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ISO 17025 Remarkable Corrective Actions Resolution

ISO 17025 Remarkable Corrective Actions Resolution

ISO/IEC 17025

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.

Structure of ISO 17025

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 accreditation for your company? We’d be happy to answer any questions you may have regarding the process. Contact us today!

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ISO IEC 17025 Laboratory Requirements: Calibration and Testing

ISO IEC 17025 Laboratory Requirements: Calibration and Testing

ISO/IEC 17025, Uncategorized

Laboratory accreditation for testing and calibration falls under the ISO IEC 17025 standard. Any laboratory that wants to demonstrate their conformity to the highest levels of quality for their results would be well-advised to seek ISO IEC 17025 accreditation. The accreditation was designed alongside eighteen liaison organizations, including the International Laboratory Accreditation Cooperation (ILAC).

Who Does the ISO IEC 17025 Apply To?

Accreditation should be a priority for labs that do testing, sampling, or equipment calibrations. Whether the lab is government-run or private doesn’t make a difference. While many labs believe they already run at peak efficiency, implementing ISO IEC 17025 usually reveals a lot of gaps in their processes and management methodologies. Among the perks of achieving ISO IEC 17025 accreditation are:

  • Quality control systems can anticipate problems and deal with preventative actions.
  • Methods of testing have specific accuracies, precision, and limits of detection.
  • The institution starts using globally published and accepted standards for their testing methodologies and calibration of instruments.
  • The accreditation similarly outlines an acceptable set of methods that the lab can use.

The Benefits that ISO IEC 17025 Brings to Institutions

Accreditation can take a lot of time, but the sheer benefits that it offers to an institution are second to none. An accredited lab is one that is afforded respect in their dealings with their business clientele. By starting on the path of ISO IEC 17025 accreditation, an institution removes any doubt that a client may have regarding their operation and methodologies. In the business of laboratory testing, trust is the most important thing for clients. The accreditation encourages trust in a laboratory because the accreditation shows that the company conforms to professional, accepted standards that are approved globally.

Clients will no longer have to worry about retesting leading to different results. The generated results from the labs’ test would be accurate and precise. This peace of mind is critical to a client’s decision to return for future business. Not only does ISO IEC 17025 affect the way a client sees the institution, but how other companies in the industry view them as well.

Institutions that are certified as ISO IEC 17025 compliant tend to be seen in a better light by other labs, both certified and uncertified. Cooperation and sharing of results will be a lot easier with other labs because of this accreditation. The partner labs will have peace of mind that their results will not end up in unauthorized hands. Since this accreditation is accepted globally, international boundaries don’t matter to this level of trust. A certified institution is accorded the same respect anywhere in the world they choose to do business.

How Long does ISO IEC 17025 Accreditation Take

Accreditation doesn’t have a specific timeline. There is no set number of days or weeks that can be applied to every organization. Accreditation depends on a handful of critical practices that may vary, depending on the institution. These are:

  • Number of locations where testing /calibration is done
  • How complex the testing methodologies and equipment calibrations are
  • How many employees the business employs
  • The number of tests or calibrations that are within the institution’s scope of operations

The 2017 Update to ISO IEC 17025

In 2017, the ISO IEC 17025 received a series of updates. Rapid progress in the technology and within the market’s demands made revamping the process of accreditation necessary to deal with these changes. The changes sought to incorporate developments within the realms of IT and technical methodologies while updating the accreditation’s vocabulary to meet the demands of the modern world. The new amendments integrated changes to the ISO 9001 standard, hoping to bring about further integration of both standards.

Significant Changes in the 2017 Amendment

With the ISO IEC 17025:2017 amendment, the industry saw the accreditation change some areas significantly, including:

  • Accreditation Scope: All of a laboratory’s sampling techniques, equipment calibration, and testing will now be covered under the new scope of the accreditation.
  • Alignment between ISO IEC 17000 and ISO IEC 17025: The accreditation was redesigned to bring about a closer alignment between the two standards.
  • Improved Approach to Processes: The accreditation system has been developed to synchronize more closely with existing accreditation systems, including ISO 15189 (Quality of Medical Laboratories), IEC 17000 (Standard of Conformity Assessment Activities), and ISO 9001 (Quality Management System).
  • Reduction in Paperwork: A broader focus on IT and software reduces the amount of paperwork a business needs to perform to conform to the accreditation’s standard.
  • Risk-Based Considerations: A section has been added to the accreditation that allows for closer integration with ISO 9001:2015.
  • Synchronization of Terms: Terminology and vocabulary have been updated to reflect standard conformity assessments.

Display of Accreditation

Once a lab has successfully achieved ISO IEC 17025, they can proudly display the certificate wherever they see fit. Additionally, they can include the accreditation in all their marketing materials, not limited to the company’s website and brochures. Accreditation puts the clients’ minds at ease since it allows them to trust the institution as an internationally recognized organization for their work.

Are you trying to get ISO IEC 17025 accreditation for your institution? Contact us today, and we can work through any questions you might have about the process or the application.

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Comparing ISO 27001 Standard and NIST Security Framework

Comparing ISO 27001 Standard and NIST Security Framework

IT Management Standards, NIST

Both the NIST security framework and the ISO 27001 standard deal with information security controls. The International Organization for Standardization (ISO) mentions that ISO 27001 provides guidelines for the establishment of an information security management system (ISMS). Digital Guardian informs us that the NIST security framework is designed to shore up inefficiencies in a business’s information security plans. 

It’s immediately apparent that both of these methodologies share a common goal. However, they’re not interchangeable. This article delves into the similarities and differences between the NIST’s framework and ISO 27001.

The Structure of the ISO 27001

The ISO 27001 standard has ten (10) clauses that outline the critical information for applicants. The first three (3) clauses go over references, terms, and a basic understanding of the standard. The seven that follow are instrumental in helping businesses develop and finalize their ISMS. They define the business’s organizational context and probe whether the company’s leadership is committed to ensuring the standard’s success. 

Other steps ask about the business’s ability to anticipate information  security threats (cybersecurity and IT security) and manage its information security risk. The ISO standard examines the company’s established support network and suggests ways to improve and develop it. It then makes suggestions on the operation of the business’s ISMS. 

As with all ISO standards, there is a built-in system for self-improvement. The final clauses of the ISO 27001 document focus on evaluating the established system’s performance and how to improve those processes. Implementing this standard can bring benefits to businesses in several ways. We covered previously how the ISO 27001 standard can work in concert with project management.

ISO 27001 Annex A has 14 Domains with 114 controls. NIST covers 110 of these controls. 

Understanding the NIST Security Framework

Since both the ISO 27001 standard and the NIST framework have similar goals, it’s evident that there will be overlap between their implementations. However, while the ISO 27001 standard was designed for a specific purpose, the NIST framework is more open-ended. As such, any business that uses information technology stands to benefit from this framework. The NIST security framework relies on five overarching principles:

  • Identify: This step determines the risks that exist within the organization from a cybersecurity perspective. It’s similar to the fourth clause of ISO 27001.
  • Protect: Businesses that have cybersecurity risks need to protect the organization’s data and infrastructure from them. This protection either stops threats from occurring or minimizes the impact of those threats if they enter the system.
  • Detect: The longer a threat remains undetected on a system, the more havoc it can cause. This step allows businesses to find threats faster and neutralize them.
  • Respond: This step creates an organized response so that all parties know what they have to do. In a cybersecurity breach, time is crucial to success. Having everything planned out beforehand speeds up deployment and engagement.
  • Recover: This stage focuses on getting the business’s systems back online and working as usual. It addresses factors such as backup and restore times, and allows the company some recovery time to get back on track after an attack.

Similar Yet Different

There are distinct similarities in how these methodologies approach the problem of information security. The NIST framework is heavily flexible, which gives it a lot of room for application. However, this flexibility leaves the interpretation of the framework to the business implementing it. The ISO standard, on the other hand, is more focused on what it provides to companies. The defined, cyclical nature of the standard makes it ideal for a specific situation. Unfortunately, it’s not very flexible in application. Despite this, we’ve covered several ways how the ISO 27001 standard can benefit businesses.

If you’ve got questions about ISO 27001 or the NIST security framework, Contact Sync Resource. Let our experts help you to understand what each offers your business and which one is right for you.

Comparing-ISO-27001-Standard-and-NIST-Security-Framework

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What Is the ISO 27001 Benefit to Business? Understanding Security Compliance

What Is the ISO 27001 Benefit to Business? Understanding Security Compliance

ISO/IEC 27001

Businesses considering implementing this standard have to answer the question of what the ISO 27001 benefit to business is. The British Assessment Bureau informs us that ISO 27001 helps companies achieve an information security management system (ISMS) that allows the company to minimize or remove the chance of a data breach.

Data security isn’t a new concern for companies. The BBC mentions that cybersecurity is of the utmost importance to any business in the twenty-first century. However, while we are aware of how important data security is, how does this tie into the ISO 27001 benefit to business?

Data Integrity and Restoration

Data corruption can be a plague that can cause an entire company’s databases to buckle and collapse. Ensuring that individual records maintain their integrity is crucial to ensuring that the company can meet its mandate to clients and suppliers alike.

With integrated databases, minor corruption could cost a company quite a lot. There’s no way to isolate and repair the corrupted data. By implementing data security systems under the ISO 27001 standard, a business sets up a framework. This framework deals with data integrity and can help with compromised datasets.
Data organization, access control, and a specific backup protocol ensure that datasets remain viable and avoid corruption. Comparing the latest backup with the current version can help a company restore the damaged data without too much hassle.

Privacy of User Data

Another crucial ISO 27001 benefit to the business is increased privacy for the company’s data. An ISMS helps businesses avoid problems that arise if they fail to secure data appropriately. Access control, group management policies, and destruction of data no longer in use are crucial parts of an ISMS. They ensure that user information doesn’t leave the company’s servers or fall into the wrong hands.

ISO 27001 regulations keep businesses secure in knowing that the data they have on their systems are protected. It also helps to avoid messy legal battles associated with data leaks.

Intellectual Property Protection

Businesses all have their own intellectual property generated within the company. Protecting a business’s intellectual property (IP) ensures that it maintains its competitive edge. Risk management techniques can help spot issues with how the company currently deals with its IPs.

Once more, access controls per ISO 27001 are crucial in ensuring that the company keeps ahold of its intellectual property rights. Secure systems stop external access to the company’s IP records. This practice helps to create an impenetrable digital barrier to anyone who would seek to appropriate the company’s IPs.

Peace of Mind to Customers

Digital security is now a hot topic for many consumers. Data breaches have become commonplace, and most users have had account information from one or more large companies compromised in the past. The incidence of these occurrences makes them less likely to trust businesses with their data.

An ISO 27001 benefit to business that is often overlooked is increased confidence in the company’s data management. This certification allows clients to be aware of how the business manages data. Customers understand the steps that the firm undertakes to ensure that all data collected by the company is stored securely. They can also rest assured that the data is destroyed when no longer in use. These steps can go a long way towards convincing a client that they can trust their user data with the business.

ISO 27001 Benefit to Business – The Never-Ending Arms Race

Business security is always about staying one step ahead of malicious actors. By implementing the guidelines set forward under ISO 27001, a company can apply industry best practices that may help them avoid problems with their data security. If you’re looking at implementing a new ISMS, we’ve got you covered. Maybe you need to audit the ISMS the business already has with the aim of certification? Contact Sync Resource today. We’d be glad to help you make your business data management a more secure process.

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Bits and Bytes – The No. 1 Formula for Learning the Benefits of How to get ISO Certification for Software Company

Bits and Bytes – The No. 1 Formula for Learning the Benefits of How to get ISO Certification for Software Company

ISO 9001, ISO/IEC 27001

Understanding how to get ISO certification for software company brings a lot of potential and possibilities for a small business. Certification underlines the company’s dedication to upholding industry standards.

Indeed reinforces this by stating that ISO certification establishes credibility within the industry and increases consumer trust with their service provider.

Many software companies avoid ISO certification because they don’t think the standards apply to their industry.

This opinion isn’t strictly true. Software companies stand to benefit from implementing two essential ISO standards: ISO 9001 and ISO 27001.

In this article, we’ll delve into what these certifications are and what they bring to the table for software companies.

Defining The Standards for How to Get ISO Certification for Software Company

Software companies, like many small businesses, utilize several standard practices. ISO 9001, as we previously explained, deals with establishing a quality management service within the company.

The International Standards Organization itself states that certifications from the ISO 9000 family help businesses to maintain the quality of their products and customer service through an iterative methodology.

In particular, software companies depend upon excellent customer support and high-quality products to help make a name for themselves and stand out from the competition.

Another vital certification that software companies shouldn’t overlook is ISO 27001.

We’ve touched on how this particular certification can be critical to small businesses since it deals primarily with data protection.

The International Standards Organization mentions that the ISO 27001 certification offers peace of mind when it comes to data security by helping a business establish an Information Security Management System (ISMS).

How to Get ISO Certification for Software Company – The Steps Involved

Each of these ISO certification standards has its own requirements, and as such, we will be covering each one separately.

ISO 9001

In a previous post, we mentioned a simplified 5-step process that a company could undertake to achieve ISO 9001 certification. For those who missed that post, the five steps we mentioned are:

  1. Get Informed:
    Source basic and essential information about the ISO certification process. Companies should start by designating a member of staff as the “point person” for this process, making them the go-to person for all ISO-related issue.
  2. Prepare Documentation:
    ISO 9001 is heavily based on documentation. At this stage, a company should be getting the documents they currently have and note the materials they lack compared to what the standard requires.
  3. Implement Certification Requirements:
    Using the information generated from the previous step, a company can note its weakest areas and its lack of documentation. Taking into account the requirements for certification, the company can see where they comply with the regulations entirely, partially, or not at all.
  4. Internal Audit:
    Once the company has arranged its documentation, it can undergo an internal audit. At this stage, the company inspects its documentation and compares it to the requirements. Glaring errors can be picked up and rectified here, and the company may need to go through multiple internal audits before it’s ready for the next step.
  5. External Audit and Certification:
    A third-party certification body will visit the company in the final step and perform a thorough audit of the company’s documents and system improvements. If it meets the standards, the company will achieve ISO 9001 certification.

ISO 27001

We also outlined a detailed methodology of how a company can obtain ISO 27001 certification in a past post. The process is a bit more involved, covering eleven steps:

  1. Identify objectives
  2. Get management on board with the plan
  3. Ensure the scope of the project is acceptable
  4. Develop an ISMS brief covering the policy
  5. Define the Methodology for Risk Assessment and the Strategy the company intends to pursue
  6. Develop a risk treatment plan and manage the risks that already exist within the system
  7. Create policies to take on risks
  8. Define the resources required for implementing those policies and train the staff to be more aware of the implementation process
  9. Monitor the ISMS after it goes online
  10. Prepare for an internal audit
  11. Have management review the ISMS periodically for improvements or updates

Certification Raises Marketability

A company that learns how to get ISO certification for software company raises its stature on the open market. Businesses know they can trust ISO certified companies. As a result, those companies tend to get more consideration compared to others in tendering processes around the world.

If you’d like to have a more competitive business, contact Sync Resource today, and let’s help you achieve how to get ISO certification for software company.

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