How to Obtain the ISO 9001 Certification in 4 Steps.

This article explains how to get the ISO 9001 Certification in 4 steps.

ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001 certification means that an organization has demonstrated the following 4 steps:

1. Follows the guidelines of the ISO 9001 standard.
2. Fulfills its own requirements.
3. Meets customer requirements and statutory and regulatory requirements.
4. Maintains documentation

Certification to the ISO 9001 standard can enhance an organization’s credibility by showing customers that its products and services meet expectations. In some instances, or in some industries, certification is required or legally mandated. The certification process includes implementing the requirements of ISO 9001:2015 and then completing a successful registrar’s audit confirming the organization meets those requirements.

Organizations should consider the following additional four (4) steps as they begin preparing for an ISO 9001 quality management system certification:

1. Registrar’s costs for ISO 9001 registration, surveillance, and recertification audits.
2. The current level of conformance with ISO 9001 requirements.
3. Amount of resources that the company will dedicate to this project for development and implementation.
4. Amount of support that will be required from a consultant and the associated costs

Read “What’s the cost?” for a checklist you can use to assess the costs of the ISO 9001 certification.

Note: CIQA does not issue ISO 9001 certification.

Example Quality Manual

Need to write a quality manual that conforms to ISO 9001:2015?

Download an example quality manual and read about how to create one.

ISO 9001 Certification Videos

• ISO 9001:2015 – 15 Things You Must Know Now
• Transforming a QMS Using ISO 9001

Other standards related to quality management systems include the rest of the ISO 9000 series (including ISO 9000 and ISO 9004), the ISO 14000 series (environmental management systems), ISO 13485 (quality management systems for medical devices), ISO 19011 (auditing management systems), and ISO/TS 16949 (quality management systems for automotive-related products).

Need help on your ISO 9001 certification or need templates to create a quality manual and procedures, visit us,

SUBSCRIBE AND FOLLOW US TO LEARN MORE ABOUT ISO 9001 CERTIFICATION.

For more details on specific FDA expectations and how to create quality management system documents necessary for the ISO 9001 Certification, follow us.

Three (3) Options to Create Quality Management System Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the quality procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on the ISO 9001 Certification?

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Management Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

For more information about ISO 9001, refer to:

httpss://asq.org/quality-resources/iso-9000

httpss://the9000store.com/what-are-iso-9000-standards/

httpss://www.iso-9001-checklist.co.uk/iso-9000-standards.htm

httpss://en.wikipedia.org/wiki/ISO_9000

httpss://the9000store.com/iso-9001-2015-requirements/what-is-iso-9001-quality-management-system/

httpss://asq.org/quality-resources/quality-management-system

httpss://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100080.pdf

httpss://www.fda.gov/files/drugs/published/Overview-of-Quality-System-Regulation.pdf

httpss://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

httpss://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation

httpss://ispe.org/initiatives/regulatory-resources/gmp

httpss://www.fda.gov/media/73141/download