ISO Document Drafting Services
Core Compliance provides ISO Document Drafting Services to organizations on their path to ISO certification. Our document drafting services include the core ISO management system related to Quality- ISO 9001:2015, Information Security- ISO 27001:2013, Environmental- ISO 14001:2015, Medical Devices-ISO 13485:2016, Aerospace-AS9100:2016 functions, customer, requirements, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity. Since the ISO standards were written to be broadly applicable, most companies/organizations require some outside help creating documentation to conform in practical, audit-able terms.
ISO Document Drafting Process
Based upon the ISO standard your organization is seeking certification in, our ISO consultants assess your current state of compliance. Core Compliance provides templates to all ISO standards that can be plugged into your organization internal business processes.
4 Step Process in Drafting Documentation
Step 1-Assessment organizations designated ISO standard to understand the scope, documentation readiness, and its resources for building the management system. The assessment includes understanding current document control process with providing the data to develop a project plan for ISO implementation with all required documentation. Identify with management documentation cloud-based online platform to manage process.
Step 2- Interviews based upon the gaps identified in the assessment, the consultants interview management and stakeholders over each process. Documenting internal processes that have not been implemented into new ISO required policies, procedures, records in developing all required documentation for the new quality, security, environmental management system.
Step 3- Review the new drafted documentation with management to ensure it represents the organization and meets ISO requirements.
Step 4- Approval add all approved documentation into organization management system
ISO Documentation Definitions and Guidelines
Understanding the ISO documentation structure is vital in building compliant ISO management systems.
 
What is an ISO Clause- When referring to the elements of an ISO management system, there is no difference between an ISO clause and element. ISO requirements are related into eight sections (called ISO clauses), five of which contain mandatory requirements for a management system: general Quality Management System requirements (clause 4), Management Responsibility (clause 5), Resource Management (clause 6), Product Realization (clause 7), and Measurement, Analysis and Improvement (clause 8)
What is the ISO High-Level Structure- The High-Level Structure (HLS) is a set of 10 clauses that all ISO management system standards are required to use in the future. This is so that all management system standards will have the same look and feel, and will enable greater integration between systems of different disciplines. The High Level Structure is mentioned in Annex SL of the ISO directive where all the new changes for the standards. What ISO Management Systems are High Level Structure- download a comprehensive list of MSS
- Scope
- References
- Terms & Definitions
- Context
- Leadership
- Planning
- Support
- Operation
- Evaluation
- Improvement
Documentation outline for ISO Management Systems
- Scope of the quality management system (clause 4.3). Documented information necessary to support the operation of processes (clause 4.4)
- Quality policy (clause 5)
- Quality objectives (clause 6.2) This documented information is subject to the requirements of clause 7.5.
- AS NEEDED – Documented information necessary to support the operation of processes (clause 4.4)
Types of documentation for ISO Compliance
- ORG – Organization charts or Process Ownership charts
- PFD – Process flow diagrams, Turtle Diagrams, SIPOC Diagrams or other process maps
- OP – Operating procedures or standard operating procedures
- WI – Work instructions, training instructions or test instructions
- SPEC – Specifications, drawings or engineering standards
- COM – Internal communication documents
- SCH – Production or delivery schedule
- ASL – Approved supplier list
- IP – Inspection plans or testing plans
- CP – Control plans or quality plans
- QM – Quality manual
- BP – Business plan, Goal Tree or strategic plan
- FM – Forms, illustrations or checklists
ISO Standards
