ISO 17025 certification in Kenya
About Kenya
Kenya, a country in East Africa where a blend of languages is spoken. The most common languages are Swahili and English, Kenyan flag that symbolizes unity, peace, and defense.
Kenya, in East Africa, varies from coastal plains to central mountains. The capital, Nairobi, is nestled here, surrounded by Ethiopia, Somalia, South Sudan, Tanzania, and Uganda. It’s the world’s 29th and Africa’s 7th most populated country, with over a million people.
Its government practices representative and direct democracy. The president is William Ruto, and its economy runs on the shilling. Kenya thrives on horticulture and tea exports. It houses over 40 ethnic groups, the biggest being the Kikuyu. Kenya’s coast by the Indian Ocean is a popular spot, with pristine beaches like Diani and Watamu.
The landscape is varied with savannas, forests, lakes, mountains, and an abundance of wildlife including elephants, lions, and leopards.
Kenya’s firm commitment to conservation is visible via its initiatives and tourism programs.
The plan to develop the Kenya area will boost Kenya’s economy. It’s geared to solve main logistical issues by building bridges and highways.
Types Of ISO Certification In Kenya
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What is ISO 17025?
ISO 17025 is standard for labs to do tests and calibrations. It aids labs in keeping their systems top-notch. ISO 17025 exists so that labs can produce reliable, high-quality work. As a lab becomes ISO 17025 certified, it conveys they’ve set up a robust system in line with the ISO 17025 standards. This certificate acts like a green light, signifying the lab operates in an optimal manner, yielding reliable outcomes.
So, why does this certification matter? Because it shows the technical progress of the lab. It reassures clients that the lab is proficient and provides precise results. Furthermore, ISO 17025 acts as a global benchmark for lab quality.
Who can implement ISO 17025?
What is Testing and Calibration?
ISO/IEC 17025 is a global rule that outlines the basic needs for labs to function efficiently, fairly, and consistently. It highlights the tasks labs must do to inspire trust in their ability to give spot on and steady testing, calibration, and sampling results. Testing labs aim to find out specific features of a product to check if it meets standards.
For instance, they check a grain sample to see if the level of pesticides aligns with legislated limits. Contrastingly, calibration labs match a measuring tool of unclear precision to one of clear precision. Like ensuring the scale at the airport accurately measures your luggage by comparing the readings against certified mass pieces.
What's the purpose of implementing ISO or IEC 17025?
This is a global standard that outlines the necessary criteria for labs to operate in a proficient, unbiased, and consistent manner. It describes important lab activities aiming to foster credibility in generating accurate and reliable test, calibration, and sampling outcomes.
Versions of ISO 17025 standard
There are various versions with notable changes include increased emphasis on senior management’s role, ongoing system enhancement, and better customer communication. It now aligns more with the ISO 9001.
The standard version compiles five components: references, teams and definitions, management requirements, and technical requirements. Management prerequisites relate mainly to the effective operation of the lab’s quality system.
Technical prerequisites cover aspects affecting the accuracy of the conducted tests and calibrations.
The 2017 version has reshaped this format to include scope, references, terms and definitions, universal requirements, structural requirements, resource requirements, process requirements, and system requirements.
Universal and structural requirements are linked to the lab’s organization. Resource requirements recognize resources a lab needs to deliver valid results.
Process requirements form the backbone of this standard version, directing activities ensuring results are grounded in accepted science, targeting technical validity.
System requirements outline steps an organization adopts to equip itself with quality system tools, supporting its team in generating technically valid outcomes.
ISO or IEC 17025-2017 is the updated standard. It was created by the International Organization for Standardization and the International Electronic Commission. ISO 9001 or ISO 14001 certifications suggest a functioning management system.
On the other hand, ISO or IEC 17025 notes a lab’s technical aptitude. Accreditation is an official endorsement from the accreditation body it’s achieved after verifying a lab’s effectiveness in meeting ISO 17025 requirements and performing accredited tests.
Both the standard and accreditation are fundamental for independent and larger organization labs, across industries and sizes, engaged in sampling or measurement. This encompasses both regulated and non-regulated sectors.
ISO or IEC 17025 in conjunction with ISO 9001 forms the foundation for ISO 15189, outlining specific requirements for medical lab expertise, quality, and accreditation.
Why is ISO 17025 vital for lab sampling?
It plays a key role in tech and trades. Both ISO and IEC 17025 help set standard methods and smooths cooperation between labs and other groups.
It also supports results being accepted globally. Benefits span from business strategy to internal growth. A few standout points include boosting client trust.
Labs accredited to ISO or IAC 17025-2017 show they can give consistent, valid results.
This proves the team’s knowledge and all results can be linked back to the global system of units. Being certified is handy it proves lab competency and reliability it helps with promotions and staffing while improving customer satisfaction. Plus, it helps labs work more efficiently and effectively.
ISO 17025 2017 version changes Impartiality, Decision rule and Process approach
The updates of the ISO 17025 version, major shifts with the revision of the main requirements for testing and calibration labs.
Starting with Impartiality, In the ISO/IEC 17025, it’s defined as objectivity. Also, there’s a note explaining objectivity means no conflicts of interest exist or they are sorted, so they can’t affect lab activities. Lab results shouldn’t look biased because of relationships of either the lab or its employees with a client. Nor should undue pressure influence lab activities.
Therefore, labs must establish a framework to handle pressures, identify and manage ongoing risk. Potential risk can come from activities, relationships of staff. Labs also need to show minimization or eradication of risk.
Consider writing down a document outlining steps to analyze potential impartiality risks, measures to minimize risk, pertinent actions, and a signed statement of laboratory integrity from top management.
This analysis needs management review and may be revised. Labs must also manage information confidentiality during activities. Customers should be notified in writing if labs plan to make any information public. Lab staff and external personnel should sign a confidentiality agreement.
The structural requirements underwent a reorganization.
Key changes: ‘Quality Manager’ term is not used; however, its duties continue to exist in the standard. ‘Technical Manager’ term not used yet duties continue. There’s no need for deputy key positions. Labs now need to document the span of their activities. These don’t include continuously subcontracted activities. The new ISO 17025 specifies clear communication about the efficiency of management systems.
But, the requirement for supervision before and monitoring after authorization has been made. The requirement to assess training efficiency and document job descriptions has been removed. However, for each function it remains necessary to define competence requirements, including non-managerial roles that impact lab results. Common methods of personnel supervision include reference standards, known samples, intercomparison samples etc. As per advice, it’s ideal to record these activities.
The new standard recognizes equipment, materials, reagents and software as part of equipment. Criteria for calibrating equipment have been set. Metrological traceability has been included in a new informative annex. A few options have been added on how to establish and demonstrate traceability.
An addition in this version is the merging of previous subcontracting concept and purchasing into a single section. The lab is expected to select, assess, monitor and re-evaluate external providers. They need to ensure all purchased products and services fulfil requirements. It should be clear to providers what they are being contracted for, the acceptance standards, required competence of staff and activities the lab aims to implement in providers’ facilities.
How to get ISO or IEC 17025 accredited?
Start with understanding ISO 17025 2017 and ISO 17025 accreditation body requirements. Get a copy of the standard, dig deep. Training is next. All staff must be trained, especially managers, technical teams, and internal auditors.
Now, identify and document the lab activities you are seeking accreditation for, along with the lab’s quality goals.
This will provide clarity on how much risk needs to be managed and processes documented. Then, perform a gap analysis. Compare current lab activities with standard requirements.
Documentation is up next. It’s not necessary to have a manual, but it’s a handy place to jot down lab policies and goals. You’ll need several procedures. And records they need to be interconnected, stored, and maintained carefully.
From strategic advantages to boosting business and enhancing internal processes, there are many plus points.
- Boosting client trust.
- Advantages are knowing your lab is skillful and dependable.
- This aids with promotion and hiring, enhances client fulfilment and can boost effectiveness and output.
- Having ISO or IAC 17025-2017 certification shows a lab's ability to consistently produce reliable findings.
- It vouches for the skill of the workforce and ensures all certified outcomes trace back to the universal unit system.
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