MODULES FOR GUIDANCE ON INTERNATIONAL ORGANIZATION STANDARD (NEW ISO 9001:2015 QMS; NEW IATF 6949:2016 Standard; ISO 14001:2004 EMS; NEW ISO 14001:2015 EMS)

I. Guidance for the New ISO 9001:2015 Quality Management System QMS

  1. Introduction
  2. The new changes in the ISO 9001:2015, identify in details, what are the concret new changes and what the company need to bear in mind in order to fulfill the new requirements as per ISO 9001:2015.
  3. The seven principles of Quality management system in which the new ISO 9001:2015 is based, identify and explain in details.
  4. The difference between the new ISO 9001:2015 QMS and ISO 9001:2008, identify and explain in details.
  5. The new ISO 9001:2015- Risk based thinking identify and explain in details, what is required by the organization to fulfill these point in their system.
  6. Support hints as per risk-based ideology as identify in the new ISO 9001:2015- identify and explain in details.
  7. The Clauses identify in the New ISO 9001:2015 standard how it ’’Organization” system, Leadership, Planning, Support, Operation, Performance evaluation, Improvement.

II. Guidance points for the New IATF16949: 2016 Standard

  1. Introduction
  2. IATF 16949 shares the same general section headings and clause structure as ISO 9001:2015, without reciting the text. This ensures all IATF 16949 requirements are fully aligned with the ISO 9001:2015 high level structure.

The clauses identify in the New IATF16949:2016 standard how it relates to:

  • Assessing manufacturing feasibility for changes to existing operations.
  • Evaluating design changes after initial product approval.
  • Reviewing control plans for changes affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis.
  • Controlling and reacting to changes that impact product realization, including changes caused by the organization, the customer, or any supplier. This includes both permanent and temporary changes.
  • Adjusting the frequency of internal audits based on occurrence of process changes.

SOME POINTS TO BEAR IN MIND REGARDING THE NEW IATF 16949:2016 Standard.

1.INTEGRATION OF CUSTOMER SPECIFIC REQUIREMENTS.Customer Requirements: All requirements specified by the customer (e.g., technical, commercial, product and manufacturing process-related requirements, general terms and conditions, customer-specific requirements, etc.)

Customer-Specific Requirements: Interpretations of or supplemental requirements linked to a specific clause(s) of this Automotive QMS Standard.

2.RISK BASED THINKING. Risk mitigation takes center stage in IATF 16949, as it does in ISO 9001:2015. IATF 16949 adds a number of specific risk-related requirements to minimize the likelihood of failure during new program development and to maximize the potential realization of planned activities

3.PRODUCT SAFETY.Product safety is an entirely new section in the IATF standard, and a transitioning organization must have documented processes for the management of product-safety related products and manufacturing processes.

4.MANUFACTURING FEASIBILITY.In the new standard, an organization is required to assess if they are capable of achieving the performance and timing targets specified by the customer, otherwise known as manufacturing feasibility.

5.WARRANTY MANAGEMENT.Based on the increasing importance of warranty management, a new requirement has been added to New IATF 16949:2016 e.t.c

6.DEVELOPMENT OF PRODUCT WITH EMBEDDED SOFTWARE.IATF 16949 requirements for products with embedded software reflect the additional challenges as we move toward more of a drive-by-wire world. The standard references embedded software in the requirements for product validation, warranty and troubleshooting of issues in the field.

In summary, here are some areas that were previously customer-specific requirements that are now included in more detail in New IATF 16949:2016 Standard for Organizations to be certify:

  • Manufacturing feasibility
  • Warranty management
  • Temporary change of process controls
  • Supplier quality management system development
  • Second-party audits
  • Control plan
  • Problem-solving methodologies
  • Control of changes
  • Total productive maintenance
  • Standardized work

III. Guidance for the Old ISO 14001:2004 Environmental Management System EMS.

  1. Introduction
  2. Area that need to be covering in details during the Audit preparation for the environmental management system (RMS) by the organization in general:
    • Environmental aspect
    • Legal and other requirements
    • Objectives, target and programs
    • Resources, roles, responsibility and authority
    • Competence, training and awareness
    • Communication
    • Documentation
    • Control of documents
    • Operational control
    • Emergency preparedness and response
    • Monitoring and measurement
    • Evaluation of compliance
    • Nonconformities, corrective active and preventive action
    • Control of records
    • Internal Audit
    • Evaluation by top management.

iv. Guidance for the New ISO 14001:2015 Environmental Management System EMS.

  1. Introduction
  2. Benefits of ISO 14001
  3. Structure of ISO 14001:2015
  4. Layout of ISO 14001:2015 Environmental Management System.1 Scope
    2 Normative References
    3 Terms and definitions
    4 Context of the organization
    4.1 Understanding the organization and its context
    4.2 Understanding the needs and expectations of interested parties
    4.3 Determining the scope of the Environmental management system
    4.4 Environmental management system
    5 Leadership
    5.1 Leadership and commitment
    5.2 Environmental policy
    5.3 Organizational roles, responsibilities and authorities
    6 Planning
    6.1 Actions to address risks and opportunities
    6.2 Environmental objectives and planning to achieve them
    7 Support
    7.1 Resources
    7.2 Competence
    7.3 Awareness
    7.4 Communication
    7.5 Documented information
    8 Operation
    8.1 Operational planning and control
    8.2 Emergency preparedness and response
    9 Performance evaluation
    9.1 Monitoring, measurement, analysis and evaluation
    9.2 Internal audit
    9.3 Management review
    10 Improvement
    10.1 General
    10.2 Nonconformity and corrective action
    10.3 Continual improvement

Modules for ISO standard