Eight Recommendations for Selecting an IATF 16949 Consultant

To meet the industry’s strict criteria, automotive suppliers must implement and maintain an IATF 16949 Quality Management System (QMS). To attain and maintain adherence to the IATF 16949 standard, one needs proficiency, commitment, and a methodical approach. Hiring an IATF 16949 expert can help expedite the implementation process and guarantee that your company is prepared for certification. However, selecting the best consultant is a crucial choice that has to be carefully thought out.

Eight Guidelines for Selecting an IATF 16949 Consultant

You could have a lot of questions about how to proceed correctly and get the desired outcomes when implementing or improving a quality management system based on the IATF 16949 standard. It will be necessary to ask for assistance at that point, and hiring an IATF 16949 consultant is advised. How can you determine which consultant is the most suitable? Eight guidelines for selecting an IATF 16949 consultant are provided below.

Think You Need an IATF 16949 Consultant: There are several ways that consultants might benefit the company:  

• Managing the implementation in part or in full by creating the necessary management system documents, such as manuals, procedures, and instructions
• By offering more practical assistance to carry out plans or specific tasks, like internal audits,
• By identifying gaps between your Quality Management System’s performance and that required by automotive industry regulations, and
• By conducting training sessions on IATF 16949 and key tools.

Assess their Level of Experience with both your Company and the Automotive Sector: Selecting the right consultant is largely dependent on their experience in the automotive industry (at least five years), as well as their knowledge of your particular industry. It is not the same to have worked in the tyre, glass, painting, or machining industries. Owing to modifications made to the ISO 9001:2015 standard—which serves as the foundation for IATF 16949:2016—the consultant additionally has to be aware of:

• Strategic Direction
• Instruments for identifying both internal and external problems
• Techniques for figuring out stakeholder requirements
• Risk-based thinking

Learn the Methodology Used by the Consultant: To enhance or execute the Quality Management System, the consultant can employ many approaches and strategies. Employee support and cooperation from the organization are necessary to get successful outcomes in the consulting. To ensure that everyone works well together, it is crucial to understand which approach will be used. To guarantee a successful implementation, the consultant will need your time, effort, and resources; be sure you are aware of and able to meet these demands.

Take the Cost-Benefit Ratio into Account: It’s crucial to have a contract that outlines the amount of time and money that will be spent on the project, as IATF 16949 consultants are highly skilled professionals whose costs can’t be taken lightly. Never overlook the necessity of having internal staff members supporting the consultant and actively engaging in implementation within the organization. Ultimately, the organization will be responsible for maintaining the Quality Management System—not the consultant.

Examine Their References: The automotive industry is highly competitive. It is imperative that the IATF 16949 consultants you are considering provide references, and they should have some experience working for an assembly line or in the automotive industry. Which tasks have they completed? What are these consultancies’ outcomes? How is this reference checked for accuracy? Request three client references from the consultants and find out if the clients were happy with the kind of job the consultants completed.

Receive Comments: There’s a good chance the IATF 16949 consultant will work extensively within your company to become familiar with its procedures and operational style. To discuss the status of the projects and the opportunities and dangers that the consultant has identified, it is therefore advisable to schedule regular meetings with the IATF 16949 consultant. The outcomes of the consultancy will be enhanced by this feedback.

Understand When They Are Available: It is critical to understand the IATF 16949 consultant’s availability about the support that will be rendered. Excellent IATF 16949 consultants typically have a packed agenda that lasts for several months. Because of this, you should set up work schedules with clear objectives, determine how many days a month the consultant will be available to you, and decide on the best channels of communication (phone, email, or chats) to use when you need help from the IATF 16949 consultant.

Recognise the Dangers Associated with Employing a Consultant: If you choose the incorrect consultant to install an IATF 16949-based Quality Management System, you could end up paying a heavy price in lost time as well as money. The most frequent hazards that could occur are as follows:

• Failure to satisfy clients’ particular needs in the automotive industries
• Not using core tools effectively as you weren’t trained to utilise them
• Possessing unnecessary and redundant documentation, which the staff member’s disregard
• Finding inconsistencies during the external audit of IATF 16949, losing the certification, and losing the clientele to whom you provide goods and/or services

 

Why Should Hire an SA8000 Consultant?

Nowadays, with the importance of corporate social responsibility growing, businesses all over the world are looking for ways to make sure that their operations adhere to moral and compassionate standards. SA 8000, a worldwide recognized certification standard for social accountability, is one of the instruments that has acquired importance in this endeavour.

Many organizations rely on SA 8000 consultants to help them negotiate the challenges involved in getting and maintaining SA 8000 certification. We shall examine what SA 8000 consultants are and the advantages they offer companies who are dedicated to moral and socially conscious operations.

SA 8000 Covers these Major Categories

1. Forced Labors: Not allow forced or compulsory labor in any industry.
2. Child Labors: No child is working in any organization or industry.
3. Health and Safety: Provide a good, secure, and safe working environment in your organizations for employees.
4. Working Hours: To know the working hours as per laws and organization standards for your employee.
5. Stipend: Give the wages and advantages of your workers.
6. Respecting employees’ freedom of association and right to collective bargaining includes allowing them to organise and join trade unions.
7. Discrimination: Discrimination is prohibited in the recruiting, compensation, training, promotion, termination, and retirement processes.
8. Discipline Processes: Discipline processes include verbal abuse, physical or mental coercion, and the use of corporal punishment. All employees must be treated with respect and decency.

Why Should Hire an SA8000 Consultant?

Professionals or consulting organizations having experience in social responsibility and the SA 8000 standard are known as SA 8000 consultants. They support businesses in putting the SA 8000 system into place and keeping it up to date while making sure the standards are followed.

1. Knowledge and Expertise: SA 8000 consultants are well-versed in the subtleties and complexities of the standard. They keep up with the most recent developments in the sector and in-laws’ social responsibility. Because of their experience, they can effectively lead organizations through the certification process.
2. Tailored Implementation Plans: Every company is different, with a distinct mix of advantages and disadvantages. The strategies used by SA 8000 consultants are customised to meet the unique requirements and situations of every customer. They create specialised implementation strategies that complement the objectives of the organization after conducting in-depth assessments.
3. Enhanced Your Social Performance: Collaboration with SA 8000 consultants may help organizations improve their social performance and make sure their policies and procedures are in line with international human rights standards. The organization’s reputation is enhanced, and it also improves community relations and the workplace atmosphere.
4. Reduced Risk: Organizations can reduce the danger of legal trouble and damage to their reputation that can arise from non-compliance by making sure SA 8000 is followed. Advisors detect possible danger zones and offer solutions for successfully addressing them.
5. Simplified Certification Process: Navigating the SA 8000 certification procedure can be challenging and time-consuming. Consultants speed up the process by providing organizations with detailed instructions on SA 8000 documents, doing internal audits, and preparing them for external audits.
6. Improve the Stakeholder’s Confidence: A dedication to moral business conduct is demonstrated by the SA 8000 certification, which inspires confidence in stakeholders such as clients, staff, investors, and the general public. Consultants help to ensure that stakeholders are informed about this commitment.

SA 8000 plays a crucial role in helping businesses to gain the SA 8000 certification. Stakeholder confidence is raised, risk is reduced, and social performance is improved thanks to their experience, tailored approach, and efficient procedures. SA 8000 consultants are useful allies in the transition to a more socially conscious and accountable future as companies come to understand the significance of ethical standards.

 

What are the Advantages of AS9100 Certification?

In manufacturing an AS9100 certification gives lots of advantages. AS9100 is a quality management system developed exclusively for the aerospace sector. It creates quality management standards and offers a framework for continuous improvement. AS9100 certification can assist increase your shop’s productivity and competitiveness, and it may also be needed by some customers and suppliers.

Many aerospace vendors require AS9100 certification to conduct business. As a result, AS9100 certification might help you broaden your customer and supplier base. In this essay, we’ll look at seven major advantages of AS9100 certification.

Who Is Required to Get AS9100 Certified?

AS9100 certification is not mandated by legislation. Many aerospace vendors, however, require AS9100 certification to participate and conduct business effectively in the aviation industry. This implies that if your shop wants to do business with these suppliers, it must be certified. During the AS9100 certification process, an impartial auditor will evaluate your shop’s adherence to AS9100 requirements. Once you are certified, you will need to maintain it by satisfying the AS9100 criteria regularly.

Key Advantages of AS9100 Certification

Here we explain the numerous advantages of AS9100 certification. Here we mention the 6 advantages of AS9100 certification listed below which give you an idea of AS9100 certification.

1. Increased Efficiency and Competition in the Market: The AS9100 quality management system offers a foundation for continuous improvement. By continuously optimising your shop’s operations, you may minimise waste, boost efficiency, and improve quality. Certification to the standard might also help you uncover cost-saving options.
2. Access to Customers and Documentation: AS9100 certification might help you acquire new clients and do business with new suppliers. Companies that satisfy AS9100 standards get access to clients and suppliers that are searching for more than simply the greatest product – they want to be confident in its perfection. This gives you a considerable edge in both preserving current partnerships and promoting your products and services to new stakeholders. Furthermore, by continuously adhering to these industry-leading standards, businesses may boost customer loyalty while also lowering operating expenses.
3. Improved Communication and Documentation: The AS9100 quality management system demands the development of quality objectives and AS9100 documents processes. This criterion can assist in guaranteeing that everyone in your business understands the shop’s quality objectives and how to fulfil them. Certification can also assist with the clarity and correctness of your shop’s documents.
4. Better Decision-Making: The AS9100 quality management system mandates the use of data and objective evidence for making choices. This can help your business make more educated decisions based on facts rather than emotion or conjecture.
5. Enhanced Consumer Satisfaction: AS9100 quality management needs close collaboration of consumer satisfaction by doing the proper survey and checking how your customers are satisfied with the products and services that you provide. This data will help you to identify in which area have need to improve your products and services. AS9100 certification might also assist you in developing and implementing strategies to increase customer satisfaction.
6. Improved Company Image: AS9100 certification can assist boost your company’s image and reputation. Certified stores are seen to be more reputable and trustworthy. This can help you get new clients and retain existing ones. This might also help you recruit and retain top personnel.

Why to Choose Punyam.com for AS9100 Certification Consultant?

Punyam.com has Over 30 years of experience, a highly skilled workforce, quick project turnaround, and competence in management system installation, ISO certification, audits, and ISO training. They serve clients in over 50 locations, have a 100% success rate, offer both on-site and off-site services, and are the industry leader in India. Punyam.com is India’s leader for AS9100 certification consultants, which is granted by approved certifying bodies. The certificate is valid for three years, with surveillance audits every 9-12 months and renewal audits three years after completion.

 

Have you Started Preparing for the IFS Food V8 Certification?

The International Featured Standard (IFS) Food is a well-recognized, leading standard that attests to the safety and excellence of processed food products and manufacturing procedures. The most recent version of the standard, V8, has been revised to reflect recent market trends and guarantee that IFS Food customers get the most out of their certification. The review’s primary goals have been synchronised with the most recent iteration of the Codex Alimentarius General Principles of Hygiene and the impending ISO 22003-2, as well as with the inclusion of IFS Doctrine rules into the IFS Food Standard and taking into account stakeholder comments from IFS Food. The standard’s terminology has been defined. The scoring methodology and new requirements added to the audit checklist are only a few of the modifications made to the certification protocol.

IFS Food certification enables businesses to demonstrate to clients, associates, and customers their dedication to high-quality and safe food. IFS Food puts a strong emphasis on customer requirements compliance and on fostering business partnerships throughout the supply chain. The continuous improvement system of the certified companies is supported by the standard’s periodic review and updating procedure. There are significant revisions in the most recent IFS V8 standard, including:  

• As is well known, in the IFS standard, an A grade indicates full compliance, whereas C and D scores indicate deviations. B score is a point that needs to be addressed and may result in a deviation in the future, whereas B score is regarded as a deviation from the current version. When the firm deviates from the B score, it will now lose 5 points while gaining 15 points. Anyone who receives a C deviation score will lose 15 points and gain 5 points. D deviation points will be penalised (-20).
• The IFS Food standard now formally incorporates the GFSI guideline that one out of every three inspections must be unaware.
• If you have a European Union PDO (Protected Designation of Origin) or Protected Geographical Indication with its Turkish equivalent, you can now add it to the IFS certificate with a disclaimer in the updated edition.
• The food safety culture item is planned to be revised, and targets for the following four culture items will be established.
  • Sharing information on responsibilities and policies for food safety
  • Education
  • Employee feedback on food safety issues
  • Performance measurement
• While complying with the documentation requirements of GFSI benchmarking and accreditation, the reporting time, number of doctrinal norms, and other administrative requirements have been greatly reduced.
• The structure of the standard’s requirements, which is also used as a list of questions, has been changed to more consistently follow the inspection process and increase the efficiency of the inspection; for example, food defence, which was previously a separate section, is now part of section 4.
• The revised versions of ISO 22003-2 and GFSI Benchmarking Requirements have been aligned with IFS Version_8 of the Codex Alimentarius.
• To better describe the objective of the standards, elements in the standard requirements, which are also used as a list of questions in audits, have been made more uniform and unambiguous. The term “Assessment/Assessment” used in IFS V7 by ISO 22003-2 has also been changed back to “Audit/Audit.”

So, if you are already started preparing for the IFS food V8 certification or planning for the certification, Punyam.com can help you. For IFS Food V8 certification, Punyam.com is the leading and one of the best consultants in India. Punyam.com offers IFS food V8 consultancy service under the direction of an accomplished IFS food consultant in the following phases to apply the IFS food version-8 standard for food product processor/manufacturer organisations and obtain IFS food V8 certification:

• The certification process starts with the micro-level survey of the existing system of the organization.
• Then conduct IFS food V8 and food safety awareness programs for all personnel.
• A task group and steering committee for IFS food V8 documentation. Also, prepare documents of IFS food V8 standard as well as risk/hazard analysis.
• Implementation and training of all personnel in the use of documented procedures and formats. Employees must be trained in the identification, evaluation, and control of issues regarding food safety. Along with that providing training to the internal auditors.
• The initial internal audit is used to evaluate the system.
• Take corrective actions for non-conformities and carry out management review meetings.
• Apply for certification. Assist the organization during the Final audit by the certification body.
• Assist the organization to take corrective actions on the nonconformities to the satisfaction of the certification body.

To know more about the consultancy service for the IFS food V8 certification, visit the official website of Punyam.com: https://www.punyam.com/ifs-food-certification-consultant.htm

 

Punyam Introduces Editable ISO 15189 Documents & Training Resources at Low Price for Medical Laboratories’ Accreditation

Punyam.com, a pioneer  in ISO  and  other international management  system consultancy services in India, has released  its comprehensive ISO 15189 documentation and training resources  based on  the latest edition of ISO 15189 standard. The newly launched ISO 15189:2022 Documentation & Training Resources include ISO 15189 Documentation Kit,  ISO 15189 Auditor Training PPT Kit   and E-learning courses for ISO 15189:2022 Awareness,   ISO 15189 Lead Auditors, ISO 15189 Certified Auditors, and ISO 15189 Implementers.

These ISO 15189 resources are created by a team of ISO 15189 consultants and trainers having more than 20 years of experience in ISO 15189 implementation and accreditation of medical laboratories across India and other countries like USA, UK, Canada, Saudi Arabia and other Gulf countries. ISO 15189 documentation and training kits of Punyam.com contain editable documents and editable ppt slides with handouts, respectively, to meet the documentation and training needs of medical laboratories. The ISO 15189 E-learning courses are certified by Exemplar Global (USA), a world-famous online training provider. Upon successful completion of ISO 15189 E-learning courses, participants will get an authentic and globally-recognized training certificate also.  All the ISO 15189 documentation and training resources presented by Punyam.com are in simple English, user-friendly and quite affordable also.  

“Our ISO 15189 resources are quite helpful for medical laboratories who are looking for ISO 15189: 2022 implementation and/or ISO 15189 accreditation for the first time as well as Medical laboratories already accredited to ISO 15189:2012 and seeking to upgrade their system and renew their accreditation as per latest ISO 15189: 2022 requirements, in a time and cost-effective way”, says Mr. Devang Jhaveri, Founder and Managing Director of Punyam.com. 

ISO 15189 is a globally recognized standard that sets forth requirements for the competence and quality of medical laboratories, ensuring the delivery of accurate and reliable results. It can be used by any medical laboratory, hospital or healthcare organization having its own medical laboratory, independent medical laboratory that performs testing of the patient sample, laboratories of medical colleges, research centers, governments, and regulatory bodies, who need to do medical testing. Punyam’s latest offering aims to simplify their compliance and ISO 15189 certification journey by providing tailored documentation templates and effective training resources for effective ISO 15189:2022 implementation and ISO 15189 accreditation. These products are highly in demand and Punyam.com has received an overwhelming response from its customers. According to company sources, it has received over 100 customer enquiries over the last week for purchasing various ISO 15189:  documentation and training products of the company. For more details about punyam.com and  ISO 15189:2022 Documentation & Training Resources, please visit: www.punyam.com

 

7 Core Principles of ISO 26000 Standard to Improve Corporate Social Responsibility

The international standard known as ISO 26000 was created to assist organizations in efficiently evaluating and addressing social responsibilities that are pertinent to and significant for their operations and processes, customers, employees, communities, and other stakeholders, as well as their impact on the environment.

ISO 26000 is not certifiable, in contrast to many other well-known ISO (International Organization for Standardization) standards. The ISO 26000 standard was introduced in 2010 and offers helpful information instead of legally binding regulations. Regardless of their activity, size, or location, it serves to support businesses and organizations in comprehending and successfully putting social responsibility concepts into practice. In summary, it acts as a worldwide resource by disseminating social responsibility best practices.

Five years of intensive negotiations involving numerous international stakeholders resulted in the establishment of ISO 26000. The standard was greatly influenced by labour organizations, industry experts, consumer groups, government representatives, and non-governmental organizations (NGOs). Through cooperation, it was made possible for ISO 26000 to reflect the various viewpoints and levels of knowledge of these stakeholders and to serve as an international consensus.

The seven fundamental principles included in the ISO 26000 standard provide businesses with a framework around which to build their action plans. Every principle covers different approaches to take, directing ethical and long-lasting behaviour:

• Organizational governance – This principle encourages integrity and ethical behaviour by supporting open, responsible, and transparent decision-making procedures within businesses.
• Human rights – This addresses a broad variety of issues related to human rights, such as preventing discrimination, defending civil and political rights, guaranteeing equitable working conditions, and promoting opportunity for all people.
• Working relations and practices – This principle highlights how crucial it is to sustain favourable employer-employee relations, advance social protection policies, guarantee workplace health and safety, and cultivate a healthy work atmosphere.
• Environmental responsibility – This principle highlights the importance of environmental stewardship, which includes steps to reduce waste, energy consumption, pollution, manage resources sustainably, and reduce greenhouse gas (GHG) emissions.
• Fair operating practices – In order to promote fair business practices, this principle calls for the implementation of anti-corruption measures, the maintenance of fair competition, the protection of intellectual property rights, and the encouragement of ethical marketing and advertising.
• Consumer protection – This principle highlights how crucial it is to defend consumer rights, which include fair marketing techniques, product safety, privacy protection, and giving customers accurate and transparent information.
• Contribution to sustainable development – Organizations are encouraged by this idea to actively support sustainable development both within and outside of their communities. This can entail programs like social welfare promotion, education and training support, employment creation, and community involvement.

For each of these seven principles, the ISO 26000 standard offers a road map, allowing businesses to evaluate their own performance and pinpoint areas in need of development. These regulations ensure a thorough approach to social responsibility by applying it to a wide range of fields and organizational activities.

Adhering to the fundamental tenets of ISO 26000 can help businesses improve their overall sustainability performance, cultivate strong relationships with stakeholders, and make a beneficial impact on society and the environment. Punyam.com can assist your company in implementing the ISO 26000 standard to reap all of its benefits. A team of highly skilled ISO 26000 consultants and globally certified lead auditors for Consulting Services will provide guidance and support for the successful implementation of the ISO 26000 standard within your company. Punyam.com implements Social Compliance in accordance with the most recent industry standards and best practices. Additionally, the ISO 26000 certification can improve the organization’s internal processes to help the environment and its external interactions with other businesses, the media, and the community, all of which can increase revenues.

 

How Effective to Have an ISO 9001 QMS Consultant While Implementing the Standard?

In order to help an organization, comply with ISO Standards, ISO consultants evaluate the procedures of the organization or firm and make recommendations. An ISO consultant, for instance, can help with spotting process issues, offering suggestions for improvement, and educating staff about new systems. We are all aware that the best consultants are experts in the industries they support and have a solid understanding of ISO Standards. In setting standards across numerous businesses, they are highly skilled. The appropriate paperwork, a quality manual, and procedures that are recorded may be finished with help from a consultant. As you implement ISO 9001, a consultant will work with the team to create targets, carry out management reviews, evaluate results, and drive the necessary measures for improvement. Here are a few instances that demonstrate how effective it is to work with an ISO 9001 consultant to put the QMS standard into practice.

Obtain Certification by Using the Proper Method: Organizations that use the ISO 9001 standard can reap numerous benefits, including improved internal controls, leadership, risk management, increased opportunities, and reduced waste. However, everyone is aware of how time-consuming the ISO certification process can be. Bringing in an ISO 9001 consultant to supervise the certification process is a long-term investment for the company. Seeking professional advice helps to shorten the time required to complete the certification actions. As a result, you will receive a low-cost certification.

High-Quality Products and Services: To continually produce high-quality products and services, a successful firm understands how to control risks and oversee its operational processes. If the organization lacks this capability, an expert consultant can assist in identifying and analyzing process risks as well as implementing effective operational management methods. Well-experienced consultants can share best practices to enhance product quality if they have expertise working with other firms in addition to your business.

Improve Customer Satisfaction: Getting advice from an IS0 9001 professional can be thought of as a long-term investment. You will be given specific instructions on how to improve customer satisfaction. Companies will continuously look for ways to enhance targeting diverse customers rather than only concentrating on one type of customer. To maintain consistency, improvement, and compliance, businesses require constant help. Successful firms embrace the concept of quality by striving for continuous improvement and putting consumers first. Customers who are happy and pleased will create long-term relationships, which means more money for your firm.

Develop Metrics for Business Performance: Organizational development cannot be quantified in the absence of knowledge regarding business performance. A corporation should spend some time developing appropriate measures for gathering data on operational performance. We can’t tell if the organization is improving or not without numbers. Business metrics can be set with the assistance of an ISO expert to evaluate performance and analyze data that will aid the organization in decision-making. As a result, you’ll have a clear image of which aspects of the operation should be prioritized.

Reducing Wastes: Many businesses are experiencing operating issues. Some of these have an impact on production and operation and include expenditures. They often believe that these operational processes are required for the organization’s success, but an ISO specialist may streamline what is only required for seamless functioning. There is no ideal procedure, but fewer errors can be avoided. Companies will save money and time if these wastes are eliminated. Companies can achieve process efficiency while also achieving significant results.

Develop a Professional Culture for Employees: Implementing ISO 9001 might result in major organizational changes. QMS sets clear expectations with job descriptions and company objectives, and provides the correct tools for the job as well as proper feedback on performance. Employees may concentrate on what is important and strive toward a single goal. A skilled ISO expert can empower and include personnel at all levels in making the necessary modifications to carry out the project.

 

6 Major Steps that Help to Get Your Company ISO Certified

Businesses today are required to get ISO certified because it serves as a benchmark of excellence that they can receive from an approved authority for demonstrating excellent devotion in a certain management area, such as quality management, information security, environmental safety, or occupational health and safety. Each of the various ISO management standards targets a particular component of management or governance and offers a unique set of advantages. Businesses require them to implement the best management practices as well as to acquire the confidence of their stakeholders by demonstrating their competence and reliability. The 6 primary steps required to obtain ISO certification are listed below.

1. Get All Your Resources Ready: You must set up the necessary resources and obtain the backing of your company’s top management to obtain an ISO management standard. The management team should commit to providing all the resources necessary for carrying out the certification procedure and should support the cause, which is certification. If they are unsure of what resources are needed to fulfil the demands of the ISO management standard, the management team may even seek advice from a third-party organization.
2. Pre-Audit or Gap Analysis: Gap analysis is a necessary step that enables you to understand where you stand about ISO compliance standards. To ensure that you are aware of the shortcomings in your current management system in comparison to the intended ISO management standard, this pre-assessment is crucial. It can be carried out by internal experts from your business or, if you’ve hired them, auditors from the consulting agency. You need to ask questions about a few topics during the gap analysis, such as which requirements are not satisfied, how long it would take to meet them, what resources and procedures are needed, and how much it would cost. As a result, you may precisely plan to fully comply with your management system.
3. Develop and Implement the Management System: The next step is to create a thorough management system by filling up all the holes identified earlier to receive the certification. This entails implementing new controls and processes within the system, giving personnel new roles, and reorganizing existing policies. Conduct training sessions for your staff to put the system into use and make it operational in your business. They must become accustomed to their new positions so they can carry out all the procedures with ease.
4. Do an Internal Audi: You should confirm that the implemented management system satisfies all requirements of the specified standard before applying for certification. An internal audit is essential because of this. It should be carried out by a few well-respected employees of your business who possess the required management system knowledge and insights. If the third-party consultancy has competent auditors who have a focus on your standard, they can also help you with the internal audit process. Regardless of who performs the audit, the findings or observations are essential to your certification achievement.
   
   You will learn about the management’s compliance status when an extensive internal audit is conducted. You learn which of the standard’s requirements are fully met, somewhat met, and not at all met. As a result, you can resolve all the noncompliance issues by taking the necessary steps or corrective actions based on the audit report.
5. Choosing an Accredited Certification Body: Your business would receive the certification from a well-known certified body. Among the many organizations that offer certifications, you must choose a trustworthy one and apply. Examine their background, customer reviews, and suitability for your company to make the best choice. An on-site audit would be conducted by that outside entity. For example, to verify that all ISO 9001 certification requirements are met, they would assess the management system from beginning to end. They would even express their views on any shortcomings they observed in the system that needed to be fixed.
6. Certification: The final phase is when the organization awards your business with the ISO certification after being convinced that your management system is effective and compliant enough. The certification will be valid for three years. After that, you must renew it. This suggests that you should conduct regular internal audits of your management system to maintain its ISO compliance over time.

Punyam.com is the leading ISO certification consultancy provider company in India. Punyam.com offers various ISO standard certifications consultancy services. Punyam.com certification consultancy service provides complete system awareness training, create ISO documentation for respective ISO standard and other standard systems, and help clients in ISO internal auditing as well as implementing and maintaining ISO systems in their organization throughout the ISO certification process. We provide such consultancy services in two ways: either by visiting the client’s place or by providing our documents and training through offline mode.

 

Consider the Fundamental Steps Before Selecting an ISO 13485 Consultant

The most effective medical device standard accessible is ISO 13485, which guarantees that all medical devices adhere to legal requirements for regulatory compliance and patient demands. An important certification created to protect staff members and patients in clinics, hospitals, and other medical environments is ISO 13485 certification. A management system standard created expressly for the production of medical devices, ISO 13485:2016 is based on the ISO 9001 process model methodology. The facilitation of unified medical device regulatory requirements is its main goal.

The top management of the firm may be considering hiring a consultant to help with the ISO 13485 implementation process if the organization has made the decision to do so. Choosing an ISO 13485 consultant wisely is one way to significantly improve the chance of success and minimize the time it takes to complete accreditation. In cases where a company chooses to implement ISO 13485 with the aid of a consultant, it is crucial to understand a few variables that will help them choose a candidate who will best suit their requirements.

Many individuals would consider that choosing to employ a consultant for work if they are not particularly knowledgeable about the subject matter is challenging. What are the essential measures for choosing an ISO 13485 consultant then? Here are some of the key steps that an organization must know:

Research and confirm the findings: Using networking tools, it is possible to endorse and comment on a person’s skillset specifically on professional social media networks. Organizations should ask potential consultants for professional references as part of the screening process. Make sure the questions that ask references about their experiences working with the potential consultant are pointed and specific to the deliverables and schedule for completion.

Understand the standard and share it with the team. Make sure the organization has a basis in the standard to be implemented before considering a consultant. Invest in ISO compliance software and spend money on educating employees about the ISO 13485 standard. When the consultant joins the project and starts conveying the requirements and compliance needs, this will give the organization an initial basis of knowledge.  

Recognize credentials. Organizations should check the source of a potential consultant’s ISO 13485 knowledge while evaluating their CV or resume. Any certifications of ISO 13485 lead auditor training should come from credible, well-known institutions. In order to ensure that a person has solid experience leading, sustaining, or adhering to the standard over a number of years, the evaluation of on-the-job training should be thoroughly understood. Examine the ISO standard that the potential consultant is familiar with because the new versions are regularly issued and standards are regularly reviewed.

The selection of an ISO 13485 consultant will be influenced by the knowledge of the organization’s risk level.  Depending on their level of experience, consultants’ fees can change. The predetermined risk level of the company should be the deciding factor in the organization’s criteria for selecting the best candidate. Even if your company is risk-tolerant, hiring a consultant will eventually affect policy, processes, and everyday operations.

The organization will create a role focused on change management as a result of hiring an ISO 13485 consultant. Every organization should strive to employ consultants in an informed and timely manner.  The goal is to avoid the chance of disclosing the important operations of the business without the right legal ISO 13485 documentation, nevertheless. During the recruiting process, the consultant’s confidentiality should be assessed, and expectations should be made very clear. On the other hand, as a company, you must minimize the chance of receiving bad advice. Make sure the possible consultant is who they say they are by checking references, and make sure their personality fits with the company’s culture.

 

How ISO 15189 Consultant Supports to Simplify the Medical Laboratories Accreditation Process

The requirements for competence and quality in medical lab environments are laid forth in ISO 15189:2022 – Medical Laboratories, an international standard. It is essentially a standard that requires laboratories to create a strong, consistent quality management system to demonstrate their competency. In December 2022, an updated version of ISO 15189 was released, bringing with it a number of improvements, clarifications, and modifications to the 2012 version.  

The key feature of the ISO 15189 standard is that it only applies to medical laboratories. As a result, it differs from ISO 9001, which specifies the standards for a quality management system in any type of organization, and ISO/IEC 17025, which specifies the general requirements for the competence of testing and calibration laboratories. These are most likely the other ISOs you’ve come across if you’ve recently begun the process of having your lab ISO accredited. ISO 15189 is critical for medical laboratories since it is a globally recognized accreditation that allows you to ensure the dependability, competence, integrity, and overall quality of the lab practices. ISO 15189 accreditation comprises an independent assessment of the medical laboratory that contains an examination of personnel qualifications and skills, equipment, components, and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors. It is critical to the perception of your entire organization as trustworthy, reputable, and competent by your consumers or business partners.

The advantages of obtaining ISO 15189 certification for a medical laboratory are numerous. It can contribute to proving the laboratory’s expertise and dedication to quality, which will improve its standing and gain the trust of patients and healthcare professionals. As the standard necessitates regular evaluation and assessment of the laboratory’s performance, certification can also assist in ongoing improvement. To achieve the full benefits of ISO 15189 accreditation, the organization must first adopt the standard and become certified with the support of an ISO 15189 consultant.  

For ISO 15189:2022 Certification, Punyam.com, a top ISO and accreditation consultant in India, offers consulting services. They have extensive expertise in implementing ISO 15189:2022 for several types of medical laboratories, including pathology, microbiology, and clinical laboratories. In order to establish the ISO 15189 system and obtain certification, a team of Punyam’s ISO 15189 consultants assists in the following ways:

• Micro-level survey for each and every test parameter of the laboratory and preparation of detailed Gap Analysis report,
• Preparation of applicable documents required by ISO 15189:2022 based on a detailed study of all activities of the laboratory, such as;
  • ISO 15189 Quality Manual,
  • Quality Procedures (Mandatory procedures required by the ISO 15189 standard),
  • Standard Operating Procedures (SOPs) to control identified activities having risk potential to the test parameter,
  • Formats to establish the objective evidence of implementation and to ensure control over all the activities,
  • Sample Risk Assessment and Opportunity Sheet
• ISO 15189 awareness training to all levels of employees within the laboratory,
• Help in the effective implementation of the system by periodic visits till accreditation,
• Conduct an internal audit to check readiness for the accreditation,
• Conduct management review meetings in the presence of Top Management to guide the laboratory for effective implementation on all the issues related to management requirements and technical requirements.