ISO 9001 & ISO 14001 Standards

ISO 9001:2008 Documentation Requirements
ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”
ISO 9001:2008 Clause 4.2.1 General explains that the quality management system documentation shall include:
documented statements of a quality policy and quality objectives;
a quality manual
documented procedures required by this International Standard
documents needed by the organization to ensure the effective planning, operation and control of its processes, and
records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.
Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:4.2.3 Control of documents4.2.4 Control of records8.2.2 Internal audit8.3 Control of nonconforming product8.5.2 Corrective action8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3
Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:- Quality policy (clause 4.2.1.a)- Quality objectives (clause 4.2.1.a)- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:- Process maps, process flow charts and/or process descriptions- Organization charts- Specifications- Work and/or test instructions- Documents containing internal communications- Production schedules- Approved supplier lists- Test and inspection plans- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.

Goal and Scope of an ISO 9000 quality system

The ISO 9000 Standard states its goal in two blunt words: customer satisfaction.How do we achieve customer satisfaction? By meeting customer requirements.The quality management system (QMS) helps us to dothis by:
a. Applying the system. Actually using it. Putting it at the heart ofour organization.b. Continually improving the system. The QMS is never done. Afterall, customer requirements do not stand still—they evolve and grow tougher.So we have to improve continually in order to survive.
(The guidance document, ISO 9004: 2000, sets a compatibleand in some respects more ambitious goal: “improving theprocesses of an organization to enhance performance.”) Prevention of nonconformity. Prevention is the key term here: prevention,rather than detection. Quality management has longsince evolved away from the old “inspect quality in” approach.Prevention is cheaper, more effective, and more protective of thecustomer. Detection is also a different mindset. It requires a veryhigh degree of process orientation, upstream thinking, and relentlessanalysis.To what types of organizations does the Standard apply? Alltypes. The requirements “are generic and applicable to all organizations,regardless of type and size.” A compliant QMS can be implementedby any organization, producing any product or service,anywhere in the world.Within the organization, the impact of the requirements and the QMS are similarly broad. The Standard “applies to the activities of organizationsfrom the identification of customer requirements, throughall quality management system processes, to the achievement of customersatisfaction.” Every activity within the organization that impactsthe process of creating customer satisfaction is affected by therequirements of the Standard.

ISO 9001 Standards – Management Review

Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system

 

- Evaluate the need for any changes to the system

- Consider the need for changes to the quality policy and objectives

Maintain records of the management reviews.

Inputs for management review must include information on:

- Results of audits

- Customer feedback

- Process performance and product conformity

- Status of preventive and corrective actions

- Follow-up actions from earlier reviews

- Changes that could affect the quality system

- Recommendations for improvement

Outputs from the management review must include any decisions and actions related to:

- Improvement of the effectiveness of the quality management system and its processes

- Improvement of product related to customer requirements

- Resource needs

ISO 9001 Standards - Design and Development

Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions

- Stages of design and development

- Appropriate review, verification, and validation activities for each stage

- Responsibility and authority for design and development

The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.

NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.

Determine product requirement inputs and maintain records. The inputs must include:

- Functional and performance requirements

- Applicable statutory and regulatory requirements

- Applicable information derived from similar designs

- Requirements essential for design and development

Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.

Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:

- Meet design and development input requirements

- Provide information for purchasing, production, and service

- Contain or reference product acceptance criteria

- Define essential characteristics for safe and proper use

- Be approved before their release

Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:

- Evaluate the ability of the results to meet requirements

- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

ISO 9001 Standards - Control of Measuring and Monitoring Equipment

- Calibrate and/or verify the measuring equipment at specified intervals or prior to use

- Calibrate the equipment to national or international standards (or record other basis)

- Adjust or re-adjust as necessary

- Identify the measuring equipment in order to determine its calibration status

- Safeguard them from improper adjustments

- Protect them from damage and deterioration

Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.

Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).

NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

For More Information Please Visit http://www.iso9001-standard.us

ISO 14001 is a series of international standards on environmental management. It provides a framework for the development of an quality management system and the supporting audit programme.· A management commitment to pollution prevention.

The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.

ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.

Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.

Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).

Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.

ISO 14000 is a series of voluntary standards and guideline reference documents.

The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.

Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).

Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.

ISO 14000 is a series of voluntary standards and guideline reference documents.

The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.

· An understanding of the environmental impacts (reducing) of an organization’s activities.

A commitment (pollution prevention) to employees, neighbors and customers

ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.

The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.

ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.

Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.

The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).

The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.

The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.

As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.

In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.

The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:

· implement, maintain and improve an environmental management system

· assure itself of its conformance with its stated environmental policy

· demonstrate such conformance to others

· seek certification/registration of its environmental management system by an external organization

· make a self-determination and self-declaration of conformance with this international standard.

All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)

- An Romania Perspective

The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.

Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.

The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.

Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.

Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.

ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.

The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.

Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.

The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.

ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.

The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.

The documentation of QMS involves:

1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)

2. Management Responsibility

3. Resource Management

4. Product Realisation

5. Measurements, Analysis and Improvement

A well managed quality system will have impact on:

1. customer loyalty and repeat business

2. market share

3. operational efficiencies

4. flexibility and ability to respond to market opportunities

5. effective and efficient use of resources

6. cost reductions

7. competitive advantages