*** Malaysia: ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 Consultant ***

Evolution of ISO 9001
The ISO 9001 Standard was first published in 1987. It was essentially based off a British Standard called BS 5750:1979. As ISO Standards are subject to review every 5 years, the ISO 9001 Standard went through further revisions in 1994, 2000, 2008 and 2015. Thus, ISO 9001:2015 is now the current version.

Requirements of the ISO 9001:2015 Standard
The standard comprises of 10 clauses, as follows:

Clause 1 Scope states that the standard may be used by organizations wishing to demonstrate their ability to meet customer and applicable requirements, and to continually improve this ability via the effective application of the system.

Clause 2 Normative references states that the ISO 9000:2015 Fundamentals and vocabulary is an essential reference when applying the ISO 9001:2015 Standard.

Clause 3 Terms and definitions states that the terms and definitions as contained in the ISO 9000:2015 document shall apply.

Clause 4 Context of the organization requires that organizations shall:
  • Identify relevant external and internal issues 
  • Identify issues arising from interested parties
  • Define the scope of the Quality Management System (QMS)
  • Define and document the QMS as per the requirements of the ISO 9001:2015 Standard.

Clause 5 Leadership states that the top management shall:
  • Demonstrate its commitment towards the QMS and be customer focused
  • Establish a Quality Policy
  • Define the roles, responsibilities and accountabilities for the QMS organization

Clause 6 Planning states that the organization shall:
  • Take actions to address the risks and opportunities arising from the identified external and internal issues, and issues related to interested parties
  • Establish relevant quality objectives for the QMS, including the action plans
  • Plan all changes to the QMS before implementing them.

Clause 7 Support states that the organization shall support the QMS with the following:
  • Resources such as people, infrastructure, suitable work environment, monitoring and measuring resources, and organizational knowledge
  • Competent workforce
  • Quality awareness amongst staff
  • Effective communications with internal and external parties
  • Effective control of documented information that are utilised within the QMS.

Clause 8 Operation specifies requirements for the following:
  • Planning and control of operational processes
  • Determination of customer requirements
  • Design and development products and services
  • Control of externally provided processes, products and services
  • Provision of products and services
  • Release of products and services
  • Control of nonconforming outputs.

Clause 9 Performance evaluation states that the organization shall:
  • Monitor and measure key  QMS performance indicators
  • Monitor and measure customer satisfaction
  • Analyse and evaluate all monitoring and measuring data.

Clause 10 Improvement states the organization shall continually improve the QMS by:
  • Improving products and services
  • Correcting, preventing or mitigating undesireable effects
  • Implementing corrective actions on all  detected nonconformities
  • Reviewing the effectiveness, suitability and adequacy of the QMS.

How to certify your QMS
There are essentially the following steps:
  1. Establish and implement the QMS for at least 3 months
  2. Appoint a Register or Certification Body
  3. Set the certification audit dates with the Certification Body
  4. Plan and implement corrective actions for all nonconformity findings as stated in the Audit Report
  5. Receive your ISO 9001:2015 from your Certification Body.












No comments:

Post a Comment