Quality Management Systems | Seth Safety Products.

UALITY MANAGEMENT SYSTEMS
SETH MEDICAL AND SAFETY EQUIPMENTS (PVT) LIMITED

AGENDA
 Introduction to ISO 9000 / ISO 14000 / OHSAS 18000 and SA 8000
 Customer Quality Audits.
 Customer HRP Audits.
 How to create Quality Mindset in Employees.
 How Audits and Certifications increasing the Quality of employees
Working Behavior.

Evolution of ISO 9001:2008
What is ISO 9001:2008.
• The ISO 9000:2008 is related to Quality Management System [QMS].
• It is designed to help organizations ensure that they meet the needs of customers and other
stake holders (Suppliers, Owners, ect.) while meeting statutory and regulatory
requirements related to the product.
• This standard is published by the ISO, the International Organization for Standardization
and that defines good Management Practices.
• It is a global recognized standard and that spells out Quality and Trust on customers and
stake holders.
• It helps to continual improvement of company operations.

Requirements of the ISO 9001:2008
1. Scope
2. Normative references
3. Terms and definitions
4. QMS
 General requirements
 Documentation requirements
5. Management responsibility
 Management commitment
 Customer focus
 Quality policy
 Planning
 Responsibility, authority and communication
 Management review
6. Resource management
 Provision of resources
 Human resources
 Infrastructure
 Work environment
7. Product realization
 Planning of product realization
 Customer-related processes
 Design and development
 Purchasing
 Production and service provision
 Control of monitoring and measuring equipment
8. Measurement, analysis and improvement
 General
 Monitoring and measurement
 Control of nonconforming product
 Analysis of data
 Improvement

Benefits of the ISO 9001:2008.
• Enhanced customer satisfaction and improved customer loyalty leading to repeat business.
• Integration and alignment of internal processes which will lead to increased productivity and results.
• Enhanced business performance and better cost management.
• Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the
organization.
• Increased credibility and competitiveness in the market.
• Consistency in the Quality, Delivery of your product or service.
• Lower costs and shorter cycle times through effective use of resources.
• Improved communication, planning and administration processes

What is ISO 14000
• An ISO 14001 environmental management system (EMS) is a systematic and process
driven approach to controlling those aspects of your business that have a significant
impact on the environment.
• The ISO 14001 standard is based on the Plan-Check-Do-Review-Improve cycle.
• The system is proven to make business owners and managers be more aware of their
environmental responsibilities, including legal and regulatory accountabilities, and
being able to manage and control the associated environmental risks.
• ISO 14000 is a series of environmental management standards developed and published
by the International Organization for Standardization ( ISO )
Evolution of ISO 14001:2004
• BSI group published the first Environment Management System Standard BS 7750:1992.
• ISO 14000 series first published in 1996. it is ISO 14001:1996.
• The Latest ISO 14000 standard published in 2004 and it is ISO 14001:2004.

ISO 14001:2004 Requirements
1. Scope
2. Normative references
3. Terms and definitions
4. Environmental management system requirements
4.1 General requirements
4.2 Environment policy
4.3 Planning
4.3.1 Environmental aspects
4.3.2 Legal and other requirements
4.3.3 Objectives, targets and programs
4.4 Implementation and operation
4.4.1 Resources, roles, responsibility and authority
4.4.2 Competence, training and awareness
4.4.3 Communication
4.4.4 Documentation
4.4.5 Control of documents
4.4.6 Operational control
4.4.7 Emergency preparedness and responses
4.5 Checking
4.5.1 Monitoring and measurement
4.5.2 Evaluation of compliance
4.5.3 Non conformity, corrective action and preventive action
4.5.4 Control of records
4.5.5 Internal audit
4.6 Management review

Requirements of ISO 14001:2004
1. An Environment Policy supported by senior management;
2. The identification of environmental aspects and impacts, and the identification of significant environmental
impacts that the organization may cause;
3. Identification of Environmental Compliance requirements;
4. The development of objectives and targets, and their environmental management programs;
5. Defined resources, roles, responsibilities and authorities for environmental management;
6. The development of competence, training and awareness procedures;
7. A communication process of the EMS to all stakeholders and interested parties;
8. The development of EMS documentation as required by the standard;
9. The development of document control procedures;
10. The development of operational control procedures;
11. The development of emergency preparedness and response procedures;
12. The development of procedures to monitor and measure operations that can have significant impact to the
environment;
13. An evaluation of compliance procedure;
14. Procedures developed for the management of non-conformance, corrective and preventative actions;
15. The development of a records management procedure;
16. A program for completing internal EMS audits and corrective actions; and
17. The development of procedures for management review by senior management.

Key benefits of the ISO 14001 standard include:
• Identify cost savings with greater emphasis on resource, waste and energy
management
• Develop the corporate image and credibility
• Quantify, monitor and control the impact of operations on the environment, now and in
the future
• Ensure legislative awareness and compliance
• Improve environmental performance.
• Protect the company, assets, shareholders and directors
• Potentially decrease public liability insurance costs for your organization.
• Grow your access to business partners and potential customers
Benefits of the ISO 14001:2004.

What is OHSAS 18001:2007.
 OHSAS 18001:2007 Occupational, Health and Safety Management Certification is an international standard
which provides a framework to identify, control and decrease the risks associated with health and safety within
the company.
 Implementing the standard will send a clear signal to your stakeholders that you view employee’s health and
safety as a principal priority within your company.
 An increasing number of organizations are completing OHSAS 18001 Certification as employers are under
increasing pressure to ensure that a rigorous health and safety policy is in place which protects employees
against possible occupational risks and reduces the likelihood of accidents in the workplace.
 By planning ahead a company can also reduce the potential for medical and compensation claims.
 The OHSAS 18001 standard provides organizations with a framework for health and safety management helping
them to:
(a). Identify, minimize and control health and safety risks.
(b). Conform to health and safety legislation.
(C). Protect the wellbeing of employees.
NOTE: Occupational Health And Safety Assessment Specification. - OHSAS

Requirements of OHSAS 18001:2007.
1. General requirements
 Defines the OHSMS and the scope of the OHSMS within the organization
2. OH & S Policy
 Creation of an OH & S policy
3. Planning
3.1 Hazard identification, risk assessment and determining controls
 Procedure for the on-going identification of hazards, assessments of risks and determination of the
necessary controls.
3.2 Legal and other requirements.
 Procedure for describing how legal information is identified and accessed.
3.3 Objectives and Programs
 OHSAS programs with objectives and targets which are consistent with the policy.
4. Implementation and operation
4.1 Resources, roles, responsibility, accountability and authority.
 Defines relevant management, accountability, structure, roles, responsibilities and includes the
appointment of an OH & S management representative.
4.2 Competence, Training and awareness
 Ensures that persons performing tasks are competent and trained to do them.
4.3 Communication, Participation and awareness
 Outlines required procedures for internal and external communications

Contd…
4.4. Documentation
4.5 Control of documents
4.6. Operational control
 Identifies critical functions associated with the identified hazards where controls are necessary.
4.7. Emergency preparedness and response
 Process required for identifying & responding to emergencies.
5. Checking
5.1.Performance measurement and monitoring.
 Measures data for action and describes the plan to monitor and measure OH&S performance on a regular
basis.
5.2. Evaluation of compliance
5.3. Incident investigation, non conformance, corrective & preventive action
 Procedures for investigating incidents and acting on health and safety non-conformance. Corrective
and preventive actions must be taken.
5.4. Control of records
5.5. Internal audit
5.6. Management review

Benefits of the OHSAS 18001:2007.
Benefits of OHSAS 18001 Certification – Health and Safety Certification.
• Improved corporate image and credibility among stake holders, regulators, customers,
prospective clients and the public
• Adoption of international best practice in relation to risk management
• Ensures health and well-being of employees, sub-contractors and the public
• Minimization of liability of employers through adoption of proactive rather than reactive controls
• Ensures legislative awareness and compliance
• Reduces accident and incident rates by reducing and elimination workplace hazards
• Improves the incident investigation process
• Increases employee motivation through the provision of a safer workplace and participation
process

What is SA 8000
 SA8000 is an international standard to promote worker’s rights and enable employers to
sustainably implement a systems-based approach to ensuring decent and ethical working
conditions.
 This standard is based on the principles of the international human rights norms and
national labour law to promote worker’s best interest, with a view to sustainable livelihoods
and employment.
 It is based on the principle that ensuring worker’s rights and well-being is not a ‘burden’ for
employers but an investment in human resources that leads to healthy and sustainable
workplace for all.
 SA 8000 is the first auditable social standard and is independent of government bodies and
single interest groups. This standard is verifiable through evidenced-based process.
 SA8000 measures the performance of organizations in eight key areas: child labour, forced
labour, health and safety, freedom of association and collective bargaining, discrimination,
disciplinary practices, working hours and remuneration.

SA 8000 Requirements
1.Child labour
 The factory must not provide employment to any personnel under the age of 18yrs nor shall support use of child labor.
2. Forced and compulsory labour
 Commitment to prohibition of forced and compulsory labor.
3. Health & Safety
 Comply with all applicable laws, regulations and industry standards and practices.
 The company should conduct regular training on health & safety, use of PPE.
4. Freedom of association and right to collective bargaining
 Worker’s council meeting, Individual grievances
5. Prohibition of discrimination
 Written policy and procedures to prohibition of discrimination
6. Disciplinary Practices
 Commitment to prohibition of harassment or abuse.
7. Working hours
 All overtime is voluntary and shall be compensations as local laws.
 Working hours and off day must comply with local rules
8. Remuneration
 Commitment to compensation and benefits
9. Management systems

Benefits of the SA 8000.
 Enhances company and brand reputation in the International market.
 Improves employee recruitment, retention and productivity.
 Proves your commitment to social accountability and to treating your employees ethically
and in compliance with global standards
 Supports your corporate vision and build and reinforce the loyalty of your employees,
customers and stakeholders.
 Enables you to demonstrate proper social accountability when going to international
contracts or expanding locally to accommodate new business.

HRP AUDITS
SCOPE DESCRIPTION
Child labour Only people above the minimum working age (18yrs-Sri Lanka labour
law) are need to be recruited.
Forced labour OT are voluntary, No systematic direct body searching, by any
personnel of the factory.No workers original certificates to keep in
the company.
Protection of Vulnerable workers Special attention to pregnant women, Special working conditions to
female workers and young workers. (No more than 10 nights/month
for female workers , Yong workers are not allowed to work in night
shifts and Max OT hours per month is 50).
H & S- Legal authorization & periodic
check
Legal authorization and machine conditions, Machine management
and check-up.
H & S- Risk & safety management Safe working conditions, protection, Risk analysis and capitalization
H & S- Chemicals management Identification, storage and usage of chemicals. Training for protection
from chemicals and preventive actions
H & S-Fire safety/evacuation Immediate and efficient evacuation, Fire control equipment and
installation, prevention and training

SCOPE DESCRIPTION
H & S-Living environment All the personal has free, safe access to toilets, lavatories. Free
access to drinking water at the workplace in adequate supply.
Sub-contracting Confirmation of people employed in external companies working on
the factory premises respect and follow the ICL social ethics.
Disciplinary practices In-house regulations, Freedom to talk/Termination procedure,
grievance and disciplinary procedure.
Working hours The working hour policy displayed and known by the workers (break
time, factory operating hours, days off, OT policy etc..)
The weekly working time doesn’t exceed 72 hrs. Working hours per
day never exceed 14 hrs. The personnel has at least 1 day off for
each 7 day period.
Compensation Minimum salary and Overtime paid must comply with local law.
HR management HR obligations, all regulatory obligations in terms of HR management
are complied with (insurance, seniority conditions, medical visits
etc..)Training and improvement
Management of SA The factory is aware of regulatory information of customer.

 Provides a safe, comfortable working environment.
 Provides a robust system to maintain and continually improve health and safety.
 Minimizing risks of downtime through accidents.
 Maintains compliance with legal requirements under chemical management,
environmental impacts and social accountability.
 Provides quality product and service.
 Increase productivity and minimize delays in production.
 Possible cost savings through reducing rejections, machine maintenance etc.
 Continuous audits create systematic, disciplined working environment.
 New business opportunities can be created through the recognition that ICL
achieves by complying with most of the international standards.
How Quality & HRP Audit Affects The Employees, Working
Environment and to the company?

How to Create Quality Mindset on Employees.
By conducting Continuous Explanations / Trainings about the importance of maintaining the
product quality.

Contact us.
SETH MEDICAL AND SAFETY PRODUCTS (PVT) LIMITED, SRI LANKA.
- +94772009477 / +94773687864 / +94777387864
- safetysethp@gmail.com.
- http://www.sethsafety.com.

Quality Management Systems | Seth Safety Products.

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Quality Management Systems | Seth Safety Products.