Compliance Documents and Management Systems

 

Since 1991 we have designed and written over 600 management systems which comply with quality, safety, environment, food safety, IT and medical device standards and industry and legal requirements.  We are specialists in plain-English procedure writing;  intranet and business SiteMap design;  compliance with standards and business statutory and legal requirements;  risk management;  system maintenance training and internal auditing.

 

Quality Management Systems

 

Compliance with ISO 9001:2015 is the standard for quality management.  RH blah blah describe standard.

Compliance with ISO 9001:2015. The quality standard sets out requirements for consistently providing products and services that meet customer and regulatory requirements. It also guides a business in enhancing customer satisfaction through applying an effective management system. 

 

Benefits of complying with ISO 9001:

  • To have a plain-English management system that is modular, allows easy access to controlled-version documents, is easy to control and will grow with the business
  • To define procedures and processes, and increase efficiencies
  • To gain certification and an advantage in the marketplace
  • To have confidence that the business complies with relevant legal obligations
  • To protect the interests of all stakeholders – directors, personnel, shareholders and the public
  • To invest in knowledge management and business sustainability.

 

 

 

Safety Management Systems

 

Compliance with AS 4801.  The standard sets out the requirements for an effective WHS management system.  They are designed for businesses of all sizes and sectors.  The standard asks that a business develops policies and procedures that comply with WHS legislation and that identify and control hazards and risks in the workplace.

 

Benefits of complying with AS 4801:

  • to gain independent third-party certification and an advantage in the marketplace
  • to be confident that you comply with legal requirements
  • to reduce the risk of penalties for breaches of acts and legislation
  • to protect the interests of stakeholders – directors, personnel, shareholders and the public.

 

 

Environmental Management Systems

 

Compliance with ISO 14001:2015.  This standard explains how a business can minimise operations that negatively affect the environment;  how to comply with legislation.

This standard explains how a business can manage its environmental responsibilities in a systematic manner that contributes positively to the environment.

Benefits of complying with ISO 14001:2015:

  • to gain independent third-party certification and an advantage in the marketplace
  • to enhance environmental performance
  • to meet compliance requirements
  • to reduce the risk of penalties for breaches of acts and legislation
  • to protect the interests of stakeholders – directors, personnel, shareholders and the public
  • to decrease waste and our impact on the environment.

 

 

Information Security

 

Compliance with ISO 27001.  This standard explains how a business can manage information and data security.  It focuses on identifying threats and risks to information security and how to develop and manage controls to manage information risks.

 

Benefits of complying with ISO 27001:

  • to gain independent third-party certification and an advantage in the marketplace
  • to be confident that information is secure and available only to the intended party
  • to reduce the risk of penalties for breaches of privacy legislation
  • to protect the interests of stakeholders – directors, personnel, shareholders and the public.

 

 

Medical Devices

 

Compliance with ISO 13485:2003.  This standard explains how a business can demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.  It applies to medical products throughout the lifecycle of a device from design, distribution, use, servicing and disposal.  This standard is based on ISO 9001.

 

This standard is being revised in 2016 and will be released as ISO 13485:2016.

 

Benefits of complying with ISO 13485:2003:

  • to gain independent third-party certification and an advantage in the marketplace
  • to be confident that medical devices controlled by the business are compliant and fit for purpose
  • to reduce the risk of penalties for breaches of legislation, e.g. TGA requirements
  • to protect the interests of stakeholders – directors, personnel, shareholders and the public.

 

 

Food Safety

 

A food business can be certified to HACCP, or ISO22000, or SQF Compliance.

 

Food safety standards place obligations on food businesses to produce food that is safe and suitable to eat.  The standards explain health and hygiene obligations for food handlers and food equipment, with the aim of lowering the incidence of food-borne illness. 

 

Food safety standards are controlled by Food Standards Australia New Zealand (FSANZ).

 

Benefits of complying with food safety standards:

  • to gain independent third-party certification and industry and customer recognition
  • to be confident that food is safe and fit for purpose
  • to reduce the risk of introducing food-borne illness to the public
  • to reduce the risk of penalties for breaches of legislation
  • to protect the interests of stakeholders – directors, personnel, shareholders.

 

 

RAWS Registered Automotive Workshop Scheme

 

This scheme allows for importation and supply of used specialist or enthusiast vehicles to Australia.  Only a Registered Automotive Workshop (RAW) can import a used vehicle to Australia.  There are various requirements to becoming a RAW, including being a company, being a registered company with ASIC and gaining certification to ISO 9001.  Visit http://raws.infrastructure.gov.au/ for more information.

 

Quality Business Documents has prepared 9001 and RAWS compliance documentation to assist an importer to become a compliant RAW.

 

Internal Auditing and Second Party Auditing

 

Quality Business Documents employs qualified auditors and can act as your internal auditor or as an independent second-party auditor, particularly if you need to demonstrate compliance to a customer.

 

Training

 

We deliver personalised training to our clients in internal auditing, system reviews and hazard and risk management.

 

System Maintenance and Upgrades

 

We conduct internal audits and reviews, address non-conformances and improvements, maintain document control, update and improve procedures and forms and prepare you for external audits.