Mandatory documents and records required by ISO 9001:2015*

According to the International Standard, Documented Information is required, but there is no prescriptive format. Anything that satisfies the requirement such that an auditor can determine compliance is acceptable. It is also important to keep in mind that one example of documented information can satisfy a single requirement, multiple requirements or multiple documents can satisfy a single requirement. You decide – just make sure that it / they are readily available for review. The following is a list of the required documented information. Note: where the term ‘maintain’ is used in conjunction with documented information it communicates a particular Procedure, Work Instruction or Form is required and that it is controlled. Where the term ‘retain’ is used in conjunction with documented information this communicates a record requirement. Information may be maintained or retained in any form or media (the Flow Chart below illustrates a risk-based corrective action process and constitutes one form of acceptable documented information.) The challenge is to determine what and how much is needed – not enough and you may have a problem ‘fighting for your right…,’ too much and you’ll have to justify how this “MIL-STD” based system is value-added to an auditor drooling to audit your Control of Documents process.

CAPA

Flow Chart concept courtesy of MasterControl.

Documented Information you need to maintain if you want to be compliant.

  • Scope of the QMS (clause 4.3)
  • Quality policy (clause 5.2)
  • Quality objectives (clause 6.2)
  • Criteria for evaluation and selection of suppliers (clause 8.4.1)

Documented Information you need to retain if you want to be compliant.

  • Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
  • Records of training, skills, experience and qualifications (clause 7.2)
  • Product/service requirements review records (clause 8.2.3.2)
  • Record about design and development outputs review* (clause 8.3.2)
  • Records about design and development inputs* (clause 8.3.3)
  • Records of design and development controls* (clause 8.3.4)
  • Records of design and development outputs *(clause 8.3.5)
  • Design and development changes records* (clause 8.3.6)
  • Characteristics of product to be produced and service to be provided (clause 8.5.1)
  • Records about customer property (clause 8.5.3)
  • Production/service provision change control records (clause 8.5.6)
  • Record of conformity of product/service with acceptance criteria (clause 8.6)
  • Record of nonconforming outputs (clause 8.7.2)
  • Monitoring and measurement results (clause 9.1.1)
  • Internal audit program (clause 9.2)
  • Results of internal audits (clause 9.2)
  • Results of the management review (clause 9.3)
  • Results of corrective actions (clause 10.1)

This is all you need to satisfy the minimum document requirements. Use this post as a checklist to make sure you have covered all the bases.

Now for a little guidance… I promised you in the last post I would give you a ‘Magic Bullet,’ here it is. (Please remember, this is only a suggestion. It is not the only way to achieve certification. In addition, since I do not know your individual situation, there is no guarantee of certification.) However, it is one way to make the auditor’s life a little easier and I want to keep ‘my right to party.’

Yes, you want a Quality Manual!**

  • The International Standard begins by telling us we need to define our context (4.1) and determine our Interested Parties’ needs and expectations (4.2.) Put it in the manual.
  • We need to determine the Scope and Boundaries of our quality management system (4.3.) Put it in the manual.
  • We need to define QMS processes, interactions, etc. (4.4.) Put them in the manual.
  • Leadership – change in focus from Management Representative (MR) to top management. The MR is no longer required, but y’all still goanna want one (5.1.) Put ’em in the manual.
    – Quality Policy (5.2.1.) Put it in the manual.
    – Organizational roles, responsibilities and authorities (5.3.) Put it in the          manual.
  • Risk-Based Thinking (6.1.) Put it in the manual.
  • If you can see Russia from your Bedroom window, put it in the manual. You got it!

To readdress a previous discussion as to whether a copy of the ISO 9001:2015 is a requirement – you know what? You won’t know all the other stuff you are going to put in your Quality Manual without it. And one more thing, unless (those of you with existing systems are planning on renumbering all those SOPs,) you’re going to want to add a table ISO 9001:2015 elements vs. what you call things so the auditor can follow along with the bouncing ball.

Non-mandatory documents (Standard Operating Procedures)

There are numerous non-mandatory documents that can be used for ISO 9001 implementation. The following (including optional procedures) are highly recommended:

  • Procedures you have documented if you have an existing QMS (20 or so.)
  • Plus a few more… See below – new 2015 procedures are bolded.

Recommended (sample) list of standard operating procedures***

SOP-4.5.2 Control of Documents
SOP-4.5.3 Control of Records
SOP-6.1.1 Risk Management
SOP-6.1.2 Business Contingency
SOP-6.3 Change Management
SOP-6.4 Management Review
SOP-7.2.1 Resource Management – Knowledge
SOP-7.2.2 Resource Management – Training
SOP-8.2.3 Customer Related Processes
SOP-8.2.4 Product Complaint Handling (Optional)
SOP-8.3 Design & Development (If design responsible)
SOP-8.4.1 Supplier Evaluation & Monitoring
SOP-8.4.2 Purchasing – Raw Material (Optional)
SOP-8.4.3 Purchasing – Equipment & Services (Optional)
SOP-8.5.1.1 Process & Service Control
SOP-8.5.1.4 Maintenance & Repair (Optional)
SOP-8.5.3 Identification & Traceability
SOP-8.5.4 Customer Supplied Property
SOP-8.5.5 Preservation of Product
SOP-8.6 Control of Monitoring & Measuring Devices
SOP-9.1.2 Customer Feedback
SOP-9.2.1 Internal Audits
SOP-9.2.2 Monitoring & Measurement of Processes
SOP-9.2.3.1 Monitoring & Measurement of Product
SOP-9.2.3.2 Receiving Goods & Materials (Optional)
SOP-9.2.3.3 In-Process Inspection (Optional)
SOP-9.2.3.4 Final Inspection
SOP-9.3 Control of Nonconforming Product
SOP-9.4 Analysis of Data
SOP-10.1.1 Corrective Action
SOP-10.1.2 Preventive Action (Optional)
SOP-10.2 QMS Maintenance & Improvement (Optional)

*Note: Documented Information would not be applicable if the company does not perform the relevant processes.

**For those of you just getting started, you might want to hold off documenting a Quality Manual until this blog series is complete. For the rest of you – have at it.

***You may have noticed my numbering system does not exactly match that of the International Standard… Very good, the Standard states it does not have to (Annex 1 – Back of the book where nobody looks!) This is just my way of having a little fun with the auditor – and yes I use a table.

See you next time with a little guidance for dealing with organizational context. Ciao!

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