ISO 9001:2015

What is ISO 9001:2015?

ISO 9001:2015 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard. ISO 9001 is the internationally recognized standard for the quality management of businesses. It applies to the processes that create and control the products and services an organization supplies. It prescribes systematic control of activities to ensure that the needs and expectations of customers are met. It is designed and intended to apply to virtually any product or service, made by any process anywhere in the world.


The Benefits of implementing ISO 9001:2015:


Is Concept Quality Assurance labs an Accredited body ?

Yes, CQAL Certification Services are internationally recognized and accredited by Accreditation Commission for Conformity Assessment Bodies(ACCAB) for QMS certification scheme with the scope covering majority of areas. Refer to Certificate of Accreditation

ACCAB LOGO (QMS)

Certification Process:

Pre Audit

Client interested in obtaining certificate of registration under QMS scheme from CQAL, shall have established a documented quality system in accordance with the requirements of current version of the ISO 9001 standard and the applicable product standards.

CQAL Certification Services reviews the submitted documentation against the requirements of ISO 9001 standard and prepares a report detailing its finding. The deficiencies, if any, will have to be corrected prior to assessment, since this documentation will form a part of assessment criteria during assessment.

Stage – 1 Audit

Stage 1 assessment shall include – Review of quality manual/ procedures, supporting documentation, evaluation of client’s location, assessment of preparedness for stage 2 audit, collecting of information regarding the scope of the management system, statutory and regulatory aspects, legal aspects and risks and processes and locations, preparation of an audit plan for stage 2 audit, evaluation of internal audits and management review performed by the customer.

Stage – 2 Audit

Stage 2 assessment is an on-site assessment which includes

- Evaluation of the implementation, including effectiveness of the client’s management system

- Evidence about conformity to all requirements of the applicable standard or scheme

- Performance monitoring and reviewing against key performance objectives and targets

- Conformance to regulatory and legal aspects relevant to the standard

- Operational control of the client’s processes

- Internal auditing, management review and management responsibility, competence of personnel, performance data, audit findings and conclusions

- Links between the normative requirements, policy, performance objectives and targets


Certification

CQAL Certification Services will issue a certificate of registration to the applicant once the corrective action has been accepted. The certificate carries a validity of three years from the date of issue subject to satisfactory findings during surveillances.

The certified clients are committed through signing of certification agreement to comply with the certification body’s requirements.


Surveillance Audit

-  Annual surveillance method – which includes conducting one surveillance audit annually, and performing a Recertification every third year

-  Semi-annual surveillance method – which includes conducting two audits annually and a Recertification every third year

- Implementation or the corrective actions required by the previous audit

- Review of changes in the organization

- Management reviews

- Internal system audits

- Customer complaints

- Corrective and preventive actions

- Scopes/activities that have changed since the last audit

- Customer complaints & appeals received in the Division concerning the organization

- Use of marks (certification logos)


Renewal

The client’s quality system is re-assessed for the renewal of certificate. All actions related with renewal (including completion of corrective actions) shall be completed before expiry of certificate to ensure continuity of certificate.


 

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Are we ready for certification audit? What is the cost of an audit to ISO 9001:2015? When can we get audited? Please Contact us for more information!