Certification/Registration to ISO 9001:2015 QMS - Part 4
Keshav Ram Singhal
What does certification or registration mean?
Certification or registration is not a mandatory requirement of implementing ISO 9001:2015 QMS standard. Certification or registration may be regarded as the formal recognition of your quality management system.
Organizations obtain certification or registration in order to have confidence of their quality management system or the same may be required by their customers. Organizations' decision regarding certification or registration might also be influenced by their competitors or by regulatory or statutory requirements.
Certification is the term most widely used worldwide, although registration is often used in America (most widely in North America) and the two are used interchangeably and having the same purpose.
Certification or registration to ISO 9001:2015 QMS takes place when an accredited third party (Certification or Registration Body) visits and assesses organization's quality management system and issues a certificate to show that the organization meets the requirements of ISO 9001:2015 QMS standard.
Why do customers require their suppliers to have ISO 9001:2015 QMS certification?
The use of quality management system standards has grown since they were first published in 1987. Now ISO 9001:2015 QMS certification has become very important criteria for selecting or identifying suppliers, because customers have confidence that ISO 9001:2015 certified organizations consistently provide product that meet their (customer) and applicable legal (statutory and regulatory) requirements. ISO 9001:2015 QMS is recognized worldwide as a successful management system for ensuring consistent quality. It is a general belief of the customers that the organization, certified to ISO 9001:2015 QMS standard, has a good quality management system in place and provides consistent quality product/service.
How much will certification cost?
This is a general question that organization's people normally ask, when they implement ISO 9001:2015 QMS standard and take decision about certification of their QMS. The cost of certification will depend on the size of the organization, and the particular certification body with whom the organization will choose to work. Certification body may be able to provide details of the cost, if the organization sends them details of the business and size of their organization. It is better to write to certification body to know their certification fee and other costs.
What is accreditation?
It is suggested to obtain accredited ISO 9001:2015 QMS certification. A question may arise in our mind - What is accreditation? Accreditation is a link in the chain of trust. If an organization meets the requirements of ISO 9001:2015 QMS standard, the organization will receive a certificate of conformity from a certification body (also known as assessing body or conformity assessment body) after formal assessment. This certificate has most value if the certification body is professional, impartial, and independent. The accreditation body with the aim of checking the expertise, impartiality and independence of certification bodies carries out accreditation task. If the results is positive, an accreditation mark is issued to certification body.
Accreditation really means 'creating trust'. Accreditation by an authoritative body is the formal recognition of the competence of the certification body to perform a specific task such as analysis, calibration, inspection or certification. Accreditation is the mechanism for indicating that the assessing organization for a demarcated area, the 'scope', justified confidence. Accreditation is the formal recognition that is based upon a series of international standards that focus particularly on the elements of expertise, independence, impartiality and continuity.
Nationally and internationally buyers want to be able to trust blindly the quality and safety of products/services provided by the certified organizations. If these are guaranteed, it not only benefit the buyer but also to the organization that supply the product/service. This strengthens the supplier organization's position in the market. In order to be able to provide an objective guarantee, the organization can have its quality management system assessed by an accredited certification body.
There are a number of accreditation bodies operating in the world that carry out the accreditation work. In India, National Accreditation Board for Certification Bodies (NABCB) grants accreditation to certification bodies with regard to ISO 9001:2015 certification and also a few certification bodies in India have taken accreditation mark from foreign accreditation bodies.
On-site Audit by Certification Body
On-site audit by certification body is also known as 'Implementation audit', 'Compliance audit', or 'Conformance audit'. This is an on-site assessment by the certification body. Certification body sends its auditor/auditors to the site of the organization seeking certification. It is a systematic examination of whether each requirement of ISO 9001:2015 QMS standard is being implemented effectively and the procedures followed. The emphasis is on the objective evidence. The first area generally examined is the findings of the internal audits, management reviews, corrective actions taken, and changes/improvements made in the quality management system. The audit generally consists of the following four steps outlined below:
1. Opening meeting: This is held to introduce the audit team, confirm the audit scope, the timetable, reporting method, and clarify any unclear aspects. Opening meeting is chaired by the auditor-in-charge and attended by audit team members, auditee team leaders including management. Generally an opening meeting is held for a period of 15 to 20 minutes and following matters are communicated during the meeting:
- Introduction of audit team members and their roles in the audit
- Introduction of auditee team leaders and management
- Scope of the audit
- Any guides, if required
- Confirmation about the about the audit process and its reporting
- Confirmation of the auditors' confidentiality about the matters that come to the notice of the auditors
- Any security requirements, if needed
- Information about the closing meeting
- Any other point or question that auditee may
2. Assessment: After the opening meeting auditor will go to the working place of the organization and interview staff at selected locations of the organization to determine how work is carried out in certain areas, establish if it conforms to the organization's policies and procedures, seek objective evidence of the facts and compare the gathered facts with the requirements of ISO 9001:2015 QMS standard. Auditor will then put their observations in writing and ask the auditee to endorse the report. Some of the actions that an auditor may take are as under:
- Ask to see customer complaints and verify actions taken
- Ask to see previous audit reports
- Ask staff how they deal with specific requirements of the standard
- Ask staff why they are performing certain tasks
- Ask staff whether a measuring and monitoring instrument has been checked or calibrated and if so where the evidence is
- Ask management to explain how the quality management system works
- Ask staff about the quality policy and quality objectives.
3. Preparation of assessment report: After the detailed on-site assessment, the auditor will prepare a report detailing observations and identifying nonconformities with the requirements of the standard. The auditor-in-charge of the audit team will draw conclusions from the findings and formulate the recommendations.
4. Closing meeting: At the end there will be a closing meeting to emphasize good points, to explain the audit observations and findings of nonconformities, and to disclose whether or not the organization will be recommended for certification/registration.
Closing meeting is also chaired by the auditor-in-charge and attended by audit team members, auditee team leaders including management. Generally a closing meeting is held for a period of 25 to 30 minutes and following matters are communicated during the meeting:
- Thanks by the audit team for the cooperation extended during audit
- Scope of the audit
- Reconfirmation of the auditors' confidentiality about the matter that came to the notice of the auditors
- Findings of the audit
- Nonconformities and their corrective action timelimit
- The audit is only look at a sample of the quality management system
- Statement of recommendations by the auditor-in-charge, if any
- Invite auditee team leaders including management to place their views
- Auditor-in-charge to thanks each and everyone in the last and close the meeting
Thus we see that the on-site audit is an essential activity carried out by the certification body's auditors to verify that the organization's quality management system is in conformance to the requirements of ISO 9001:2015 QMS standard.
For Training Handbook on ISO 9001:2015 QMS Awareness, please Click Here
For Training Handbook on ISO 9001:2015 QMS Implementation in a School, please Click Here