ISO 17034 2016 Package
2024-11-24 12:48ISO 17034 2016 Package
Get your accreditation at the lowest possible cost
ISO 17034 complete package
2016 version
Price : 389 $
The complete ISO 17034 2016 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 17034 process.
- Create your ISO 17034 documentation.
- Quickly access ISO 17034 accreditation.
- Benefit from an ISO 17034 management system that is simple and adapted to the needs of your organization.
Why start with a blank page. Start your Project TODAY, and save up to 80% on your time and money.
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.
Cost-Effective Implementation: Much cheaper than an on-site consultant, and requires much less time than doing it from scratch
ISO 17034 2016 Version Complete Package
• Added Value: All ISO 17034 2016 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 17034.
• Simplified: Bureaucracy and excessive paperwork have been eliminated from each process to make it easy – while remaining fully compliant with ISO 17034 2016.
Start your Project TODAY, and save up to 80% on your time and money.
The all-in-one document package for ISO 17034 2016 version
Save time, save money and simplify the accreditation process.
Documents included:
Procedures
- Calibration and maintenance of equipment procedure
- Competence, awareness, and training procedure
- Confidentiality and data security procedure
- Corrective action procedure
- Design and development procedure
- Document Control Procedure
- Handling customer complaints procedure
- Homogeneity and stability testing procedure
- Infrastructure and work environment procedure
- Interlaboratory comparisons and proficiency testing procedure
- Internal Audit Procedure
- Management Review Procedure
- Monitoring and measuring procedure
- Preventive action procedure
- Production and service provision procedure
- Purchasing and supplier evaluation procedure
- Record Control Procedure
- Reference material characterization procedure
- Reference material packaging procedure
- Reference material storage and distribution procedure
- Risk assessment procedure
- Sample preparation procedure
- Traceability and uncertainty of measurement procedure
- Waste management and environmental safety procedure
Plans
- Business Continuity Plan
- Data Security and Confidentiality Policy
- Emergency Response Plan
- Environmental Policy
- Quality Policy
Quality Manual
- ISO 17034 Quality Manual
- Organizational Chart
- Process Flowchart
- Job Descriptions
- List of Applicable Legal and Regulatory Requirements
- Quality Policy
- Quality Objectives
- Scope of the Quality Management System
Forms
- Audit Report
- Batch Release Authorization Form
- Certificate of Analysis
- Competency Assessment Form
- Confidentiality and Data Security Record
- Corrective Action Request
- Customer Complaint Form
- Customer Feedback Form
- Document Control Form
- Emergency Response Drill Log
- Environmental Compliance Checklist
- Equipment Calibration Record
- Equipment Maintenance Log
- Hazard Identification and Risk Assessment Form
- Homogeneity and Stability Testing Record
- Interlaboratory Comparisons and Proficiency Testing Record
- Internal Audit Checklist
- Material Characterization Record
- Preventive Action Form
- Proficiency Test Result Analysis Form
- Proficiency Testing Participation Form
- Quality Control Test Record
- Record Control Log
- Risk Assessment Form
- Risk Register
- RM Production Planning Form
- Supplier Evaluation Form
- Traceability and Uncertainty of Measurement Record
- Training Record Form
- Waste Management and Environmental Safety Record
Comprehensive Guide to ISO 17034:2016: Chapter-by-Chapter Breakdown for Reference Material Producers
Chapter 1: Scope
This chapter outlines the scope and purpose of ISO 17034:2016, which defines requirements for the competence of reference material producers (RMPs) and their ability to consistently produce reference materials.
Key Requirements:
- Applicability: ISO 17034 is applicable to organizations that develop, produce, and distribute reference materials. These reference materials can be used for calibration, quality control, and method validation in testing and analytical laboratories.
- Competence of RMPs: The standard ensures that RMPs have the necessary competence, facilities, and processes to produce high-quality reference materials that meet customer and regulatory requirements.
Chapter 2: Normative References
This chapter specifies other relevant standards referenced within ISO 17034 that are necessary for its implementation.
Key Requirements:
- ISO/IEC 17025: Laboratories involved in testing or calibration that are associated with reference material production must also meet the requirements of ISO/IEC 17025, ensuring that the laboratory operations are competent and technically sound.
Chapter 3: Terms and Definitions
This chapter provides definitions of the key terms and concepts used throughout the ISO 17034 standard.
Key Requirements:
- Key Terminology: Definitions of terms such as “reference material (RM),” “certified reference material (CRM),” “traceability,” and “homogeneity” are provided to ensure uniform understanding across all users of the standard.
Chapter 4: General Requirements
This chapter covers the organizational and legal aspects required for a reference material producer to demonstrate competence.
Key Requirements:
- Impartiality: RMPs must ensure the impartiality of their operations, avoiding conflicts of interest that could compromise the quality or reliability of reference materials.
- Confidentiality: Information regarding customers, production processes, and reference material specifications must be protected and kept confidential unless disclosure is agreed upon or legally required.
Chapter 5: Structural Requirements
This chapter addresses the organizational structure of the reference material producer and its role in ensuring competent operation.
Key Requirements:
- Organizational Structure: RMPs must establish a clear organizational structure, with defined responsibilities and authorities for all personnel involved in the production of reference materials.
- Independence: The organization must have mechanisms in place to ensure that all decision-making processes related to reference material production are independent and objective.
Chapter 6: Resource Requirements
This chapter focuses on the necessary resources, including personnel, facilities, and equipment, required to produce high-quality reference materials.
Key Requirements:
- Personnel Competence: All personnel involved in the production, testing, and distribution of reference materials must be competent for their roles. This includes adequate training, qualifications, and experience.
- Infrastructure: RMPs must maintain appropriate facilities and environmental conditions to ensure the production of consistent, high-quality reference materials.
- Equipment Management: Equipment used in the production and certification of reference materials must be suitable for the tasks and properly maintained, calibrated, and monitored for accuracy.
Chapter 7: Technical and Production Requirements
This chapter outlines the technical processes that must be in place for producing and certifying reference materials.
Key Requirements:
- Production Planning: RMPs must plan and control all aspects of reference material production, from design to final packaging. This includes ensuring that the production process consistently meets specifications.
- Characterization of Materials: RMPs must perform thorough characterization of reference materials to ensure that the certified values are accurate, traceable, and reproducible. This includes testing for homogeneity and stability.
- Metrological Traceability: Reference materials must be traceable to international or national standards through an unbroken chain of comparisons. This ensures the validity and reliability of the certified values.
- Certification: Certified Reference Materials (CRMs) must have well-documented certification processes, including the assignment of property values, uncertainties, and traceability. The certification must be based on robust measurement procedures and appropriate statistical analyses.
Chapter 8: Material Handling and Storage Requirements
This chapter covers how reference materials should be handled, stored, and distributed to ensure their stability and usability throughout their lifecycle.
Key Requirements:
- Handling and Transportation: Reference materials must be handled and transported in ways that preserve their integrity, ensuring that environmental factors like temperature, humidity, and light do not compromise their quality.
- Storage Conditions: RMPs must establish and maintain proper storage conditions to prevent the degradation of reference materials over time. These conditions must be regularly monitored.
- Shelf Life and Stability: Stability testing must be conducted to define the shelf life of reference materials. Appropriate measures must be in place to monitor stability during storage, ensuring that materials remain fit for use within the certified period.
Chapter 9: Management System Requirements
This chapter details the management system requirements for RMPs, ensuring the effective operation of processes related to quality management, customer satisfaction, and continual improvement.
Key Requirements:
- Quality Management System (QMS): RMPs must establish, implement, and maintain a QMS that is appropriate for their activities. This system should be documented, including policies and procedures related to reference material production.
- Customer Communication: Processes must be in place to ensure effective communication with customers, addressing their needs, handling inquiries, and resolving complaints. Customer feedback should be used to improve the quality of reference materials.
- Internal Audits and Management Reviews: Internal audits must be conducted periodically to evaluate the effectiveness of the QMS. Management reviews should assess the overall performance of the system, identify areas for improvement, and ensure that the objectives of the QMS are being met.
- Corrective and Preventive Actions: When nonconformities arise, RMPs must take appropriate corrective actions to prevent recurrence. Preventive actions should also be identified and implemented to address potential risks before they occur.
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The package includes all the documents you need to comply with ISO 17034 2016 – these documents are fully acceptable by the accreditation audit.
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.
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 17034 documentation, so as to assure all its users that they have completed everything accurately and with the utmost efficiency.
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 17034 2016 Kit
Price: 389 $
– Documentation included: 58 documents for the implementation of ISO 17034
– Language: English
– Documents are fully editable – just enter the information specific to your business.
– Acceptable for the ISO 17034 2016 accreditation audit? Yes, all the documents required by ISO 17034 2016 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 17034 2016 Package
The complete kit to implement ISO 17034
Price : 389 $
Total Implementation Duration: 8 Months
ISO 17034 Implementation Project Plan
Achieving ISO 17034 is a significant milestone for any organization, signifying a commitment to data protection and privacy. 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 compliance certification. With our comprehensive project plan, tailored training programs, and dedicated support, we ensure your organization meets all ISO 17034 requirements efficiently and effectively. Partner with us to enhance your organization’s credibility, improve data handling processes, and gain trust on an international scale. Let us help you achieve excellence in data privacy management.
Introduction: Project Kick-off and Gap Analysis (Duration: 1 Month)
Introductory Tasks
1.1 ISO 17034 Kick-off and Awareness
Task: Organize Kick-off Meeting
- Description: Conduct a kick-off meeting to introduce the ISO 17034:2016 project to key stakeholders, discussing the objectives, scope, timelines, and resource requirements.
- Deliverables: Project plan, meeting agenda, and minutes.
- Meeting: Initial consultation with senior management and the implementation team.
1.2 Perform Gap Analysis
Task: Conduct Gap Analysis Against ISO 17034:2016 Requirements
- Description: Assess the current processes and quality management system against the ISO 17034:2016 requirements to identify gaps.
- Deliverables: Gap analysis report with identified non-conformities.
- Meeting: Review findings with management and the technical team.
Section 1: QMS Documentation and Quality Policy (Duration: 2 Months)
2.1 Develop Quality Policy and Objectives
Task: Define Quality Policy and Objectives
- Description: Establish the organization’s quality policy and measurable quality objectives, ensuring alignment with ISO 17034:2016.
- Deliverables: Documented quality policy and objectives.
- Meeting: Review with senior management for approval.
2.2 Develop Quality Management System Documentation
Task: Create QMS Documentation (Procedures, Work Instructions)
- Description: Develop necessary documentation for the QMS, including a quality manual, process procedures, and work instructions, covering production, certification, and testing of reference materials.
- Deliverables: Quality manual, procedures, and work instructions.
- Meeting: Review QMS documentation with the quality and technical teams.
Section 2: Reference Material Production and Characterization (Duration: 2 Months)
3.1 Develop Reference Material Production Procedures (ISO 17034 Clauses 7.4-7.7)
Task: Establish Procedures for Reference Material Production
- Description: Develop procedures for the production of reference materials, including planning, material sourcing, preparation, and homogeneity testing.
- Deliverables: Standard operating procedures (SOPs) for production.
- Meeting: Review and approve SOPs with the technical team and laboratory staff.
3.2 Implement Characterization and Measurement Procedures
Task: Establish Procedures for Material Characterization
- Description: Develop procedures for the characterization and measurement of reference materials to ensure they meet specified properties and quality standards.
- Deliverables: Characterization protocols, measurement records.
- Meeting: Review with laboratory and technical teams.
Section 3: Competence of Personnel and Equipment Management (Duration: 1 Month)
4.1 Ensure Competence of Personnel (ISO 17034 Clause 5.2)
Task: Define Competence Requirements for Personnel
- Description: Establish and document competence requirements for all personnel involved in the production, testing, and certification of reference materials.
- Deliverables: Competence matrix and job descriptions.
- Meeting: Review with HR and technical teams to finalize roles and competence requirements.
4.2 Develop Personnel Training Program
Task: Implement Training and Competency Assessment Program
- Description: Develop a training program to ensure that all personnel are competent to perform their tasks, with ongoing competency assessments.
- Deliverables: Training program documents, competency assessment records.
- Meeting: Train staff on new processes and assessments.
4.3 Implement Equipment Management Procedures (ISO 17034 Clause 7.8)
Task: Establish Equipment Calibration and Maintenance Procedures
- Description: Develop procedures for the calibration, maintenance, and qualification of equipment used in the production and testing of reference materials.
- Deliverables: Equipment calibration schedule, maintenance logs.
- Meeting: Review and approve equipment management procedures with the technical team.
Section 4: Homogeneity and Stability Testing (Duration: 1 Month)
5.1 Implement Homogeneity Testing Procedures (ISO 17034 Clause 7.7)
Task: Develop Procedures for Homogeneity Testing
- Description: Establish procedures to test the homogeneity of reference materials, ensuring consistency across batches or units.
- Deliverables: Homogeneity test procedures and results.
- Meeting: Review testing procedures with the laboratory staff.
5.2 Establish Stability Testing Procedures (ISO 17034 Clause 7.7)
Task: Implement Stability Testing Procedures
- Description: Develop procedures to test the stability of reference materials over time and under specified conditions to ensure long-term reliability.
- Deliverables: Stability test protocols and records.
- Meeting: Review with laboratory staff and quality teams.
Section 5: Certification and Control of Non-Conforming Products (Duration: 1 Month)
6.1 Implement Certification Procedures for Reference Materials (ISO 17034 Clause 7.10)
Task: Develop Certification Procedures
- Description: Establish procedures for the certification of reference materials, ensuring all data and documentation are verified before certification.
- Deliverables: Certification procedure, certification reports.
- Meeting: Review certification processes with the certification team.
6.2 Control of Non-Conforming Products (ISO 17034 Clause 8.7)
Task: Develop Procedures for Handling Non-Conforming Products
- Description: Implement procedures for identifying, documenting, and managing non-conforming products, ensuring corrective actions are taken to prevent recurrence.
- Deliverables: Non-conformance reports, corrective action logs.
- Meeting: Post-audit review to discuss non-conforming products and corrective actions.
Section 6: Internal Audits and Management Review (Duration: 1 Month)
7.1 Develop Internal Audit Program (ISO 17034 Clause 8.8)
Task: Create an Internal Audit Plan
- Description: Establish an internal audit program to evaluate the effectiveness of the QMS, covering all critical processes related to reference material production and ISO 17034 requirements.
- Deliverables: Internal audit plan, audit checklist.
- Meeting: Review audit plan with the audit team and quality manager.
7.2 Conduct Internal Audits
Task: Perform Internal Audits
- Description: Conduct internal audits to verify compliance with ISO 17034 requirements and the QMS. Identify areas for improvement and implement corrective actions.
- Deliverables: Internal audit reports, non-conformance reports.
- Meeting: Post-audit review meeting with the management team to discuss findings and corrective actions.
7.3 Conduct Management Review (ISO 17034 Clause 8.9)
Task: Schedule and Conduct a Management Review
- Description: Conduct a management review to assess the effectiveness of the QMS and its alignment with business objectives. Ensure top management evaluates QMS performance and opportunities for improvement.
- Deliverables: Management review meeting minutes, action plans.
- Meeting: Present results and discuss strategic improvement actions with senior management.
Final Assessment: Certification Preparation and External Audit (Duration: 1 Month)
8.1 Conduct Pre-Certification Internal Audit
Task: Perform a Pre-Certification Internal Audit
- Description: Conduct a pre-certification audit to verify that the QMS meets ISO 17034:2016 requirements and is ready for the certification audit. Address any remaining non-conformities.
- Deliverables: Pre-certification audit report, corrective action plan.
- Meeting: Final review with senior management to confirm readiness for the external audit.
8.2 Certification Body Selection and External Audit
Task: Select Certification Body and Schedule Certification Audit
- Description: Research and select an accredited certification body for the ISO 17034 audit. Schedule the external audit and ensure the organization is fully prepared.
- Deliverables: Certification body selection report, external audit schedule.
- Meeting: Final meeting with management and quality team to confirm readiness for the certification audit.
This 8-month project plan for ISO 17034:2016 implementation provides a structured approach to achieving accreditation for reference material producers. The plan covers all key areas, including quality management, reference material production, personnel competence, non-conformance handling, internal audits, and certification preparation, ensuring compliance with ISO 17034 by the end of the project.
What our customers think:
QSE Academy’s ISO 17034:2016 kit — just what we needed to navigate accreditations with ease. The templates and guides were pre-built which in return saved us plenty of hours worths on document preparation. We were able to modify the forms and procedures provided for us, which saved as about 80% of our effort as appose from starting from scratch. The package enabled us to concentrate on the real work of producing reference materials and we made significant savings in external consultant fees. Recommended for: any producer of reference material needing to comply without straining the resources too much.
Sophie L.
Quality Assurance Manager
These packages are probably going to be what makes the difference before registering, and purchasing QSE Academy’s package provided me a solid ROI. … The documents were 90% but in need of our specific process related tweaking. The face-to-face my personal tutor call was actually the best part of getting through some of the secions in accreditation. And the most cost-effective, we didnt need to employ a full time consultant. The package really made the whole process painless, we were accredited much quicker than expected.”
David M.
Technical Director
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We offer a 30-day money-back guarantee. If you are not satisfied with our service for any reason, you can cancel within the first 30 days and receive a full refund, no questions asked.
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