Resources
ISO Standards and Industry Resources

0 1603
Accreditation bodies allow organizations seeking accreditation can demonstrate to their customers that they have been successful at meeting the requirements of international accreditation standards.

An accredited registrar, also called an accredited certification body (CB), is an organization accredited by a recognized accrediting body for its competence to audit and issue certification confirming that an organization meets the requirements of a standard (e.g. ISO 9001 or ISO 14001). There are many benefits of using an accredited registrar when looking to obtain certification for your organization.

Accreditation means an independent, objective body recognizes that an organization is qualified to provide specific services. An accreditation body should assess a registrar’s facilities, procedures and staff against a set of criteria that define acceptable competence levels and capabilities.

There are many registrar companies that offer their services to audit and determine if an organization meets the requirements of a specific standard; however, not all registrars are accredited. An organization may decide to seek certification from any of these registrars, accredited and non-accredited. Nonetheless, choosing an accredited registrar can bring the following benefits to an organization:

  • Organizations can be assured of the registrar’s ability, since the accreditation represents an independent assessment of the registrar’s credibility to perform management system registration.
  • It provides assurance that the certification is based on conformance with internationally accepted practices and procedures, thus offering credibility to the certificate.
  • Many clients and customers require suppliers’ management system is certified by an accredited registrar.
  • Accredited registrars are prohibited to offer both consulting and registration services to one organization, in order to ensure that the value of the certificate will not be compromise due to conflict of interest; on the other hand, some non-accredited registrar do offer both services as one package in order to offer more competitive prices whilst jeopardizing the credibility of the certification.
  • Accreditation assures organizations that a registrar meets specific requirements on an ongoing basis.
  • Accredited registrars can assure that the auditors selected are properly qualified for the industry specialty, and that certification audits will be effective and objective.
  • Accreditation provides an added safeguard against improper and fraudulent activities.
  • In order to maintain accreditation, registrars are pressured to enforce internationally sanctioned registration standards and practices within its organization and among its auditors.
  • Accreditation registrar are often stipulated and supported by local governments.

Organizations that choose an accredited registrar and develop an active relationship with it will ensure the value of its registration certificate, and they can guarantee their customers and clients that their management system has been certified by an unbiased, objective and professional audit.

0 1876

The quality management system (QMS) standard ISO 9001:2008 is currently under review. Like all ISO standards, which go through a revision every 5 years, ISO 9001 is being updated to reflect new technological advancements in the workplace and a to give a higher focus on the quality of outputs to customers.

The review process is currently at the Final Draft International Stage (FDIS), the fifth stage of a six stage process and  the final revised ISO 9001:2015 is due to be published by September 2015. Some of the upcoming changes to ISO 9001:2008 are:

  1. The new ISO 9001 standard aligns with high-level organizational structure established on the ISO Guide 83 (“Annex SL”), requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. This structure aims to facilitate the implementation process and the integration of several management systems in a harmonized, structured and efficient manner. Such structure is as follow:
    1. Scope
    2. Normative References
    3. Terms and Definitions
    4. Context of the Organization
    5. Leadership
    6. Planning
    7. Support
    8. Operation
    9. Performance Evaluation
    10. Improvement
  2. Some concepts are replaced, such as the term “product” is replaced by “goods & services” and “continual” by “continual improvement.” “Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”
  3. The new standard puts a greater emphasis on the “context of the organization” which implies a broader measurement, planning and implementation view.
  4. The new standard will take a risk-based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services. The proposed standard addresses risks which can affect conformity of goods and services as well as customer satisfaction.
  5. Senior management will be required to take a more active involvement in the quality management system.
  6. There will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records. The DIS refers to “Documented Information.”
  7. The need for exclusions may not be considered to be necessary in the new version of the standard but feedback on this is being sought as part of the revision process.

Regardless of the upcoming changes, ISO 9001 will continue to be a generic standard, relevant to all sizes and types of organizations in any sector and it will continue to deliver “confidence in the organization’s ability to consistently provide product or services that meets customer and applicable statutory and regulatory requirements”.

0 1323

No one can deny the increasing impact of human activities on our environment. Our society is ever more preoccupied and occupied on the many issues affecting our environment today, such as pollution, over-consumption of resources, degradation of ecosystems and biodiversity, and an increasing world population that demands resources in the amount and quality that will ensure a decent and fulfilling life.

Organizations everywhere have implemented environmental management systems (EMS) to ensure compliance with an increasingly stringent legislation, control the impacts of their activities, products or services, and increase sound environmental performance.

Implementing and conforming to an EMS based on the ISO 14001 standard not only shows that an organization is environmentally responsible, but it also brings numerous benefits within the organization by:

  • Identifying cost savings with greater emphasis on resources, waste and energy management.
  • Quantifying, monitoring and controlling the impact of operations on the environment, now and in the future.
  • Increasing profits through potential process improvements and energy conservation.
  • Reducing costs as a result of potentially lower insurance rates.
  • Verifying your systems for recognizing and complying with environmental laws and regulations.
  • Improve environmental performance of supply chain.
  • Ensuring that information is properly documented, communicated and retained.
  • Increasing employee awareness and participation by making it clear that environmental performance is an important part of the organization’s culture
  • Improving management of environmental risks and emergency preparedness and response procedures.

Other benefits of ISO 14001 come from how the organization is seen from outside by interested parties, some of these are:

  • Improved corporate image among business partners, regulatory agencies, and community by showing that the organization is environmentally responsible.
  • Improved relationships with government regulatory agencies; organizations that have implemented ISO 14001 find that regulators are quicker to provide technical support, and find that the regulators are much more supportive in general.
  • Advantage over competitors when tendering for business.
  • Grow access to business partners and potential customers.

ISO 14001 provides organizations with knowledge, tools and techniques to build success over the long term and create new opportunities for development and growth. These tools can be aligned with an organization’s priorities, strategy and decision-making by integrating them with other business requirements and embedding environmental governance into its overall management system, thereby achieving both environmental and economic goals.

The market is driving organizations to demonstrate their success in protecting our environment; more and more people want to be environmentally responsible and they are doing so by choosing products and services that have been designed, produced, developed and delivered in an environmentally friendly way. Therefore, in the near future, ISO 14001 will become a prerequisite for doing business worldwide.

0 1331

Today, more and more organizations are deciding to adopt the ISO 9001 standard as a guideline for their quality management system (QMS). With the implementation of ISO 9001, an organization demonstrates its ability to consistently provide products or services that comply with applicable law and meet the demands of its customers. If an organization implements and maintains a successful QMS it will gain a number of benefits.

Benefits of ISO 9001 within the market:

  • Improved image of products or services offered.
  • Level playing field with large companies when bidding for new contracts.
  • Preferential treatment from potential customers who themselves have implemented ISO 9001.
  • Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.
  • For organizations that obtain certification, most certification bodies keep an updated list of certified companies and organizations and provide this list upon request to potential customers or other interested parties.

Benefits of ISO 9001 with customers:

  • Improved customer satisfaction.
  • Obtaining certification will reduce the frequency of audits of the QMS by different customers.
  • Secure customers’ loyalty as their needs and expectations will be continually met, leading to more business opportunities.

Benefits of ISO 9001 for the organization’s QMS:

  • Quality will be seen as everyone’s responsibility instead of being the sole responsibility one person (the quality control inspector or manager).
  • Serve as a means to maintain and improve the effectiveness and adequacy of the QMS, by highlighting areas with potential for improvement.
  • Increase motivation and participation of staff and improve resources management.
  • QMS will provide you with a means of documenting the organization’s experience in a structured manner (quality manual, procedures, instructions, etc).
  • You will generate savings, as the costs of reprocessing, rework, repeat inspections, replacing products, penalties due to delayed deliveries, customer returns, customer complaints and warranty claims will gradually fall.

The biggest benefit to be gained from maintaining a QMS from ISO 9001 is the huge savings an organization can make by considerably reducing the cost of failures. By aiming to consistently produce quality products or services, organizations will reduce waste and thus lower costs. They will have more satisfied customers who will have fewer problems with their product or service.

All these will have a major effect on sales revenue, improve market share and engender in an organization’s customers a higher level of satisfaction.

0 1732

In order for organizations to successfully implement an ISO 9001 Quality Management System (QMS) that provides confidence to customers and serves as an instrument for continuous improvement, the implementation process should be taken up as a project, following these steps and recommendations:

Step 1: Nominate a Team.

  • A small team consisting of a senior person from each department should be appointed by management for system development.
  • A coordinator must be designated.
  • The team should undergo awareness and documentation training on the ISO 9000 family of standards with a professional training organization.

Step 2: Carry out a gap analysis

  • Start with a flow chart showing how information currently circulates, from order placement by the customer to delivery of the product or service.
  • Follow with a flow chart of activities in each department.
  • Formulate a list of existing procedures and work instructions for the most relevant activities in each department.
  • Other activities and processes that are considered relevant at this point can be added.
  • Identify gaps throughout this process.
  • A time-bound action plan to close the gaps identified during this exercise should be prepared and action taken as planned.

Step 3: Prepare documentation

  • Procedures should be limited the documentation that is required.
  • Additional procedures and records should be devised only if they add value to the system.
  • Involve all personnel concerned in the development of the procedures and work instructions applicable to their areas.
  • Documentation should reflect current practice and not ideas of what should be implemented.
  • New forms and checklists should be created if necessary; otherwise adopt existing ones to the extent possible.

Step 4: Train and implement

  • Train all employees. Everyone should know their responsibilities in order to successfully implement and maintain the QMS.

Step 5: Conduct Internal audit and improvement

  • Some managers and staff members should be trained by a professional trainer to carry out internal auditing.
  • Conduct the first internal audit approximately three months from implementation.
  • Correct any gap found during the audit.
  • Once the system stabilizes, internal audits should be conducted at planned intervals.
  • To improve the system internal audits, customer feedback data, process and product monitoring data, evidence of the attainment or not of quality objectives, corrective actions taken, etc. should be used.
  • Management should provide financial and other resources for improvement projects and monitor the progress of improvement.

Step 6: Management review

  • Top management should review the QMS.
  • As a result of this review, management may decide to set new targets for quality objectives and to make the improvements needed in the QMS.

Step 7: Certification

  • Certification is voluntary; therefore the need for it should be decided by management.
  • Once the system has been in operation for a few months, organizations may consider making an application for certification.

An action plan for developing QMS covering the above activities should be prepared. The plan should define the responsibilities of team members and management and set target dates. Full implementation may require six to nine months.

0 1181

If your organization is ready to become ISO 9001 certified, there are a number of steps you can expect to go through on your path to certification. Once an organization has decided to obtain certification and has made a choice of the certification body (CB), the organization must:

 Make a formal certification application to the CB.

  • Fill out the application forms, which require a large amount of information about the organization and its operations. This will enable the CB to determine the scope of the certification activities and to appoint the team leader for the audit process.

 The initial certification audit consists of a two-stage audit as described below:

 The Stage 1 Audit determines if an organization is ready or not for a compliance audit.

  • Organizations need to supply all relevant management and quality documentation to the CB.
  • The CB determines if the organization is ready or not to undergo Stage 2 or compliance audit.
  • If the organization is not ready, the CB will inform accordingly and stop the process.
  • If the organization is ready, but a few nonconformities have to be rectified before the compliance audit can take place, the CB will provide the organization with a report.
  • After nonconformities have been corrected, the organization must inform the CB, and if they concur with the actions taken, a compliance audit is arranged.

 The Stage 2 Audit evaluates the implementation and effectiveness of the organization’s QMS.

  • The team leader assembles a team of auditors and experts concomitant with the organization’s scope of activities, complexities and size of operations.
  • A time for the audit is agreed and scheduled.
  • Auditors will assess whether the contents of the documentation provided is consistent with the activities of the organization as well as the requirements of the standard.
  • Overall findings and the list of non-conformities (if any) are presented.
  • If the QMS complies with the requirements, the team will recommend to the certification committee of the CB that the organization should be certified.
  • If there are non-conformities found, the team will agree with the organization a time schedule (typically 3 months) and the modalities for rectifying the non-conformities.
  • The team may wish to witness the new procedures, or if the non-conformities are of a minor nature, the organization can send them evidence that these non-conformities have been fixed.
  • The team will recommend to the certification committee of the CB that the organization should be certified.

Learn more about Stage 1 and 2 audits.

Certification

  • Authorized persons or a committee which was not involved in the audit will review the audit report and the clearance report of the nonconformities and make a decision regarding certification.
  • The decision will be followed by the issue of certification documents.

 Surveillance Audits

  • The CB will conduct a surveillance audit usually once a year.
  • There are a few areas that will always be included in the surveillance audit, such as internal audits and management reviews as well as the non-conformity system.
  • If any non-conformity is raised during the surveillance audits, the organization must correct them efficiently within an agreed time frame, otherwise certification may be lost.

 Recertification Audit

  • In the third year of certification, a re-certification audit will be conducted, similar to the original compliance audit.
  • If this is negotiated successfully, the organization will be recertified for another three-year period, and the whole cycle repeats itself.

0 1699

The ISO 9000 series of quality standards is the most used management system worldwide; thousands of organizations rely on these standards to establish an effective quality management system. Here are some facts every organization pursuing to implement ISO 9001 should know.

  1. The ISO 9000 family of standards are a set of standards and guidelines that have global reputation as being the basis for the establishment of quality management systems (QMS).
  2. The adoption of all standards published by ISO, including standards in the ISO 9000 family, is voluntary in nature.
  3. In the ISO 9000 series, all standards can be implemented without certification. Any business can use the models from the standards to improve quality management systems.
  4. Many countries have adopted the ISO 9000 family of standards and have also appropriated its numbering system for their national standards. For instance in the United Kingdom, ISO 9001 is referred to as BS EN ISO 9001:2008, with BS standing for British Standard and EN for European Norm. In Sri Lanka, the standard is numbered SLS ISO 9001:2008, with SLS denoting Sri Lankan Standard.
  5. Any organization, regardless of the type of products or services they offer, can use ISO 9001 as their guideline to implement, maintain and improve a successful QMS.
  6. ISO 9001 provides a process approach for its execution, which enables the QMS to connect with other organizational processes; and its focus on continuous improvement and customer satisfaction will lead to an improved business performance.
  7. ISO 9001 specifies what an organization “should” do, but not “how” they should do it, giving great flexibility for any company, large or small, to use this standard. Additionally, ISO 9001 does not establish specific quality requirements; this is a decision taken by each organization; the standard is only a guide to achieve the goals and objectives set by each organization.
  8. Specific industry requirements were added to ISO 9001 to create standards for organizations in the automotive, telecommunications, aerospace, medical devices, oil and gas, and information technology sectors. These QMS standards have not diluted or modified the requirements of the ISO 9001 generic standard, but have added some sector-specific requirements, guidelines and clarifications. Some of these are:
    • Automotive industry:  ISO/TS 16949
    • Medical devices: ISO 13485
    • Primary packaging materials for medicinal products: ISO 15378
    • Petroleum, petrochemical and natural gas industries: ISO/TS 29001
    • Telecommunications industry: TL 9000
    • Aerospace Industry: AS 9100; AS9110 and AS9120
  9. Certification of your QMS by an accredited certification body generates confidence among your existing and potential customers and other interested parties that you are capable of supplying consistently conforming products or services.
  10. Adherence to the ISO standards can be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.

0 1953

Ready to implement ISO 9001 in your organization? Here are some ISO 9001 tips that will help make the process easier.

Implement ISO 9001 for the right reason.

When implementing a quality management system (QMS) for ISO 9001, management should be clear about the purpose of the QMS. If the only driver is to get on customers’ tender lists or because a competitor has already got one, it’s highly likely that the QMS will remain a set of documents for certification purposes only. Rather, management should aim for a QMS that will help the organization produce quality products or services, continuously improve its process, and provide confidence to customers that the organization is capable of meeting their requirements all the time.

Motivate your workforce.

In order for organizations to achieve a desired level of quality, people need to get involved. People are the essence of organizations and their full involvement is essential to implement and maintain ISO 9001. Employees can be motivated by:

  • Ensuring that everyone knows and understands the organization’s quality policy;
  • Defining and communicating responsibilities and authorities within the organization;
  • Building the competence of employees;
  • Providing adequate infrastructure and work environment;
  • Initiating improvements, e.g. by implementing employees’ suggestions.

Hire a consultant if…

If an organization’s staff does not have the time or skills to develop the QMS by themselves, a good consultant will make possible a speedy transfer of knowledge and skills. If the staff does have the time, there are enough published materials available from the web that will help staff obtain the necessary skills to develop the QMS.

Take the necessary time to implement your QMS.

All too often organizations are in a hurry to obtain certification and do not spend the time needed to implement the system effectively. Before applying for certification, your QMS needs to be in place for at least three months and its effectiveness checked through an internal audit, followed by corrective actions on audit findings.

Define SMART objectives.

Many organizations set quality objectives that are impossible to meet. Objectives need to be specific and relevant to the process or task to which they are being applied. They also need to be measurable and achievable within the resources that can be made available in a realistic and timely manner. It’s helpful to have a start and completion date.

Go easy with the paperwork.

Many believe that everything in the system needs to be elaborately documented. ISO 9001 only requires one quality manual, six procedures, and approximately 20 records. Many organizations are better off sticking to what is required and keeping those documents simple; additional procedures and records should be considered only if they add value to the system.

Set the example.

Some employees, especially mid-level managers, may find it difficult to change their ways of doing things and some can have a tendency to deviate from defined procedures. To change this, top management should ‘walk the talk’, i.e. they should not allow deviations from set procedures or permit the release of materials with deviations. Under such an approach, the mid-level managers will start respecting system requirements and everyone will take account of their responsibilities for the success of the QMS.

 

0 2581

Small and large organizations recognize that the implementation of an ISO 9001 quality management system (QMS) in their processes gives them a competitive value. However, the task of implementing and successfully obtaining the certification requires time and money. Therefore, a popular question when deciding to implement is “What is the Cost to Implement ISO 9001?”

There are 2 kinds of costs associated with the implementation of ISO 9001. These are:

  1. The costs for implementation.
  2. The costs for the certification.

In order to effectively estimate the cost for implementation, an organization will have to go through a gap analysis or assessment. However, there are three main factors that an organization should take into account when estimating cost:

  1. The size and complexity of the organization. Is it a small single location organization? or is it a large company  with processes such as design, manufacture, installation, test, etc.?
  2. The type of quality system that is currently in use. Does it have a structured and disciplined system in place? Is the system documented, and how well?
  3. The time that staff and other members of the organization have to devote to the project. Will the organization create everything with its current members? Will it hire someone to guide them? Or, will it hire an ISO consultant to complete the entire process?

The major cost items that every organization needs to consider when implementing ISO 9001 are:

  • Training managers to get them to understand the requirements of ISO 9001
  • Assessment of current quality control practices and creating additional testing facilities routine if necessary
  • Renew the workspace, equipment, machines, public services, supporting facilities, etc, if necessary
  • Review and revamping arrangements for the handling and storage of raw materials, semi-finished and finished products, as appropriate necessary and safe
  • Review existing procedures / practices and listing of new procedures, checklists and records to be prepared
  • Development of QMS related documents
  • Conduct outreach activities of everyone who has roles and responsibilities for implementing the QMS
  • The various expenses such as word processing, stationery and other supplies necessary for the production of manuals, procedures and the like

Regarding the cost of initial certification and costs associated with maintaining certification the main cost items are:

  • Registration and certification fee payable to the certification for a period of three years
  • Fees for the two-stage audit visit nominated by the certification body
  • Audit Committees regularly monitored by the certification agency nominated
  • Travel, accommodation and meals for auditor(s) of certification

The implementation and consequent maintenance of a QMS based on ISO 9001 is an investment of time and money for any organization. The success of the system will rely mainly in the commitment of all its members, especially on how senior management is committed to making ISO 9001 an effective tool to integrate their processes, continuously improve their QMS, and satisfy their customer’s expectations.