Excellence is the unlimited ability to improve the quality of what you have to offer; (Rick Pitino)
More organizations are preparing and expecting a yearly schedule of Surveillance Audits from an ISO Certification Body ensuring its compliance and conformance to the requirements of ISO 9001 International Standards. ISO Audits are straight-forward verifying and validating if an organization is consistently doing what they have committed to offer as described in its documentation and implemented as demonstrated in its quality records.
For continued certification, an organization may consider the following guidance or mindset as to assure readiness and confidently passing ISO 9001 QMS Certifying Body surveillance audit:
1- CONTROLLED CONDITION
ISO 9001 Clause 8.5.1 states the organization shall implement production and service under controlled condition. This requirement is the do; part of the process-based approach on implementing a quality management system. Controlled conditions shall include availability of documented information, the use and implementation of monitoring and measuring resources, the use of suitable infrastructure and environment for the operation of the processes, the appointment of competent persons, the validation and periodic revalidation of the ability to achieve planned results and the implementation of consistent delivery of products and services throughout and at all levels of process performances. Alignment and integration of such demonstration is interface with the following ISO 9001 clauses and tagged as plan part of the process-based approach on implementing a quality management system: ISO 9001 Clause 6- Planning (Actions to Address Risks and Opportunities, Quality Objectives and Planning to achieve them, and on Planning of Changes) ISO 9001 Clause 8.1 and 8.2 Operational Planning and Control and Requirements for Products and Services
2- CONFIDENT EVIDENCE
ISO 9001 Clause 4.4.2-a states that to the extent necessary, the organization shall retain documented information to have confidence that the processes are being carried out as planned.
This requirement is the check part of the process-based approach on implementing a quality management system. These are also tagged as objective evidence as ISO Audit is all about gathering evidence to demonstrate conformance and effectiveness in the implementation of the QMS. The trailing on evidence starts from the suitability of documented procedures and other documents and comparing to the actual evidence through control of records or what we now call retained documented information. The confidence is on the easily and readily retrievable of records and the substantiveness of those evidence towards supporting on the audit criteria and QMS requirements. Alignment and integration of such demonstration is interface with the following ISO 9001 clauses:
-; ISO 9001 Clause 7.5 Documented information including control of documented information
-; ISO 9001 Clause 9 Performance Evaluation including Monitoring, measurement, analysis and evaluation
3- CONTINUAL IMPROVEMENT
ISO 9001 Clause 10.3 states that the organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.
This requirement is the act part of the process-based approach on implementing a quality management system. This is the heart of having been certified to ISO9001 QMS wherein the organization shall demonstrate on a culture of continual improvement and commitment of such shall demonstrate from leadership to the operational process owners and influence across all levels and functions of the organization. This calls for acting on the performance results as evidence in the implementation of QMS processes - quality objectives monitoring, risk assessment process, control of documented information process, internal audit process, corrective action process and the management review process. Alignment and integration of such demonstration is interface with the following ISO 9001 clauses:
ISO 9001 Clause 10.2 Nonconformity and corrective action which emphasizes sub-Clauses D- Review the effectiveness of any corrective actions taken, E- Update Risks and opportunities and F-Make changes to the quality management system
Moreover, it is critical that there are two saving grace manifestation on supporting in the readiness and successful passing an organization continued certification to ISO9001 QMS.First is the commitment of the organization leadership as demonstrated of presence in all QMS programs and activities. And second, is the competency of the organization internal quality audit team as demonstrated in their substantive and independent audit reports that translated into a value-adding and drive to support in the attainment of an organization outcome-based results.
Lastly, the key is sustainability that entails mindset, mastery and maturity of an organization quality management system towards integrity, influence and inspiration. The bottom-line is the transformation from not just compliance but to performance leading to confidently passing your ISO 9001 QMS surveillance or even certification and recertification audits.
BCJA Training and Consultancy vision is to help you succeed! We have a mission and success-driven programs and services as we offer to be your partner in your continued journey for ISO 9001 Certification:
1- BCJA Comprehensive PRE-ASSESSMENT READINESS AUDIT that will assure your organization process owners to be more confidently beautiful and handsome in any ISO-Certification Surveillance Audits
2- BCJA Complete ISO9001 QMS SUSTAINABILITY PROGRAMS that will assure your organizations adoption of the 3-C - Controlled Condition, Confident Evidence, Continual Improvement.
BCJA extends a BEYOND BLESSED partnerships through customer satisfaction, cost-effectiveness and competent ISO 9001 consultants and QMS experts.
An inspiring quote from Bruce Hamilton expounds that - Continuous Improvement is about removing the things that get in the way of your work. The headaches, the things that slow you down, thats what continuous improvement is all about.;