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ISO/IEC 17025 2017 complete package
for calibration and testing laboratories
2017 version
All you need to achieve ISO 17025 2017 accreditation
1 hour Live 1-to-1 Online Session with ISO Expert
2017 Transition blueprint Included
Limited time offer
Price : 289 $
The complete ISO/IEC 17025 2017 package is a comprehensive document package that contains everything from all the templates of procedures, processes, forms, checklists, tools, detailed guides and instructions needed to:
• Start your ISO/IEC 17025 process.
• Create your ISO/IEC 17025 documentation.
• Quickly access ISO/IEC 17025 accreditation.
• Benefit from an ISO/IEC 17025 management system that is simple and adapted to the needs of your laboratory.
Save time
Why start with a blank page. Start your Project TODAY, and save up to 80% on your time and money.
Online consulting
This package comes with 1 hour Live 1-to-1 Online Session with ISO consultant, document reviews, continual email support for 12 months and regular update service.
Save money
Cost-Effective Implementation: Much cheaper than an on-site consultant, and requires much less time than doing it from scratch
ISO/IEC 17025 2017 Version Complete Package
• Added Value: All ISO/IEC 17025 2017 requirements have been developed into an efficient process that adds operational value to your Laboratory and consequently increases productivity.
• Effective: Minimal effort is required to follow procedures necessary to meet all requirements of ISO/IEC 17025.
• Simplified: Bureaucracy and excessive paperwork have been eliminated from each process to make it easy – while remaining fully compliant with ISO/IEC 17025 2017.
Start your Project TODAY, and save up to 80% on your time and money.
The all-in-one document package for ISO/IEC 17025 2017 version
Save time, save money and simplify the accreditation process.
Forms
• Master List of Controlled Documents
• Master List of Controlled Records
• Master List of Computers
• E-Data Backup
• Risks and Opportunities Registry
• Management Review Meeting Template
• Corrective Action & Improvement Request
• Corrective Action Form
• Job Fact Sheet for Competence requirements
• Performance & Training Record
• Training Evaluation
• Annual Training Program
• Approved External Provider form
• External Provider Evaluation form
• Customer Satisfaction Survey
• Master List Of Equipment, Gauges & Measuring Instruments
• List of key Laboratory Equipment
• Preventative and corrective Maintenance Schedule & Log
• Method validation Plan – Generic
• Measurement Uncertainty Record
• Measurement Uncertainty Checklist
• Internal Audit Program
• Internal Audit Checklist
• Internal Audit Report
• Audit Nonconformity Report
• Record of Laboratory Environmental Controls
• Sampling Plan
• Sample Submission Form
• Sampling Test Form
• Order Review
• Calibration Schedule & Log
Manual and quality policy
• Quality manual
• Quality policy
SOPs
• Ensuring Impartiality (procedure)
• Impartiality statement
• Handling Confidential Information (procedure)
• Ensuring Confidentiality During Visits
• Confidentiality statement
• Control of Documents and records
• Risk & Opportunity Management procedure
• Corrective Action procedure
• Competence, Training and Awareness procedure
• Externally provided products and services procedure
• Complaints and customer service procedure
• Equipment management procedure
• Equipment calibration procedure
• Ensuring the Validity of Results
• Evaluation of Measurement Uncertainty
• Handling of test or calibration items
• Method validation procedure
• Internal audits
• Requirements for Facilities and Environmental Conditions
• Review of requests, tenders and contracts
• Sampling Plan & Method
• Testing Report
• Calibration Report and Certificate Requirements
• Control of data and information management
ISO/IEC 17025 2017 changes in the new revision :
The three main changes in the ISO/IEC 17025:2017 to keep in mind are more options, the involvement of risk, and updates in current technology.
Back in November 2017, the ISO/IEC 17025:2017 general requirements for the competence of calibration and testing were published. QSE Academy reminds that all accredited laboratories have to shift to the new standard by late 2020, three years after the final version’s release.
It includes major differences with the numbering, phrasing, and formatting of sections from the 17025:2012.
QSE Academy has created its own cross-referencing table to help organizations find specific differences between the two versions.
Change in structure :
The standard’s new structure is no longer based on the two main chapters– five for Technical Requirements and two for Management Requirements.
To integrate with the rest, QSE Academy has found that the changes are more process-oriented and follow the CASCO guidelines for conformity assessment standards.
It includes Structure Requirements, Resource Requirements, Process Requirements, and Management System Requirements.
The standard includes two Annexes that were not introduced in the previous version:
• Informative Annex A, related to metrological traceability
• Informative Annex B, related to the different options of the laboratory management system.
Change in structure :
Chapter 4: GENERAL REQUIREMENTS
4.1 Impartiality
ISO/IEC 17025:2017 defines the word ‘impartiality’ as the ‘presence of objectivity’. Meanwhile, ‘objectivity’ means that ‘conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory’.
Any pressure put on the people involved cannot influence laboratory activities. Likewise, results from testing or calibration laboratories cannot have the appearance of being altered by any relationships the laboratory or the people involved in laboratory activities may have with the client.
QSE Academy recommends to draft a document in which, depending on the needs, shall include the following steps:
• Laboratories must create a structure to determine, analyze, and handle potential impartiality risks, and minimize pressures to secure impartiality.
• Laboratories must show how to mitigate or eliminate risks. Risks may come from activities and the relationship of laboratory personnel.
• Laboratories must design and implement a pertinent action plan.
• Laboratories must commit to integrity through the signature of a statement by the senior management.
This must be reviewed at the management review and be revised if necessary.
4.2 Confidentiality
The laboratory holds the responsibility for managing all information acquired during laboratory activities, in accordance with legally enforceable commitments.
Customers should be notified in writing if the laboratory expresses the desire to make information about an assignment available to the public. A laboratory’s personnel, external personnel, and providers should also agree and sign a confidentiality declaration.
Chapter 5. STRUCTURAL REQUIREMENTS
The reformation of the structural requirements includes the following significant changes:
• The terms ‘quality manager’ and ‘technical manager’ are not mentioned, yet the functions remain in the standard. In addition, it is no longer imperative for key positions to have deputies.
• The laboratory is required to write a range of activities, but it does not include permanently subcontracted activities.
Following the new ISO 9001:2015, sufficient communication processes about the management system’s effectiveness is also required.
Chapter 6: RESOURCE REQUIREMENTS
There are no substantial changes, but the most notable include:
• Taking up supervision before authorization and monitoring after authorization of the personnel.
• Removing the assessment of the training’s efficiency.
• Eliminating the documentation of job descriptions, but it is necessary to outline competency requirements for each function, including managerial functions and those that have an effect on the laboratory results.
Blind samples, inter/intra-laboratory comparisons, inter-comparison samples, reference standards, and exams are the most frequently used monitoring or supervision methods for personnel.
6.3 Facilities and Environment Conditions
Facilities and Environment Conditions have no substantial changes. However, a new standard compels that environmental and facilities related requirements should be fulfilled when tests are conducted in facilities outside its permanent control.
6.4 Equipment
QSE Academy has discovered that equipment now encompasses standards, software, reagents, and reference materials. Equipment must be calibrated if its accuracy can impact the results’ validity and if calibration is needed to identify metrological traceability.
Take note that reference to ISO 17034 has been added to highlight the competence of RM producers.
6.5 Metrological Traceability
A new Informative Annex on metrological traceability has been created while most of the notes were erased. In Annex A, possibilities have been added on how to determine and show traceability:
• Through the use of an NMI.
• Accredited calibration laboratory.
If possible, it is easier and cost-efficient for laboratories to use NMIs or accredited calibration laboratories. Otherwise, a laboratory can opt to assess its competence based on ISO/IEC 17025.
6.6 Externally provided products and services
This new item is comprised of the previous concept of subcontracting, meaning subcontracting and purchasing are now collated in one clause.
The laboratory should have a system to select, assess, monitor, and reassess external providers. It shall also ensure that all purchased products and services meet the requirements.
Lastly, the laboratory shall clearly state to the provider what is to be bought, the acceptance criteria, the needed personnel competence, and the activities intended to be executed in the provider’s facilities.
Chapter 7: PROCESS REQUIREMENTS
7.1 Review of requests, tenders, and contracts
The laboratory should have a procedure for the reviews, requests, tenders, and contracts. The documentation of this procedure is needed as well. It includes:
• Advising the customer when the method requested by the customer is out of date or inappropriate.
• Clearly defining a statement of conformity when requested by the customer.
• Settle any differences between the contract and the tender or request before starting work.
• Inform the customer of deviations from the contract.
• Repeat contract review if amended after work and communicate to all impacted personnel.
• Coordinate with customers or their representatives in clearing up a request and in checking the laboratory’s performance associated with the work performed.
• Keep records of reviews.
7.2 Selection, verification, and validation of methods
The laboratory shall use appropriate procedures and methods for all activities. Updated procedures, methods, and supporting documents should be retained and made available to personnel.
Furthermore, the laboratory shall use the latest version of methods unless not possible to do so. It must also choose a suitable procedure when the customer wasn’t able to specify.
The laboratory must verify methods before introducing them to make sure they can attain the required performance. Other than having an action plan for method development, the laboratory must validate laboratory-developed methods, standard methods, and non–standard methods used outside their intended scope.
In the case of deviation from methods, the customer must document, technically justify, authorize, and accept it. As a general rule, the laboratory must preserve records of validation.
7.3 Sampling
The laboratory shall have a sampling method and sampling plan when it executes sampling of products, materials, or substances, for subsequent calibration or testing.
To ensure the legitimacy of subsequent calibration or testing, the sampling method shall address the aspects to be controlled. Just like the other parts, the laboratory must retain records.
7.4 Handling of test or calibration items
The laboratory shall have a procedure for the handling, receipt, retention, storage, protection, transportation, disposal, and return of calibration items or tests, including all provisions necessary to protect the integrity of the calibration item or test and to protect the interests of the customer and the laboratory.
Similarly, there should be precautions to avoid contamination, deterioration, loss, and damage to the item during handling, storing, waiting, transporting, and preparing for calibration or testing. Handling instructions provided with the item shall be followed.
The laboratory must have a system for the unambiguous identification of calibration items or tests. The identification shall be kept while the item is under the laboratory’s responsibility. The laboratory must maintain records of the calibrated item or tests.
7.5 Technical Records
This is about adequate information and tracking amendment to original observations or previous versions.
To further explain, the laboratory shall assure that technical records for laboratory activities include sufficient results and reports. It must cover information to facilitate and identify factors affecting the measurement result and its associated measurement uncertainty, and enable the repetition of the laboratory activity under conditions as close as possible to the original.
The technical records shall enclose the date and the identity of personnel responsible for each activity such as checking data and results.
7.6 Evaluation of measurement uncertainty
Laboratories shall identify the contributions to measurement uncertainty. All significant contributions, including those coming from sampling, shall be included using appropriate methods of analysis when evaluating measurement uncertainty.
7.7 Ensuring the validity of results
The laboratory shall be responsible for having a procedure in monitoring the validity of results. It includes checking the performance by comparison with the results of other laboratories.
Moreover, the laboratory must analyze and use data from monitoring to control and improve the laboratory’s activities. Finally, it must take action when data from the monitoring are found to be outside of pre-defined criteria.
Chapter 8: MANAGEMENT SYSTEM REQUIREMENTS
8.1.2 Option A
The laboratory’s management system shall address the following:
• Management system documentation (see 8.2)
• Control of management system documents (see 8.3)
• Control of records (see 8.4)
• Actions to address risks and opportunities (see 8.5)
• Improvement (see 8.6)
• Corrective actions (see 8.7)
• Internal audits (see 8.8)
• Management reviews (see 8.9)
Option B
A laboratory meets at least the intent of the management system requirements specified in 8.2 to 8.9 if it:
• has determined and retains a management system in accordance with the ISO 9001 requirements.
• is capable of supporting and proving the consistent fulfillment of the requirements of Clauses 4 to 7.
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All documents required for the implementation of ISO/IEC 17025 2017
The package includes all the documents you need to comply with ISO/IEC 17025 2017 – these documents are fully acceptable by the accreditation audit.
Fully editable documents
All documents are in MS Word or MS Excel, to make them very easy to customize for your business. You can customize them by adding company logos and colors, and edit headers and footers to match your favorite style.
Documents are 90% complete and require only a simple customization
We have already completed about 90% of the information requested on the documents. To complete them you must fill in only the name of the company, the responsible parties, and any other information unique to your company. you will be guided through the process, commenting on the elements that are needed and those that are optional.
We presented the ISO 17025 documentation, so as to assure all its users that they have completed everything accurately and with the utmost efficiency.
Clearly organized, understandable steps
All the documents are made so that you can follow the proposed order perfectly, which allows you to make sure that nothing is missing, and that no one gets lost in the process.
The included comments and flowcharts help your staff understand each document and its usefulness, which helps you to make quality management more fluid, and processes easier to follow.
Features of the complete ISO/IEC 17025 2017 Kit
Price: 289 $
– Documentation included: 58 documents for the implementation of ISO 17025
– MS Office 2007 format, MS Office 2010, MS Office 2013
– Language: English, also available in french
– Documents are fully editable – just enter the information specific to your business.
– Acceptable for the ISO 17025 2017 accreditation audit? Yes, all the documents required by ISO 17025 2017 are included, as well as the quality policy and the current but optional procedures.
Instant Delivery – The package is downloadable immediately after purchase
Free Consultation – In addition, you can submit two complete documents for review by professionals.
Created for your business – The models are optimized for small and medium businesses.
Complete ISO/IEC 17025 2017 package for
calibration and testing laboratories
The complete kit to implement ISO/IEC 17025
For calibration and testing laboratories
Price : 289 $
What our customers think:
“Our laboratory got overwhelmed with the prospect of undergoing ISO/IEC 17025 accreditation.
Good thing that we’ve discovered QSE Academy because the firm was able to help us in applying the requirements into our processes.
As a result, we got efficient operational value and increased productivity.
We developed our system around the standard’s requirements using QSE Academy’s simplified paperwork.
We also got so much information from our email and one-on-one sessions, which led to our employees becoming fully informed about how to comply with the requirements.
Thank you, QSE Academy, for giving us an edge in the global arena/
Dominique Wyatt
Quality Manager
“One of my industry colleagues recommended QSE Academy to assist us in our bid to accreditation.
He recalled how QSE Academy toolkits made their implementation simple and productive.
After reviewing the firm’s packages and assessing customer reviews, our management decided to obtain toolkits from QSE Academy so we could quickly secure ISO/IEC 17025 accreditation.
Indeed, consultants from QSE Academy were very hands-on even if the documents they have provided are well-explained and very detailed.
This is one of the best investments our business has made, especially since we’re already reaping the rewards of this journey.”
Morgan Chen
Quality Manager
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