Rehan Khan

Mastering Quality Management: Awareness, Communication, and Documentation for Success Introduction Quality Management Systems (QMS) are essential for organizations to deliver consistent, high-quality products and services. Three key pillars of an effective QMS are awareness, communication, and documentation. This blog explores how these elements work together to ensure smooth operations, employee engagement, and compliance with standards like ISO 9001 Certification. Whether you’re a small business or a large enterprise, understanding these principles can help you build a robust QMS that drives success. 1. Awareness In a small organization, usually it is easy to make employees aware of the role they have in the organization and how their activity has an influence on product quality. It could be made in individual informal communications, group meetings or internal audits. Even for a small organization, it could be appropriate to have awareness training for new hires (including temporary and part-time employees as well as full-time employees). This could cover- the nature of the organization, the health, safety and environmental regulations, the quality policy, quality objectives and other internal policies, the role of the new employee, and the procedures and instructions of relevance to them. This needs to be reviewed/revised for larger organization implementation because methods could be different. Awareness of the policy should not be taken to mean that it needs to be memorized; rather, persons should be aware of the key policy commitments, and their role in achieving them. 2. Communication Keeping the organization informed An effective internal communication process contributes to the success of any organization’s quality management system. Conversely, many problems that occur with an organization’s quality management system can often be traced back to poor communication. For your quality management system to work effectively, good communication is essential. Your top management needs to establish the processes which encourage your people to communicate at all levels of the organization.   You should keep all information clear and understandable and adapted to the person it is intended for. The effectiveness of the quality management system will be determined at the management review (see 9.3) and should be appropriately communicated. Some examples of communication methods include posting information on bulletin boards, holding meetings or circulation of information via electronic media (e.g. e-mail). 3. Documented Information Where ISO 9001:2008 would have referred to documented procedures (e.g. to define, control or support a process) this is now expressed as a requirement to maintain documented information. Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information. Documenting your quality management system Documented information can refer to     -information created in order for the organization to operate (documentation);     -evidence of results achieved (records) This clause describes what documentation is required by the standard. The term “documented information” is used to cover the range of different types of documents. It is entirely up to you whether you think it will be helpful to have “documented information” (documented procedures). The minimum documented information required to be created. controlled and/or maintained in a MSS includes: Scope of the management system Policy Objectives Evidence of competence Documented information of external origin necessary for the planning and operation of the management system Documented information necessary to have confidence that the processes have been carried out as planned Monitoring, measurement, analysis and evaluation results Evidence of internal audit program implementation Internal audit results Management review results Nature of nonconformities and actions taken Corrective action results Documented information, originally created for purposes other than the MSS, may be used. The important issue is that your people have the information they need to do their job. Documented information comes in many different formats and on various media. Electronic storing and distribution are one common approach. This is the definitive list of documented information (documents) mandated by the standard: Scope (4.3) To the extent necessary to support the processes (4.4) Quality policy (5.2.2 a) Other things that are maintained (NOT documented information) possibly ‘maintain status/integrity?” Quality management system (4.4) Focus on consistently providing…… (5.1.2 c) Focus on enhancing customer satisfaction (5.1.2 d) Quality policy (5.1.2) Integrity of the quality management system (5.3 e) The infrastructure… (7.1.3) The environment… (7.1.4) Monitoring and measuring resources (7.1.5 b) Organizational knowledge (7.1.6) Process to determine the requirements… (8.2.2) Design and development process (8.3.1) Traceability (8.5.2) Process outputs…. Conformity to requirements (8.5.4) Quality management system (9.2.1 b) – audit program that is the mechanism to do this, ref 4.4 Audit program (9.2.2 a) Quality management system (9.3.1 c-6) – adequate resources The following list is not inclusive, but indicates the many different forms documents may take- Procedures work instructions operating instructions user manuals regulatory requirements industry standards schedules Computer Aided Design (CAD files) manufacturing routers control plans preferred supplier lists specifications drawings. Master sample Restaurant menus Customer survey College curricula Speaker notes Call center script Visual aids e.g. photographs Think of medical example Meeting agendas and minutes Reports Inspection certificate Samples (e.g. sales) Forms SME- consultant’s telephone customer contact list SME- setup notes SME- website (contact details) Things that are information (but NOT documented) Internal and external issues (4.1) Interested parties (4.2) Intellectual property, lessons learned (7.1.6 – Note 1) Products and services (8.2.1) Information for external providers (8.4.3) Title only Competence Other stuff Customer views and opinions of the organization and its products and services (9.1.2) Customer views (9.1.2 Note) Monitoring, measuring and other sources (9.1.3) Conformance of the quality management system (9.2.1) Quality performance, including. (9.3.1 c) Trends etc. Other stuff Evidence (that is NOT information): Give details of different levels of controls (risk) – type and extent of control status and importance necessary and sufficient confidential Consider giving details – DI for the user with the least experience The type and extent of control might vary on the size and complexity of the organization and the risk/impact of the product services provided. Documentation should indicate, to the extent necessary, who does what, where, when, why and how, Who the creator (author), reader, updater etc. Electronic format Who is assumed to be a human