparation.

  • Management Support: It is the most critical. Without the support of management, the implementation of SCMS will almost certainly fail. So, start with planning for the sales pitch, well to convince the management that this is a good idea.
  • Establish ISO 28000 Certification Project, Project Plan, and Resources: Determine the cut-off period by which the organization needs to have ISO 28000 certification in place. Enables reverse engineering of the project and the importance of timelines, including the early start-off date. Identify the project leader. Recognize the products or services to be included in the scope of certification. Do the costing. It includes implementation learning costs and certification fees.
  • Conduct ISO 28000 Awareness Training: It is necessary to learn the principles of this standard from A to Z. As a result, we need to cover all resources within the scope. Specialists and industry experts deliver this training in batches. Training records must be kept on file for demonstration during the certification audit.
  • Identify the ISO 28000 Implementation Team: The implementation cannot be delegated to a single individual or a small group of people within the organization. This standard is based on Risk-Based Thinking, and risk management must be handled by various departments and functions, with the department heads acting as “Risk-Owners.” As a result, in addition to the central team in each function, the implementation team would include department heads, deputies, or other important resources.
  • Context, Scope, and Policy: Defining the context, scope, and policy of the supply chain management system can help guarantee that they know the limitations of what needs to be done so that organization does not include sections of the business that may not have an impact on the system.
  • Risk Assessment and Risk Treatment: Risk Assessment and Risk Treatment are the backbone of ISO 28000 objectives to help conduct dipstick checks of performance levels. In addition, documentation will include the mandatory procedures defined by the SCMS standard and any additional processes and procedures required by the company to ensure consistent and adequate results concerning the supply chain system.
  • Implement ISO 28000 Processes and Procedures: These processes are usually there in existence at the organization and must be fully documented procedures. Regardless, determining which one is required is critical to ensuring compliance with products and services.
  • Conduct Internal Auditor Training: The ISO 28000 standard mandates the organization needs to train internal auditors by providing ISO 28000:2022 internal auditor training, who will perform audits on one another regularly. Furthermore, the firm will require a professional industry expert to provide internal auditor training to demonstrate the same.
  • Conduct Internal Audits: ISO 28000 requires that the organization audit each process internally before the Lead Auditors of the Certification body visit to audit the system. It will also have the opportunity to take corrective actions to address any issues that arise.
  • Closure activities and Corrective Action Reports: It is the step where the organization finds the root cause of any problems found during the measurements, internal audits and management review, deviations from established processes, and customer concerns, and takes action to correct the root cause. It is a vital step toward continual improvement.
  • Conduct management reviews: Similarly, management must support ISO 28000 implementation. Top management must analyze particular data from the supply chain system’s activities to verify that the processes have enough resources to be effective and improved.
  • Gap Analysis: During the pre-assessment/Gap analysis, the gap analysis supports identifying gaps. It is implemented before the organization begins the certification audit. Furthermore, it is a critical step in increasing auditee confidence.
  • Choose a Certification Body: The certification body is the organization that will finally audit the supply chain system and determines whether it meets ISO 28000 requirements and is effective and improving.
  • Operate & Measure the Supply Chain Security Management: When a business collects the records required in audits to demonstrate that its processes meet the requirements set out, adjustments to the supply chain system are made as needed. Certification bodies require this to occur over a specific period, which they will designate to verify that the system is mature enough to demonstrate compliance.
  • ISO 28000 Certification Audit-Stage 1: The certification body auditors analyse the ISO 28000:2022 documents to ensure that the organization has handled all of the ISO 28000 standard requirements on paper. The Auditors will issue a report detailing where they comply and where there are issues, and the organization will have the opportunity to implement any remedial actions to resolve the issues.
  • ISO 28000 Certification Audit-Stage 2: When the certification body auditors analyze the records that have accumulated by operating the supply chain system procedures, including internal audit records, management review, and corrective actions, this is the leading audit. If the organization meets all of the standards, the auditors will also suggest certification. However, if there are any serious non-Conformances, then must take corrective action before recommended certification.
  • Time to Plan: A proper plan will help while implementing ISO 28000 and working toward certification, so plan ahead of time and know what resources where need, this will save time and cost later on.
 

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What Benefits Does the ISO 22301 System Offer to the Company?

Business continuity management is defined by ISO 22301 as a component of comprehensive risk management in the enterprise, with some overlap with information security management and IT management. Implementation and certification can help an organization demonstrate compliance with its partners, owners, and other stakeholders. Furthermore, ISO 22301 assists in acquiring new clients by making it easy to demonstrate that it is the best in the business. The most recent revision of ISO 22301 was released in October 2019. ISO 22301:2019 has taken the position of ISO 22301:2012, which was based on the British standard BS 25999-2. The ISO 22301:2019 standard adds more flexibility and less prescriptiveness to enterprises and their consumers. So, here are some of the advantages that ISO 22301 provides:

  • Operational resilience: The ability to maintain business operations in the face of a minor or severe event is becoming increasingly crucial for organizations of all sizes. A Business Continuity Management System (BCMS) enables a corporation to prepare for such events. This increases competitiveness and reduces the amount of operational downtime a business will experience if the unexpected occurs.
  • Emergency preparedness: ISO 22301 enables businesses and organizations to respond appropriately in the case of disruptive situations, avoiding waste or unnecessary loss. Business continuity management identifies the products and services that are critical to the organization’s survival by proactively assessing the impact of the disruption. It aims to ascertain what remedies and contingency planning will be required in the event of an incident.
  • Corporate governance: Compliance with ISO 22301 contributes to meeting corporate governance criteria. Essentially, the standard can give evidence that the organization has taken the necessary steps to comply with regulatory obligations that necessitate an effective business continuity management program.
  • Crisis management: The total coordination of an organization’s reaction to a crisis in an effective and timely manner is referred to as crisis management (CM). The purpose of individuals in charge of crisis management is to avert or minimize harm to the organization’s revenue, reputation, or capacity to operate. Meeting the ISO 22301 standard demonstrates that the necessary precautions are in place.
  • Disaster recovery: Following an acute occurrence, disaster recovery efforts focus on returning the organization to “business as normal” and putting it on course for complete recovery. It is critical to distinguish this from business continuity management, which is concerned with ensuring that the firm can continue to lower the likelihood of natural disasters and function during a crisis.
  • Protection of reputation in a crisis: ISO 22301 certification demonstrates to stakeholders that your organization’s business continuity capacity is acceptable for its size and breadth. It fosters increased trust, similar to ISO 27001, especially when certified by an independent certifying organization. With the help of an ISO 22301 consultant, it is easy to achieve the certification. It helps to understand business requirements by detecting probable failures and dangers. Businesses can then show stakeholders, customers, vendors, and regulators that they have a strong business continuity management system and processes in place. ISO 22301 will help boost stakeholder confidence in the organization’s ability to respond to disruptive occurrences and events and maintain vital business processes in the event of a disaster.
  • Preparation for technology failures: Technology failures can be extremely harmful to an organization’s revenue and reputation, ranging from telecommunications failure to loss of access to stored data. ISO 22301 guarantees that all measures to minimize such interruption are in place and that all departments are prepared for the worst-case scenario.
  • Reduce business interruption insurance costs: A BCMS that complies with ISO 22301 provides an organization with more useful insights on the effects of a possible calamity. This allows the company to better evaluate the type and value of insurance coverage it needs, perhaps saving money in the long run.
  • Plan for the sudden loss of critical resources: As a result, if the impact of disruption is identified in advance, an organization will be in a strong position to sustain business continuity. Business continuity management systems aid in determining what responses will be required if a disruption happens, and ISO 22301 gives the capability to appropriately respond in the event of such a disturbance.
 

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6 Steps of Getting an ISO/IEC 17025 Accreditation and its Benefits

ISO/IEC 17025 is a global standard that specifies the general requirements for laboratories to perform competently, impartially, and consistently. The International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC) collaborated on the publishing of the standard. It identifies the activities that must be included in laboratory operations to encourage trust in the laboratory’s ability to produce valid and consistently reliable testing, calibration, and sampling results. ISO/IEC 17025:2017 is the most recent revision.

Accreditation is a formal recognition by an Accreditation Body that a laboratory is effective in fulfilling the requirements of ISO 17025 standard to perform tests within its accredited scope. The standard and accreditation are used by laboratories that are independently owned and operated as well as those that are part of larger organizations, regardless of industry or size, that are involved in sampling or measurement activities. This includes both regulated government and public sectors and unregulated sectors. ISO/IEC 17025, along with ISO 9001, serves as the foundation for ISO 15189, which specifies requirements for competence and quality, as well as medical laboratory accreditation. ISO/IEC 17025 Consultant will make the accreditation process easy. Accreditation implies several actions, including document review, process audits, and accreditation results provided by third-party accreditation bodies. All these steps are encapsulated below:

  • Start Your Research/Preparation: The accreditation process starts with the research and learning about 17025. Take ISO/IEC 17025 awareness training and discover what the individual requirements are. Learn about the scope of accreditation and different requirements, including general, structural, resource, and process requirements, to prepare by hand at all levels of organizations.
  • 17025 Gap Analysis and Checklist: Make a summary of the areas of improvement in the laboratory management system to meet the management and technical requirements of ISO 17025 accreditation. Also, a gap analysis checklist will help identify what the lab already has, an area to improve, and how much time need to complete the accreditation procedure.
  • Create the ISO/IEC 17025 Implementation Project Plan: Prepare a framework for approaching accreditation bodies by referring to the checklist created in the earlier step. Design a system and timeline of the steps that the organization will follow while applying for accreditation and elsewhere.
  • Documentation: In this step, the organization will need to document all the processes, methods, and procedures of the lab. Appropriate documentation includes:
    • Quality Manual
    • Functional Procedures
    • Work Instructions
    • Quality Records
    • System Procedures and Formats
  • Audit QMS Performance: The organization has enhanced the quality management system and curated all documentation, Now the lab needs to know if all is working well. For that, the lab will need to conduct internal audits to learn about any non-conformities based on the internal audit report and build an action plan. This will support the lab in modifying any issues before beginning the accreditation assessments.
  • Final Audit from an Accreditation Body: The final assessment of labs will be performed by an accrediting body. They may interview some employees of the organization or lab, inspect documents and records, observe selected calibrations or tests, and examine equipment. They look for statements, documented procedures, records, and written policies to check your lab’s technical competency. If any non-conformities are found, the organization will be asked to correct them. After modifying the non-conformities, a lead assessor will authenticate them. The accreditation body will then prepare and transfer the accreditation certificate to the lab when there are no longer any issues. The certificate will demonstrate the technical capability of the organization or lab in providing calibration or testing services.

Benefits of an ISO 17025 Accreditation 

  • The ISO 17025 accreditation saves enough time and operational capital by avoiding retesting products.
  • Laboratory accreditation is a sustainable approach for labs to demonstrate technical competence, instilling trust among their customers.
  • The standard validates test and calibration methods and ensures accurate results.
  • The globally recognized accreditation certificate validates the performance of your lab for your customers and stakeholders, thus giving you an edge over your competitors and boosting your reputation at the international level.
  • Lab accreditation means measurement traceability and calibrations meet the highest standards, it provides correct and valid results. 
  • The ISO 17025 accreditation is the best for testing laboratories to develop operational efficiency and productivity. Sustaining high-quality results and reducing measurement uncertainties and mistakes are dangerous for a testing or calibration lab’s success.
 

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Understand the ISO 15189 Internal Audit of Quality Management System

ISO 15189 is an international standard for medical laboratories – Requirements for quality and capability, after this referred to as ISO 15189, was first published in 2003 and revised in 2007 and again in 2012. ISO 15189 is not a tool simply to meet accreditation requirements or deliver quick fixes for specific mistakes. Instead, laboratories executing ISO 15189 strive to:

  • Make systems that are as failure resistant as possible, will catch errors before they become a problem, and decrease errors by getting things right the first time.
  • Identify opportunities for enhancement at all times.
  • Contain and empower their staff by including them in the solving of problems and the implementation of solutions.

ISO 15189 inspires full involvement and utilization of the capabilities of all employees at all levels to expand the organization. In a laboratory accredited to ISO 15189, the goal is constant enhancement, and for staff members to know precisely what to do, how to do it, who is in charge of a procedure, and where to find all information essential to perform their jobs. In the United States, accreditation to ISO 15189 is voluntary, as no governmental or regulatory agency needs laboratories or health care providers to conform to ISO 15189.

Internal Audit of ISO 15189 Quality Management System:

ISO 15189 accredited laboratories have to accomplish internal audits of their Quality Management System on a regular basis. Such audits essential to contain the managerial and technical components, as well as pre-examination, examination, and post-examination procedures. These serve to:

  • Establish that all activities of the QMS are covered.
  • Assure that processes are effective.
  • Identify opportunities for enhancement.

ISO 15189 accredited laboratories generally perform internal audits by section, with an entire cycle completed within one year. ISO 15189 Internal Auditor Training develop capability to plan, initiate, and conduct an internal audit of the management system of a medical laboratory in accordance with the requirements of ISO 15189: 2012 standard. Improved frequency of audits may be essential depending on risk and occurrence management outcomes. Internal audit results are one of some inputs for the regular, high-level management review required of ISO 15189 accredited laboratories. Management review meetings offer the opportunity to review problems that affect the laboratory’s processes, with, but not limited to, internal audit results, quality metrics, ongoing quality improvement projects, opportunities for enhancement, complaints, and forthcoming new technologies or regulatory changes.

Quality management system conclusions in an ISO 15189 are based on facts and data. This stops personal preferences or a top-down management style from inhibiting procedure and quality enhancement. Constant enhancement is a permanent objective of ISO 15189 standard quality management. This does not mean, for example in anatomic pathology that every possible effort should be made to decrease the frozen section turnaround time by 1 min. The laboratory would find meaningful metrics that are associated with the laboratory’s mission. Enhancements may affect any aspect of the quality management system and its procedures. They may contain problems such as saving control tissue for immunohistochemically stains, making the work instructions for lymphoma workups more succinct and accessible, or automating frozen section against final diagnosis associations using the laboratory information system.

Also, in clinical chemistry, constant improvement does not mean making every possible effort to decrease hemoglobin turnaround time by 10 sec. Though, it may mean making efforts to drive down variation and risk, which can help an essential laboratory avoid repeating testing, incorrect results, physician complaints, or even probably having to add a satellite lab with its associated overhead costs. More significantly, constant improvement also refers to the improvement of the quality management system.

 

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9 Important Guidelines for Implementing GMP According to ISO 22716 Standard

GMP-related processes are essential to quality assurance and the guidelines help organizations manufacture practices that are constantly high in quality from every batch. Also, implementing industry-standard GMP according to ISO 22716 that requires considering the following GMP guidelines:

  1. GMP for Cosmetics – Employees
    Cosmetics GMP highlights the importance of ensuring that employees of the cosmetics company are all sufficiently skilled, knowledgeable, and capable of correctly producing, as well as storing and controlling the products according to the organization’s specifications, also contributing to safety and quality moderately than compromising it. Also, the necessary support from the organization in the form of providing GMP training, regulation, safety equipment, as well as the personal protective equipment, and resources to perform their job and tasks efficiently.
  2. Premises
    The premises of a cosmetics manufacturer should always meet the GMP specifications like providing a safe, hygienic environment that reduces the risk of contamination. The facilities should be planned to allow for suitable division of storage, manufacture, quality control, washing, purification, and any further subsidiary facilities, and confirm that cleaning and maintenance rules are prepared.
  3. Equipment
    All equipment used should be suitable for its purpose and must be sufficiently cleaned, disinfected, and kept to avoid air contamination. An essential part of a company’s GMP procedure is that the equipment used for the manufacture of the cosmetic product is only used for this purpose. The equipment should also be stored properly and calibrated every so often if needed.
  4. Raw Materials and Packaging
    All ingredients, raw materials, and packaging materials should meet an acceptable measure to ensure the quality of the finished product. All raw materials should be well prepared and appropriately labeled along with packaging materials to prevent mix-ups with any products. These labels must contain batch information so that they can be traced at any point in the manufacturing process.
  5. Production
    All the measures should be taken during each step to ensure that the finished product meets its specifications. Proper ISO 22716 documents and records should be created to capture all features of the production process. The guideline recommends establishing ISO 22716 standard operating procedures (SOPs) for all processes. It also contains GMP for cosmetics procedures, as well as a new product formulation of the cosmetic product in percentages, and weight/volume.
  6. Finished Products
    Finished products must meet all the quality standards established by the company and reflect good manufacturing products. Once a complete product is placed on the market, it is necessary to validate compliance with defined quality criteria. Some strict rules of storage must be followed for finished products, ensuring appropriate conditions. Finished product storage containers should be listed with the product’s name, its batch number, any relevant storage conditions, and its quantity.
  7. GMP for Cosmetics – Quality Control
    Quality refers to the faithfulness of a cosmetic product, its preservation, and its overall purpose. Many of the tests that are required check that the quality of a product remains to a high standard, any products holding water are at risk of contamination by microbial development and will require sampled quality checks to ensure a product remains unchanging and passes challenge tests. For sampling and testing purposes, samples must be identifiable by their name, concentration, expiration date, opening date, storage conditions, etc.
  8. Complaints and Recalls
    Any complaints or any events reported about a cosmetic product must be reviewed, investigated, and followed up on. The GMP for cosmetics ISO 22716 requirement may be a legal requirement as part of the cosmetics principles. All complaints should be centrally recorded, and investigating complaints should include the steps to prevent a product defect from reoccurring, also recognizing possible issues with safety or quality. If a severe or high-risk safety or quality issue is suspected, an organization must be capable of implementing a product recall speedily and proficiently.
  9. GMP for Cosmetics Audit and Documentation
    To assure the implementation and execution of good manufacturing practices for cosmetics, it is important to conduct a regular audit, to evaluate the overall performance of a quality management system. It should be able to identify the system’s strengths and weaknesses, as well as advise a plan of action to overcome failings in GMP good manufacturing practice cosmetics. Also, maintain proper documentation of all the procedures as well as any action taken in the organization.
 

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The Role of Risk Management in ISO 14001 Environmental Management System

The ISO 14001:2015 standard published and among many fundamental changes, it pressures the necessity for better strategic risk management to change and enhance the present system that relies more on a “reactive” protective action process. Another important change is the increasing contribution of “top management” in this procedure. These changes may not sound affected, but they need organizations to demonstrate evidence of improved and better strategic risk planning and implementation.

Preventive measures versus strategic risk management:

The ISO 14001:2015 standard depend on risk assessment along with corrective and protective actions to decrease the impact that a business has on the environment; however, the ratios in which the above are expected to be performed are not definite. The 14001:2015 standard will seek to replace the “preventive action” with “improved risk management”. So, the attention will transfer from preventive actions, which may be less effective because they may be carried out by only certain individuals within an organization, to risk management, which should be a more systematic process due to input and assurance from multiple stakeholders, with a heightened sense of importance due to the change in the ISO 14001 standard.  Also, if organization have to deliver a corrective action, reacting to an event that has already occurred. The new standard purposes to stop these incidents defined by the use of risk management and proactive risk assessment.

The purpose of “strategic risk management” is to attention the organization’s top management and team to both spend more time measuring, investigating, and understanding features that may current risk to the environment, and implement these actions before any environmental effect is felt, as different to during or after.

The Environmental Benefits of Risk Management:

It is clear that the changes in the Draft International Standard are considered to confirm that a proactive, measured, and strategic outlook is occupied toward environmental concerns. The key benefits to the environment should come from a main bias toward identification and prevention of occurrences, rather than reactions to events. This attention will have an enormously positive effect on the environment and the legacy leave for future generations. With the collective enhancements of ISO 14001, accredited and obedient organizations throughout the world will positively impact the planet and the resources leave for others.

The Benefit of Risk Management to Organization:

The swing in the direction of strategic planning of how evaluate environmental aspects, by contribution of management team, will generate a fundamental change in environmental performance. Consider that now it will become normal for whole management team to think about any aspects that may affect business and discuss how these risks will be accomplished, mitigated, and removed. Many environmental “aspects,” which in time convert “incidents,” are costly not only to the environment, but also to business. organization must now see a conclusive enhancement in this area of performance criteria, and environmental key performance indicators should improve. Continual review, adjustment, and constant enhancement will confirm that this cycle remains. Prevention, with the help of forward planning and risk management, is much better than a cure.

An improved shift toward strategic risk management will result in benefits both to the planet and to the financial performance of organization. ISO 14001 Lead Auditor Training deliver knowledge and skills to qualify and get certified as lead auditor for environmental management system. ISO 14001 Lead auditor training will help to properly interpret ISO 14001:2015 requirements and then plan, conduct and close an audit of the environmental management system based on ISO 14001:2015, and also understands the new concepts of impartiality, risk management and risk evaluation techniques, decision rule, and procedure approach.

 

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Understand The ISO 29001 Standard And Its Benefits

ISO 29001 standard describes the quality management system requirements for the plan, development, manufacture, connection, and service of products for the petroleum, petrochemical, and natural gas industries. To support users of the documents, the requirements of ISO 29001 are given with specific guidance and supplementary requirements for its implementation within the industry. Though some of the supplementary requirements may be viewed as not specific to the oil and gas industry, they are needed in ISO 29001 to ensure that the requirements are clearer and can be more readily verified/audited.

What is ISO 29001?

The quality management system for product and service supply organizations in the petroleum, petrochemical, and natural gas sectors is defined by ISO 29001. ISO 29001 requirements are like API Q1 system specifications, such as ISO 29001 documents, methods for conception, getting audit training, and other fundamental organizational activities. The standard also contains unique sector requirements for design, development, production, installation, and product services.

The ISO 29001 standard is an extension of the ISO 9001 quality management systems standard, which is internationally recognized and includes supplementary requirements with importance on fault stoppage and the decrease the variation and waste from service providers. These necessities have been established discretely to ensure that they are clear and auditable. ISO 29001 explicitly focuses on the oil and gas supply chain.

Who Benefits from ISO 29001 standard?

ISO 29001 Standard is accessible by manufacturers, both upstream and downstream, of oil and gas industry apparatus and materials, service providers to the oil and gas industry, and purchasers of gear, resources, and services. The standard can also be used for organizations to perform auditing of their suppliers and for 3rd party certification purposes. Organizations may benefit from this standard if they:

  • Those who are involved in the exploration, production, pipelines, transportation, and refining of petroleum and natural gas products.
  • Also, those who are involved in the design, manufacturing, installation, service, and repair of equipment used in the exploration, production, transportation, and refining of petroleum and natural gas products.
  • And those who provide technical, operational, and support services to the various industry sectors identified above.

What is the need for ISO 29001 implementation?

critical industry. It not only covers the systems and procedures, but it also demonstrates that you care for the employees and the public. The oil and gas sectors are rife with danger. In the industry that handles fluids (liquids and gases), frequently at extremely high pressures, through a range of products and processes, strict adherence to engineering, user, and regulatory criteria is necessary. Hazardous liquids and gases may cause serious harm to humans and the environment if they are mishandled or inadequately controlled. Considerations for worker safety are essential. Protecting the environment and the public necessitates having a high level of operational integrity. Complicating matters, oil and gas industry equipment and service providers are dispersed globally, and many operate in underdeveloped countries with very different cultural approaches. Adherence to ISO 29001 ensures better business continuity (maintenance of revenue streams, both for companies and national economies) and should assist in the mitigation of operational risks because of products’ existence in full conformance with conditions and guidelines.

The benefits of implementing ISO 29001

  • ISO 29001 standard helps to improve the ability to gain a license to trade, resulting in increased contracts and prospects
  • Also, it demonstrates to stakeholders and customers of commitment to quality and best practices
  • It helps in better risk management and increased performance
  • Having efficient operations that improve quality and reduce waste
  • And the continual improvement has resulted from improved communication and regular assessment.
 

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How to conduct an internal audit according to ISO 9001 Quality Management System?

Organization sees the essential process for Internal Audit as a form of necessary evil that they want to endure in order to maintain ISO 9001 registration. They think it is a duplicate effort of the registrar, not realizing that the Internal Audit can be much more effective because it looks at the processes more often and more carefully than the registrar has time for. At worst, the Internal Auditors are seen as some sort of internal police force that it is best to guard yourself against by hiding important data or outright misleading with false information.

In fact, as a process owner, the ISO 9001 Internal Audit process can be the finest way to have an outside set of eyes take a close look at procedure. They can help identify areas for improvement, or possibly complacency, which can benefit process to run better, quicker or more efficiently. Below are main steps that explain how to conduct an internal audit according to ISO 9001, and how they can finest be used to focus the internal process owners on enhancement of those procedures.

Planning the ISO 9001 Audit Schedule: A significant part of a good process is having an overall ISO 9001 Audit Schedule that is readily available to let everybody know when each process will be audited over the upcoming cycle. By publishing the audit intentions, the message is that this is meant as a support to the process owners and the ISO 9001 auditors are there to help. This can permit the process owners to time the finish of any enhancement projects that they are working on to be before the audit, so that they can collect valued information on the implementation, or to request the ISO 9001 auditors to focus on helping to collect information for other planned enhancements.

Planning the Process Audit: The first step in planning the individual process audits is to approve with the process owners when the audit will take place. The complete plan above is more of a guideline as to how often procedures will be audited, and roughly when, but the confirmation permits the ISO 9001 auditor and process owner to cooperate to determine the best time to review the process. This is when the auditor can review previous audits to see if any follow-up is essential on concerns previously found, and when the process owner can classify any areas that the ISO 9001 auditor can look at to assist the process owner to identify information. A good audit plan can assure that the process owner will get value out of the audit process.

Conducting the ISO 9001 Audit: An ISO 9001 audit should start with a meeting of the process owner to assure that the audit plan is ready. Then there are many paths for the auditor to collect information during the ISO 9001 audit: studying records, talking to employees, analyzing key process data. The focus of this activity is to collect evidence that the process is functioning as planned in the QMS, and is effective in creating the essential results. One of the most important things that an auditor can do for a process owner is not only to classify areas that do not have evidence that they are functioning appropriately, but also to point out areas of a process that may function improved if changes are made.

Reporting on the Audit: A closing meeting with the process owner is a necessity to confirm that the flow of information is not delayed. The process owner will want to know if there are any areas of weakness that want to be addressed, but it will also be interested in knowing if any areas occur that might be enhanced. This must be followed with a written record as soon as possible to deliver the information in a more permanent format to allow follow-up of the information. By classifying not only the non-conforming areas of the process, but also the positive areas and potential development areas, the process owner will get a better value from the ISO 9001 Internal Audit, which will permit for process enhancements.

Follow-up on Issues: As with many areas of the ISO 9001 standard, follow-up is a critical step. If problems have been found and corrective actions taken, assure that the problem is actually fixed is a key part of fixing it. If development projects have been accomplished from opportunities recognized in the audit, then seeing how much the process has enhanced is a great motivator for upcoming improvements.

By using the ISO 9001 Internal Auditor training to focus on helping to better the processes, and not just to maintain compliance, the organization can see more value out of the ISO 9001 audits. Process improvement is one of the key elements of an ISO 9001 Quality Management System, and should be one of the chief motivators of an organization that wants to implement and maintain a good QMS. Process improvement not only helps with efficacy, but also saves time and money in the process. If used correctly, the ISO 9001 Internal Audit, instead of being a “necessary evil,” can be one of the biggest contributors toward process improvement in the Quality Management System.

 

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