ISO 9001 Certification
You can apply for an audit of your QMS according to the current standard ISO 9001:2015. Our audit teams audit locally in most jurisdictions around the world. The ISO 9001 auditors inspect your Quality Management System in over 7 different languages (English, German, Dutch, Spanish, French, Turkish and Polish). Apply now for an ISO 9001 Certification! Is your main business location is in USA, Europe, Africa or Asia? Certification audits are possible in many regions.
ISO 9001 Certification Areas
Within the ISO 9000 Standard is the main core standard 9001, which is the required certification for any kind of Addon. If your organization has never been through an audit and you have just recently introduced your QMS, then focus on ISO 9001 Certification. Once your QMS has a substantial maturity, you can go for expanding your ISO 9001 certificate with special certifications.
Quality Management
QMS: Reliable products and services required processes and policies that drive quality control and continuous improvement.
ISMS: Implement a management system to protect the data in your company with a ceetified information security
Environmental Management
EMS: Protecting the environment is so important as it can destroy nature and risk the health of local communities.
What is ISO 9001?
The international Standards Organisation (short: ISO) introduced the ISO 9001 standard in order to help organisations set up and operate a management system, which is geared towards the quality process of any kind of product or service delivery. Such quality processes may include sales processes, new product develepment, research, manufacturing, customer support and delivery.
The ISO 9001:2015 standard has following structure:
- Clause 0: Introduction,
- Clause 1: Scope,
- Clause 2: References,
- Clause 3: Terms and Definitions
- Clause 4: Context of the organization
- Clause 5: Leadership and commitment
- Clause 6: Planning for the QMS
- Clause 7: Support & resource management
- Clause 8: Operational planning and control
- Clause 9: Performance evaluation
- Clause 10: Improvement actions
Why can an ISO 9001 certification be beneficial to you?
When an organization decides to become ISO 9001 certified, they undergo a journey towards building their QMS documentation. All relevant processes need to be written down and displayed in graphical workflow maps. This allows staff to better understand the correct work flows and prepare for applying the new quality control measures. Thereby, the organisational processes achieve a greater maturity. Once the certification audit is successfully completed, the ISO 9001 certificate will show to outsiders following positive aspects:
- Greater quality output
- Regular quality improvements
- Greater trustworthiness
- Greater reliability
- Lower risk to low quality outcomes
Furthermore, an organization also experiences following inner improvements:
- improved internal processes and efficiency
- qualifying for tenders and longterm contracts
- less production waste and fewer defektive products
- increased ability to gain business overseas
- fewer import / export restrictions
- faster cashflow due to higher demand
What is required for ISO 9001:2015 certification?
The ISO 9001:2015 standard requires following items to be compliant within the QMS documentation in order to issue a certificate:
- Scope of the QMS (clause 4.3)
- Quality policy (clause 5.2)
- Quality objectives (clause 6.2)
- Criteria for evaluation and selection of suppliers (clause 8.4.1)
- Monitoring and measuring equipment calibration records (clause 7.1.5.1)
- Records of training, skills, experience and qualifications (clause 7.2)
- Product/service requirements review records (clause 8.2.3.2)
- 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 10.1)
Which documents are not mandatory for a QMS audit?
The following documents are not mandatory, unless the organization’s nature makes it necessary to have them in place:
- Procedure for determining context of the organisation and interested parties (clauses 4.1 and 4.2)
- Procedure for addressing risks and opportunities (clause 6.1)
- Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3)
- Procedure for equipment maintenance and measuring equipment (clause 7.1.5)
- Procedure for document and record control (clause 7.5)
- Procedure for Sales (clause 8.2)
- Procedure for design and development (clause 8.3)
- Procedure for production and service provision (clause 8.5)
- Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2)
- Procedure for monitoring customer satisfaction (clause 9.1.2)
- Procedure for internal audit (clause 9.2)
- Procedure for management review (clause 9.3)
How will the audit plan be influenced by the statement of applicability?
Our audit teams follow an audit plan which takes your organisation’s specific industry sector and business model into consideration. The compliance of your QMS will be reviewed in relation to the different chapters and parts of Annex A. In order to conduct a proper audit, it is necessary for the audit client to name staff members, who can answer questions in relation to parts of the audit plan. An organisation must review regularly its statement of applicability (SoA), in order to decide which controls are necessary. Auditors will will review the SoA and question in particular controls that have been stated as not applicable. The controls marked as applicable will also be inspected but in a different way.
How much will the audit and ISO 9001:2015 certification cost?
The cost of an ISO 9001:2022 certification process is dependent on the size and risk profile of the organization. The IAF MD 5 Standard document provides an average number of audit days for an organization of average risk and certain number of included staff. Our audit estimators evaluate the to be expected audit time in relation to company specific parameters. Some factors allow for a reduction of audit duration and thereby positively reducing the audit costs.
Where risks require additional depth of audit activities, the audit plan will have to allocate extra time for it. This increases the audit time and the audit related costs. In addition if auditors have to travel to the client’s operational locations, the client organization will incur additional travel expenses. The ISO standard allows for up to 30% of the audit to be conducted as remote audit. If the company structure (home office) or the situation (e.g. pandemic) required a 100% remote audit, the certification body is required to gain consent from the respective accreditation body. Remote audits avoid travel costs and are usually ideal for “virtual organizations” (e.g. 100% home office based teams).
| Number of persons doing work under the organization’s control | QMS audit time for initial audit (auditor days) |
|---|---|
| 1~5 | 1,5 |
| 6-10 | 2 |
| 11-15 | 2,5 |
| 16-25 | 3 |
| 26-45 | 4 |
Above table is based on the IAF MD 5 document (Annex A, Table QMS 1).
FAQ for ISO 9001 Certification
The cost of your ISO 9001 certification will be quoted based on organization size and risk profile. The offer will contain a fixed fee basis and the estimated audit days. This will allow you to better budget your certification project.
The cost of certification will depend on:
- your organisation’s total size
- the sector you operate in
- the number of locations you operate from and their particular activities
- your organisation risk profile
You will be assigned an account manager who coordinates the first stage of your journey towards the ISO 9001 certificate. This person will get you a fixed fee quote and gather the key details of your desired scertification scope.
The lead auditor will then arrange with you a 1-2 hour call to check that all aspects of your sik profile have been considered and that the audit plan structure matches the availability of the key people in your organization.
Once you have completed the audit, the account manager will keep you updated while the audit documentation is being processed by the compliance team in the certification body. After a positive review the ISO 9001 certificate will be issued to you.
We will also help you understand how to best use the certificate and associated logos, in order to avoid conflicts with the ISO rules.
Stratlane's accreditation is a key part of the assurance we can guarantee those who trust you by trusting your certificate.
Our accredited ISO 9001 certificates include not only your logo but also the logo of the accreditation body and respective accreditation associations.
Let's Get Your Company Certified!
Make use of our certification services so that your businesss gains the competitive advantage of having accredited ISO certifications.