ISO/IEC 17025 2017 Complete Package [Downolad]

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ISO/IEC 17025 2017 Complete Package [Downolad]

ISO/IEC 17025 2017 complete package

for calibration and testing laboratories

2017 version

ISO/IEC 17025 2017 Complete Package [Downolad]
ISO/IEC 17025 2017 Complete Package [Downolad]
ISO/IEC 17025 2017 Complete Package [Downolad]
All you need to achieve ISO/IEC 17025 Accreditation
2 hours 1-to-1 Online Sessions with our ISO Expert
Continuous Email Support and Updates

 Price :  489 $

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.
ISO/IEC 17025 2017 Complete Package [Downolad]
Save time

Why start with a blank page. Start your Project TODAY, and save up to 80% on your time and money.

ISO/IEC 17025 2017 Complete Package [Downolad]
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.

ISO/IEC 17025 2017 Complete Package [Downolad]
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.

Documents included:

ISO/IEC 17025 2017 Complete Package [Downolad]

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

ISO/IEC 17025 2017 Complete Package [Downolad]

Manual and quality policy

• Quality manual
• Quality policy

ISO/IEC 17025 2017 Complete Package [Downolad]

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 Complete Package [Downolad]

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 :

ISO/IEC 17025 2017 Complete Package [Downolad]

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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ISO/IEC 17025 2017 Complete Package [Downolad]

If for whatever reason during the FIRST 90 days of your purchase, you are not satisfied for any reason, simply contact support@qse-academy.com and our support team will issue you an immediate and full refund.

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.

ISO/IEC 17025 2017 Complete Package [Downolad]
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.

ISO/IEC 17025 2017
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.

ISO/IEC 17025 2017 Complete Package [Downolad]
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: 489 $
– 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.

ISO/IEC 17025 2017
ISO/IEC 17025 2017 Complete Package [Downolad]

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 :  489 $

Explore Our Tailored Consulting Packages

At Qse Academy, we understand that each laboratory’s needs are unique. That’s why we’ve designed three distinct consulting packages to suit different levels of support and budget requirements. Whether you are just starting out with ISO 17025 accreditation or looking for comprehensive, end-to-end support, our expertly crafted packages ensure that you receive exactly the assistance you need.

Basic

$ 489 One time fee
  • Comprehensive Documentation Kit
  • Two Hours Consultancy Sessions
  • Continuous Email Support
  • Initial Gap Analysis

Advanced

$ 1199 /month
  • Comprehensive Documentation Kit
  • Full Training ISO/IEC 17025
  • Dedicated Lead Implementer
  • Dedicated Workspace
  • Weekly Meetings
  • Continuous Email Support
Limited Sale

Premium

Done For You
$ 1899 /month
  • Complete Documentation Preparation
  • Dedicated Lead Implementer
  • Comprehensive Training Program
  • Regular Progress Meetings
  • Priority Email and Phone Support
  • Post-Accreditation Support

Our Plans

1. Starter Consultancy Package

Description: Ideal for small labs or those just beginning their ISO 17025 accreditation journey, the Starter Consultancy Package offers essential guidance and resources to help you set the foundation for compliance and success.

2. Advanced Support Package

Description: Tailored for laboratories that require more in-depth support, the Advanced Support Package includes detailed documentation assistance, training, and regular consultation meetings, ensuring ongoing compliance and streamlined operations.

3. Premium Full-Service Package

Description: Our most comprehensive package, the Premium Full-Service Package, is designed for organizations seeking extensive support. It covers all aspects of the accreditation process from A to Z, with dedicated experts managing the entire procedure, providing training, and ensuring full compliance with ISO 17025 standards.


Choose the package that best fits your needs and budget, and let us help you achieve and maintain ISO/IEC 17025 accreditation with confidence and ease.

Total Implementation Duration: 8 Months

ISO/IEC 17025 Implementation Project Plan

Achieving ISO/IEC 17025 accreditation is a significant milestone for any laboratory, signifying a commitment to quality and competence. Our expert consultants are here to guide you through every step of the implementation process, from initial consultation and gap analysis to final assessment and accreditation. With our comprehensive project plan, tailored training programs, and dedicated support, we ensure your laboratory meets all ISO/IEC 17025 requirements efficiently and effectively. Partner with us to enhance your laboratory's credibility, improve operational processes, and gain international recognition. Let us help you achieve excellence in laboratory management.

Introduction: Consultant Engagement and Initial Training   (Duration: 0.5 Month)

Introductory Tasks

1.1 Initial Consultation and Project Kick-off

Task: Schedule Initial Consultation

  • Description: Arrange a meeting with the lead implementer and the consultant to discuss the project scope, objectives, timelines, and responsibilities.
  • Documentation: Project plan and meeting agenda.
  • Meeting: Initial consultation meeting.

Task: Conduct Gap Analysis

  • Description: Perform a detailed gap analysis to identify the current state of the laboratory and areas needing improvement to meet ISO/IEC 17025 requirements.
  • Documentation: Gap analysis report.
  • Meeting: Meeting with the consultant to review gap analysis findings.

1.2 Training

Task: Develop Training Plan

  • Description: Create a comprehensive training plan covering all aspects of ISO/IEC 17025 implementation.
  • Documentation: Training plan document.
  • Meeting: Meeting with the consultant to review and finalize the training plan.

Task: Conduct Staff Training

  • Description: Provide training sessions for all relevant staff on ISO/IEC 17025 requirements and the implementation process.
  • Documentation: Training materials and attendance records.
  • Meeting: Training sessions with the consultant.

Section 1: General Requirements   (Duration: 0.5 Month)

4.1 Impartiality

Task: Develop an Impartiality Policy

  • Description: Create and document a policy ensuring that all laboratory activities are conducted impartially.
  • Documentation: Impartiality policy document.
  • Meeting: Initial meeting with the consultant to discuss and draft the policy.

Task: Conduct Risk Assessment for Impartiality

  • Description: Identify and assess risks to impartiality in laboratory activities, and document mitigation strategies.
  • Documentation: Risk assessment report.
  • Meeting: Periodic meetings with the consultant to review identified risks and mitigation strategies.

Task: Implement Mitigation Measures

  • Description: Apply and document measures to eliminate or minimize identified risks to impartiality.
  • Documentation: Risk mitigation action plan.
  • Meeting: Follow-up meeting with the consultant to evaluate the effectiveness of mitigation strategies.

4.2 Confidentiality

Task: Draft Confidentiality Agreements

  • Description: Create legally binding confidentiality agreements for personnel and external parties.
  • Documentation: Confidentiality agreements.
  • Meeting: Consult with legal and compliance experts to finalize agreements.

Task: Establish Confidentiality Procedures

  • Description: Develop procedures to manage information confidentiality in laboratory activities.
  • Documentation: Confidentiality management procedures.
  • Meeting: Training session with staff and consultant to ensure understanding and compliance.

Section 2: Structural Requirements (Duration: 0.5 Month)

5.1 Legal Entity

Task: Verify Legal Entity Status

  • Description: Ensure the laboratory is a legal entity or part of a legal entity, and document the status.
  • Documentation: Legal entity documentation (e.g., registration certificates).
  • Meeting: Initial meeting with legal advisors to review and confirm the legal structure.

5.2 Management Responsibility

Task: Define Management Responsibilities

  • Description: Identify and document the responsibilities of management personnel for laboratory activities.
  • Documentation: Organizational chart and management responsibilities document.
  • Meeting: Meeting with senior management to confirm responsibilities and authority.

5.3 Scope of Laboratory Activities

Task: Define Scope of Activities

  • Description: Document the range of laboratory activities that conform to ISO/IEC 17025 requirements.
  • Documentation: Scope of activities document.
  • Meeting: Consultation with the consultant to review and validate the defined scope.

5.4 Organizational Structure

Task: Establish Organizational Structure

  • Description: Define and document the organizational structure, including relationships between management, technical operations, and support services.
  • Documentation: Organizational structure document.
  • Meeting: Meeting with all relevant departments to communicate and validate the structure.

5.5 Resource Allocation

Task: Allocate Necessary Resources

  • Description: Ensure the allocation of necessary resources (personnel, equipment, facilities) to laboratory activities.
  • Documentation: Resource allocation plan.
  • Meeting: Periodic meetings with the consultant to assess resource needs and adjustments.

Task: Monitor and Review Resources

  • Description: Regularly monitor and review resource allocation to ensure ongoing compliance and effectiveness.
  • Documentation: Resource review reports.
  • Meeting: Quarterly review meetings with the consultant to discuss resource adjustments and improvements.

Section 3: Resource Requirements (Duration: 1.5 Months)

6.1 General

Task: Review and Identify Resource Requirements

  • Description: Assess and document all necessary resources including personnel, facilities, equipment, systems, and support services.
  • Documentation: Resource requirement document.
  • Meeting: Schedule a meeting with the consultant to verify and validate resource requirements.

6.2 Personnel

Task: Define Competence Requirements

  • Description: Document the competence requirements for each function influencing laboratory activities, including education, qualification, training, technical knowledge, skills, and experience.
  • Documentation: Competence requirements matrix.
  • Meeting: Initial meeting with HR and the consultant to discuss competence criteria.

Task: Develop Training Programs

  • Description: Develop and implement training programs to ensure personnel are competent to perform assigned tasks.
  • Documentation: Training program documents.
  • Meeting: Training session with the consultant to guide staff through the new training programs.

Task: Authorize Personnel

  • Description: Formally authorize personnel to perform specific laboratory activities.
  • Documentation: Authorization records.
  • Meeting: Internal review meeting to approve personnel authorizations.

6.3 Facilities and Environmental Conditions

Task: Assess Facility Requirements

  • Description: Evaluate and document the facility and environmental conditions necessary for laboratory activities.
  • Documentation: Facility assessment report.
  • Meeting: Consultation with the consultant to review facility requirements.

Task: Monitor Environmental Conditions

  • Description: Implement a system to monitor, control, and record environmental conditions.
  • Documentation: Environmental monitoring logs.
  • Meeting: Regular review meetings to ensure compliance with environmental control measures.

6.4 Equipment

Task: Inventory and Assess Equipment

  • Description: Create an inventory of all equipment and assess its suitability for laboratory activities.
  • Documentation: Equipment inventory list.
  • Meeting: Review meeting with the consultant to verify equipment suitability.

Task: Implement Equipment Maintenance Procedures

  • Description: Develop and document procedures for handling, transport, storage, use, and planned maintenance of equipment.
  • Documentation: Equipment maintenance procedures.
  • Meeting: Training session with the consultant to ensure all personnel are aware of equipment handling procedures.

6.5 Metrological Traceability

Task: Establish Calibration Program

  • Description: Develop a calibration program to ensure the metrological traceability of measurement results.
  • Documentation: Calibration program document.
  • Meeting: Periodic review meetings with the consultant to assess the effectiveness of the calibration program.

6.6 Externally Provided Products and Services

Task: Evaluate Suppliers

  • Description: Assess and approve suppliers of externally provided products and services to ensure they meet laboratory requirements.
  • Documentation: Approved supplier list.
  • Meeting: Initial and periodic meetings with the consultant to review supplier evaluations.

Section 4: Process Requirements (Duration: 2 Months)

7.1 Review of Requests, Tenders, and Contracts

Task: Develop Review Procedures

  • Description: Create procedures to review requests, tenders, and contracts to ensure the laboratory has the capability to meet requirements.
  • Documentation: Review procedure document.
  • Meeting: Training session with staff to ensure understanding of review procedures.

7.2 Selection, Verification, and Validation of Methods

Task: Document Method Selection Procedures

  • Description: Establish procedures for the selection and verification of methods used in laboratory activities.
  • Documentation: Method selection procedures.
  • Meeting: Review meeting with the consultant to validate method selection procedures

Task: Validate Methods

  • Description: Perform validation of methods to ensure they are fit for intended use.
  • Documentation: Method validation reports.
  • Meeting: Periodic meetings to review validation results and approve methods.

7.3 Sampling

Task: Develop Sampling Plans

  • Description: Create sampling plans and methods to ensure the validity of subsequent testing or calibration results.
  • Documentation: Sampling plans and methods.
  • Meeting: Review sampling plans with the consultant to ensure they meet laboratory requirements.

7.4 Handling of Test or Calibration Items

Task: Establish Handling Procedures

  • Description: Develop procedures for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items.
  • Documentation: Handling procedures document.
  • Meeting: Training session with staff to ensure proper handling of items.

7.5 Technical Records

Task: Implement Record Keeping System

  • Description: Create and maintain a system for managing technical records, including procedures for record retention and retrieval.
  • Documentation: Technical records management procedures.
  • Meeting: Internal meeting to train staff on the new record-keeping system.

7.6 Evaluation of Measurement Uncertainty

Task: Establish Measurement Uncertainty Evaluation Procedures

  • Description: Develop procedures to evaluate measurement uncertainty for relevant laboratory activities.
  • Documentation: Measurement uncertainty evaluation procedures.
  • Meeting: Review meeting with the consultant to validate and approve the evaluation procedures.

7.7 Ensuring the Validity of Results

Task: Implement Quality Control Procedures

  • Description: Establish procedures for ensuring the validity of results, including the use of control charts, proficiency testing, and inter-laboratory comparisons.
  • Documentation: Quality control procedures document.
  • Meeting: Regular review meetings with the consultant to discuss quality control measures.

7.8 Reporting of Results

Task: Develop Reporting Procedures

  • Description: Create procedures for reporting test and calibration results, ensuring they meet customer and regulatory requirements.
  • Documentation: Reporting procedures document.
  • Meeting: Training session with staff to ensure understanding of reporting procedures.

7.9 Complaints

Task: Establish Complaints Handling Procedures

  • Description: Develop and document procedures for handling complaints from customers and other stakeholders.
  • Documentation: Complaints handling procedures.
  • Meeting: Periodic review meetings with the consultant to assess the effectiveness of the complaints handling process.

7.10 Nonconforming Work

Task: Develop Procedures for Nonconforming Work

  • Description: Create procedures to manage nonconforming work, including identification, documentation, evaluation, and corrective action.
  • Documentation: Nonconforming work procedures.
  • Meeting: Training session with staff to ensure understanding and compliance.
  • 7.11 Control of Data and Information Management

Task: Implement Data Management System 

  • Description: Establish a system for managing data and information, ensuring accuracy, security, and confidentiality. –
  • Documentation: Data management procedures. –
  • Meeting: Training session with staff to ensure proper data management practices.

Section 5: Management System Requirements (Duration: 1.5 Months)

8.1 Options

Task: Choose Management System Option

  • Description: Decide whether to adopt Option A or Option B for the management system.
  • Documentation: Decision document.
  • Meeting: Meeting with the consultant to discuss options and make a decision.

8.2 Management System Documentation

Task: Document Management System

  • Description: Develop and maintain documentation for the management system, including policies, procedures, and records.
  • Documentation: Management system documentation.
  • Meeting: Review meeting with the consultant to ensure completeness and compliance.

8.3 Control of Management System Documents

Task: Implement Document Control Procedures

  • Description: Establish procedures for controlling management system documents, ensuring they are reviewed, approved, and accessible.
  • Documentation: Document control procedures.
  • Meeting: Training session with staff to ensure proper document control.

8.4 Control of Records

Task: Develop Record Control Procedures

  • Description: Create procedures for controlling records, ensuring they are maintained, protected, and retrievable.
  • Documentation: Record control procedures.
  • Meeting: Internal meeting to train staff on record control procedures.

8.5 Actions to Address Risks and Opportunities

Task: Conduct Risk and Opportunity Assessment

  • Description: Identify and assess risks and opportunities related to the laboratory’s activities, and develop action plans.
  • Documentation: Risk and opportunity assessment report.
  • Meeting: Regular review meetings with the consultant to discuss and update action plans.

8.6 Improvement

Task: Implement Improvement Actions

  • Description: Develop and document actions to improve the effectiveness of the management system.
  • Documentation: Improvement action plan.
  • Meeting: Periodic meetings to review progress and effectiveness of improvement actions.

8.7 Corrective Actions

Task: Establish Corrective Action Procedures

  • Description: Create procedures to identify, document, and address nonconformities and implement corrective actions.
  • Documentation: Corrective action procedures.
  • Meeting: Training session with staff to ensure proper implementation of corrective actions.

8.8 Internal Audits

Task: Plan and Conduct Internal Audits

  • Description: Develop an internal audit program to evaluate the effectiveness of the management system.
  • Documentation: Internal audit plan and reports.
  • Meeting: Audit planning and review meetings with the consultant.

8.9 Management Reviews

Task: Conduct Management Reviews

  • Description: Plan and conduct management reviews to ensure the continuing suitability, adequacy, and effectiveness of the management system.
  • Documentation: Management review meeting minutes and reports.
  • Meeting: Periodic management review meetings.

Final Assessment and Accreditation Preparation (Duration: 1 Month)

9.1 Final Assessment Preparation

Task: Conduct Final Pre-Assessment

  • Description: Perform a final assessment to ensure all ISO/IEC 17025 requirements are met and identify any remaining gaps.
  • Documentation: Pre-assessment report.
  • Meeting: Meeting with the consultant to review the final assessment findings.

9.2 Internal Audit

Task: Conduct Internal Audit

  • Description: Perform a comprehensive internal audit to verify compliance with ISO/IEC 17025 standards.
  • Documentation: Internal audit report.
  • Meeting: Post-audit meeting with the consultant to discuss findings and corrective actions.

9.3 Management Review Preparation

Task: Prepare for Management Review

  • Description: Organize and document the management review process, ensuring all aspects of the management system are evaluated.
  • Documentation: Management review documents.
  • Meeting: Management review meeting to finalize the review process.

9.4 Accreditation Body Selection 4.

Task: Select Accreditation Body

  • Description: Research and select a suitable accreditation body for ISO/IEC 17025 certification.
  • Documentation: Accreditation body selection report.
  • Meeting: Consultation with the consultant to finalize the selection of the accreditation body.

These tasks ensure a thorough and organized approach to implementing ISO/IEC 17025:2017, promoting competence, impartiality, and consistent operation within the laboratory.

What our customers think:

ISO/IEC 17025 2017 Complete Package [Downolad]

“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

ISO/IEC 17025 2017 Complete Package [Downolad]
ISO/IEC 17025 2017 Complete Package [Downolad]

“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

ISO/IEC 17025 2017 Complete Package [Downolad]

Meet Our Expert Consultants

Marilyn C.​

Marilyn C.

Labs & Accreditation 
ISO Expert ⭐⭐⭐⭐⭐

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Marilyn C. 👋 is an expert in Labs & Accreditation ISO with a wealth of experience and knowledge in the field. She has extensive experience with the development, implementation, and maintenance of Laboratories management systems (LMS) for international organizations. Her expertise lies in developing effective processes to ensure that standards are met, as well as creating plans to continuously improve performance against those standards. 

Marilyn C. is a seasoned consultant in laboratory accreditation, with a specialized focus on ISO/IEC 17025 and internal audits. Her extensive experience includes developing and implementing management systems tailored to the specific needs of laboratories to ensure compliance with international standards. Marilyn’s expertise is particularly strong in enhancing the operational efficiencies of testing and calibration labs, ensuring they meet the rigorous requirements of ISO/IEC 17025. Her practical approach helps laboratories maintain continual improvement and compliance in a dynamic regulatory environment.

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ISO/IEC 17025 2017

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