Management System

ISO 9001:2008 CERTIFICATION

ISO 9001 is a Quality Management Standard. It applies to all types of organizations. It doesn’t matter what size they are or what they do. It can help both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.

The ISO 9001:2008 quality certification is based on the following eight fundamental quality management principles:

Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships

The ISO 9000 series of standards have been developed to enable organizations to have quality based management systems. This enables them to understand their customer’s requirements and improve customer satisfaction, through the review and improvement of their internal activities.

The benefits of using the standards are as follows:

Improved consistency of service and product performance
Higher customer satisfaction levels
Improved customer perception
Improved productivity and efficiency
System approach to management
Cost reductions
Improved communications, morale and job satisfaction
Competitive advantage and increased marketing and sales opportunities.

ISO 20000 CERTIFICATION

An ISO 20000 certification aims to establishes that your IT organization is customer-focused able to deliver services which meet defined quality levels making use of resources in an economical way.

As such, the ISO 20000 certificate and the corresponding logo are increasingly a competitive advantage in the market:

Many clients even demand ISO 20000 compliance as a condition for awarding contracts to IT service providers

ISO 20000 CERTIFICATION
ISO 20000 CONSULTANCY
ISO 20000 CONSULTANT
ISO 20000 TRAINING
ISO 20000 AUDIT
ISO 20000 GAP ANALYSIS
ISO 20000 CHECKLIST

ISO 10002 CERTIFICATION

ISO 10001 :2007 customer satisfaction management system & ISO 10002 Complaint handling system. This guidelines draws focus on :

Designing Customer Feedback / complaint handling system
Interpretation of the feedback parameters / complaint parameters
Data Analysis of the feedback / complaint root cause
Continual Improvement projects based on the feedback / corrective actions

In todays competitive world the organizations that are proactive in managing their customers go a long way in establishing themselves as industry leaders. The best way to achieve this leadership is have an efficient customer satisfaction management system and an effective customer complaint handling system. ISO 10001 is the standard for how an organization manages its customer satisfaction process and ISO 10002 talks about how an organization manages its complaint handling system.

ISO 22000:2005 CERTIFICATION

This International Standard ISO 22000 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of this International Standard can be accomplished through the use of internal and/or external resources.

PROCESS OF ISO 22000:2005 CERTIFICATE

To plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer
To demonstrate compliance with applicable statutory and regulatory food safety requirements
To evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction
To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain
To ensure that the organization conforms to its stated food safety policy
To demonstrate such conformity to relevant interested parties and to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to this International Standard.

ISO 27001:2005 CERTIFICATION

Information Security Management Systems Certification (ISO/IEC 27001:2005) covers all types of organizations (e.g. commercial enterprises, government agencies, not-for profit organizations).

ISO/IEC 27001:2005 specifies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving a documented Information Security Management System within the context of the organization’s overall business risks. It specifies requirements for the implementation of security controls customized to the needs of individual organizations or parts thereof.

ISO/IEC 27001:2005 is designed to ensure the selection of adequate and proportionate security controls that protect information assets and give confidence to interested parties.

ISO/IEC 27001:2005 is intended to be suitable for several different types of use, including the following:

Use within organizations to formulate security requirements and objectives
Use within organizations as a way to ensure that security risks are cost effectively managed
Use within organizations to ensure compliance with laws and regulations
Use within an organization as a process framework for the implementation and management of controls to ensure that the specific security objectives of an organization are met.
Definition of new information security management processes.
Identification and clarification of existing information security management processes
Use by the management of organizations to determine the status of information security management activities
Use by the internal and external auditors of organizations to determine the degree of compliance with the policies, directives and standards adopted by an organization
Use by organizations to provide relevant information about information security policies, directives, standards and procedures to trading partners and other organizations with whom they interact for operational or commercial reasons
Implementation of business-enabling information security
Use by organizations to provide relevant information about information security to customers

ISO 13485:2003 CERTIFICATION

Management system for medical device manufacturers (ISO 13485:2003) specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system.

TIPS :

13485 emphasize meeting regulatory as well as customer requirements, risk management and maintaining effective processes.
13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and global regulators.
Benefits can be reaped from being both 9001 and 13485 certified, because 9001 focuses on business aspects not found in 13485 that are good for all businesses.

BENEFITS OF DUAL CERTIFICATION: 13485 & 9001

Medical device manufacturers can benefit from being both 9001 and 13485 certified. While such manufacturers are not required to have 9001 certification, it can bring further business benefits, because it focuses on business aspects that are good for all businesses. For example, the emphasis on customer satisfaction and continuous process improvement that a 13485 management system omits. Manufactures of medical devices also will need to acquire 9001 certification if they wat to branch out to other industries, as 13485 certification will not be honored where 9001

ISO 14001:2004 CERTIFICATION

ISO 14001:2004 specifies requirements for an Environmental Management System to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects.

It applies to those environmental aspects that the organization identifies as those which it can control and those which it can influence. It does not itself state specific environmental performance criteria.

FIVE KEY PHASES :

Phase 1: Establishing the environmental goals (policy).
Phase 2: Planning the elements of the EMS.
Phase 3: Implementing the EMS.
Phase 4: Checking for any problems and correcting them.
Phase 5: Evaluating the effectiveness of the EMS and improving it, and launching into a new cycle of improvement.

BENEFITS OF IMPLEMENTING ISO 14001 :

Reduce cost of waste management
Savings in consumption of energy and materials
Improved compliance
Overall Costs Reduced
Fewer accidents
Competitive advantage
Improved use of resources
Framework for continuous improvement of your environmental performance

OHSAS 18001:2007 CERTIFICATION

OHSAS stands for Occupational Health and Safety Assessment Series. OHSAS 18001 is a consensus standard developed in 1999 by an independent group of national standards bodies and certification bodies (registrars).

OHSAS 18001 is structured the same way as ISO 14001, the environmental management system standard, and has essentially the same elements. It was specifically developed to be compatible with ISO 9001, the quality management system standard, and ISO 14001 to allow companies to develop and register integrated quality, environmental and occupational safety and health management systems.

BENEFITS OF OHSAS CERTIFICATION

Organizations that have implemented a system to improve the management of health and safety practices have reported reduced improved employee safety awareness, fewer accidents and reduced costs. In addition, OHSAS 18001 provides a structure, companies can use to integrate quality, environmental and safety and health program management for increased management efficiencies. Many companies find they need to address health and safety elements as they implement ISO 14001 management systems because of the strong interconnection between environmental and safety and health programs in areas such as emergency planning and risk assessment.

THE ELEMENTS OF OHSAS 18001 AND INCLUDE:

Developing an OHS Policy
Hazard Identification & Risk Assessment
Identifying Legal Requirements
Setting OHS Objectives
Training Employees
Establishing an OHS Management Program
Implementing OHS Control Measures
Emergency Planning
Document and Record Control
Internal Audit Programs
Corrective and Preventative Action
Management Involvement and Management Review
Steps to OHSAS 18000 Certification

ISO/TS 16949:2009 CERTIFICATION

The ISO/TS16949 is an international standard aiming to the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. TS16949 applies to the design/development, production and, when relevant, installation and servicing of automotive-related products. It is based on ISO9001. The requirements are intended to be applied throughout the supply chain. For the first time vehicle assembly plants will be encouraged to seek ISO/TS16949 certification.

BENEFITS OF TS 16949 CERTIFICATION

Identify opportunities for improvement
High quality auditing will ensure that your organization is always compliant with the necessary requirements of TS 16949.
Each participant will receive a seminar manual and a team breakout workbook that includes case studies.
A guide on “how to” audit TS 16949 elements and the objective evidence required will be taught and provided for participants.

TS 16949 IMPLEMENTATION PROCESS

Management Commitment and Support.
TS 16949 Audit/Assessment (Gap Analysis).
Development of an Implementation Plan.
Provide Awareness Training to all employees.
Allocate Resources that will be necessary to develop and implement the system
Prepare Quality System Documentation – Tier 1, 2, 3 documents (Quality Manual, Quality System Procedures, Work Instructions and Quality Records/Forms).
Determine Training Needs of Employees – Job and Employee Skill Matrix (ie. overview of new system, internal auditing, problem solving, teamwork, etc…).
Implement the New System.
Conduct Internal Audits.
Take Corrective Actions, if necessary.
Re-Audit/Follow-up, if necessary.
Registrar Audit Preparation/Training
Registration Application.
Registration Audit.
Registration Certificate Issued.
Maintain, Improve and Innovate the System.
TS 16949 INTERNAL AUDITOR Training

cGMP CERTIFICATION

W.H.O. defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization”.

GMP covers all aspects of the manufacturing process:

Full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints.
Defined manufacturing process;
Validated critical manufacturing steps;
Suitable premises, storage, transport;
Qualified and trained production and quality control personnel;
Adequate laboratory facilities;
Approved written procedures and instructions;
Records to show all steps of defined procedures taken;

The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled – controlling the quality of the facility and its systems, controlling the quality of the starting materials, controlling the quality of production at all stages, controlling the quality of the testing of the product, controlling the identity of materials by adequate labeling and segregation, controlling the quality of materials and product by adequate storage, etc. All of these controls must follow prescribed, formal, approved procedures, written as protocols, SOPs, or Master Formulae, describing all the tasks carried out in an entire manufacturing and control process.

WRAP CERTIFICATION

The Worldwide Responsible Accredited Production (WRAP) program is the worlds largest facility certification program mainly focused on the apparel, footwear and sewn products sectors. Facilities receive a certification of six months to one year based on compliance with the 12 WRAP Principles.

More details can be found at:

CLICK HERE to go through more details on WRAP Certification

HACCP CERTIFICATION

This International Guideline HACCP made by philsbery specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

PROCESS OF HACCP CERTIFICATE

To plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer
To demonstrate compliance with applicable statutory and regulatory food safety requirements
To evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction
To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain
To ensure that the organization conforms to its stated food safety policy
To demonstrate such conformity to relevant interested parties and to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to this International Standard.

REACH CERTIFICATION

REACH Certification – Registration, Evaluation & Authorization of Chemicals

The new European Union chemical policy, REACH (Registration, Evaluation and Authorization of Chemicals), is aiming at ensuring a high level of protection of health and the environment as well as enhancing innovation of green chemicals.

The Regulation (EC) N 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of chemicals (REACH) and Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC (relating to the classification, packaging and labelling of dangerous substances) were published in the Official Journal on 30 December 2006

When REACH comes into force on 1 June 2007, it will replace around 40 existing EU Regulations and Directives so as to provide a single system to regulate chemicals in a more organized manner. Replaces 40 existing EU Chemical Regulations and Directives aims at ensuring a high level of protection of health and the environment and at giving industrials, EU manufacturers and importers a sense of responsibility most industries are affected by REACH (toy, textile, electrical, cosmetic) industries will have to improve the communication through its supply chain; suppliers will have to provide information on substances; information about safety to be communicated to the downstream users and distributors recommends a single system to regulate chemicals of 1 tonne or more on the European market (priorities on high volumes and substances of very high concern SVHC) data base of registered substances managed by the European Chemicals Agency (ECHA, 25 Member States) located in Helsinki, Finland around 30 000 substances will be registered 500 substances are classified as CMR (Carcinogens, Mutagens, Reprotoxic) with 140 priority substances

WHO DOES IT AFFECT

REACH obliges manufacturers or importers to register substances on its own, in preparation or in article they place on the EU market with relevant information with a threshold limit of 1 tonne per annum.Distributors and downstream users will also be concerned by REACH, as they use substances in the course of their industrial or professional activities.

CONSULTANCY FOR GAIN CERTIFICATION

STEP 1 – PLANNING FOR SUCCESS: Obtaining certification against a BRC Global Standard may represent a major challenge to some companies. It is therefore essential that companies interested in becoming certificated consider carefully what needs to be achieved prior to arranging a certification audit.
STEP 2 – GETTING PREPARED: Order a copy of the Standard and assess the compliance of your site to its requirements. The BRC have published guidance documents on best practice and on the use of standards for some sectors which may also be of assistance.
STEP 3 – SELF ASSESSMENT: Review your current systems and practices against the requirements of the Standard in order to identify areas which may need further work before undertaking a full audit. This can be carried out by your own site, by a consultant familiar with the BRC Standard or by asking a Certification Body to undertake a pre-assessment. Please note Certification Bodies are not able to provide consultancy although they can identify areas where further work is required.
STEP 4 – SELECT A CERTIFICATION BODY: Select an accredited Certification Body to carry out the evaluation on your site. Only Certification Bodies that are registered by the BRC can undertake audits. Certification Bodies can be selected by country by clicking here. Certification Bodies will require details of your site and operation before being able to provide a quotation for the audit. Typical audit durations are indicated in the Standards.
STEP 5 – AUDIT: A plan for the audit should be provided by your Certification Body to ensure that you and your team are properly prepared. The audit may be extended if staff or documentation is not available at the audit so preparation is essential. It is important that the site is in production at the time of the audit otherwise a further audit will be required.
STEP 6 – CORRECTIVE ACTIONS: At the end of the audit the Certification Body should provide a written list of any areas which need improvement in order to gain certification, this will also be discussed at the closing meeting. Where non-conformances have been identified, these must be addressed and suitable evidence provided to the Certification Body for assessment within 28 days. In some circumstances it may be necessary for the auditor to return to the site to check that appropriate corrective action has been taken.
STEP 7 – CERTIFICATION DECISION: The Certification Body will review the audit report from the auditor and corrective action documentation provided in order to make a certification decision.
STEP 8 – ISSUE OF REPORT AND CERTIFICATE (IF APPLICABLE): The audit report and certificate (if applicable) should be issued within 42 days of the original audit date to the person who paid for the audit (usually the site). A copy of the report is automatically sent to the BRC to allow quality control checking of the Certification Body undertaking the audit. Certificated sites are invited to have site details placed on the BRC Directory website to advertise their achievements.
STEP 9 – ISSUE OF REPORT TO CUSTOMERS: It is a principle of the BRC scheme that the audit report is owned by the company paying for the audit and copies can only be provided to other parties at the request of the owner (a copy is provided to the BRC and this is held confidentially). It is usual to authorise the release of a copy of the report and/or certificate for customers.

ISO 9001:2008 & HACCP CERTIFICATION

ISO 9001:2008 & HACCP CERTIFICATION

This International Standard ISO 9001:2008 & The Guideline HACCP made by philsbery specifies requirements for a food safety with Quality management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

PROCESS OF HACCP CERTIFICATE:

To plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer
To demonstrate compliance with applicable statutory and regulatory food safety requirements
To evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction
To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain
To ensure that the organization conforms to its stated food safety policy
To demonstrate such conformity to relevant interested parties and to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to this International Standard.

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