How to get ISO 9001:2015 certified
Getting certified to ISO 9001 implies that your organization is credible and that you value your service and also showcases that your products and services meet the expectations of the customers.
A few points to keep in mind:
- Cost/ expenses for registrar to get ISO 9001 certification
- Conformance levels i.e. Meeting ISO 9001 Requirements
- Resource allocation for development and implementation for the ISO 9001 standard
ISO 9001 certifications can be issued only to companies and not for individuals. However, individuals can get qualified as ISO 9001 auditors that include internal and lead auditors.
- QMS process – The primary step in getting certified to ISO 9001 is to create and implement a Quality Management System (QMS) in accordance with the latest ISO 9001 standard requirements
- Auditing – The next step is to have your audits assessed by a certified body or a registrar in order to determine the performance of your QMS as per the requirements of the 9001 standards.
- Certification – The final step is receiving the certification; after which your organization will have to be re-certified after a period of 3 years to make sure your organization is meeting the latest QMS requirements.
Key requirements of ISO 9001:2015?
There are numerous reasons for the global adoption of this QMS standard. The standard is flexible and does not dictate companies to employ a certain set of specific standards. Rather, the objectives of the standard can be defined by the company that adopts the ISO 9001:2015.
The major requirements for a Quality Management System (QMS) are mentioned in ISO 9001. ISO 9001 is mainly divided into 10 sections (Clauses) along with additional sub-clauses related to the Plan-Do-Check-Act system. However, only sections 4-10 contain requirements that are auditable clauses. It is important to satisfy the requirements within clauses 4-10 as well as in order to implement ISO 9001:2015, they have to satisfy by meeting customer and applicable statutory and regulatory requirements.
Below are the lists of documents required for companies to become compliant with ISO 9001.
- Scope of QMS
- Quality Management system and processes
- Quality policy
- Quality objectives
- Process and sequence interaction matrix
- Risk and Opportunity assessment
- Criteria for evaluation and selection of suppliers
- Documents / records / procedures / instructions master list
These are the mandatory records that must be kept (note that records indicated with * are only required in cases when the relevant clause is not excluded):
- Monitoring and measuring equipment calibration records* (clause 188.8.131.52)
- Records of training, skills, experience, and qualifications (clause 7.2)
- Product/service requirements review records (clause 184.108.40.206)
- Record about design and development outputs review* (clause 8.3.2)
- Records about design and development inputs* (clause 8.3.3)
- Records of design and development controls* (clause 8.3.4)
- Records of design and development outputs *(clause 8.3.5)
- Design and development changes records* (clause 8.3.6)
- Characteristics of product to be produced and service to be provided (clause 8.5.1)
- Records about customer property (clause 8.5.3)
- Production/service provision change control records (clause 8.5.6)
- Record of conformity of product/service with acceptance criteria (clause 8.6)
- Record of nonconforming outputs (clause 8.7.2)
- Monitoring and measurement results (clause 9.1.1)
- Internal audit program (clause 9.2)
- Results of internal audits (clause 9.2)
- Results of the management review (clause 9.3)
- Results of corrective actions (clause 10.2)
Omnex Certificate Accreditation – Exemplar Global QM, AU & TL/ Omnex
Omnex follows Exemplar Global, a worldwide recognized “Training Provider and Examiner Certification Scheme (TPECS)”, and depending on the courses and examination you have chosen to become qualified. The courses offered by Omnex comprises of three separate Exemplar Global Competency Units with the following objectives:
Exemplar Global-QM (Understanding the QMS requirements)
Exemplar Global-AU (Understanding the Auditing requirements
Exemplar Global-TL (Understanding the Lead Auditing/Team Leader requirements)
Omnex specializes in Quality Management Systems methodologies such as ISO 9001, IATF 16949, QOS/BOS, APQP (new product development), SPC, MSA, and Management of Continuous Improvement. Additionally, Omnex provides extensive services in Environmental Management Systems (EMS) ISO 14001 and Safety Management Systems ISO 45001. Omnex consultants have been involved in the development and implementation of Quality, Environmental, and Safety Management Systems and methodologies at over 500 client sites. Omnex has benchmarked credentials in achieving zero non-conformity certification to the standard sought.
Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global QM, AU, and TL Competency Units. Our seminar leaders have conducted Consulting, Implementation, & Coaching, Training & Competency Development, and Auditing in QMS, EMS, and OH&S at various client locations globally.
Trainings offered by Omnex
We have Private Training available for more than 5 people from an organization. This training is provided at your location.
Consulting, Implementation & Coaching
Click here to know how Omnex can help you with Consulting, Implementation, & Coaching support for ISO 9001.