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ISO- 9001

ISO- 9001

ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.

ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.

Who should use the ISO 9001:2015 revision?

ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.

Organizations of all types and sizes find that using the ISO 9001 standard helps them:

  • Organize processes
  • Improve the efficiency of processes
  • Continually improve

All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others.

What topics does ISO 9001:2015 cover?

ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on topics such as:

  • Requirements for a quality management system, including documentation of a quality manual, document control, and determining process interactions
  • Responsibilities of management
  • Management of resources, including human resources and an organization’s work environment
  • Product realization, including the steps from design to delivery
  • Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action.

Looking for a longer introduction to the ISO 9001 standard and the process approach?

Changes introduced in the 2015 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include the introduction of new terminology, restructuring some of the information, an emphasis on risk-based thinking to enhance the application of the process approach, improved applicability for services, and increased leadership requirements.

How do I get started with ISO 9001:2015?

Organizations and individuals that use ISO 9001 are encouraged to transition to the 2015 revision as soon as possible. However, the International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment (CASCO) have agreed to a three-year transition period from the publication date of ISO 9001:2015.

What are the benefits of ISO 9001:2015?

ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.

Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:

  • Organize processes
  • Improve the efficiency of processes
  • Continually improve
  • Organize a QMS
  • Create satisfied customers, management, and employees

ISO 9001:2015 as a “business management tool”

In an article for ASQ’s QP magazine, Oscar Combs summarizes results of a Harvard Business School study comparing 916 organizations that have adopted ISO 9001 and 17,849 non-adopters. As Combs explains, the “business benefits” enjoyed by the ISO 9001 organizations included higher rates of survival and growth, increased wages, reduced waste, enhanced productivity, and improved health and safety performance.

ISO 9001:2015- Process to obtain the certification

  • Identify the requirements of ISO 9001:2015 to your organization.
  • Make Decision for ISO Implementation/Certification.
  • Get skilled team or hire services of consultant.
  • Identify GAP Analysis.
  • Make Implementation Plan.
  • Opt PDCA [Plan-Do-Check-Act] cycle.
  • Design, implement, aware about the Quality Policy, QMS Manual & SOP (Standards Operating Procedure).
  • Establish & evaluate the system and procedure.
  • Identify the boundaries of the management system and produce documented procedures as required.
  • Ensure these procedures are suitable and adhered to.
  • Once developed, internal audits are needed to ensure the system carries on working.

ISO 9001 Assessment Process

The ISO 9001 standard covers every part of your business management systems. It is therefore vital to appoint an assessor who has the experience to implement ISO 9001 certification across all areas of your organization.

This will give you the most effective quality management system that will work for your business. It will provide a system that can be constantly monitored and improved upon by your internal team. In addition, an external assessor will bring in expertise and best practice from a wider industry perspective. This will help to ensure that when the audit is done, your management systems comply with the requirements of ISO9001.

Other things you will need to consider:

  • Gain support from employees throughout the organization
  • Allow 3 to 6 months to achieve certification
  • Gather information on current systems
  • Compare and improve current systems in line with ISO 9001 requirements
  • Develop and review your quality manual and ensure it meets the requirements of ISO 9001
  • Identify non compliance areas
  • Set up a monitoring schedule
  • Review any training requirements for employees
  • Do a company management review and internal audits
  • Set a date for your first audit
  • ISO 9001 Regular Auditing Procedure

Once you have successfully negotiated your first audit, it is important to continue to monitor the process and improve your systems.

Annual surveillance visits need to be arranged; this will help to ensure that the re-certification audit carried out every 3 years is a formality rather than a major process overhaul.

During the audit you will be assessed on:

  • Documentation control
  • Records being kept
  • Staff and management conformance to the system
  • How the system is working in each area of the organization
  • Staff training necessary to meet the requirements