QMS Guidance Pt. 14 – Documents Required and Others

ISO 9001: 2015 has changed and in theory at least simplified the way it required information to be documented. Out is the old split of ‘procedures’ and ‘records’. In is ‘documented information’ which covers both!

Confusing possibly so I’m offering you an overview of whats explicitly required, whats in essence implied and what I as your consultant would recommend you add to make things better and easier to run the QMS effectively. And effectively is the key word here. Please don’t assume that the adage ‘less is more’ applies, yes I too have heard the stories of consultants telling their clients that they can get a Quality Manual down to just 3 pages. Well if you want to fork over a fortune for just 3 pages then be prepared for the audit, its certainly NOT what I would be offering in the way of help.

Required Documented Information

Clause 4.3 – Scope of what the Quality Management System covers

Clause 4.4.2 – Documentation needed to support the operation of the organisations processes

Clause 5.5.2 – A Quality Policy

Clause 6.2.1 – Quality Objectives, most organisations capture this information in the form of records which is okay

Clause 8.1 – Procedure for Operational Planning and Control

Clause – Records of Calibrated Equipment

Clause – Records of basis for calibration when there are no traceable standards

Clause 7.2 – Records of Competence (training records)

Clause – Records of Contract Review

Clause 8.3.3 – Records of Design Inputs

Clause 8.3.4 – Records of Design Control Activities

Clause 8.3.5 – Records of Design and Development Outputs

Clause 8.3.6 – Records of Design and Development changes

Clause 8.4.1 – Supplier Evaluations

Clause 8.5.2 – Traceability (records of product serialisation)

Clause 8.5.6 – Records of Production Changes Review

Clause 8.6 – Inspection and Test records

Clause 8.7.2 – Nonconforming product or service records

Clause 9.1.1 – Monitoring, Measuring, Analysis and Evaluation (MMAE) results

Clause 9.2.2 – Internal Audits

Clause 9.3 – Management Review Outputs

Clause 10.2.2 – Records of Non-conformance

Implied Documented Information

Clause 4.4.1 – Processes needed the QMS

Clause 5.3 – Roles and Responsibilities

Clause 6.2.2 – Quality Objectives planning activities

Clause 7.1.6 – Retained Organisational Knowledge

Clause 7.4 – Internal and External communications

Clause 8.2.1 – Specific requirements for contingency actions

Clause 8.4.1 – Controls of Suppliers

Clause 8.4.2 – Verification activities for purchased products and services

Clause 9.1.1 – Methods for MMAE activities

Clause 9.1.2 – Methods for review of Customer Satisfaction

Clause 9.2 – Internal Audit Intervals

Clause 9.3.1 – Management Review Intervals

Clause 10.1 – Method for determining opportunities for improvement

Clauses 4.1/5.1.1/5.2.1/9.3.1 – Strategic direction of the organisation

Clause 4.2 – Interested Parties (stakeholders) and their requirements

Clause 5.1.2/6.1.1/6.1.2 – Statutory and Regulatory requirements (risk and opportunity)

Clause 7.1.1/7.1.2/7.1.3/7.1.4 – Resources, People, Infrastructure and Special Work Environment Requirements

Clause – Records of validity of previous results when calibrated equipment is adversely affected

Clause 7.2 – The necessary competence requirements for job roles

Clause 8.1 – Records of Process Control

Clause 8.2.2 – Customer Requirements

Clause 8.4.3 – Information for Suppliers

Clause 8.5.1 – Definition of products or services to be provided and the results to be achieved

Clause 8.5.3 – Report to customer or supplier of lost, damaged or unusable third party property

Clause 8.7.1 – Records of Authorisation and Acceptance of Concessions

Clause 9.2.2 – Criteria for Internal Audits

Clause 10.2.1 – Causes of Non-Conformity and similar that exist

Documented Information You’d be Crazy Not to Consider Having

Clause 4.1/4.2 – Context of the Organisation

Clause 6.1 – Risk and Opportunity Management (you might even split this up into two separate procedures)

Clause 7.1 – Resource Management Procedure (for facilities & equipment management)

Clause 7.1.5 – Calibration Procedure

Clause 7.2 – A procedure for determining when and how training is to be commissioned

Clause 7.5 – Document and Record Control Procedures (you might split this up into two separate procedures)

Clause 8.2 – Contract Review Procedure

Clause 8.3 – Design and Development Master and Specific Plans

Clause 8.4 – Purchasing Procedure

Clause 8.5 – Production /Service Control Procedure

Clause 8.6 – Testing and Inspection Plans and Procedures

Clause 8.7 – Control of Non-Conforming product Plan

Clause 9.1.2 – Customer Satisfaction data gathering ‘How To’

Clause 9.2 – Internal Audit ‘How To’ procedure

Clause 9.3 – Management Review procedure

Clause 10.2 – Corrective and Preventative Action ‘How to’ procedure

Some Closing Words

Plainly you will have to do and have the ‘Required Documented Information’ but after that its really up to you what you have in the way of procedures and records. Those procedures and records that are implied, you should consider very carefully if you ‘re not going to have them, life could get awful difficult at the audit without them. The final section are my own recommendations which I think you’d be crazy not to at the very least consider them as options.

What I’ve offered over the course of these 14 Guidance Notes is advice and direction on how to best interpret ISO 9001: 2015 requirements which I hope you’ve found informative without being too boring, all feedback is very welcome so please get in touch.

Philip Dawson MBA | Lead Auditor | ISO 9001 | ISO 14001 | ISO 45001 | OHSAS 18001 | ISO 27001 | Lean 6-Sigma Practitioner

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