ISO Certification

What is ISO 9001:2015 and Does My Company Need It?

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What is ISO 9001: 2015? 

ISO 9001 is the international standard that outlines detailed requirements for a quality management system (QMS), risk-based requirements, and commitment. Businesses that follow this standard can prove that they can provide products and services in accordance with customers’ regulatory requirements. The certification improves customer satisfaction through effective record keeping, implementing procedures aimed at improvement of the process, and ensuring product conformity. 

The ISO 9001 standard was originally published in 1987 but the most recent version was released in September of 2015. Businesses that were ISO 9001: 2008 certified should have already transitioned to the 2015 standard by September 14, 2018. 

ISO9001 is a general standard that will benefit any organization. In its current version 9001: 2015 does not apply to any single industry, business size, product, or service. Instead, ISO 9001: 2015 provides the outline and process to give any compliant company the tools to improve their QMS, expand risk-based thinking, and ensure businesses have the procedures in place to maintain these critical processes. 

Other popular ISO standards include:

  • Aerospace – AS9100
  • Medical Device – ISO 13485:2016
  • Automotive – IATF 16949

Can ISO 9001 Certification Benefit My Business? 

Maintaining and managing the quality of any product or service is the foundation on which ISO 9001 is based. A company must document responsibilities and procedures to achieve an effective level of quality and business management to comply with ISO 9001: 2015 standards. 

Topics in the list below are included in the standard: 

  • Outlined quality management system requirements 
  • Clearly defined roles of management to maintain the management processes
  • Business management including, Personnel, Human Resources and Work Environment 
  • Documentation for product design all the way through to delivery
  • Continuous improvement strategies, measurement, and analysis through internal audits, corrective, and preventive action

The Six Quality Management Principles of ISO 9001: 2015 are:

  • Customer Focus
  • Leadership
  • Workforce 
  • Process Approach
  • Improvement
  • Evidence-based Decision Making
  • Relationship and Workforce Management

Businesses of all kinds can gain from the above-mentioned improvements. ISO 9001: 2015 provides an outline for organizations to create a clear and concise QMS, help customers remain satisfied with high-quality products, create an environment that encourages improvement, defined structure to manage risk, and reduce costs. Furthermore, satisfaction among management teams and employees will increase. Accurate documentation eliminates employees’ confusion about who is responsible for what business processes. 

ISO 9001 Standards

ISO 9001 is comprised of 10 sections companies must follow. After the introductory sections, six critical components make up ISO 9001. 

Section 5: Leadership – Top management must play an active role in the implementation of the QMS and processes.

Section 6: Planning – Top management must have a structured plan in place to ensure the ongoing function and utilization of a company’s QMS. 

Section 7: Support – All resources for the QMS must be managed effectively. All documents and records that support the process are required and outlined in detail. 

Section 8: Operation – Product planning, review, design, control of external providers, development and distribution of a product or service, and controlling noncompliant process outputs must be planned for and documented. 

Section 9: Performance Evaluation – Businesses must have a way to track the performance of the QMS. 

Section 10: Improvement – A continuous improvement plan for the QMS and risk management is required. 

ISO 9001 – How to Get Started

There are two types of certifications. One is the certification of a company’s QMS against ISO 9001, and the other is a certification that allows individuals to internally audit a company against ISO 9001 requirements. 

For a company that wants an ISO 9001 certification, a recognized certification body must audit and approve a QMS. There is an incredible amount of moving parts when it comes to obtaining an ISO 9001 certification. From management support and identifying customer requirements of a QMS to an organization’s ability to create and deliver a product or service within the guidelines of ISO 9001 standards, each process must be compliant. Businesses must define the scope of implementation of the QMS and the mandatory and additional processes and procedures that assist in product development and resource management are required to be documented. 

After all the required documentation is completed to implement a continuous improvement QMS strategy, there are additional steps needed to achieve ISO 9001 certification:

  • Internal audit – Reviewing the QMS process and plan to manage the ability to manage and maintain records must be able to be effectively implemented.
  • Management Review – Management must complete a formal review of the process and resources assigned.
  • Corrective Actions – The root cause of any identified issues must be identified and documentation must be created to address how they were resolved. 

Final certification happens in two separate stages:

  • Stage One – Documentation review – Certification auditors will check the submitted documentation to see if it meets all requirements of ISO 9001.
  • Stage Two – Main audit – Certification body auditors will review the steps being taken by a company to ensure they are compliant with ISO 9001 standards. 

Ask an Expert if ISO 9001 is Right for You

Taking the step to become ISO 9001 certified is a challenge without the right support. NJMEP has ISO 9001 experts at the ready to support any New Jersey business interested in exploring ISO and the benefits it can offer an organization

Asking a qualified expert if and how a business strategy shift like implementing ISO 9001 into an organization is the right move will be essential. Moving forward with an in-depth certification process without understanding the time and effort it requires on one’s own is the wrong decision. NJMEP is equipped with the necessary experience to ensure an ISO 9001 certification process moves forward seamlessly. Additional funding opportunities are often available as well. 

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