ISO 9001 Mythology

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ISO 9001 Mythology
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Platinum Registration

• Management System Registration
• ISO 9001, AS9100
• Precise
• Passionate
• Polite
• 24/7 Support

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Mythology

• Young industry
• Poor auditing assumed correct
• Grapevine effect
• Lack of refuting information

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Debunking Myths 101

• Learn of perceived requirement
• Read the standard
• Identify actual requirements

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Myth 1 Document Approval Signatures

• Every documented instruction must be signed to
  indicate approval.

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Signatures Requirement Debunked

• Requirements include
• Needed documents
• Approve prior to issue
• Review, update, reissue as necessary
• No Signatures
• How else might approval be indicated?

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Myth 2 Management Review Meetings

• Senior managers must meet every year to review
  the effectiveness of the management system.

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Meetings Determined Passé

• Requirements include
• Top management involvement
• Review of effectiveness, suitability, etc.
• Planned intervals
• No Requirement to Gather
• How else might management review be accomplished?

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Extra Credit Management Review Records

• What information must be included in management
  review records?
• Unclear!
• Records shall be established and maintained to
  provide evidence of conformity to requirements
  (4.2.4)

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Myth 3 Customer Surveys

• We have to send surveys to our customers every
  year.

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Are Customer Surveys Best?

• Requirements include
• Monitor perception related to customer
  perception
• Determine methods for obtaining and using
  information
• Surveys are one method
• What other types of data may suffice?

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Myth 4 Approved Supplier List

• We have to keep a list of our approved suppliers
  to prove which suppliers have been evaluated and
  meet our requirements.

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Evaluation? Yes. List? Up to you.

• Requirements include
• Apply controls on suppliers based on effect on
  final product
• Establish evaluation criteria
• Evaluate suppliers
• Maintain records of evaluation results and
  actions
• Name methods besides a list

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Taking on Myths

• Read the standard
• Identify requirements
• Think

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ISO 14001 Basics
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Dueling ISO Standards?

• ISO 9001 Happy Customers
• ISO 14001 Happy Planet
• OK, we also must comply with local and Uncle
  Sams environmental regulations.

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ISO 9001 Overlap

• Quality (Environmental) Policy
• Quality (Environmental) Objectives
• Responsibility and Authority
• Competence and Training
• Documentation and Document Control
• Control of Records
• Control of Product and Service Provision
  (Operational Control)
• Monitoring and Measurement
• Corrective and Preventive Action
• Internal Audit
• Management Review

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ISO 14001 Requirements Not in ISO 9001

• 4.3.1 Environmental Aspects
• 4.3.2 Legal and Other Requirements
• 4.4.3 Communication
• 4.4.7 Emergency Preparedness and Response
• 4.5.2 Evaluation of Compliance

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The Significant Work of ISO 14001

• Identify Environmental Aspects
• Determine which Environmental Aspects have (or
  can have) Significant Environmental Impacts
• Called, Significant Environmental Aspects
• Identify applicable regulations / legal
  considerations
• Set Objectives and Targets based on
• Significant Environmental Aspects
• Legal and Regulatory Requirements
• Environmental Policy
• Implement programs to achieve the Objectives and
  Targets (many of these programs may have already
  been in place)

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Definitions

• Environmental Aspect - Element of an
  organization's activities or products.
• NOTE - A significant environmental aspect has or
  can have a significant environmental impact.
• Environmental Impact - Any change to the
  environment, whether adverse or beneficial,
  wholly or partially resulting from an
  organization's environmental aspects.

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Keys to Successful ISO 14001 Approach

• Remember Happy Planet
• Dont overcomplicate
• Happy Wallet often equates to Happy Planet
• Its all about
• Aspects / Impacts
• Objectives
• Targets
• Measures

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RoHS / WEEE

• A brief investigation of affected products

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The Apparent Problem
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The Big Scare

• New restrictions on
• Lead
• Mercury
• Cadmium
• Hexavalent chromium
• Polybrominated biphenyls (PBB) or
• Polybrominated diphenyl ethers (PBDE)

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Timing

• New electrical and electronic equipment put on
  the market after July 1, 2006
• Valid for, each individual piece of equipment
  put on the market (after July 1, 2006), and not
  to the launch of a new product or product line.
• must not contain listed substances

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Affected Products

• Per Annex IA to Directive 2002/96/EC (WEEE).
  (Specifics in Annex IB)
• Large household appliances
• Small household appliances
• IT and telecommunications equipment
• Consumer equipment
• Lighting equipment
• Electrical and electronic tools (with the
  exception of large-scale stationary industrial
  tools)
• Toys, leisure and sports equipment
• Automatic dispensers
• Electric light bulbs
• Luminairies in households

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Included and Exempt

• Included Equipment
• Listed on previous slide
• Dependent on electric current or electromagnetic
  fields
• Designed for use with voltage less than 1,000 AC,
  1,500 DC
• Exempt
• Spare parts for equipment put on market prior
  to July 1, 2006
• Covered by other waste legislation (car radios,
  etc.)
• Military Equipment

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Other Exemptions

• Granted by the community for specific technical
  applications (not products)
• Onus on is on the producer who is the person best
  placed to assess the characteristics of his
  product.
• Report on the scientific and technical background
  of exemption is expected September 2006.

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So Wheres the Loophole?

• Demonstrating Compliance Unclear
• No specific compliance procedures, certificates
  or testing methods.
• Member States are fully responsible for setting
  compliance rules.
• Member States Figuring Out Compliance
• Director General of the responsible Commission
  suggests direct contact with Member State
  authorities responsible for enforcement of the
  national legislation implementing the provisions
  of the RoHS Directive for more information.

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Information Sources for RoHS/WEE Presentation

• Main Europa page on Waste Electrical and
  Electronic Equipment
• http//ec.europa.eu/environment/waste/weee_index.h
  tm
• WEE FAQ
• http//ec.europa.eu/environment/waste/pdf/faq_weee
  .pdf
• ROHS Directive
• http//eur-lex.europa.eu/LexUriServ/LexUriServ.do?
  uriCELEX32002L0095ENHTML
• WEE Directive
• http//eur-lex.europa.eu/LexUriServ/LexUriServ.do?
  uriCELEX32002L0096ENHTML

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Closing Credits

• Matt Leiphart
• Platinum Registration
• 303 639-9001
• matt_at_platinumregistration.com
• www.platinumregistration.com