ISO 9001 Standard certification belongs to the family of ISO 9000 quality management systems. The certification designates a company entirely capable of meeting their customer’s requirement and is persistently working on improving the quality of their products and services. ISO 9001 is crowned as the widely used management system in the world today.
What’s ISO 9001?
An ISO 9001 certification dignifies a company that it ensures business risk identification and control, its protection, customer satisfaction along with accomplishing statutory and regulatory requirements in relation to the product. ISO 9001 singularly stands as the directed audit against any third party assessment purposes.
ISO 9001 is globally adopted which is attributed to majority of factors listed as follows:
Several major purchasers insist on their suppliers to be ISO 9001 certified.
A Risk Based approach in implementing management system to mitigate business and operational risks.
Number of stakeholders benefits
A series of studies have analyzed the compelling financial benefits for companies that are certified to ISO 9001.
New structure of ISO 9001 Standard has aligned with the common ten clauses to ensure greater harmonization among its many different management system standards. The new standard is risk based process approach based. This standard will help organizations for integrate the requirements of more than one ISO Management system standard.
The Main differences in content between the new and old version?
• The adoption of the high level structure as set out in Annex SL of ISO Directives Part 1,
• An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach,
• Fewer prescriptive requirements,
• More flexibility regarding documentation Improved applicability for services,
• A requirement to define the boundaries of the QMS Increased emphasis on organizational context,
• Increased leadership requirements,
• Greater emphasis on achieving desired process results to improve customer satisfaction,
Clauses for ISO 9001:2015 certification are:
Section 1: Scope
Section 2: Normative references
Section 3: Terms and definitions
Section 4: Content of the organization
Section 5: Leadership
Section 6: Planning for the quality management system
Section 7: Support
Section 8: Operation
Section 9: Performance evaluation
Section 10: Improvement
There are some guidance for understand the requirement of ISO 9001:2015.
• Understand your firm and determined inner issues such as related to values, culture, knowledge and performance of the firm and external issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether global, national, regional or local.
• Who are the relevant interested parties (the preferred term to stakeholders) and what are their needs? Generally customers of course – so what do they want? always better products/services as per their needs, and on time. Other interested parties could be end users, suppliers, distributors, retailers or others in the supply chain, regulators etc.
• You need to determine QMS scope and where are the boundaries of the management system? What is in and what is out? This needs to be appropriate to the firm and its objectives
• Exclusion term is not now used and replaced by applicability and non applicability.
• You need to document the scope.
• There is no change in this requirement just an improved the version.
• You need to determine what your processes are (including support/management processes.)
• There is more here; top management now has to have a greater involvement in the management system.
• Customers have to demonstrate their commitment by making sure that the management system achieves its intended outcome and has adequate resources. Also they have to inform everyone that the management system is important and that everyone should participate in its successful implementation.
• The ISO 9001 policy has been strengthened More Focus on application of the policy across the firm. There is a need for “documented information”, as opposed to a documented statement.
• Top level commitment & empowerment of senior management has been raised up now, and of course now the responsibility will not lie on one customer. Job descriptions are a good way to define roles and responsibilities.
• Risk Based Thinking is a fresh and welcome addition to ISO 9001.
• How will the firm prevent, or reduce, undesired effects? How will the organization firm that it can achieve its intended outcomes and continual improvement?
• One big plus is that preventive action does not appear now. The assumption is that the risk management process has features which create inherent preventive actions via the improvement cycle.
• The requirements around QMS ISO 9001 objectives have been also create more detailed. They are to be consistent with the ISO 9001 Standard policy, measurable practicable, monitored, communicated, and updated as suitable. They have to be established at relevant functions and levels.