And tips for making the preparation process painless
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May 29, 2018
    Article highlights
  • Overview of ISO 17025 accreditation
  • Why ISO 17025 accreditation is important
  • Preparing for an ISO 17025 accreditation assessment

Standards in world trade and business ensure safety, consistency, and quality of products and services.The International Organization for Standardization works to maintain these standards across industries, both protecting consumers and helping businesses reduce error margins and increase efficiency.

ISO 17025 provides the general requirements for competence in testing and calibration laboratories of all kinds and ensures consistent, safe practices. From testing evidence for a local police department to dealing with patient blood samples, laboratories are responsible for sensitive specimens. Even the simplest testing error could result in major inaccuracies, which is detrimental to all parties.

Standards for machinery, lab equipment, and testing methods and procedures can safeguard labs from liability concerns. It also equips labs to deliver precise results in the safest, most effective way possible. The ISO 17025 standard is only useful if labs comply with it; which is why ISO 17025 accreditation, a crucial step toward ensuring safety and quality in lab operations, is important.

Ace your Accreditation

Download this ISO 17025:2017 checklist for your internal audit.

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ISO 17025 Accreditation

Obtaining ISO 17025 accreditation provides external validation your lab complies with the standard. On the simplest level, accreditation means a lab has demonstrated competence and integrity by fulfilling regulatory compliance.

An ISO 17025 accreditation certificate has many benefits. It creates credibility and shows potential consumers that your lab is focused on reliability and quality. To establish your lab as a competitor among other labs, it’s important to demonstrate your commitment to technical and managerial competence.

How to Achieve ISO 17025 Accreditation

The first step to achieving ISO 17025 accreditation is choosing an accrediting body to carry out the assessment. The accrediting body will ultimately decide whether or not your lab is compliant with the ISO 17025 standard. It’s important to make this decision as a team. Consider the organization’s location, reputation, and credentials. Once you choose an accrediting organization, you will file an application, receive a quote, and enter a contract with the accrediting body. Once you have the accreditation assessment set up, it’s time to prepare.

People working in a lab.

Preparing for An Accreditation Assessment

The most important aspect of ISO 17025 accreditation is ensuring your lab’s policies and procedures fully align with the standard’s requirements. You’ll review all your lab’s managerial and technical documents and fill in any gaps.

Once you update your documents, your employees need to be familiar with your systems. You’ll also need to create an evidentiary trail of documents for assessors to review. This includes all quality manuals, procedures, work instructions, quality documentation, and quality records.

Because this process is highly detailed, you may want to utilize an ISO audit checklist to conduct an internal audit. We’ve put together an ISO 17025 checklist you can download that summarizes each clause in the standard. You can also purchase ISO 17025 templates and policy manuals to use as you prepare for the assessment.

Keep in mind that your preparation journey will be quite extensive. Preparing for an accreditation assessment can take anywhere from six months to one year, depending on the size of your lab. The actual accreditation process takes a few months, unless your lab needs to take corrective action to resolve any areas of noncompliance.

Reduce Assessment Deficiencies

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  • Using Technology to Make Obtaining ISO 17025 Accreditation Easier

    The accreditation process is extensive for a reason. Accreditors want to make sure your lab has a solid understanding of and commitment to the ISO 17025 standard. To make the process simpler for everyone, consider investing in a document management software (DMS). A DMS is especially important to ensure your lab is meeting all of the ISO document control requirements.

    Keeping all your important documents and files in one, central location helps eliminate confusion. Employees can access policies and procedures from anywhere, anytime, to ensure they are abiding by your laboratory’s established management system. Additionally, if you edit a policy document to align with the ISO 17025 standard, a DMS allows you to quickly edit and disseminate it. You can also make the sign-off process easier by tracking signatures digitally when you re-distribute files.

    A user-friendly, cloud-based DMS will help your lab ensure effective document control. Employees will find a software, like PowerDMS, is easy to use and navigate, while meeting the ISO requirements. It doesn’t help your laboratory to have a “compliant” software if your employees are too overwhelmed to log in and use it.

    Most document management software also has training capabilities. As you prepare your staff for the assessment, you can create custom training courses and tests to ensure their competence.

    Ensuring a Successful ISO 17025 Accreditation Process

    Organization and efficiency during your accreditation preparation make the process simpler for everyone. Taking time to ensure your documents and employees align with the standard and its requirements can save your company time, effort, and money. Choosing an effective document management software your employees will use will empower you to ace your ISO 17025 assessment the first time, allowing you to focus on what your lab does best.

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