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 Requirements1. 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 14001:20041. 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 Requirements1.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 AUDITSSCOPE 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.