Quality Management Standard

ISO 9001

The advantages, disadvantages and requirements of the ISO 9001 Quality Management Standard are much talked about in business circles though still not well understood, even after being around since 1987.

In the global market place organisations are now willing and able to buy and sell locally, nationally and internationally but how do they know, what assurance do they have, that when they deal with you, that your organisation ‘can do what you say you can do’. Of course there is no substitute for direct experience with your organisation, yet this is not available to customers until after the contract has been signed and the first consignment delivered? It may be too late for them by then, so what options are left for your customer? The customer may ask others about you and get a jaundiced view, may come out and inspect your facilities which is very expensive or your customers may seek independent confirmation that you have a system in place which should enable you to perform as you say it can perform. This is the basis of ‘Certification’ to an ISO9001 International Standard

Some of the Benefits :

The advantages of being an ‘ISO 9001 APPROVED COMPANY’ are many and varied, some of which are:

– Market differentiation and competitive advantage;
– Meeting basic tender requirements to be certified to an ISO9001 standard;
– Proven that your claim to quality commitment and operational quality are firmly based upon independent assessment and certification by CBS;
– Reduction of liability exposure;
– Safety system compatibility;
– Continuous improvement and cost efficiency;
– Improved organisational morale.

Note: CBS Guidelines

The Government relies on service providers that are committed to continual improvement in their efficiency and effectiveness. For this reason, the Government and its agencies seek service providers that take a systematic approach to the management of quality, and in so doing better control and improve performance.

These Quality Management Systems Guidelines are designed to assist agencies and other customers in the subcontract delivery chain, and their service providers, in agency construction works (including ancillary asset maintenance and operation) procurement, by providing a framework, based on the current ISO 9001, Quality management systems – Requirements, for applying a systematic approach to the management of quality. This includes:

• customers developing and implementing Quality Management Systems
• service providers developing and implementing Quality Management Systems, Quality Management Plans, and Inspection and Test Plans
• service providers achieving a certified Quality Management System for agency contracts valued at $1 million or more with sufficient risk to quality, as determined by the agency, from a date to be determined by the agency.

Safety Management

ISO 45001

 Safety management system certification has become an important compliance issue for many organisations, with specific certifications becoming major requirements for many contracts and tenders.

This British Standard specifies requirements for an occupational health and safety management system (OHSMS), to enable an organisation to formulate a policy and objectives taking into account legislative requirements and information about hazards or risks. It applies to those hazards or risks over which the organisation may exert control and over which it can be expected to have an influence. It does not state specific OHS performance outcomes.

This Standard is applicable to any organisation that wishes to—
(a) implement, maintain and improve an OHSMS;
(b) assure itself of its conformance with its stated OHS policy;
(c) demonstrate such conformance to others;
(d) seek certification/registration of its OHSMS by an external organisation; or
(e) make a self-determination and declaration of conformance with the Standard.

All the requirements in the Standard are intended to be incorporated into any OHSMS. The extent of the application will depend on such factors as the OHS policy of the organisation, the nature of its activities and the conditions in which it operates.

Effective implementation of an OHS management system should seek to ensure the organisation complies with relevant OHS legislation, standards and codes of practice. However, the implementation of any of the requirements of this Standard, whether or not the organisation has gained certification from a third-party certification body or is otherwise recognized, does not in any way assure compliance with legal requirements, or other obligations placed upon the organisation by a statutory body. Hence, the implementation, either actual or intended, of this Standard, or parts thereof, would not preclude any action by a statutory body.

ISO 45001 is the international version of the safety management system standard and is very well known in most parts of the world. This standard has recently gained popularity in Australia and New Zealand as many organisations deal with customers and suppliers around the world and like to have a mutually recognized certification. Plans are in place to publish a new ISO standard for safety management systems, to take the place of OHSAS 18001.

You can learn more about the new ISO45001 standard here: ISO.org – ISO45001

The Work Health and Safety Management Systems and Auditing Guidelines (Edition 5) have been developed to enable   government agencies which undertake construction and infrastructure projects to work with the construction industry in a manner that:

• Improves safety outcomes for all construction industry participants;
• Provides a consistent minimum standard across all   government construction projects that construction industry participants must meet;
• Facilitates a safety management systems approach by construction contractors;
• Increases productivity and efficiency by improving planning and reducing accidents;
• Supports   government agencies in demonstrating they are meeting their obligations under Work Health and Safety laws.

The Guidelines require that for all contracts valued at $1million or more, or as determined by an agency, the renderers’ must provide evidence of an acceptable corporate WHS Management System.  Corporate WHS Management Systems must comply with the requirements of the Work Health and Safety Management Systems and Auditing Guidelines (Edition 5).

 Agencies may accept a Corporate Work Health and Safety Management System if they are provided with:

• Evidence that the Corporate Work Health and Safety Management System was accredited in accordance with the Government Occupational Health and Safety Management Systems Guidelines Edition 4 within the preceding three year period;  or
• An audit report by an OHS Auditor (in compliance with the Work Health and Safety Management Systems and Auditing Guidelines Edition 5) attesting that the Corporate Work Health and Safety Management System:
  • complies with the documentation requirements of the Work Health and Safety Management Systems and Auditing Guidelines (Edition 5);
  • appropriately comprehends all current Work Health and Safety Legislation and other Work Health and Safety requirements;  and
  • includes requirements for audit, by an OHS Auditor independent of the Contractor, of compliance, currency and effective implementation at intervals of not less than three years.

Environmental Management

ISO 14001

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The ISO 14001 environmental management standard exists to help organisations minimize how their operations negatively affect the environment (cause adverse changes to air, water, or land) and comply with applicable laws and regulations.

ISO 14001 is the international specification for an environmental management system (EMS). It specifies requirements for establishing an environmental policy, determining environmental aspects and impacts of products/activities/services, planning environmental objectives and measurable targets, implementation and operation of programs to meet objectives and targets, checking and corrective action, and management review.

ISO 14001 is similar to ISO 9001 quality management in that both pertain to the process (the comprehensive outcome of how a product is produced) rather than to the product itself. The overall idea is to establish an organized approach to systematically reduce the impact of the environmental aspects which an organisation can control. Effective tools for the analysis of environmental aspects of an organisation and for the generation of options for improvement are provided by the concept of Cleaner Production.

What accredited certification to ISO 14001 means

The accredited certification process is expected to ensure that the organisation has an environmental management system, suitable for the nature of its activities, products and services, that conforms to the requirements of ISO 14001, and in particular can demonstrate for the defined scope that the organisation:

1. has defined an environmental policy appropriate to the nature, scale and environmental impacts of its activities, products and services.
2. has identified the environmental aspects of its activities, products and services that it can control and/or influence and determined those that can have a significant environmental impact (including those related to suppliers/contractors).
3. has procedures in place to identify applicable environmental legislation and other relevant requirements, to determine how these apply to its environmental aspects and to keep this information up to date.
4. has implemented effective controls in order to meet its commitment to comply with applicable legal and other requirements.
5. has defined environmental objectives and targets that are measurable, where practicable, taking into account legal requirements and significant environmental aspects, and has programmers in place to achieve these objectives and targets.
6. ensures that people working for or on behalf of the organisation are aware of the requirements of its environmental management system and are competent to perform tasks
   that have the potential to cause significant environmental impacts.
7. has implemented procedures for communicating internally, as well as responding to and
   communicating (as necessary) with interested external parties.
8. ensures that those operations associated with significant environmental aspects are carried out under specified conditions and monitors and controls the key characteristics of its operations that can have a significant environmental impact.
9. has established and (where practicable) tested procedures to address and respond to emergencies that can have an effect on the environment.
10. periodically evaluates its compliance with applicable legal and other requirements.
11. aims to prevent nonconformities, and has procedures in place to:
    1. correct any nonconformities that do occur
    2. analyze the cause of any such nonconformities and take corrective action to avoid their
    recurrence
12. has implemented effective internal audit and management review procedures.

 The Government Environmental Management System Guidelines (Edition 3 – August 2013) were developed to facilitate the achievement of improved environmental performance by the construction industry.

Government Agencies may accept a Corporate Environmental Management System if they are provided with:

• Evidence that the Corporate Environmental Management System was accredited in accordance with the Government Environmental Management Systems Guidelines Edition 2 within the preceding three year period;  or
• An audit report by an Approved Assessor attesting that the Corporate Environmental Management System:
  • complies with the documentation requirements ISO 14001:2004 Environmental management systems;
  • appropriately comprehends all current Environmental Legislation and other Environmental requirements;  and
  • Includes requirements for audit, by an Approved Assessor independent of the Contractor, of compliance, currency and effective implementation at intervals of not less than three years.

Health, Safety and Environmental Standards (HSE)

Health, Safety and Environmental Standards (HSE)
A growing number of rules and policies affecting Health, Safety and Environmental (HSE) compliance are being issued by such diverse groups as the United States Sentencing Commission, the Occupational Standards and Health Administration, (OSHA), and the International Standards Organisation (ISO), thus giving companies more reasons to consider adopting voluntary HSE programs.
Here are some of the more significant of these rules and policies:
•Federal Court Requirements. The Federal Sentencing Guidelines already encourage companies to adopt reporting and compliance programs (See my article in the previous issue.) Furthermore, a set of similar guidelines specifically targeted at environmental crimes may be enacted by the Sentencing Commission soon.
•Governmental Standards for Legal Action. The enforcement policies of the Department of Justice, EPA and state environmental protection agencies now provide a basis for dropping charges under environmental laws in the accused company voluntarily discloses the violation, cooperates with governmental investigations, implements preventive measures, and enforces an internal compliance program.
•Occupational Health and Safety Standards. The Occupational Safety and Health Administration’s (“OSHA”‘s) Voluntary Compliance Program allows companies to reduce the number of government inspections by adopting an OSHA voluntary compliance program.
• International Standards. The proposed ISO 14000 standards will, when adopted, provide incentives to companies to meet self auditing and environmental management standards that are similar to incentives under the ISO 9000 quality standards.
•Confidentiality of Audits. A growing number of states (Oregon, Indiana, Kentucky, Colorado) provide that corporations performing environmental audits may protect their audit and related documents from disclosure (the “Self Evaluative Privilege”).
Moreover, criminal enforcement of HSE laws and increased policing by state and federal agencies evidence greater legal risks to companies that fail to adopt and maintain HSE compliance programs.
The following actions are recommended for a company to implement a cost effective HSE compliance program:
1.Make managers responsible for continuous monitoring of HSE compliance. HINT: For every documented problem, also document all steps taken to correct the problem.
2.Adopt an HSE compliance policy and communicate that policy to employees. HINT: Consolidate various HSE programs into one comprehensive program, thus maximizing communication.
3.Establish procedures for internal audits, internal reporting of violations and documenting the resolution of problems. HINT: Conduct audit programs with counsel to take advantage of the attorney-client privilege; since the privilege is subject to exceptions, document all corrective and preventive measures taken.
4.Train employees at all levels; maintain regulatory expertise; and evaluate employees’ performance of HSE duties. HINT: Impress upon upper level management the importance of HSE compliance and their responsibility for the program.
5.Offer incentives for compliance. HINT: Provide the largest incentives for total environmental quality, e.g., waste minimization, toxic use reduction, etc. and integrate these incentives with corporate goals such as increased productivity and efficiency.
6.Establish disciplinary procedures. HINT: Ensure the discipline of employees who either fail to report violations, interfere with the reporting of violations, or fail to cooperate with auditing.
7.Continuously evaluate and improve your company’s HSE compliance program. HINT: Periodically, obtain an outside assessment of your compliance program.

GMP – Good Manufacturing Practices

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company’s responsibility to determine the most effective and efficient quality process.

HACCP

Hazard analysis and critical control points or HACCP is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level.

The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc.

HACCP Principles

1. Conduct a hazard analysis

Plans determine the food safety hazards and identify the preventive measures the plan can apply to control these hazards. A food safety hazard is any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

1. Identify critical control points

A critical control point (CCP) is a point, step, or procedure in a food manufacturing process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to an acceptable level.

1. Establish critical limits for each critical control point

A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level.

1. Establish critical control point monitoring requirements

Monitoring activities are necessary to ensure that the process is under control at each critical control point.

1. Establish corrective actions

These are actions to be taken when monitoring indicates a deviation from an established critical limit. The final rule requires a plant’s HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product is injurious to health or otherwise adulterated as a result of the deviation enters commerce.

1. Establish procedures for ensuring the HACCP system is working as intended

Validation ensures that the plants do what they were designed to do; that is, they are successful in ensuring the production of a safe product. Plants will be required to validate their own HACCP plans. FSIS will not approve HACCP plans in advance, but will review them for conformance with the final rule.

Verification ensures the HACCP plan is adequate, that is, working as intended. Verification procedures may include such activities as review of HACCP plans, CCP records, critical limits and microbial sampling and analysis. FSIS is requiring that the HACCP plan include verification tasks to be performed by plant personnel. Verification tasks would also be performed by FSIS inspectors. Both FSIS and industry will undertake microbial testing as one of several verification activities.

Verification also includes ‘validation’ – the process of finding evidence for the accuracy of the HACCP system (e.g. scientific evidence for critical limitations).

1. Establish record keeping procedures

The HACCP regulation requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities, and the handling of processing deviations. Implementation involves monitoring, verifying, and validating of the daily work that is compliant with regulatory requirements in all stages all the time. 

The seven HACCP principles are included in the international standard ISO 22000 FSMS. This standard is a complete food safety and quality management system incorporating the elements of prerequisite programmers’ (GMP & SSOP), HACCP and the quality management system.

Food Safety Management Systems

ISO22000

The ISO 22000 family of International Standards addresses food safety management.

The consequences of unsafe food can be serious and ISO’s food safety management standards help organisations identify and control food safety hazards. As many of today’s food products repeatedly cross national boundaries, International Standards are needed to ensure the safety of the global food supply chain.

ISO 22000:2005 sets out the requirements for a food safety management system and can be certified to. It maps out what an organisation needs to do to demonstrate its ability to control food safety hazards in order to ensure that food is safe. It can be used by any organisation regardless of its size or position in the food chain.

Energy Management Systems

ISO 50001

CBS is the world’s leading accredited certification body in relation energy management system certification, as we issued the world’s first accredited EN 16001 certificate in 2009.ISO 50001:2011 is a newly developed international standard for an energy management system (EnMS). ISO 50001 Energy Management Systems certification provides a framework for establishing energy management best practice to help organisations to improve their energy efficiency in a logical, controlled and systematic way. “The purpose of the International Standard ISO 50001 is to enable organisations to  establish the systems and processes necessary to improve energy performance, including energy efficiency, use, and consumption.” The energy standard specifies that an organisation must integrate an energy management system (enMS) within the organisation in conjunction with establishing and instigating an energy policy, objectives, targets, and action plans, which take into account legal requirements and information related to significant energy use. The energy standard is applicable to organisations both large and small, irrespective of geographical, cultural or social conditions. ISO 50001 has been structured to be aligned with other popular industry management system standards so it is possible integrate an energy management system (EnMS) with your existing management system(s). The company has operational experience in the EU, Africa and Asia in the energy management.

Information Security Management Systems

ISO 27001

ISO 27001 Information Security and data protection brings supreme importance to data for organisations globally. Business who are safeguarding both their client and company data against potential threats. By integrating a robust information security management system your organisation can ensure that the quality, safety, service and product reliability of your organisation has been safeguarded to the highest level.