№ lp_1_2_33246
File format: docx
Character count: 2137
File size: 39 KB
This document is a formal declaration by a company certifying that it conforms to the ISO 13485 or GDPMDS standards for manufacturing, importing, or wholesaling Class A medical devices.
Year:
2010
Region / city:
[not specified]
Topic:
Medical Devices, Quality Management Systems
Document Type:
Declaration
Organization / Institution:
[Company name]
Author:
[Company representative]
Target Audience:
Health regulatory authorities
Period of validity:
[not specified]
Date of approval:
[not specified]
Date of amendments:
[not specified]
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2025
Region / City:
Not specified
Subject:
Business information management, client onboarding, and compliance
Document Type:
Business policy and procedure manual
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Business clients, tax agents, BAS agents
Period of validity:
Ongoing
Approval Date:
6th May 2025
Date of Amendments:
Not specified
Note:
Year
Subject:
Quality Management System for tax practitioners
Document type:
Guide
Organization / Institution:
Tax Practitioners Board
Target audience:
Tax practitioners
Note:
Year
Topic:
Quality Management System
Document Type:
Template
Year:
2024
Region / City:
United States
Subject:
Safety Assurance Evaluation
Document Type:
Instructional Reference
Organization:
FAA
Author:
Daniel J. Elgas
Target Audience:
Approval holders in the aviation industry
Period of Validity:
Ongoing
Approval Date:
05/03/2024
Amendment Date:
N/A
Year:
2023
Region / city:
Birmingham
Topic:
Quality Management System in Clinical Research
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
University of Birmingham
Author:
Clinical Research Compliance Team (CRCT)
Target Audience:
Research teams, Clinical Trials Units, QMS managers
Effective Date:
[Not specified]
Date of Approval:
[Not specified]
Date of Changes:
[Not specified]
Year:
2025
Region / City:
Brussels, Belgium
Topic:
Quality Management System Compliance
Document Type:
Report
Organization:
ETICS
Author:
ETICS
Target Audience:
Inspectors, ETICS-CIG-Inspection Scheme Members
Validity Period:
Not specified
Approval Date:
April 2025
Date of Amendments:
Not specified
Supersedes:
OD CIG 023 Appendix 2 – December 2020
Year:
2015
Scope:
Quality Management System (QMS) implementation
Document Type:
Guide
Organization:
ISO
Target Audience:
Consultants, Organizations seeking ISO 9001 certification
Regulatory Requirements:
ISO 9001:2015
Industry Standards:
ISO 9001:2015
Key Personnel:
Consultants, Management
Process:
QMS implementation, internal audits, ISO registration
Training:
QMS training, internal audits
Certification:
ISO 9001 Certification
Phase:
Initial Assessment, Planning, Development and Implementation, Concluding, Pre-assessment, Registrar Audit and Registration, Post Registration and Surveillance Audits
This document outlines the phases and steps for implementing an ISO 9001:
2015 Quality Management System (QMS), focusing on the assessment, planning, development, and certification process.
Year:
2024
Document Type:
Form Template / Instructional Reference
Revision:
0
Effective Date:
05/03/2024
Approval:
Daniel J. Elgas, Director, Policy and Standards Division, AIR-600
Objective:
Confirm communication of safety information and training within organization
Evaluation Tool:
Data Collection Tool (DCT) – Safety Promotion
Regulatory References:
§ 5.23, § 5.91, § 5.93, § 5.97(c-d), AC21-58
Year:
2024
Region / City:
Not specified
Subject:
Safety Risk Management (SRM)
Document Type:
Template
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Approval holders, SMS teams
Effective Period:
Not specified
Approval Date:
05/03/2024
Modification Date:
Not specified
Year:
2024
Region / City:
Not specified
Subject:
Safety policy and performance evaluation
Document Type:
Instructional Guide
Organization:
AIR-600, Policy and Standards Division
Author:
Daniel J. Elgas
Target Audience:
Approval holders, SMS team members, evaluators
Period of Validity:
Not specified
Approval Date:
05/03/2024
Date of Last Changes:
Not specified
Note:
Revision History
Rev:
0
Description of Change:
Original Release
Effective Date:
05/03/24
Approval:
/s/ Daniel J. Elgas
Date:
05/03/2024
Approval Holder:
SMS
Verification Dates:
SMS Follow Up Verification Dates (if applicable):
REGULATORY REQUIREMENT:
§ 5.91
REFERENCE:
AC21-58, paragraph 2.6.1
Year:
2024
Region / City:
United States
Subject:
Safety Performance Monitoring and Assurance
Document Type:
Instructional Reference
Organization:
AIR-600
Author:
Daniel J. Elgas
Target Audience:
Approval Holders, SMS Teams
Period of Validity:
N/A
Approval Date:
05/03/2024
Amendment Date:
N/A
Year:
2024
Region / City:
N/A
Theme:
Safety Risk Management, SMS Verification
Document Type:
Instructional Reference
Organization / Institution:
N/A
Author:
Daniel J. Elgas
Target Audience:
Approval holders, SMS team members
Period of validity:
N/A
Approval Date:
05/03/2024
Date of Changes:
N/A
Context:
Instructional reference document detailing the verification process for Safety Management Systems (SMS) within aviation organizations, specifically focused on Safety Risk Management (SRM) compliance.
Year:
2024
Region / City:
N/A
Theme:
Safety Policy
Document Type:
Template
Organization:
AIR-600
Author:
Daniel J. Elgas
Target Audience:
SMS Verification Teams
Effective Period:
From 05/03/2024
Approval Date:
05/03/2024
Revision Date:
N/A
Year:
TBD
Region / City:
TBD
Topic:
Safety Policy, SMS Evaluation
Document Type:
Template
Organ / Institution:
FAA
Author:
Daniel J. Elgas, Lirio Liu
Target Audience:
SMS Evaluation Teams, Approval Holders
Period of Validity:
TBD
Approval Date:
MM/DD/YYYY
Modification Date:
MM/DD/YYYY
Note:
Year
Subject:
Portland Cement Concrete Pavement Conformity
Document Type:
Contract Specification
Target Audience:
Contractors, Engineers
Year:
2017
Region / City:
European Union
Theme:
Medical Device Regulation
Document Type:
Regulatory Document
Organization / Institution:
Medical Device Coordination Group (MDCG)
Target Audience:
National Authorities, Notified Bodies, Conformity Assessment Bodies
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2017
Region / City:
N/A
Theme:
Medical Device Regulation
Document Type:
Fee List
Organization / Institution:
Notified Body XXXX
Target Audience:
Manufacturers of medical devices
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Year
Topic:
Transportation Air Quality Conformity
Document Type:
Checklist