ANSI/AIHA Z10
 
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ANZI

Occupational Health and Safety Management System
 

Occupational Health and Safety Management System

ANSI/AIHA Z10 standard is the American National-Occupational Health and Safety (OH&S) Management System.
The management system components of ANSI/AIHA Z10 were developed to be consistent with those of ISO 14001 and ISO 9001.
ANSI/AIHA Z10 expands “customer requirements” from ISO 9001 to include regulatory and other mandatory Occupational Health & Safety requirements.
ANSI/AIHA Z10 does not replace ISO 9001 or ISO 14001. All are part of an organization’s overall management system.
ANSI/AIHA Z10 uses the same fundamental principles as ISO 14001 and ISO 9001 such as document and data control, auditing, process control, record control, training, corrective and preventive action and statistics.

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AS9100
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AS9100

Quality Management Systems - Suppliers to Aerospace and Defense Industry

Quality Management Systems - Requirements for Aviation, Space and Defense Organizations

SAE AS9100 is the quality system requirements for suppliers to the aerospace and defense industries. It was developed in the United States as AS9000 in 1996, expanded to address international aerospace requirements, and is now approved by aerospace companies in Asia and Europe as well.

The Standard has several additional requirements and amplifications of the ISO 9001 Standard. This book of requirements was developed by the International Aerospace Quality Group (IAQG)  and is the technically equivalent to AECMA prEN 9100 for European Aerospace suppliers.

 

NOTE:
It was recently learned plans had gone awry due to a delay in translating the AS9100 upgrade documents in Europe and since the IAQG endeavors to release the documents across all sectors (Americas, Asia Pacific and Europe) at the same time, this issue has caused a delay in the release of the standards for all sectors.

There has been much brainstorming on ways to expedite the current time line which hopefully will allow for the documents to be released earlier. As of right now, this is what we know: 

  • AS9100:2016 was released in October 2016
  • AS9110:2016 was released in November 2016
  • AS9120:2016 was released in November 2016
  • All audits after June 1st 2017must be to the new version of the applicable standard

All companies currently certified to AS9100, 9110 or 9120 should complete their transition audit by June 15, 2018 (to allow enough time for any NCR’s to be processed and entered into OASIS prior to the 15 September 2018 deadline).
All companies currently certified to AS9100, 9110 or 9120 must have their new AS91XX:2016 certificate published in OASIS by 15 September 2018.
Any company that has not successfully upgraded to the new standard(s) by 15 September 2018 will have  certification revoked and their history in OASIS erased 
 The intent is to achieve significant improvements in quality and reductions in cost throughout the value stream or supply chain.
The aerospace/defense customers are placing the requirement for conformance on their suppliers It primarily pertains to part and/or process suppliers.

 

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ISO 9001
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ISO9001

Quality Management Systems - International Standards

Quality Management Systems-Requirements

ISO 9001 is an international standard designed to provide companies and organizations with a common approach to applying a Quality Management System.  Over 150 countries have adopted the standard since its inception in 1987.  It also forms the base requirements for many other standards, including ISO 13485, AS9100, and the ISO/Technical Specification 16949.
Industry Specific Standards:
There are several industry specific standards that apply the ISO 9001 standard to a specific industry such as Medical devices or automobiles.  These standards all have ISO 9001 at their core and add additional requirements for the specific industry.

NOTE:
ISO 9001:2015 has been released and organizations currently registered to ISO 9001:2008 will have until September 2018 to become compliant to the revised standard.

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ISO 13485
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ISO13485

Quality Management Systems - Medical Devices

Medical devices - Quality management systems

An international standard designed to provide medical device suppliers with a common approach to applying a Quality Management System that addresses most FDA requirements.  The ISO 13485 standard was based on the ISO 9001 standard (but does not track with the ISO 9001:2015 numbering system). Unlike ISO 9001, Continuous Improvement and Customer Satisfaction are not as stressed in ISO 13485; instead, more emphasis is placed on regulatory requirements.

Intent: ISO 13485 is to provide for the development of a Quality Management System that ensures to prospective customers and regulatory bodies that the goods and services offered by the organization will meet customer and regulatory requirements. 

ISO 13485 can be applied to any type or size of organization that designs, develops, produces, installs or services medical devices.

NOTE:
ISO 13485:2016 has just been published and it is expected that users will adopt the updated standard within 3 years.  This version of 13485 has not adopted the Annex SL High Level Structure (i.e. it is not numbered the same as ISO 9001:2015) it is expected that future releases will conform to this structure.

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ISO 14001
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environmental

Environmental Management Systems

Environmental Management Systems - Requirements with guidance for use

The ISO 14000 series of standards that includes ISO 14001 Environmental Management Systems (EMS) grew out of the international success of the ISO 9000 series of Standards and the emergence of excessive country and regional standards for managing the environment.  ISO and IEC formed the Strategic Advisory Group for the Environment (SAGE) in 1991. Currently there are many 14000 series Standards. Organizations self certify or register to only the ISO 14001 Standard. The others are used for guidance, specification, evaluation and qualification criteria. 

There are ten (10) primary sections that classify the requirements in ISO 14001. Within these ten sections of the Standard are the specific requirements that an organization must apply to implement an EMS.

ISO 14001 Comparability to ISO 9001

Both Management Systems share the same document structure and ISO 14001 was designed to allow ISO 9001 system extension.

ISO 14001 is not prescriptive, but requires specific commitments to regulatory compliance, prevention of pollution, and continuous improvement.

Intent: The application of the 14001 standard is to provide organizations with the elements of an effective EMS that can be integrated with or into other management systems requirements, to assist organizations achieve their environmental and economic goals and objectives.  The overall aim is to support environmental protection and prevention of pollution in balance with socioeconomic needs. The success of an EMS depends on a commitment from all levels and functions within an organization and especially from senior or top management.

14001 enables an organization to establish and assess the effectiveness of procedures to set an environmental policy including objectives, achieve conformance with them, and to demonstrate conformance to others, including interested external parties.

14001 is not intended to address and does not include requirements for any aspects of occupational health and safety management. Registration is limited to the applicable aspects of the documented EMS.

14001 shares common management system principles with ISO 9000 and ISO 45001 system standards. While the 9000 series of standards deal with customer needs, an EMS addresses the needs of a broad range of interested parties and evolving needs of society for the protection of the environment.  In a lot of cases it should be very possible to comply with the requirements of ISO 14001 by adapting the existing ISO 9000 based management system elements, procedures, policies, etc.

NOTE:
ISO 14001:2015 has been released and organizations currently registered to ISO 14001:2004 will have until September 2018 to become compliant to the revised standard.Applicability: ISO 14001 can be applied to any type of business, organization or industry. Initial interest in applying the Standard is coming from a wide range of industries, including; Agriculture, Forestry & Mining; Petrochemicals & Plastics, Food, Tobacco, Textiles & Wood products, Electronics & Instruments, Manufacturing, Metals & Machinery.

Thousands of organizations in North America have adopted the ISO 14001 Standard in manufacturing, medical, transportation and a variety of service industries.

Note: Registration to ISO 14001 has become a requirement for a number of customers, such as the automotive industry requirements for registration for manufacturing facilities.

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ISO 15189
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ISO15189

Quality and Competency - Medical Laboratories

Medical laboratories - Particular requirements for quality and competence

This standard is basically the application of the ISO/IEC 17025 and ISO 9001 standards to a Medical Laboratory.

Accreditation to ISO 15189 requires that: The laboratory has a quality system meeting requirements of ISO 15189; The lab facility has adequate equipment to perform its testing tasks; The lab facility has adequate laboratory personnel with the competence to perform the testing; In addition most accreditation schemes in the United States require proficiency testing amongst the laboratories.

Therefore, ISO 15189 is recognition of medical laboratory competence, while ISO/IEC 17025 and ISO 9000 are simply recognition of competency of a laboratory management system.

The intent of ISO 15189 is to provide confidence in medical laboratories because medical services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients.
 

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IATF 16949
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ISO16949

Quality Management Systems - for Automotive Production and Service Parts Organizations

Quality management system requirements for automotive production and relevant service parts organizations

IATF 16949 is the automotive ISO Technical Specification that applies to ISO 9001 standard to an automotive supplier.  In addition to all the ISO 9001 requirements you also need to meet additional automotive supplier tools such as PPAP and Measurement Systems Analysis (think of it as ISO 9001 on steroids).

A key difference from the older Automotive Quality Management Systems (such as QS-9000) that really is not apparent by reading the specification is the requirement that you use the "Process Approach" when setting up your system.  Your Management System should be set up around your processes not the IATF 16949 specification.

What about all those AIAG manuals?  Hang on to them, PPAP and MSA is to be used if the customer does not specify otherwise.  The remaining manuals are for reference (still have APQP, FMEA and SPC requirements).

NOTE:
October 2016

As of October 2016, a new International Standard, IATF 16949:2016, supersedes and replaces ISO 16949:2009. The goal of this International Standard is the development of a quality management system that:

  • Provides for continual improvement,
  • Emphasizes defect prevention,
  • Includes specific requirements and tools from automotive industry,
  • Promotes reduction of variation and waste in the supply chain.

This International Standard, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for automotive production, service and/or accessory parts organizations.

IATF 16949:2016 represents an innovative document with a strong customer orientation.

Feedback solicited from certification bodies, auditors, suppliers, and original equipment manufacturers (OEMs) shaped development of this International Standard.

IATF 16949:2016 also incorporates common automotive customer-specific requirements.

The IATF 16949:2016 automotive sector-specific requirements were created by the International Automotive Task Force (IATF) and copyright for this text is held by the members of the IATF. The title for this international standard, IATF 16949, is a registered trademark of the IATF.

Requirements for certification to IATF 16949:2016 are defined in the new revision of the IATF document Rules for achieving and maintaining IATF recognition, scheduled for release in November 2016 Guidance for the transition from ISO 16949:2009 to IATF 16949:2016 will provided through a separate document, posted on the IATF Global Over sight website, and distributed separately.

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ISO/IEC 17025
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ISO17025

Competency of Testing and Calibration Laboratories

General requirements for the competency of testing and calibration laboratories

 Note:   It is currently scheduled to be released in late 2017 or early 2018.

Accreditation to ISO/IEC 17025 requires that: The laboratory has a quality system meeting requirements of ISO 9001; The lab facility has adequate equipment to perform its testing or calibration tasks; The lab facility has adequate laboratory personnel with the competence to perform the calibration and testing; In addition most accreditation schemes in the United States of America. require proficiency testing amongst the laboratories.

Therefore, ISO/IEC 17025 is recognition of laboratory competence, while ISO 9001 alone is simply recognition of conformance to a quality system.

Note:  A specific version of this standard for Medical Laboratories has been developed. 

See  ISO 15189.

Drivers of ISO/IEC 17025 are: IATF 16949 – Requirement for outside laboratories performing inspection, testing or calibration (Accreditation required). Reference 7.6.3.2

Fastener Quality Act – Requirement for outside laboratories doing inspection and testing for manufacturers of fasteners for sale in the United States (Accreditation required).

Intent: ISO/IEC 17025 is to provide testing and calibration laboratories with a common standard to apply while permitting third party accreditation.

It applies to testing and calibration laboratories seeking laboratory competence.
 

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ISO 45001
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ISO45001

Occupational Health and Safety Management System - International Standard

Health & Safety Standard

ISO 45001:2018 specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.

ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.
 

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RC14001
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AmericanChemistryLogo208-108

 

Based on the ISO 14001 Environmental Management Systems (EMS)

and has been expanded to address the Responsible Care® Principles.  The registration to this standard will address all customer requirements for registration to ISO 14001.

The application of the RC14001 standard is to provide organizations with the elements of an effective Environmental, Health, Safety & Security Management System (EHS&SMS) that can be integrated with or into other management systems requirements, to assist organizations achieve their environmental, health, safety, security and economic goals and objectives.  The overall aim is to support security, health and safety, environmental protection and prevention of pollution in balance with socioeconomic needs. The success of an EHS&SMS depends on a commitment from all levels and functions within an organization and especially from senior or top management.

RC14001 enables an organization to establish and assess the effectiveness of procedures to set a policy including objectives, achieve conformance with them, and to demonstrate conformance to others, including interested external parties.

RC14001 shares common management system principles with ISO 9000 and OHSAS 18001 system standards. While the 9000 series of standards deal with customer needs, an EHS&SMS addresses the needs of a broad range of interested parties and evolving needs of society for the protection of the environment, security, health and safety.

Responsible Care® RC14001

Technical Specification: The American Chemistry Council (ACC) has created two Technical Specifications that addresses the environment, health, safety and security.  They are RC14001 and RCMS.
 

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RCMS
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AmericanChemistryLogo208-108

Technical Specifications: Health, Safety, Security, and the Environment - American Chemistry Council

The American Chemistry Council has created a Technical Specification that addresses the health, safety, security and the environment and is available for Registration by ACC members/affiliates only.  

Note 1: There are two Responsible Care Management System Technical Specification, the RCMS and RC14001.

Note 2: RC14001 registration is open to all companies but the RCMS document is limited to ACC and ACC Affiliate members.

Major changes to RCMS and primarily deal with having the organization address:

  • Energy efficiency consideration for aspects,
  • Waste minimization, reuse ,and recycling for aspects
  • Addition of Product Safety as a consideration.
  • Requires the organization to evaluate compliance “with their Responsible Care related requirements to which it subscribes”.
  • Being more prescriptive on evaluating system  effectiveness by specifying that “Internal Audits” will be conducted and,
  • Allowing more flexibility in the Corrective/Preventive Actions process.

* ACC members are required to address the Product Safety, Process Safety, and Security codes, as “other requirements to which the organization subscribes”.  External auditors will be required to verify these requirements are being met per the ACC time-line.

If you are interested in complying with both the ACC's Responsible Care® requirements and the requirements of ISO 14001, please contact us.

Intent: The application of the RCMS® standard is to provide organizations with the elements of an effective Environmental Health, Safety and Security Management System that can be integrated with or into other management systems requirements, to assist organizations achieve their environmental, health, safety and economic goals and objectives.  The overall aim is to support Health, safety, security and environmental protection and prevention of pollution in balance with socioeconomic needs. The success of an RCMS® depends on a commitment from all levels and functions within an organization and especially from senior or top management.

RCMS® enables an organization to establish and assess the effectiveness of procedures to set a policy including objectives, achieve conformance with them, and to demonstrate conformance to others, including interested external parties.

RCMS® shares common management system principles with ISO 9000, RC14001 and OHSAS 18001 system standards. While the 9000 series of standards deal with customer needs, an RCMS® addresses the needs of a broad range of interested parties and evolving needs of society for security, protection of the environment, health and safety.
 

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Risk-Based Performance Standards
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security

Chemical Facility Anti-terrorism program by the Department of Homeland Security
 

A Chemical Facility Anti-terrorism program overseen by the Department Of Homeland Security

Congress mandated the Department of Homeland Security (DHS) to implement the Chemical Facility Anti-terrorism Standards (CFATS) that high-risk chemical facilities must meet to comply with the Act.

CFATS establishes eighteen Risk-Based Performance Standards (RBPSs) that identify the areas for which a facility's security program will be examined. To meet the Risk-Based Performance Standards, covered facilities are free to choose whatever security programs or processes they deem appropriate, so long as they achieve the requisite level of performance in each applicable area. Each of the RBPSs describe the performance level expected of the facilities based on their status (Tier 1, Tier 2, Tier 3 and Tier 4).

The eighteen Risk-Based Performance Standards are as follows:

Restrict Area; Secure Site Assets; Screen and Control Access; Deter, Detect, and Delay; Shipping, Receipt, and Storage; Theft or Diversion; Sabotage; Cyber; Response; Monitoring; Training; Personnel Surety; Elevated Threats; Specific Threats, Vulnerabilities, or Risks; Reporting of Significant Security Incidents; Significant Security Incidents and Suspicious Activities; Officials and Organization; Records.

For information on Risk-Based Performance Standards please   contact us.
 

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