ISO 9001 Certification Process
The 9001 Simplified System gives you all the tools to set up an efficient ISO 9001 quality management system that fits the individual circumstances of your organization. To ensure that you’ll succeed, we include here the import, and valuable information about the documents your organisation needs before you are fully ready to be Certified.
Step 1: Preparation
The first step addresses how to properly prepare the implementation of ISO 9001:2015 at your small or midsize company. It’s not a difficult step but it’s important and should not be missed.
Get an Understanding of ISO 9001:2015
The ISO 9001 quality management system focuses on a large variety of business activities – not merely on quality control. Implementing ISO 9001 will, in some way, affect virtually all of your business processes.
Before setting target dates and diving into the actual ISO 9001 implementation, it is important to understand the ISO 9001:2015 requirements and the implementation steps.
ISO 9001:2015 Training
The new ISO 9001:2015 places emphasis on training and awareness programs. Besides being necessary in order to meet ISO 9001 requirements, proper training will any task easier, faster and smoother. The most obvious candidate for ISO 9001 training is your team who at this point may still be wondering how to proceed in order to get ISO 9001 certification. You can ask Us to provide the introduction training free of Charges.
Develop your Documented management System
To achieve your ISO 9001:2015 QMS Certification your next step is to prepare the necessary documents which is mentioned in ISO 9001:2015 as Documented information system.
Here are the documents you need to produce if you want to be compliant with ISO 9001:2015. (Please note that some of the documents will not be mandatory if the company does not perform relevant processes.):
- Mandatory Documents
|S.NO||Document Name||QMS Standard Clause|
|1.||Scope of QMS||Clause 4.3|
|2.||Quality Policy||Clause 5.2|
|3.||Quality Objectives||Clause 6.2|
|4.||Criteria for Evaluation and Selection of Suppliers||Clause no 8.4.1|
- Mandatory Records
And, here are the mandatory records (note that records marked with * are only mandatory in cases when the relevant clause is not excluded):
|5||Monitoring and measuring equipment calibration records*||clause 22.214.171.124|
|6||Records of training, skills, experience and qualifications||Clause 7.2|
|7||Product/service requirements review records||Clause 126.96.36.199|
|8||Record about design and development outputs review*||Clause 8.3.2|
|9||Records about design and development inputs*||Clause 8.3.3|
|10||Records of design and development controls*||Clause 8.3.4|
|11||Records of design and development outputs *||Clause 8.3.5|
|12||Design and development changes records*||Clause 8.3.6|
|13||Characteristics of product to be produced and service to be provided||Clause 8.5.1|
|14||Records about customer property||Clause 8.5.3|
|15||Production/service provision change control records||Clause 8.5.6|
|16||Record of conformity of product/service with acceptance criteria||Clause 8.6|
|17||Record of nonconforming outputs||Clause 8.7.2|
|18||Monitoring and measurement results||Clause 9.1.1|
|19||Internal audit program||Clause 9.2|
|20||Results of internal audits||Clause 9.2|
|21||Results of the management review||Clause 9.3|
|23||Results of corrective actions||Clause 10.1|
There are numerous non-mandatory documents that can be used for ISO 9001 implementation.
|Procedure for determining context of the organization 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)|
|• Sales procedure (clause 8.2)|
|• Procedure for design and development (clause 8.3)|
|• Procedure for production and service provision (clause 8.5)|
|• Warehousing procedure (clause 8.5.4)|
|• Procedure for management of non conformities 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)|
Your organisation should have a clear idea of your objectives and what benefits it will gain by achieving ISO 9001:2015 Certification. You have to be prepared to incorporate the Quality Management Systems into every area of the business.
All staff must be aware of what is expected of them and where their areas of responsibility lie, in order to achieve ISO 9001 Certification.
Documented Information does not equal “piles of papers” and stack of shelf’s full of files. The standard allows documents to be in any form or type of medium, including, but not limited to paper, magnetic, electronic or optical computer disc, photograph, and master samples. Your team can determine what is appropriate for your organization to demonstrate compliance to the standard and your own processes.
Lastly, the days are gone when the ISO Auditor and Management Representative sit with auditor in a conference room for several days and come out with an ISO certificate. Today’s ISO auditor is going to talk with the top executive first and work through the entire organization to get proof that the ISO 9001:2015 QMS is a way of life and not just a row of neat binders on a shelf.
ISO Certification Body- k2A Management is here to help you understand through the standards and make your journey to certification surprisingly simple.