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OHSAS 18001 Safety Procedures

A key part of the OHSAS 18001 standards will be the preparation and implementation of SAFETY PROCEDURES for effective OHSAS control. These procedures should cover all functions, activities and processes that have, or could have (if uncontrolled), a significant direct or indirect effect on the OHSAS.

The type and scope of the safety procedures should be appropriate to the nature, complexity and OHSAS significance of the function, activity or process that they address. In all cases, however, the objectives should be to control the activity in question in accordance with specified requirements.

OHSAS 18001 Procedures need to be written down, made available to relevant employees, monitors, documented and updated. The safety procedures should not be issued in isolation; they should be an integral part of the enterprise???s OHSAS Policy and management system as a whole. Their purpose is to define clearly the organisational structure and management controls. In order for procedures to be effective, employees at all levels of the enterprise will need to be given training in their use and control.

The enterprise???s OHSAS policies, objectives and programmes need to be translated into specific safety procedures, which set out:

• Actions necessary to support the OHSAS 18001 Policy and to carry out tasks without detriment to the OHSAS performance of the enterprise.
• Uniformity of understanding and action.
• Continuity and consistency of performance when personnel and changes occurs and
• A basis for control of the OHSAS management system and its effectiveness.

Occupational Health and safety management system procedures are likely to be required for the areas given below. However this is not the exhaustive list. Depending on the requirement of the proposed OHSAS many more procedures may need to be developed.

• Work instructions covering day-to day activities and arrangements, abnormal working and emergency situations.
• Monitoring and control arrangements and activities.
• Contractor, supplier and other procurement activities and arrangements.
• Product, process and other change procedures; and
• Other requirements necessary to achieve the OHSAS Policy and programme; these may relate to:

1. Achieving compliance with particular programme requirements.
2. Research compliance with particular programme requirements.
3. Selection and use of raw materials, purchasing, product take back, energy use, life cycle analysis; and]
4. Support functions such as finance, personnel and recruitment, marketing and publicity, and general administration.

Development Structure of OHSAS 18001 Safety Procedure

The OHSAS 18001 safety procedures may be developed in the format given below.

1. Purpose

Here the objectives of the procedure are clarified.

2. Scope

Define the area/dept./activities to which the procedure is applicable.

3.Responsibility

Determine the person who is responsible for execution of the purpose. Write the designation of that person.

4. Activities

Here steps of the activities should be mentioned i.e. the sequence of the actions required for achieving the purpose.

5. Verification and Monitoring

Here the answer to the following question should be given.

• Who will verify that the set procedure is being followed?
• How will the procedure be verified?
• What will the frequency of verification?

6. Records

Every procedure may generate some document e.g. procedure Deviation Report (PDR), Action Taken Report (ATR) etc. Here all records should be compiled in a table.

ISO (International Organization for Standardization) and IEC (International Electro technical Commission) have just published a new guide ISO/IEC 63:2012 with improved safety aspects in medical devices and instruments.

As per ISO latest press release on 28th Feb 2012, ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in International Standards for medical devices, improves on and replaces a 1999 edition. It will responds to the risk-based framework set out in ISO 14971: 2007, Medical devices ??? Application of risk management to medical devices.

ISO/IEC Guide 63 is prepared to improve the interface between the standards-developing committees and the stakeholders they serve, as well as to make the optimal use of resources by only developing medical device safety standards for which there is a clear market requirement. ISO/IEC Guide 63 is intended to be used by all ISO and IEC bodies involved in the development of medical device safety standards. It can also be used by non-ISO and IEC standards development organizations at the international, regional or national levels that are considering or are in the process of developing medical device safety standards and/or comparable documents.

A global approach among manufacturers, users, regulatory authorities and other stakeholders is needed for the planning and development of medical device safety standards. To create a coherent approach to the treatment of safety in the preparation of standards, close coordination within and among committees responsible for different medical devices is necessary.

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Source: iso.org