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Cybersecurity Standards: Why CMMC Compliance is Good for Business

CMMC compliance is an important standard for companies and not just those that are IT-based either. CSO Online defines the Cybersecurity Maturity Model Certification (CMMC) as a unified standard for implementing cybersecurity across the defense industrial base. The news has been covering the Coronavirus a lot, so it’s no surprise that the CMMC isn’t getting the attention it deserves. With more defense contractors offering employees to work from home, the standard becomes even more critical.

Useful For Keeping Business Data Safe

As any cybersecurity expert will tell you, having remote workers is a double-edged sword. Yes, you are likely to get higher productivity levels, but if your employee uses their own hardware, it presents a direct threat to business security. Even in regular remote working that doesn’t involve CUI data, workers can be a potential backdoor into the company’s network. Implementing CMMC compliance ensures that a business follows the industry best-practice when it comes to network access. If your company intends to go down this route, your employees might find that their ability to access company resources remotely would have diminished.

The 5-tiered CMMC system is based on the NIST 801-171 standard but takes it to a much more stringent implementation at higher levels. If a business already complies with the NIST 800-171, it should achieve a level-3 certification for the CMMC without much more effort. The CMMC system was designed to incorporate five levels because of progression. Still, even at lower levels, it was understood that the steps that a business was taking would benefit it. At level 1, it was assumed, most defense contractors would already be obeying the protocols put in place. They were just set forth as a formality. Unfortunately, that wasn’t true for all of them.

Moving to CMMC

According to the Federal Registry, the Defense Federal Acquisition Regulation Supplement (DFARS) supports the existing Federal Acquisition Regulations regarding how the government does business with contractors. Before the CMMC was implemented, DFARS was the standard for data security that contractors within the industry. The government moves from DFARS to CMMC for a single, critical reason. On audit, the DOD found that many contractors claiming compliance during the Request for Proposal (RFP) process were not honest about their level of compliance. However, since the DFARS was based on an honor system, there was little the DOD could do aside from revamping the system. The CMMC incorporates third-party appraisals to move away from an honor-based system and guarantee the certification’s integrity.

The “Culture of Security”

When developing the CMMC, the DOD realized that many of a contractor’s problems could be quickly dealt with if there was a pervading “culture of security” among the workforce. CMMC compliance, therefore, seeks to incorporate this into every company adopting the standard. The culture of security starts at level 1 compliance, but at levels three to five, it ramps up intensely. The two significant components a lot of businesses overlook when seeking CMMC compliance are almost the same across the board:

Buying unnecessary solutions: Businesses can afford a lot of high-tech cybersecurity equipment, but just because it’s expensive doesn’t mean it’s what the business needs

No contingency plans: When disaster strikes (as it almost always does), a business must have a plan in place to deal with the fallout and keep systems running, even while dealing with the issue.

When businesses implement CMMC standards, these are the critical issues they need to address to institute the culture of security the standard calls for.

Not Just for IT Companies

A common misconception for businesses is that CMMC compliance doesn’t apply to them. Because of how it was designed, CMMC standards may be applied to any company in any industry. It was intended as a comprehensive security framework to keep business data assets safe. If you’re not in the defense industry, you can still benefit from implementing the standard. Contact Sync Resource to learn how to adapt this standard to your own business today.

Title: Cybersecurity Standards: Why CMMC Compliance Is Good for Business

Description: CMMC compliance helps businesses that want to qualify for Department of Defense contracts, but they can be used anywhere. Learn how they could be adapted here.

Article Source: https://sync-resource.com/cmmc-compliance/

#iso 9001 certification #iso 27001 certification #iso 13485 certification

Exploring What Is Required to Attain NIST 800-171 Compliance

Federal contractors have no doubt heard about the NIST 800-171. As Dark Cubed tells us, the certification deals with ensuring that controlled unclassified information (CUI) doesn’t fall into the wrong hands. The Department of Defense defines CUI as information that is relevant and sensitive to the government of the United States, yet not strictly classified. The NIST 800-171 was initially designed to safeguard this information from malicious actors that could use this data to gain an advantage over the United States. Here, we’ll look at what the NIST 800-171 is and how an organization can seek to meet this standard’s requirements.

What Exactly Is the NIST 800-171?

In 2003, the United States Government passed the Federal Information Security Management Act (FISMA). Under the FISMA, the NIST 800-171 was developed to ensure that cybersecurity practices among defense contractors and other federal agencies were of a certain standard. Prior to FISMA, several well-publicized breaches alerted the administration that their cybersecurity health wasn’t the best. As a result, the FISMA outlined a few guidelines to create a “culture of cybersecurity” among these contractors and governmental agencies. The NIST itself states that the standard aims to ensure that unclassified data in governmental repositories were both safe and consistent across all of its iterations.

Several governmental agencies, among them the DOD, NASA, and the GSA, implemented a revised set of rules for the NIST in December of 2017. Any contractor that works with CUI from those agencies is required to demonstrate compliance with the standard. Among the guidelines included an overhaul of how these companies dealt with CUI and the procedure they would use to report potential or confirmed breaches. The policies are robust, dealing with all the details of a company’s data system, ranging from network configuration to how employees receive and utilize the CUI data.

Seeking Compliance With the NIST 800-171

The NIST 800-171 has fourteen significant points that companies which want to comply with the standard need to observe. These are:

System Information Integrity: how fast threats to the network or individual systems are recognized and dealt with

System and Communications Protection: Data should be monitored at critical locations both inside the company and once it leaves

Security Assessment: Businesses need to assess the level of their security and whether the procedures they have previously implemented are still valid

Risk Assessment: Businesses need to perform simulated attacks and penetration testing to ensure their systems don’t introduce or harbor unnecessary risk

Personnel Security: Contractors are screened on how they allow access to the CUI and the qualification that employees must have to access the data

Physical Protection: The physical defenses of the site where the CUI is stored must be assessed and recorded as being compliant with the standards

Media Protection: CUI data must be stored on secure backups, which may be kept off-site in another secure facility. Access to these records are also examined to ensure that no unauthorized personnel can get them

Maintenance: Companies need to outline the routine maintenance of their locations and which personnel have access for the duration of that maintenance

Incident Response: The response that the contractor has to any potential breach or suggestion of a breach

Identification and Authentication: The process the business uses to qualify employees to use the CUI data is examined, including verification before access

Configuration Management: The business’s network configuration and security protocols are scrutinized to ensure that it meets agency expectations

Audits and Accountability: This process identifies what records are kept of access, both authorized and unauthorized, and whether unauthorized access can be tracked

Awareness and Training: In keeping with the NIST’s aim to ensure a “culture of security,” employees are to be trained to follow security protocol at all times

Access Control: The business should have something in place to limit access to the CUI data.

Contractors and other companies that want to qualify under the NIST 800-171 standard need to follow these guidelines to a certain level of competence. Businesses who work with the Department of Defense have a separate certification known as the CMMC, which is based heavily on the NIST-800-171 standard. If you’re interested in meeting the measures proposed in either of these, you should contact Sync Resource today. With years of experience in cyber security training, we can offer you a unique road to reaching NIST 800-171 compliance.

Article Source: https://www.sync-resource.com/blog/nist-800-171/

#iso 9001 certification #iso 27001 certification #iso 13485 certification

How to Overcome the Challenges of ISO 27001 Certification

A business seeking ISO 27001 certification will face several major and minor hurdles to its goal. Several of these companies give up, considering that the certification might be more trouble than it’s worth. There are two ways to view certification hurdles. The first is that it makes the achievement of certification a meaningful experience. If it were so simple that anyone could achieve it, it wouldn’t be worth anything. The second and more critical ideal is that difficult certifications show competence and mastery of a particular field. ISO 27001 certification, according to the International Organization for Standardization, is a framework for developing an information security management system (ISMS). Businesses that manage to achieve this certification show their dedication to creating a robust information management system that remains secure and has contingencies in place to keep it that way. But this is no easy task. What is the most challenging part of getting ISO 27001 Certification?

Risk Assessment and Management

One of the core competencies in ISO 27001 certification has to do with risk management. For a business to cope with the current threats to the industry, it must first realize where these threats come from. Assessing and treating information security risks across the organization is crucial to meeting the requirements of ISO 27001. Risk assessment, therefore, needs to be the first and most vital pillar in a business’s ISO 27001 certification attempt. Unfortunately, some businesses start the process without conducting proper research into the threats to their own organization. The result is a company that’s woefully underprepared to deal with the demands of the standard. More often than not, this leads to businesses quitting before they achieve certified status.

Lack of Proper Planning

Preparation is crucial to achieving any goals, and this is doubly true for ISO certification. Planning requires a company to map out their path from uncertified to certified, going through each step of the process and outlining ways to tackle the challenges the standard presents. Lack of adequate planning leads to complications. While some companies see planning as an unnecessary time-sink, others realize how crucial it is in a complex undertaking like ISO certification. The businesses that realize how vital planning is to reaching their goals are the ones who manage to achieve them.

Performance Evaluation and Self Improvement

I’ve mentioned the benefits that ISO 27001 offers to a business before. Many of these bonuses come from the fact that self-improvement is hard-wired into the standard. The ISO requires that companies inspect their ISMS and develop ways to improve them throughout their operation. Unfortunately, many businesses trip in this hurdle. Failure at this critical task might be due to internal auditors not looking at the company’s efforts objectively. It’s easy to fall into the trap of thinking that the business doesn’t need to improve what it’s doing. The problem with this shortsightedness is that it could extend the time the company needs to achieve certification. Calling in an external consultant can help to mitigate this issue.

Access Control

An ISMS requires a business to have appropriately managed access controls. This access control requirement ensures that individuals can’t access data without the proper credentials. Unfortunately, many companies don’t have a robust access control system in place. Despite the criticality of this point, many companies overlook it, with roles not being adequately defined within the access database. This issue is a technical one that should be addressed before the business seeks external audits for its certification.

Overcoming These Challenges

While many other hurdles exist that a business needs to vault over to get to ISO 27001 certification, these are the most pressing issues. In most cases, dealing with these issues requires outside input. Hiring external consultants can go a long way towards providing the perspective a business needs to properly approach the problem and achieve certification in a reasonable timeline. Contact Sync Resource today to schedule a meeting with a professional ISO consultancy group!

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Article Source: https://sync-resource.com/overcome-challenges-iso-27001-certification-2/

#iso 9001 certification #iso 27001 certification #iso certification requirements #iso 13485 certification

ISO 9001 is proven and tested quality management system that has been declared successful in almost every type of business. Consider Sync Resources in your assistance to get you ISO 9001 certification and to help in maintaining the ISO 9001 certification requirements. Book A Call With Expert.

#ISO 9001 Consultant #iso 9001 certification #iso 27001 certification #iso 13485 certification

When Does a Business Need ISO 9001 Internal Auditor Training

Internal audits are the most critical part of the ISO 9001 quality management system (QMS). Having someone with ISO internal audit training can be valuable to a business seeking to achieve and maintain the certification. According to the International Standards Organization (ISO), it is recommended that institutions seeking ISO 9001 certification have regular internal audits to ensure that all the parts of the system are working well. ISO 9001 certification depends on internal audits as part of its continual improvement process, as mentioned before. Here, we delve into when a business should have an ISO 9001 internal auditor training and what this entails.

What Does Internal Auditor Training Involve?

It’s not a requirement for businesses undertaking the ISO 9001 certification to get training from external organizations. However, businesses that offer external auditing services may also provide training for ISO 9001 internal audits. Companies that want their internal auditors to be trained appropriately would be wise to enroll them in either these supplemental courses or in a lead auditor training course. Typically, these training courses include information that auditors ought to know, including:

Understanding the structure and function of the ISO 9001 certification and the entire listing of the Requirements and Structure of the standard.

Utilizing the ISO 9001 guidelines for auditing management systems, allowing them to assess how well the company’s processes measure up against the requirements.

Real-world scenarios to help auditors understand what they may encounter during their new role as internal auditors.

Company-Specific Topics

ISO 9001 internal auditor training will give individuals the chance to learn about the intricacies of applying the standard. Additionally, it will allow them insight to understand what they should learn from their own institutions. Every QMS system tends to have its own needs and functions. While the standard provides a generalized overview of how the system should function, it’s up to the internal auditors to pinpoint the specific topics within the company they need to focus on. These include:

QMS Specifics for the Institution: To properly audit a company’s QMS, an auditor needs to be aware of the processes, policies, procedures, and how these interact to get a complete idea of how the QMS functions. Asking people involved in the process can help the auditor develop a roadmap that they can use to speed up their auditing.

Checklists: Audit checklists are useful tools in helping auditors get and stay on track with their audit. It also helps them to underscore the elements of the QMS that they think need improvement.

Auditing With a Purpose

Anyone involved in ISO 9001 internal training should be aware of the reason for their practice. Auditing plays a crucial role in helping institutions achieve their ISO 9001 certification. An internal auditor must ensure that their audits are done thoroughly and comply with the ISO 9001 rules. Additionally, any suggestions they present to the company should help to improve its QMS. We’ve touched on how essential employee training is to the success of an ISO 9001 certification. It might be tempting to consider internal audits as a way to force change into the system, but doing so can lead to unforeseen problems. It’s much better to use the standards as a guideline for your own suggestions for improving the company’s QMS.

Planning For Success

Enterprises that establish a QMS already have the right idea in mind. However, without constant auditing, there are many places where the QMS can falter. Internal auditors are the best way to avoid having the institution slip back into an uncoordinated mess. Interested in learning more about ISO 9001 internal auditor training? Send Sync Resource a message today! We can help you with your ISO 9001 internal auditor training program.

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#Iso 9001 #iso 9001 consultant #iso 27001 certification

In order to get an ISO certification, one must be able to get a consultancy of an experienced and well-trained ISO consultant. Hire an experienced ISO Compliance consultant knows what needs to be done to get ISO certification within as little time as possible and will eliminate maximum ambiguities and non-conformities in your current management thus increment in your chances to get ISO certification.

#iso 9001 certification #iso 27001 certification #iso 13485 certification #cmmi certification #cmmi process #isms iso 27001

Does it Take Too Long to Implement a Quality Management System

It’s based on your resource availability and capacity, it’s critical that timelines are created. It helps to ensure an appropriate budget is allocated and to monitor the important milestones.

How long will it take to implement a quality management system?

Here are some rules of thumb.

A generic guideline based on the employee count & number of locations is as below:

· 50 people or less: Smaller business? Play your cards right, and you’re looking at 6-8 months.

· Under 500 employees: Get the right people on your team, and you’re doing it in under a year.

· 500+: Larger means longer, yet you could finish in as few as 15 months.

Most small businesses can implement ISO in 3 months or less with Sync Resource.

Start with a detailed gap analysis. Gap Analysis helps identify the gaps in policies, procedures, processes, a document review as compared to the standard requirement. Once you know where the difference is, we can figure out how to close the gap.

You can implement quality management by yourself but getting an expert to help you will absolutely speed up the process since the expert focuses on “how to.” While doing it yourself may seem economical, the time and resources used in the trial and error will cost the organization the next customer or contract.

An expert will help you understand the requirement and identify the best way to implement it without changing the core processes. The bottom line is with the right people, you can implement a quality management system quickly, effectively, and most important, correctly.

Become ISO 17025: 2017 accredited. Schedule a call with an ISO expert today! You can also reply to this email or call us now at 1.678.257.2242 for faster service.

Article Source:

https://www.sync-resource.com/implement-a-quality-management-system-1/

#Iso 9001 #iso 9001 certification #iso certification consultants

Savvy Tips to Hire an ISO Consultant

Hire an ISO Consultant that is a Superhero…

In order to get an ISO certification, one must be able to get a consultancy of an experienced and well-trained ISO consultant.

An ISO consultant can “sink” or “sail” you through the ISO certification process.

If ISO consultant doesn’t know about ISO standards, standard’s compliance, non-conformists, and re-certification process then only a holy miracle will get you ISO certification.

If your hired ISO consultant fails to understand the procedures and standards then it will probably result in wastage of your time and money because that way you won’t be getting ISO certification.

On the other hand, if you take help from an experienced and a well-trained professional for your ISO Certification, you don’t have to worry about compliance of your current management system with other ISO standards because well-trained and experience ISO consultant will ensure to help you redesign or modify your current management with your team to the maximum compliance to other ISO standards.

Hire an ISO Consultant Right for the Job for ISO Certification

1- Your In-House Team Versus ISO Consultants’ Team

If your organization needs to develop the current management system in accordance with ISO standards that means your in-house team will be having very little familiarity with ISO standards and its compliance.

If that is exactly the same situation in your organization, then we would recommend you hire an ISO consultant to hire a knowledgeable and experienced because that ISO consultant will be on a higher level than your in-house team.

Ask yourself a question that if your in-house doesn’t know about ISO standards and its compliance then how can your newbie in-house team will be able to achieve ISO certification within defined timelines.

Most probably you will be thinking that by proper training and post-evaluation tests, your in-house team can become capable to help themselves get ISO certification then it is must for us to inform you that there is a significant chance that your team can achieve ISO certification but will take so long-time period that can affect your profit margins negatively.

2- Risk of Time and Money Wastage

A hired delegated team of ISO consultants will ensure to get your organization ISO certified within timelines and obviously this is what they get paid for. Getting ISO certification is not everyone’s cup of tea.

Relying on your less experienced and less ISO familiar in-house team may lead to complete failure to comply with ISO standards thus resulting in complete drainage of your time, energy and money.

On the other hand, an experienced ISO consultant knows what needs to be done to get ISO certification within as little time as possible and will eliminate maximum ambiguities and non-conformities in your current management thus increment in your chances to get ISO certification.

3- Better Real World Implementations & Suggestions by ISO Consultants

Your in-house team might get immune to observing loopholes in your system.

They might have gone blind to indicate the leak points in your current management system. When you hire an ISO consultant, he or she will be able to pick those loopholes efficiently and will also make all the necessary improvements or modifications in your current management system making it easier to get ISO certification within as less time as possible.

What to Consider to Hire an ISO Consultant

ISO certification process can be a very daunting journey without getting involved an experienced and knowledgeable ISO consultant. Following are the attributes that need to be considered while hiring an ISO consultant for your company’s ISO certification:

1- Relevant ISO Certification Skills Set

ISO consultant should have knowledge about all versions of ISO standards and its practical application. Manufacturing and service providing firms differ from each other and so their internal operations too.

The right ISO consultant must be able to understand all types of management styles which means he/she should be able to decipher formal and informal management styles and should be able to perform gap analysis by doing Internal audits, ensure and report all highlighted gap closure.

2- Experience and Track Record

While hiring an ISO consultant Georgia, consider educational background and degrees.

For relevant experience, don’t just get satisfied by looking at the number of years and number of clients only. Instead see the success rate of the project on which the ISO consultant worked, look into the type of clients with which the ISO consultant worked in past years.

For further verification, you can check on their references and past case studies.

3- Pricing & Ability to Meet Deadlines

The pricing of ISO consultancy depends on few factors depending on the type of organization like the size of the organization, the number of employees and the level of employee engagement leading to effective teamwork.

Small to medium companies usually get ISO certification within less time period thus incur a lower cost as compared to bigger companies.

Big companies that get basic training and design their management system in accordance with ISO standards takes a longer time period to get ISO certified thus incurs a higher cost as compared to smaller companies.

During price agreement, it is important hire an ISO consultant and discuss your budget and their pricing to get your organization ISO certified.

To see if the client will be able to meet the deadlines for ISO certification, do look into their past projects’ success rate within defined timelines.

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Article Source: https://sync-resource.com/hire-an-iso-consultant/

#iso 9001 certification #iso 27001 certification #iso 13485 certification

What is ISO 13485 sterilization requirement? One of the must-haves for medical device industries is to have an established set up for sterilization of medical devices. Looking to get ISO 13485 certification for your business? What questions do you have, and how can we help? Book A Call With An Expert Now.

#iso 9001 certification #iso 27001 certification #iso 13485 certification #cmmi certification #isms iso 27001 #iso compliance consultants #iso 13485 requirements

Structure of ISO 17025 - ISO Certification for your Company

The International Standards Organization has outlined a series of qualifications that pertain to quality assurance of products and services. ISO 17025 deals specifically with Laboratory Management Systems. If a company is seeking ISO 17025 accreditation, they need to conform to the rules set forward by the ISO committee. Before a business can determine whether it should start on the path of accreditation or not, however, the structure of the ISO program should be evaluated.

There are a series of headings to review for ISO 17025. Among these are:

Scope: This heading covers the requirements (both scientific and technical) that a lab must display to demonstrate that it operates at the quality standards set forth by accreditation.

Normative References: Outlines a non-ambiguous framework for discussion of ISO 17025.

Terminologies and Definitions: The specific phrases and words that will be used to discuss laboratory Management Systems.

General Requirements: Requirements that the management system must have that encompass standard operating procedures and interface.

Structural Requirements: Infrastructure necessary to attain ISO 17025 accreditation.

Resource Requirements: Resources that a laboratory seeking ISO 17025 accreditation should have access to.

Process Requirements: Internal lab procedures should follow the guidelines set forward in this section.

Management Requirements: The management and running of the lab should use this section as a general guideline.

In addition to these clauses, two Annexes are also attached, viz.:

Annex A: Metrological Traceability (Informative)

Annex B: Management System (Informative)

To ensure that results delivered are accurate and precise, testing and calibration labs work within strictly defined guidelines for these specific tasks:

Documentation of results into a readable format

Sample analysis

Sample testing

Sample labeling

Sample identification

ISO 17025 requires a continuous review of processes. This review happens both during the audit process as well as after accreditation. The ISO 17025 methodology comes with a clause that focuses on corrective and preventative actions. The clause in detail states:

Clause 8.7 “Corrective Action” 8.7.1: Procedure for implementing Corrective Action: Selection and implementation of Corrective Action Selection and implementation of the most suitable Corrective Action. Document and implement any changes as a result of Corrective Action 8.7.2: Effectively addressing Nonconformities, Cause Analysis – Investigation of the root cause 8.7.3: Recording and Monitoring, Monitoring of Corrective Action

Steps in Addressing Corrective Actions

When corrective actions are prescribed to a laboratory, implementation of these corrective actions is done as follows:

Root Cause Analysis: A problem can’t be solved unless the root cause of the issue is located. A cross-functional team is best suited to examining every aspect of the matter in detail to determine where the problem exists within the procedure.

Examination of non-conformity: Non-conformity is a precursor to a problem arising within a process. The Corrective Actions unit should address any non-conformity that has occurred or has the possibility of re-occurring.

Determining Corrective Actions and Implementation: The most suitable corrective actions that will ensure the quality of the process would be selected from the potential actions, under the supervision of management. The chosen works will then be implemented to bring about change.

Monitoring of Actions: The team is required to observe and record what happens after the measures have been applied. If the discrepancy re-occurs, the process must be redone.

Additional Auditing: Determine whether internal audits are higher in quantity, or create any further non-conformity.

Record-Keeping: Meticulous recording of problems and actions taken to alleviate them allows for analysis of the methods undertaken both quantitatively and qualitatively. A review of records will make it easier to determine whether suggested activities are likely to work or not based on previous implementations.

Evaluation of Corrective Actions: Quality assurance departments are required to revisit the activities performed periodically to determine their long-term success. Management teams can use these periodic reports in the future for both internal and external audits.

The Vital Role of Continuous Improvement

ISO 17025 is an iterative process seeking to ensure that a laboratory raises the quality of methods with each audit. Daily improvement is facilitated by embedding a continuous improvement cycle and using Six Sigma Quality Management within the institution. Additionally, the current level of the institution’s Quality Management Service can be referenced. Additional benefits of a continuous improvement cycle include:

Reduction in customer complaints due to a higher quality of service, which leads to better customer response times.

Making it easier to gain ISO accreditation or re-accreditation.

Reduction in non-conformities that impact the efficiency and effectiveness of the system.

Delivering continual betterment through corrective actions.

Overview and verification of how effective the implemented corrective actions have been in both the short and long term.

Examining other opportunities the business has for improvement.

Checks on the efficiency of the company’s QMS.

Be updated with the current advances and changes to the company’s processes to match those developments.

Are you interested in gaining ISO certification for your company? We’d be happy to answer any questions you may have regarding the process. Contact us today!

https://sync-resource.com/iso-17025-corrective-actions-resolution-2/

#iso 9001 certification #iso 27001 certification #iso certification consultants #ISO 13485 requirements

In order to read the complete ISO 9001 guidelines and compliance criteria in detail, International Organization for Standardization has developed a couple of easy to access and far more easy to learn handbooks of ISO 9001 standard to help you go through the requirements in convenient way. Here are the ISO 9001 certification steps briefly defined that will enhance your knowledge about ISO 9001 certification process and its requirements in detail.

#how to get iso certification #iso internal audit #iso certification requirements #iso 9001 certification

ISO 9001 & ISO 13485 Certification: A Professional’s Future

ISO 9001 and ISO 13485 certification both offer significant benefits to an individual. We’ve covered ISO 9001 certification in great detail on our blog before. ISO 13485 certification, according to the International Organization for standardization, covers quality management for medical devices. It’s immediately apparent that these certifications may be linked. ISO 13485 certification can trace its roots back to the ISO 9001 standard, but the processes used within the standard are defined specifically for medical devices. If someone were to be qualified with both ISO 9001 and ISO 13485 certification, they would be an asset to their business. But what would their future be if they leave the company?

Trained Staff Is Crucial for ISO Certification

If a business is trying to achieve ISO certification, it needs to start with qualified personnel. Several companies have put a lot of time and effort into educating and training their employees to take up positions as internal auditors. These auditors are a crucial part of the certification process. In ISO 13485 certification, a business must constantly inspect its products to ensure they meet a certain minimum standard. As with most ISO certification processes, the idea is to establish a system of self-improvement within the manufacturing process. Most individuals who have had experience with the ISO certification system would have immediately spotted the process flow of the Plan-Do-Check-Act (PDCA) cycle. Unfortunately, this isn’t immediately obvious to a new trainee.

A professional with both ISO 9001 and ISO 13485 certification can be a priceless addition to any business seeking its own accreditation. Aside from being a pillar of the business’s certification push, the expert can guide others to becoming auditors themselves. It’s crucial to have someone who understands the process of ISO certification within a company’s hierarchy. Without this intimate knowledge of the standard, a business risks making mistakes. While this might not seem like a massive deal in the grander scheme of things, these mistakes can take a toll on a company. Minor errors in implementing a standard could have severe knock-on effects in terms of cost and time. Achieving certification can take a lot longer if the business isn’t sure what it’s doing.

ISO 13485 Certification Requires Constant Monitoring

Both ISO 9001 and ISO 13485 certification have self-improvement as a core function of the standard. Trained personnel know how to best apply the tenets of the standards towards improving the business’s processes regarding quality. ISO 9001 helps develop a quality management system (QMS) that the company can rely on in a general sense. ISO 13485 certification focuses on medical device production specifically. In tandem, they could make a business globally competitive, but only if it has a qualified person to guide them towards achieving this goal.

Constant monitoring forms a core part of all ISO standards. Self-improvement and internal audits are helpful in determining where the company’s shortcomings are. With skilled, trained personnel dedicated to performing audits, a business can reliably find its weaknesses and shore them up. The goal of implementing and ISO standard is to allow a business to be competitive globally. To maintain this competitiveness over the long term and retain certification requires trained staff. But internal personnel need to have support from consultants. There’s such a thing as being too close to the forest to see the trees, after all.

External Help Can Be Useful

As with most certifications, it may be impossible to achieve relying entirely on internal personnel. ISO 9001 and ISO 13485certification requires external auditors to verify the business’s attempts before becoming certified. Sync Resource has been offering support to businesses on the road to ISO certification for years. Contact us today to get professional guidance on achieving the elusive goal of ISO 13485 certification.

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Article Source : https://sync-resource.com/iso-9001-iso-13485-certification-future/

#iso certification consultants #iso 9001 certification #ISO 13485 requirements

ISO 9001 & ISO 13485 Certification: A Professional’s Future

Trained Staff Is Crucial for ISO Certification

ISO 13485 Certification Requires Constant Monitoring

External Help Can Be Useful

Book A Call With An Expert Now

Article Source : https://sync-resource.com/iso-9001-iso-13485-certification-future/

#iso 9001 certification #iso 27001 certification

ISO 27001 Certification: Is It Necessary in 2021?

Most businesses that rely on information technology systems view ISO 27001 certification standards as dated. They don’t see the need to invest money into establishing a standard that can compete globally. Unfortunately, this could lead to their downfall. With businesses moving to a more distributed working environment, data security and information systems security management become more of a concern. Statista mentions that the average cost of a data breach in 2020 came up to a whopping US$3.86 million. Businesses need to secure their internal information, but is that even something a company can securely do in the age of remote working? It’s clear that having a robust information security management system is of crucial importance in 2021, but how does a business ensure it can protect itself from global threats? ISO 27001 certification was developed for just this reason.

How Does ISO 27001 Certification Help?

We’ve delved into the benefits of ISO 27001 certification on this blog many times before. Even so, there are distinct benefits that the certification offers to businesses. The International Organization for Standardization (ISO) mentions that the ISO 27001 standard sets up a framework to secure a wide range of data, ranging from financial information to personal and employee data. Business data, in particular, is as valuable as gold in the modern age. Malicious users would stop at nothing to gain access to a company’s databases. It might not even be the company’s finances that they’re after, but concrete data that they can sell to competitors. The framework established and maintained by ISO 27001 certification keeps that data safe.

The framework itself isn’t a plug. Implementing it won’t magically fix the problem of data breaches or scams that intend to extract the company’s information. However, it helps to create a culture of security. With employees having a focus on keeping their data secure, it’s second nature to do the same for the business’s data. Remote working means that home computers are the “weak link” when it comes to security. A business culture centered on keeping data secure will ensure that it’s much more difficult for a malicious user to leverage an employee’s machine to get access to company data. ISO 27001 helps to create that culture of security.

Added Value Through Certification

Certification gives businesses that want to enter global markets a leg-up in dealing with local regulations. Because the global marketplace is now connected seamlessly through the internet, a business’s care for client data is as vital as securing their own information. An established ISO 27001 standard ensures that a company has a framework in place to shut down data breaches and prevent information extraction from malicious users. From a business perspective, a client will see this as an absolute plus. Ideally, if all businesses within a supply chain demonstrate ISO 27001 certification, all data within the supply chain will remain protected at all times. In areas of the world such as the EU, this is a prelude to data security as mentioned under the General Data Protection Requirements (GDPR).

Staying Ahead of the Arms Race

Data security relies heavily on staying ahead of threats. With each passing day, the threats to a business’s data increase. Having a robust framework in place as established by the ISO 27001 certification ensures that the enterprise is ready to face threats. From security exploits to scams coming through email, a company cannot be too prepared to deal with these issues. Unfortunately, not every business has trained personnel to offer feedback on their ISO 27001 certification attempts. Hiring an external consultant can be a helpful addition. Sync Resource has been helping companies to achieve their ISO 27001 certification goals for years. Contact us today, and let’s help guide you towards certification and shore up your information security management systems.

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Article Source : https://sync-resource.com/iso-27001-certification-2021/

#iso compliance consultants #iso consulting georgia #tqm principles

Total Quality Management, most commonly abbreviated as TQM is another branch of continuous improvement approach. Following are the eight key principles of TQM that are widely used in TQM implementation in manufacturing firms.

#iso 9001 certification #iso 27001 certification #iso 13485 certification

Capability Maturity Model Integration, commonly abbreviated as CMMI is the process improvement approach which has proven background of providing organizations with all the very essential basic elements of making the processes more effective and efficient. CMMI level certification has over 300 relevant “generic” and “specific“ processes on the basis of which organizations are to be rated.

#iso 9001 certification #iso compliance consultants

The Link between ISO 9001 Certification and Service/Product Reliability

Businesses may have heard about ISO 9001 certification and might have even considered becoming certified in the past. For whatever reason, these businesses might have decided against certification. In most cases, it’s because they don’t see the tangible evidence for ISO 9001 certification making a difference to a business’s products or services. While it can be difficult for the non-specialist to spot, ISO certification does help businesses a lot. Despite the claims, is there any objective evidence that shows a positive link between business performance and ISO 9001 certification?

What Is ISO 9001 Certification?

We’ve already covered ISO 9001 in our previous blogs. To recap, the International Organization for Standardization (ISO) mentions that ISO 9001 certification sets the criteria for establishing a quality management system within the company. The establishment of this system, it is claimed, will help a business be surer of its products and services. At its heart, it focuses on the business’s responsibility to the consumer. The certification process allows the company to examine its processes and products to ensure that its quality remains constant throughout the business’s lifetime. Achieving certification doesn’t mean the enterprise can relax, however. The ISO certification needs to be renewed ever so often to ensure that the business doesn’t lapse in its responsibility to the end-user.

Does It Make Any Difference?

Over the years, companies have applied to and achieved ISO 9001 certification but have not felt any difference in their business processes. They may have seen better customer acceptance of their products and a more substantial market presence, but they might have overlooked these apparent benefits without anything to compare them to.

The January 2021 issue of the journal Heliyon addresses this in a study that examines the relationship between ISO 9001:2015 certification and business performance for a manufacturing company in the developing world. The paper mentions a noticeable lack of research into ISO 9001 certification in this particular industry and its ability to make a business more competitive. In undertaking the study, they covered fifty (50) companies and used them as a representative sample size.

The results showed a significant and noticeable improvement in companies’ operational and business performance that had implemented the certification against those that hadn’t. However, it did note that, in this particular locale, the most significant hurdle businesses faced was finding competent staff that could implement the guidelines of ISO 9001 effectively. Inadequate training and a lack of qualified personnel is a genuine hurdle to overcome. These issues were further exacerbated by a lack of commitment from upper management towards establishing and improving the QMS.

Why Establish a QMS?

A typical question that businesses ask is why they should even bother to set up a QMS system. The ISO 9001 standard helps a business put together an infrastructure for ensuring quality in their products and services. Aside from making a business competitive internationally, it allows a company to gauge itself based on the performance of other businesses in the industry worldwide. Locally, a company that states it’s ISO 9001 certified shows that it is as good as any international company when it comes to its products or services. This distinction shouldn’t be underplayed, since it grants an edge against the competition.

What Is The Solution?

Developing ISO 9001 certification is laudable, but only if properly implemented. Finding the proper process towards reaching ISO 9001 certification is not something that happens overnight. Luckily, Sync Resource has been in the business of securing ISO 9001 certification for clients for years. We know what works and what doesn’t and can even help a company define its problems and overcome them through dedicated effort. If your business is seeking ISO 9001 certification, contact Sync Resource today to access trained and qualified professionals to help you in your journey.

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Article Source : https://sync-resource.com/iso-9001-certification-service-product-reliability/

#iso 9001 certification #iso 27001 certification

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