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Currently Active Discussions:
 
Training Records - People who are not directly involved in processing product
      Last Post or Poll Vote: 25th August 2016 05:58 PM by Jen Kirley » Replies: 12
ISO9001:2015 Process Interactions
      Last Post or Poll Vote: 25th August 2016 05:43 PM by Jen Kirley » Replies: 7
Using Bugzilla as a Quality Reporting Tool
      Last Post or Poll Vote: 25th August 2016 05:39 PM by Marc » Replies: 9
To 510(k) or not 510(k), that is the question!
      Last Post or Poll Vote: 25th August 2016 04:36 PM by QA-Man » Replies: 0
TS 16949 Clause 4.2.3 - How many Procedures are Required?
      Last Post or Poll Vote: 25th August 2016 03:05 PM by Kronos147 » Replies: 13
EU classification for a Medical Device Accessory
      Last Post or Poll Vote: 25th August 2016 12:25 PM by shimonv » Replies: 2
PEMS Documentation for Medical Device Software - Requirements
      Last Post or Poll Vote: 25th August 2016 12:17 PM by mihzago » Replies: 2
CBA (Certified Biomedical Auditor) exam - March 7, 2015
      Last Post or Poll Vote: 25th August 2016 11:08 AM by NicoleinFlorida » Replies: 12
Ballooning/Bubbling PDF drawings - My Dynamic Stamp
      Last Post or Poll Vote: 25th August 2016 10:35 AM by CNCist » Replies: 19
Sample Size Justification for Medical Device Shelf-Life
      Last Post or Poll Vote: 25th August 2016 08:44 AM by NicoleinFlorida » Replies: 12
File Attachments - Searching - Attachments to Posts in the Forum
      Last Post or Poll Vote: 25th August 2016 08:42 AM by Marc » Replies: 13
ISO14001:2015 Factory Process Mapping
      Last Post or Poll Vote: 25th August 2016 08:28 AM by charanjit singh » Replies: 7
Customer request VDA 6.3 as well as TS 16949
      Last Post or Poll Vote: 25th August 2016 06:12 AM by michajel86 » Replies: 14
TS16949 Work Instruction Requirements
      Last Post or Poll Vote: 25th August 2016 04:57 AM by michajel86 » Replies: 7
Neutral Code Requirement - Medical Devices Outsourced from India
      Last Post or Poll Vote: 25th August 2016 03:34 AM by Nash27 » Replies: 3

Welcome to the The Elsmar Cove Business Systems and Standards Discussion Forums.
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Manufacturing, Service, and Business Systems Processes
Please use these forums to discuss manufacturing, services, processes, materials and related Business Systems Process aspects.
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Human Factors and Ergonomics in Engineering related discussions
by JoShmo
10th August 2016 09:01 PM Go to last post
55 594
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Lean Manufacturing, including Lean in Service Industries, questions and discussions.
8th August 2016 09:37 AM Go to last post
492 4,523
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Discussions related to specific manufacturing processes, materials, manufacturing systems or related topics.
23rd August 2016 03:33 AM Go to last post
1,167 8,283
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Process Maps, Process Mapping and Turtle Diagram Discussions and Examples
by Ninja
4th August 2016 10:37 AM Go to last post
182 2,416
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Reliability Analysis discussions, including Reliability Predictions, Reliability Testing and Reliability Standards, including Dependability.
by Marc
11th August 2016 12:45 AM Go to last post
229 1,452
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Service Industry specific and related discussions.
by Miner
24th August 2016 10:03 AM Go to last post
190 1,400
National and International Business System Standards
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by CNCist
25th August 2016 10:35 AM Go to last post
1,783 15,599
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Business continuity planning (BCP) identifies an organization's exposure to internal and external threats and provides for effective prevention and recovery for the organization.
by Marc
19th August 2016 03:40 PM Go to last post
43 325
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CE Marking (Conformité Européene) / CB Scheme discussions - CE Marking and the CB Scheme help manufacturers improve their marketing efficiency by establishing a way to meet one Standard for their products which will harmonize with Standards from different governments.
by SteveK
24th August 2016 04:07 AM Go to last post
334 1,985
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Environmental related specifications and standards including ISO 14001 and the ISO 14000 Series of documents.
25th August 2016 08:28 AM Go to last post
803 7,337
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by Ronen E
22nd August 2016 07:56 PM Go to last post
1,120 6,043
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All topics connected to Food management systems to include ISO 22000, Hazard Analysis and Critical Control Points (HACCP) and other related food safety systems.
11th August 2016 09:55 PM Go to last post
315 2,070
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JCAHO, CCHSA, HQA, ANAES, JSQua, ACHS, NZCHS, MSQH, NCAIO - Best Practices" accreditation organizations, in the US, Canada, UK, France, Japan, Australia, New Zealand and Malaysia, and the CMS-approved (in the USA) accreditation organization.
21st August 2016 05:49 PM Go to last post
64 399
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IEC 27001 is part of a growing family of IEC Information Security Management Systems (ISMS) standards.
by pkost
10th August 2016 08:08 AM Go to last post
118 649
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ISO 900x Quality Management Systems related discussions.
25th August 2016 05:58 PM Go to last post
4,922 59,998
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IEC 20000 is the first international standard for IT Service Management. It is based on, and intended to supersede, BS 15000.
12th July 2016 08:10 AM Go to last post
20 114
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TL 9000 is a two book standard created by QuEST (Quality Excellence for Suppliers of Telecommunications) Forum based on ISO 9001.
16th August 2016 04:58 AM Go to last post
44 307
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Occupational Safety and Health Administration (OSHA), Occupational Health & Safety Management Standards (OHSAS 18001, ANSI Z10, CSA Z1000, ILO-OSH, GOST 12.0.230, AS/NZS 4801, etc...)
4th August 2016 06:39 AM Go to last post
263 2,905
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Oil and Gas Industry Standards and Regulations discussions including API (American Petroleum Institute) documents such as API Q1.
21st August 2016 05:50 PM Go to last post
96 802
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RoHS, REACH, ELV, IMDS and other Related Restricted Substances International Regulation discussion topics
16th August 2016 04:52 AM Go to last post
242 1,846
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The ISO PAS 28001 addresses potential security issues at all stages of the supply process, thus targeting threats such as terrorism, fraud and piracy.
4th August 2016 06:46 AM Go to last post
7 32
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Sustainability is the reconciliation of environmental, social and economic demands - often known as the "three pillars". Ecology is the scientific study of the distributions, abundance, share affects, and relations of organisms and their interactions with their environment. ISO 50001 addresses Sustainability, Green Initiatives and Ecology.
24th August 2016 10:34 AM Go to last post
58 417
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In 2000, TS 16949 evolved from QS-9000. TS16949 is an automotive sector specific standard.
25th August 2016 03:05 PM Go to last post
2,836 23,050
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Verband der Automobilindustrie e. V. (VDA) - VDA 6.1 is the German Quality Management System for the automotive industry. Based on ISO 9001:1994, it includes all elements of QS-9000.
25th August 2016 06:12 AM Go to last post
100 680
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Please use this forum for questions about other ISO standards, various International standards, European Regulations and related discussions and issues.
16th August 2016 04:56 AM Go to last post
597 4,151
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ANSI, ASTM, US DoD and Mil-Standards such as MIL-STD-810, etc., Process tests and related 'standards', specifications and such.
by QA-Man
9th August 2016 12:47 PM Go to last post
596 3,585
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device, Medical Information Technology, Medical Software and Health Informatics and related discussion topics.
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by QA-Man
25th August 2016 04:36 PM Go to last post
3,218 19,980
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Medical devices standards, national and international. Standards are published by standards writing bodies (such as ISO and IEC internationally, ANSI, CEN, CENELEC, CSA and others nationally) and are generally voluntary. You can use standards to fulfill regulations, depending on the way the regulation uses standards.
by mihzago
25th August 2016 12:17 PM Go to last post
3,240 24,111
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Information Technology used in medicine including includes topics (which are used interchangeably sometimes) such as medical Information technology, medical software (software used in healthcare) and health informatics, including Health Information and Communications Technology (ICT). Examples are standards from the IEC 80001 series and the works of ISO TC 215.
7th June 2016 07:15 AM Go to last post
30 127
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Other various Medical Device and Orthopedic related discussions.
by Ronen E
18th August 2016 09:07 AM Go to last post
276 1,714
Common Quality Assurance Processes and Tools
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For discussion of Definitions, Acronyms, Abbreviations and Interpretations
22nd August 2016 08:56 PM Go to last post
594 5,546
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APQP and PPAP (6 Viewing)
Discussions related to Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP).
20th August 2016 06:05 AM Go to last post
869 6,271
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Guidelines for quality and/or environmental management systems auditing, including Internal Audit and Process Audit sub-forums
24th August 2016 05:48 PM Go to last post
1,783 24,293
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Benchmarking Methods and Related General Discussions.
by Marc
4th June 2016 05:51 AM Go to last post
116 806
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Capability and Stability related discussions - Cp, Cpk, Pp, Ppk, Mp, Mpk (et al).
27th July 2016 02:09 PM Go to last post
423 3,757
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Consultants and discussions related to consultants including ISO 10019 "Guidelines for the selection of quality management system consultants and use of their services" aspects / requirements.
by Hershal
10th July 2016 01:34 PM Go to last post
110 1,254
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Contract Review Process Discussions and Information
22nd October 2013 04:31 PM Go to last post
60 483
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Dealing with Customer complaints/concerns.
10th August 2016 01:37 AM Go to last post
137 1,315
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Customer Requirements and Company Specific Requirements - including Ford's Q1 'Award' program. GM has it's GM-9000. Etc. Nissan and Honda have their requirements. Company specific requirements questions here, please!
17th August 2016 08:54 AM Go to last post
451 3,118
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Process and Product Design and Development discussion discussions. Design Verification and Validation included.
10th August 2016 07:15 PM Go to last post
505 3,650
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Documentation Systems (Document Control), including Procedures, Forms, and Templates.
by Mikael
22nd August 2016 09:21 AM Go to last post
2,201 20,642
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Failure Modes Effects Analysis (FMEA) and Control Plan discussions here.
22nd August 2016 11:01 AM Go to last post
835 6,768
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Calibration "Catch All" forum - ISO 17025, Calibration of Measurement Devices, Measurement Devices, Metrology (Calibration) and Test Laboratory related discussions. Many discussions in this forum are beyond ISO 17025 specific topics.
by Miner
24th August 2016 02:52 PM Go to last post
4,213 31,178
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Please use this forum to discuss Inspection, Prints (Drawings), Testing, Sampling and Related Topics.
25th August 2016 08:44 AM Go to last post
1,565 12,066
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Management Review related Discussions and Information.
by JoShmo
19th July 2016 09:49 AM Go to last post
144 2,094
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Various other quality assurance and business systems related topics like Cost of Quality and other focused topics. Topics outside Quality and Environmental are allowed.
24th August 2016 04:20 PM Go to last post
755 7,389
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Significant Systems, including 8-D / 7-D, etc. Can you prove Effectiveness (for example) of a Corrective Action?
by Mike_H
27th July 2016 06:26 PM Go to last post
673 7,665
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Let's talk Deming! And who doesn't have a copy of Juran's 15 pound tome Quality Control Handbook? We all do. For discussion of Sarasohn, Protzman, Armand V. Feigenbaum, Crosby, Ishikawa, Taguchi, Shewhart, Imai and others. Philosophy, Gurus, Innovation and Evolution.
19th December 2014 06:01 PM Go to last post
209 3,886
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What is a Corrective Action vs. a Preventive Action?
by Raffy
24th August 2016 03:42 AM Go to last post
209 3,030
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Principles and generic guidelines on Risk Management.
by Juzaili
16th September 2014 11:22 PM Go to last post
12 70
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Problem Solving, 5s Problem Solving, 5 Whys - Root Cause Fault and Failure Analysis discussions.
24th June 2016 11:51 AM Go to last post
157 2,294
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Quality Manual Development and Quality Systems Manual related Discussions.
23rd August 2016 11:23 AM Go to last post
270 4,063
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Quality Manager and Quality Assurance Management Issues/questions
by Bev D
24th August 2016 12:49 PM Go to last post
647 6,408
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Balanced ScoreCard, QFD, Taguchi & Shainin's Techniques, Pre-Control, Pareto, etc. - How to use them - When to use them - How to analyze the results - Success stories - Failures - Questions and general discussions.
by Marc
25th August 2016 05:39 PM Go to last post
1,606 12,834
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Includes legal and other related records and data discussions. What is a Quality Record and what quality records are required? What other required records are there in your company? Records are Evidence. What is Data?
12th June 2015 04:48 AM Go to last post
302 2,992
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Six Sigma (4 Viewing)
Love it or hate it, what ever six sigma is, it's been around for quite a while and looks to stay for quite a while.
10th June 2015 06:37 AM Go to last post
372 3,892
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Software Quality Assurance topics including CMMI (Capability Maturity Model Integrated), TickIT, Information Security Management (ISO 17799 and BS 7799), ISO/IEC 12207 Software Life Cycle Processes, ISO 15504, etc.
218 1,138
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SPC (Statistical Process Control) and all of the various Statistical Analysis tools and techniques!
by Bev D
17th August 2016 10:24 AM Go to last post
1,317 10,712
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A focused forum on Supplier Quality Assurance and related Supplier (aka Vendor) issues as requested.
by neash83
23rd August 2016 11:57 AM Go to last post
667 5,757
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Training and related topic discussions.
16th August 2016 04:55 AM Go to last post
742 6,285
Registrars and National / International Organizations
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ASQ (American Society for Quality), IRCA (International Register of Certified Auditors), IATF (International Automotive Task Force), RABQSA, IMDRF (International Medical Device Regulators Forum), and related discussions.
25th August 2016 11:08 AM Go to last post
236 2,992
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The Registrar (Certification Bodies) and Registration Forum is for addressing Registrar and Registration specific issues.
5th June 2015 03:54 PM Go to last post
383 5,889
Information Resources - Files - Papers - Articles - Etc.
This forum contains various information resources.
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Read a book you would like to share or find a good web site or blog? Tell us! This forum is for books and sites from all quality and environmental arenas and branches.
8th August 2016 11:48 PM Go to last post
270 1,842
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General Resources (1 Viewing)
Various Uploaded Data and other Information Files
Sub-Forum(s): Outdated Threads
22nd August 2013 07:29 AM Go to last post
35 124
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The Reading Room (2 Viewing)
Where members can share "stand alone" articles and "white papers" on various subjects allied with Quality and Business Systems and Standards Strategies.
17th May 2016 12:03 PM Go to last post
154 1,894
Professional Employment and Occupation Related
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Questions, discussions and comments about careers and occupations. Resume content and other information can be discussed here as well.
by Marc
15th August 2016 04:47 PM Go to last post
793 10,926
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What hotels do you stay at? Have you traveled by train? Which airline do you prefer and why? Travel discussions, experiences, news and recommendations.
25th July 2016 11:37 PM Go to last post
144 2,537
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Many people now work outside their 'native' countries either for a foreign company or for a company in their home country. Thinking of moving? Questions and discussions here.
8th August 2016 11:33 PM Go to last post
29 290
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Members, Companies and Recruiters - If you have a position opening (job opening), please post it in this forum. Please - ONLY post for specific, available positions (including consulting). Please - No 'Fishing'. Need to outsource Internal Audits? Find someone here!
4th November 2009 01:13 PM Go to last post
11 32
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Elsmar Cove members offering specific services (such as internal audits and training) and/or consulting.
29th June 2015 03:11 PM Go to last post
8 57
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Please use this forum to discuss Professional Certifications including CQM, CQE, CQA, CSQE, CRE, CCT, CQT, CSSBB, ISTO, Six Sigma, QAI Software certifications, etc.
3rd August 2016 07:54 AM Go to last post
383 3,244
Elsmar Cove Forum Essentials
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Elsmar Cove Forum ToS (Terms of Service) and Policies are documented here.
by John P
5th June 2016 10:33 AM Go to last post
25 356
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How To Do Things in the Forums - Detailed Use ("Work") Instructions - This forum contains information on 'How To' do things, such as Start a New Discussion Thread, or Add a Poll to a Thread or Attach a File to a Post in a Thread. Explanations of how the software features work.
by Marc
25th August 2016 08:42 AM Go to last post
110 869
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Something new happening? Please post related topics here.
by Marc
5th July 2016 06:49 PM Go to last post
322 5,681
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Please post Forum Software Suggestions, Complaints, Problems and Bug Reports here.
Listen To Me! Closed or Resolved: Elsmar.com Website goes down...
8th August 2016 05:21 PM Go to last post
155 1,693
Elsmar Cove Forum Community Forums
Discussions of all sizes, shapes, forms and opinions that are NOT 'business' related. In short, Chit Chat and Community Discussions.
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Looking for used equipment or trying to sell equipment? Books? Other stuff? Whatever. Post it here. PLEASE! NO COMMERCIAL ADVERTISEMENTS!
by Marc
5th July 2016 05:41 PM Go to last post
247 1,127
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by Marc
25th August 2016 03:22 AM Go to last post
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News! (1 Viewing)
by Marc
21st July 2016 02:40 PM Go to last post
742 5,189
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by Marc
28th June 2016 08:16 AM Go to last post
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